Description of the dosage form

Smooth, transparent, colorless or almost colorless ring without much visible damage with a transparent or almost transparent area at the junction.

pharmachologic effect

Pharmacological effect - contraceptive.

Pharmacodynamics

Mechanism of action. NovaRing® is a hormonal combined contraceptive containing etonogestrel and ethinyl estradiol. Etonogestrel is considered a progestogen (a derivative of 19-nortestosterone) that has a high affinity for progesterone receptors in target organs.

Ethinylestradiol is considered an estrogen and is widely used in the manufacture of contraceptives.

hemolytic-uremic syndrome;

conditions that may make it difficult to use the vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe.

Use during pregnancy and lactation

NovaRing® is intended for the prevention of pregnancy. If a woman wants to stop using a medicine to become pregnant, it is suggested to wait until the natural cycle is restored before conception. this will help to correctly calculate the date of conception and childbirth.

The use of NovaRing® during pregnancy is contraindicated. If pregnancy occurs, the ring must be removed. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took COCs in early pregnancy without knowing about it. Although this applies to all COCs, it is not known if this also applies to NuvaRing®. A clinical examination in a small group of women showed that, nevertheless, that NovaRing® is administered into the vagina, the concentrations of contraceptive sex hormones inside the uterus when using NovaRing® are similar to those when using COCs. Pregnancy outcomes in women who used NovaRing® during a clinical study have not been described.

The use of NovaRing® during breastfeeding is contraindicated. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive sex hormones and / or their metabolites can be excreted in milk, but there is no evidence of their negative effect on the health of children.

Side effects

When using the drug, there may be side effects that occur with different frequencies: often (? 1/100); infrequently (?1/1000,<1/100); редко (?1/10000, <1/1000) см. табл. 1.

1The list of side effects is based on data obtained from spontaneous reports. It is not possible to accurately determine the frequency.

2 Data from an observational cohort study? 1/10,000 -<1/1000 женщино-лет.

3Local partner reactions include reports of local penile reactions (particularly pain, bruising, and abrasions).

Side effects that occurred when taking CHC are described in detail in the "Special Instructions" section: pancreatitis, cerebrovascular disorders, benign and malignant liver tumors, chloasma, changes in insulin resistance.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.

Interaction

Interaction with other medicinal drugs

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and / or contraceptive failure. The following interactions with combined oral contraceptives are described in the literature in general.

Hepatic metabolism: There may be interactions with drugs that induce microsomal liver enzymes, which can lead to an increase in the clearance of sex hormones. Interactions have been established, in particular with phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and also, probably, with oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and drugs containing St. John's wort (Hypericum perforatum). When treating with any of the listed means, it is necessary to temporarily use a barrier method of contraception (condom) in combination with the use of NovaRing® medicine or choose another method of contraception. During the concomitant use of drugs that induce microsomal enzymes, and within 28 days after their withdrawal, barrier methods of contraception should be used.

Antibiotics: A decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with concomitant use of antibiotics, such as tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, ingestion of amoxicillin (875 mg 2 times a day) or doxycycline (200 mg / day, and then 100 mg / day) for 10 days during the use of NovaRing® drug had little effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (excluding and), it is necessary to use a barrier method of contraception (condom) during treatment and for 7 days after antibiotics are discontinued.

If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be inserted immediately, without the usual interval.

Pharmacokinetic studies have not revealed the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive efficacy and safety of NovaRing®. With the combined use of suppositories with antifungal drugs, the risk of ring rupture slightly increases. Hormonal contraceptives can cause a violation of the metabolism of other drugs. Accordingly, their plasma and tissue concentrations may increase (in particular) or decrease (in particular lamotrigine).

To exclude a possible interaction, you need to read the instructions for use of other drugs.

Other types of interaction

Laboratory research. The use of contraceptive steroids may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function; on the plasma concentration of transport proteins, in particular corticosteroid-binding globulin and SHBG in plasma; on lipid/lipoprotein fractions; on indicators of carbohydrate metabolism; as well as on indicators of blood clotting and fibrinolysis. Indicators, basically, change within normal values.

Sharing with tampons. Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NovaRing® vaginal ring. In rare cases, the ring may be accidentally removed when removing the tampon (see subsection What to do if the ring has been temporarily removed from the vagina in the section "Method of application and dosage").

Dosage and administration

Intravaginally. To achieve a contraceptive effect, NovaRing® should be used according to the instructions.

A woman can independently insert the NovaRing® vaginal ring into the vagina.

The doctor should inform the woman how to insert and remove the NovaRing® vaginal ring (Fig. 1, 2).

For the introduction of the ring, the woman should choose a comfortable position, in particular standing, raising one leg, squatting or lying down. The NovaRing® vaginal ring should be compressed and inserted into the vagina until the ring is in a comfortable position. The exact position of the ring in the vagina is not critical for the contraceptive effect (Fig. 3).

Insertion technique (see Figure 4a, 4b, 4c).

1. With one hand, insert the ring into the vagina, if necessary, spread the labia with the other hand (Fig. 4a).

2. Push the ring into the vagina until the ring is in a comfortable position (Fig. 4b).

3. Leave the ring in the vagina for 3 weeks (Figure 4c).

After insertion (see How to start using NuvaRing®), the ring should be constantly in the vagina for 3 weeks. It is advisable for a woman to regularly check whether it remains in the vagina. If the ring was accidentally removed, follow the instructions in What to do if the ring was temporarily removed from the vagina.

The NovaRing® vaginal ring should be removed after 3 weeks, on the same day of the week when the ring was inserted into the vagina. After a week break, a new ring is inserted (in particular, if the NovaRing® vaginal ring was installed on Wednesday at about 22.00, then it should be removed on Wednesday after 3 weeks at about 22.00. A new ring is inserted on the next Wednesday). To remove the ring, pick it up with your index finger or squeeze it with your index and middle fingers and pull it out of the vagina (Fig. 5).

The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded. Bleeding associated with the discontinuation of the NovaRing® drug often begins 2-3 days after the removal of the NovaRing® vaginal ring and may not completely stop until the new ring is installed.

How to start using NovaRing®

In the previous cycle, hormonal contraceptives were not used. The drug NovaRing® should be administered on the 1st day of the cycle (i.e. on the 1st day of menstruation). It is allowed to install the ring on the 2-5th day of the cycle, but in the first cycle, in the first 7 days of using NovaRing®, additional use of barrier methods of contraception is offered.

Switching from combined hormonal contraceptives (CHCs). A woman should insert the NovaRing® vaginal ring on the last day of her usual CHC cycle interval (tablet or patch). If a woman has been taking CHC correctly and regularly and is sure that she is not pregnant, she can switch to the vaginal ring on any day of the cycle. In no case should the recommended hormone-free interval of the previous method be exceeded.

Switching from drugs containing only progestogen (mini-pills, progestin oral contraceptives, implants, injectable forms or hormone-containing intrauterine systems - IUDs). A woman taking mini-pills or progestin-only oral contraceptives can switch to NovaRing® any day. The ring is inserted on the day the implant or IUD is removed. If a woman received injections, then the use of NovaRing® begins on the day when the next injection should have been made. In all these cases, the woman must use a barrier method of contraception during the first 7 days after the introduction of the ring.

After an abortion in the first trimester. A woman can insert the ring immediately after an abortion. In this case, she does not need additional contraceptives. If the use of NovaRing® immediately after an abortion is undesirable, the recommendations given in subsection should be followed. Hormonal contraceptives were not used in the previous cycle. At interval, the woman is recommended an alternative method of contraception.

After childbirth or after an abortion in the second trimester. A woman is recommended to enter the ring no earlier than the 4th week after childbirth (if she is not breastfeeding) or an abortion in the II trimester. If the ring is installed at a later date, then an additional barrier method is suggested for the first 7 days. But if sexual intercourse has already taken place, then before using NovaRing®, pregnancy must be excluded or the first menstruation must be waited.

The contraceptive result and cycle control may be impaired if the woman does not follow the recommended regimen. To avoid a decrease in the contraceptive effect, the following recommendations should be followed.

What to do in case of lengthening the break in the use of the ring. If during the break in the use of the ring there were sexual intercourse, pregnancy should be excluded. The longer the break, the higher the chance of pregnancy. If pregnancy is ruled out, the woman should insert a new ring into the vagina as soon as possible. Over the next 7 days, an additional barrier method of contraception, in particular a condom, can be used.

What to do if the ring has been temporarily removed from the vagina. The ring must be constantly in the vagina for 3 weeks. If the ring was accidentally removed, it should be rinsed with cold or slightly warm (not hot) water and immediately inserted into the vagina.

- If the ring was left outside the vagina for less than 3 hours, then its contraceptive result is not reduced. The woman should insert the ring into the vagina as soon as possible (no later than 3 hours later).

- If the ring was outside the vagina for more than 3 hours during the 1st or 2nd week of use, then the contraceptive result may decrease. The woman should insert the ring into the vagina as soon as possible. Over the next 7 days, you need to use a barrier method of contraception, in particular a condom. The longer the ring has been out of the vagina and the closer this period is to the 7-day break in the use of the ring, the higher the likelihood of pregnancy.

- If the ring was outside the vagina for more than 3 hours at the 3rd week of use, then the contraceptive result may decrease. The woman is to discard this ring and choose one of the following two methods:

1. Immediately install a new ring (a new ring can be used for the next 3 weeks. There may be no bleeding associated with the discontinuation of the drug. But there may be spotting of blood or bleeding in the middle of the cycle).

2. Wait for bleeding associated with the cessation of the drug, and introduce a new ring no later than 7 days after the removal of the previous ring (this option should be selected only if the regimen of using the ring during the first 2 weeks was not violated).

What to do in case of prolonged use of the ring. If the drug NovaRing® was used for no more than a maximum period of 4 weeks, then the contraceptive result remains sufficient. A woman can take a week off from using the ring and then insert a new ring.

If the NovaRing® vaginal ring has remained in the vagina for more than 4 weeks, then the contraceptive result may worsen, so pregnancy must be excluded before the introduction of a new ring. If a woman does not adhere to the recommended regimen of use and bleeding does not occur after a week's break in using the ring, then pregnancy should be excluded before the introduction of a new ring.

How to move or delay the onset of menstrual bleeding. To delay menstrual-like withdrawal bleeding, a woman can insert a new ring without a week's break. The next ring should be used within 3 weeks. This may cause spotting or bleeding. Further, after the usual week-long break, the woman returns to the regular use of NovaRing®.

To move the onset of bleeding to another day of the week, a woman may be advised to take a shorter break from using the ring (for as many days as needed). The shorter the break in the use of the ring, the higher the likelihood of no bleeding that occurs after the removal of the ring, and the appearance of bleeding or spotting during the period of the next ring.

The safety and efficacy of NuvaRing® in adolescent girls under 18 years of age have not been studied.

Overdose

Serious consequences of an overdose of hormonal contraceptives are not described. Possible symptoms include nausea, vomiting, and slight vaginal bleeding in young girls. There are no antidotes. Treatment is symptomatic.

special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits of using NovaRing® and the possible risks for each individual woman should be evaluated before she starts using NovaRing®. In the event of an exacerbation of diseases, a deterioration in the condition, or the appearance of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of NovaRing®.

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep veins and pulmonary) and arterial thrombosis, as well as complications associated with them, sometimes with a fatal outcome.

The use of any COC increases the risk of developing VTE compared with the risk of developing VTE in patients not using COCs. The greatest risk of developing VTE is observed in the 1st year of COC use. Data from a large prospective cohort study on the safety of various COCs suggest that the greatest increase in risk, compared with the level of risk in women who do not use COCs, occurs in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more). In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 cases per 10,000 woman-years (WL). In women using oral contraceptives, the risk of developing VTE is from 3 to 9 cases per 10,000 VL. But the risk increases to a lesser extent than during pregnancy, when it is 5–20 cases per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in studies; when converted to a gestation duration of 9 months, the risk is from 7 to 27 cases per 10,000 JL). In women in the postpartum period, the risk of developing VTE is from 40 to 65 cases per 10,000 VL. VTE is fatal in 1-2% of cases.

According to the results of studies, the increased risk of developing VTE in women using NovaRing® is similar to that in women using COCs (adjusted risk ratio, see table 2 below). A large prospective observational study, TASC (Transatlantic Active Safety Study of NovaRing® for CCC), assessed the risk of VTE in women who started using NovaRing® or COCs, switched to NovaRing® or COCs from other contraceptives, or resumed using NovaRing ® or COC, in a population of typical users. Women were followed up for 24–48 months. The results showed a similar level of risk of developing VTE in women using NovaRing® (8.3 cases per 10,000 VL) and women using COCs (9.2 cases per 10,000 VL). For women using COCs other than those containing desogestrel, gestodene and drospirenone, the incidence of VTE was 8.5 cases per 10,000 VL.

A retrospective cohort survey initiated by the FDA (US Food and Drug Administration) showed that the incidence of VTE in women who started using NovaRing® is 11.4 cases per 10,000 YL, while in women, who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 VL.

table 2

Assessment of the risk (risk ratio) of developing VTE in women using NovaRing®, compared with the risk of developing VTE in women using COCs

1 Incl. low-dose COCs containing the following progestins: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethinodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate or norgestrel.

2 Taking into account age, body mass index, duration of use, history of VTE.

3 Incl. low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel.

4 Taking into account the age, place and year of inclusion in the survey.

Extremely rare cases of thrombosis of other blood vessels (in particular arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) are known when using COCs. It is not known whether these cases are associated with the use of COCs. Possible symptoms of venous or arterial thrombosis may include unilateral edema and/or pain in the lower extremity, localized fever in the lower extremity, redness or discoloration of the skin on the lower extremity; sudden severe chest pain, probably radiating to the left arm; an attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or; dizziness; collapse, with or without focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; acute abdomen.

Risk factors for the development of venous thrombosis and embolism:

- age;

- the presence of diseases in the family history (venous thrombosis and embolism in brothers / sisters at any age or in parents at a young age). If a hereditary predisposition is suspected, before starting the use of any hormonal contraceptives, a woman should be referred to a specialist for advice;

- prolonged immobilization, major surgery, any surgery on the lower extremities or serious injury. In such situations, it is proposed to stop the use of the drug (in the case of a planned operation for at least 4 weeks) with the subsequent resumption of use no earlier than 2 weeks after the full restoration of motor activity;

- probably thrombophlebitis of superficial veins and.

There is no consensus on the likely role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

- age;

- smoking (with heavy smoking and with age, the risk increases even more, especially in women over 35 years old);

- dyslipoproteinemia;

- obesity (body mass index over 30 kg/m2);

- increase in blood pressure;

- migraine;

- valvular heart disease;

- atrial fibrillation;

- the presence of diseases in the family history (arterial thrombosis in brothers / sisters at any age or parents at a relatively early age).

If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting the use of any hormonal contraceptives. Biochemical factors that may indicate a hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (anti-cardiolipin antibodies, lupus anticoagulant).

Other conditions that can lead to unwanted circulatory disorders include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (particularly Crohn's disease or ulcerative colitis), as well as sickle cell anemia. It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

An increase in the frequency or severity of migraine (which may be a prodromal symptom of cerebrovascular accident) during the use of hormonal contraceptives may prompt immediate discontinuation of hormonal contraceptive use.

Women using CHCs should be advised to contact their doctor if they develop possible symptoms of thrombosis. If thrombosis is suspected or confirmed, CHC use should be discontinued. In this case, it is necessary to use effective contraceptives, since anticoagulants (coumarins) have a teratogenic effect.

The risk of developing tumors

The most important risk factor for developing cervical cancer is infection with a human virus. Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear how much this is due to other factors, such as more frequent cervical smears and differences in sexual behavior, incl. use of barrier contraceptives. It remains unclear how this result is associated with the use of NuvaRing®.

According to a meta-analysis of the results of 54 epidemiological studies, there was a slight increase (1.24) in the relative risk of developing breast cancer in women taking COCs. The risk gradually decreases over 10 years after stopping the drugs. rarely develops in women under the age of 40, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women using COCs is clinically less pronounced than cancer detected in women who have never used COCs. An increased risk of developing breast cancer may be due to both the earlier detection of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both.

In rare cases, women taking COCs have experienced the development of benign, and even more rarely, malignant liver tumors. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. The physician should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NovaRing® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia or a family history of hypertriglyceridemia have an increased risk of developing pancreatitis when taking hormonal contraceptives.

Many women taking hormonal contraceptives experience a slight increase in blood pressure, but a clinically significant increase in blood pressure is rare. A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established.

If a constant increase in blood pressure is noted when using NovaRing®, you should contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate control of blood pressure with antihypertensive drugs, the resumption of the use of NovaRing® is likely.

Against the background of pregnancy and during the use of COCs, the development or worsening of the following conditions was noted (although their relationship with the use of contraceptives has not been fully established): jaundice and / or itching caused by cholestasis, the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic- uremic syndrome, Sydenham's chorea (chorea minor), pregnant women, hearing loss due to otosclerosis, (hereditary) angioedema.

Acute or chronic liver dysfunction may be grounds for discontinuation of NovaRing® until normalization of liver function parameters. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex hormone preparations, requires the withdrawal of NovaRing®.

Although estrogens and progestogens may have an effect on peripheral and tissue tolerance to, there is no evidence in favor of the need to change hypoglycemic therapy against the background of the use of hormonal contraceptives. But women with diabetes should be under constant medical supervision when using NuvaRing®, especially in the first months of contraception.

There is evidence of worsening of the course of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

In rare cases, pigmentation of the skin of the face (chloasma) may occur, especially if it occurred earlier during pregnancy. Women who are predisposed to the development of chloasma should avoid exposure to sunlight and UV radiation while using NuvaRing®.

The following conditions may prevent proper insertion of the ring or cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.

In very rare cases, women have inadvertently inserted the NuvaRing® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, the possibility of incorrect insertion of the ring should be taken into account.

Cases of vaginitis have been described during the use of NovaRing®. There is no evidence that the treatment of vaginitis affects the effectiveness of the drug NovaRing®, as well as evidence of the effect of the use of the drug NovaRing® on the effectiveness of the treatment of vaginitis.

Very rare cases of difficult removal of the ring have been described, requiring its removal by a healthcare professional.

Medical examination/consultation

Before prescribing NovaRing® or resuming its use, you should carefully review the medical history (including family) of the woman and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions and follow all recommendations. It is necessary to inform the woman that NovaRing® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of NovaRing® may be reduced if the regimen is not followed or if concomitant therapy is carried out.

Changing the nature of menstruation

During the use of NovaRing®, acyclic bleeding (spotting or sudden bleeding) is likely. If such bleeding is observed after regular cycles against the background of the correct use of NovaRing®, you should contact your gynecologist for the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. Diagnostic curettage may be required. Some women do not bleed after the ring is removed. If the drug NovaRing® was used in accordance with the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after the removal of the ring, as well as in the absence of bleeding for two cycles in a row, pregnancy should be excluded.

The effect of ethinylestradiol and etonogestrel on the sexual partner

The possible pharmacological effects and degree of exposure of ethinyl estradiol and etonogestrel to male sexual partners (due to absorption through the tissues of the penis) have not been studied.

Ring damage

In rare cases, when using NovaRing®, a ring rupture was observed.

The core of NovaRing® is considered solid, so its contents remain intact, and hormone secretion does not change significantly. In the event of a rupture of the ring, it often falls out of the vagina (see the recommendations of the subsection What to do if the ring was temporarily removed from the vagina in the section "Method of application and dosage"). If the ring breaks, a new ring must be inserted.

Ring drop

Sometimes there was a prolapse of the NovaRing® vaginal ring from the vagina, in particular when it was inserted incorrectly, the tampon was removed, during intercourse, or against the background of severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NovaRing® vaginal ring in the vagina. In case of loss of the NovaRing® vaginal ring from the vagina, follow the recommendations of the subsection What to do if the ring has been temporarily removed from the vagina in the section "Method of application and dosage".

The contraceptive ring is a vaginal female hormonal agent of a new generation. Contraceptive ring novaring

Hormonal contraceptive for intravaginal use.

Preparation: NovaRing ®
Active substance: ethinylestradiol, etonogestrel
ATX code: G02BB01
KFG: Hormonal contraceptive for intravaginal administration
Reg. number: P No. 015428/01
Date of registration: 25.12.03
The owner of the reg. acc.: ORGANON N.V. (Netherlands)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

vaginal ring smooth, transparent, colorless or almost colorless, without much visible damage, with a transparent or almost transparent area at the junction.

Excipients: ethylene vinyl acetate copolymer (28% vinyl acetate), ethylene vinyl acetate copolymer (9% vinyl acetate), magnesium stearate, purified water.

1 PC. - aluminum foil bag (1) - cardboard boxes.

The description of NuvaRing is based on officially approved instructions for use.

PHARMACHOLOGIC EFFECT

Hormonal contraceptive for intravaginal use containing estrogen - ethinyl estradiol and progestogen - etonogestrel. Etonogestrel, a derivative of 19-nortestosterone, binds to progesterone receptors in target organs.

The contraceptive effect of NovaRing is based on various mechanisms, the most significant of which is inhibition of ovulation. The Pearl Index of NuvaRing is 0.765.

In addition to the contraceptive effect, NuvaRing has a positive effect on the menstrual cycle. Against the background of its use, the cycle becomes more regular, menstruation is less painful, with less bleeding, which in turn can help reduce the frequency of iron deficiency. In addition, there is evidence to reduce the risk of endometrial cancer and ovarian cancer.

PHARMACOKINETICS

Etonogestrel

Suction

Etonogestrel released from NovaRing is rapidly absorbed by the vaginal mucosa. C max etonogestrel, equal to approximately 1700 pg / ml, is achieved approximately one week after the introduction of the ring. Serum concentration fluctuates slightly and slowly reaches the level of 1400 pg / ml after 3 weeks. Absolute bioavailability is about 100%.

Distribution

Etonogestrel binds to serum albumin and sex hormone-binding globulin (SHBG). V d etonogestrel 2.3 l / kg.

Metabolism

Etonogestrel is metabolized by hydroxylation and reduction to sulfate and glucuronide conjugates. Serum clearance is about 3.5 l / h.

breeding

The decrease in serum etonogestrel concentration is biphasic. T 1/2 ?-phase is about 29 hours. Etonogestrel and its metabolites are excreted in the urine and bile in a ratio of 1.7:1. T 1/2 metabolites about 6 days.

Ethinylestradiol

Suction

Ethinylestradiol released from NovaRing is rapidly absorbed by the vaginal mucosa. C max is about 35 pg / ml, is reached by the 3rd day after the introduction of the ring and decreases to 18 pg / ml after 3 weeks. The absolute bioavailability is about 56%, which is comparable to oral bioavailability.

Metabolism

Ethinylestradiol is initially metabolized by aromatic hydroxylation to form a variety of hydroxylated and methylated metabolites, which are present both in the free state and as glucuronide and sulfate conjugates. Serum clearance is about 3.5 l / h.

breeding

The decrease in the concentration of ethinylestradiol in serum is biphasic. T 1/2 α-phase is characterized by large individual differences, and, on average, is about 34 hours. Ethinylestradiol is not excreted unchanged; its metabolites are excreted in the urine and bile in a ratio of 1.3:1. T 1/2 metabolites is about 1.5 days.

INDICATIONS

Contraception.

DOSING MODE

NuvaRing is inserted into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week that it was placed in the vagina. After a week break, a new ring is introduced. Bleeding associated with the cessation of the drug usually begins 2-3 days after the removal of NovaRing and may not completely stop until the next ring is needed.

Hormonal contraceptives were not used in the previous menstrual cycle

NuvaRing should be administered between days 1 and 5 of the menstrual cycle, but no later than day 5 of the cycle, even if the woman has not completed her menstrual bleeding. During the first 7 days of the first cycle of NovaRing, additional use of barrier methods of contraception is recommended.

Switching from taking combined oral contraceptives

NuvaRing should be administered no later than the day following the interval in taking the drug. If the combined oral contraceptive also contains inactive tablets (placebo), then NovaRing should be administered no later than the day following the last placebo tablet.

Switching from progestogen-based contraception (mini-pill, implant, or injectable contraception) or progestogen-releasing intrauterine device (IUD)

The introduction of NuvaRing should be carried out on any day (if the patient took mini-pills), on the day of removal of the implant or IUD, and in case of injectable contraception, on the day when the next injection is needed. In all these cases, an additional barrier method of contraception should be used during the first 7 days of using NuvaRing.

After an abortion in the first trimester of pregnancy

NuvaRing can be used immediately after an abortion. In this case, there is no need for additional use of other contraceptives. If the use of NuvaRing immediately after an abortion is undesirable, the use of the ring should be carried out in the same way as if hormonal contraceptives were not used in the previous cycle.

After childbirth or abortion in the second trimester of pregnancy

The use of NuvaRing should begin within the 4th week after childbirth or abortion. If the use of NovaRing is started at a later date, then additional use of barrier methods of contraception is necessary in the first 7 days of using NovaRing. However, if sexual intercourse has already taken place during this period, you must first exclude pregnancy or wait for the first menstruation before using NovaRing.

The contraceptive effect and cycle control may be impaired if the patient violates the recommended regimen. To avoid losing the contraceptive effect in case of deviation from the regimen, the following recommendations should be followed:

When extended break in the use of the ring a new ring should be placed in the vagina as soon as possible. Additionally, a barrier method of contraception must be used for the next 7 days. If during the break in the use of the ring there were sexual contacts, the possibility of pregnancy should be considered. The longer the break, the higher the risk of pregnancy.

If the ring was accidentally removed and left outside the vaginaless than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible. If the ring has been outside the vagina for more than 3 hours, the contraceptive effect may be reduced. The ring should be placed in the vagina as soon as possible, after which it should be permanently in the vagina for at least 7 days, and an additional barrier method of contraception should be used during these 7 days. If the ring was out of the vagina for more than 3 hours during the third week of its use, then its use should be extended beyond the prescribed three weeks (until the end of 7 days after the re-insertion of the ring). After that, the ring should be removed, and a new one placed after a week break. If the removal of the ring from the vagina for more than 3 hours occurs during the first week of using the ring, the possibility of pregnancy should be considered.

When extended use rings, but not longer than 4 weeks, the contraceptive effect is maintained. You can take a week break and then place a new ring. If NuvaRing has been in the vagina for more than 4 weeks, the contraceptive effect may decrease, and pregnancy must be excluded before using a new NuvaRing ring.

If the patient does not adhere to the recommended regimen and then there is no bleeding caused by removal of the ring within a week of using the ring, pregnancy must be excluded before using a new vaginal ring.

To delay the onset of menstruation, you can start using a new ring without a week's break. The next ring should also be used within 3 weeks. This may cause bleeding or spotting. Further, after the prescribed weekly break, you should return to the regular use of NuvaRing.

To shift the onset of menstruation to another day of the week from the day that falls on the current scheme of using the ring, you can shorten the upcoming break in the use of the ring by as many days as necessary. The shorter the break in the use of the ring, the higher the likelihood of the absence of bleeding that occurs after the removal of the ring, and the occurrence of untimely bleeding or spotting during the period of use of the next ring.

Rules for using NovaRing

The patient can independently insert NuvaRing into the vagina. To introduce the ring, a woman should choose the most comfortable position for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing must be squeezed and passed into the vagina until the ring is in a comfortable position. The exact position of NuvaRing in the vagina is not decisive for the contraceptive effect of the ring.

After insertion, the ring must remain in the vagina continuously for 3 weeks. If it is accidentally removed (for example, when removing a tampon), the ring must be rinsed with warm water and immediately placed in the vagina. To remove the ring, you can pick it up with your index finger or squeeze it between your index and middle fingers and pull it out of the vagina.

SIDE EFFECTS NovaRing

From the side of the central nervous system: headache, migraine, depression, emotional lability, dizziness, anxiety, fatigue.

From the digestive system: nausea, abdominal pain, diarrhea, vomiting, decreased libido.

From the endocrine system: increase or decrease in body weight.

From the reproductive system: vaginal discharge ("whites"), vaginitis, cervicitis, soreness, tension and enlargement of the mammary glands, dysmenorrhea.

From the urinary system: urinary tract infections (including cystitis).

Local reactions: prolapse of the ring, discomfort during intercourse in women and men, sensation of a foreign body in the vagina.

CONTRAINDICATIONS NovaRing

Venous or arterial thrombosis / thromboembolism (including history);

Thrombosis risk factors (including history);

Migraine with focal neurological symptoms;

Diabetic angiopathy;

Pancreatitis (including history) in combination with a high degree of hypertriglyceridemia (LDL concentration more than 500 mg / dl);

Severe liver disease (before normalization of function indicators);

Tumors of the liver (benign or malignant, including in history);

Hormone-dependent malignant tumors (established or suspected, for example, tumors of the genital organs or mammary glands);

Vaginal bleeding of unknown etiology;

Pregnancy or suspicion of it;

lactation period;

Hypersensitivity to the components of the drug.

WITH caution the drug should be prescribed for diabetes mellitus, obesity (body mass index over 30 kg / m 2), arterial hypertension, atrial fibrillation, heart valve disease, dyslipoproteinemia, liver or gallbladder disease, Crohn's disease or ulcerative colitis, sickle cell anemia, SLE, hemolytic uremic syndrome, epilepsy, smoking in combination with age over 35 years, with prolonged immobilization, major surgical interventions, fibrocystic mastopathy, uterine fibromyoma, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome), chloasma (avoid exposure to ultraviolet rays) , as well as conditions that make it difficult to use the vaginal ring (cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation).

PREGNANCY AND LACTATION

The use of NovaRing during pregnancy, suspected pregnancy and lactation is contraindicated.

SPECIAL INSTRUCTIONS

Before prescribing NuvaRing, a detailed patient history should be collected, a medical examination should be carried out, taking into account contraindications and warnings. During the period of application of NuvaRing, the examination should be repeated at least 1 time per year. The frequency and list of studies should be selected individually for each patient, but in any case, special attention should be paid to blood pressure control, examination of the mammary glands, abdominal and pelvic organs, including cytological examination of the cervix and appropriate laboratory tests.

The effectiveness of NovaRing may be reduced in case of non-compliance with the regimen or the concomitant use of other drugs.

If it is necessary to use drugs against the background of the use of NovaRing, which may affect the contraceptive effect of the ring, you should use a barrier method of contraception in addition to the use of NovaRing or choose another method of contraception. When taking inducers of microsomal liver enzymes while using NuvaRing, a barrier method of contraception should be used during the course of taking concomitant drugs and for 28 days after stopping them. While taking antibiotics (excluding rifampicin and griseofulvin), the barrier method should be used for at least 7 days after stopping the course of antibiotic therapy. If the course of therapy with concomitant drugs continues for more than 3 weeks of using the ring, the next ring is placed immediately, without a weekly break.

The use of contraceptive steroids may affect certain laboratory test results, including biochemical parameters of liver, thyroid, adrenal, and kidney function, plasma levels of transport proteins (eg, corticosteroid-binding globulin and sex hormone-binding globulin), lipid/lipoprotein fractions, carbohydrate metabolism and indicators of coagulation and fibrinolysis. Indicators, as a rule, change within normal values.

Against the background of pregnancy or taking oral hormonal contraceptives, conditions such as herpes pregnant, hearing loss, Sydenham's chorea (chorea minor), porphyria may occur.

The patient should be informed that NovaRing does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

During the use of NuvaRing, irregular bleeding (minor discharge or sudden bleeding) may occur.

Some women do not bleed during the break from ring use. If NuvaRing has been used as recommended, it is unlikely that the woman is pregnant. In case of deviation from the recommended regimen and the absence of bleeding from discontinuation of the drug, or in the absence of bleeding 2 times in a row, the presence of pregnancy should be excluded.

The degree of exposure and possible pharmacological effects of ethinyl estradiol and etonogestrel on sexual partners through their absorption through the skin of the penis have not been studied.

OVERDOSE

Cases of overdose are unknown.

Alleged symptoms: nausea, vomiting, vaginal bleeding.

Treatment: carry out symptomatic therapy. There are no antidotes.

DRUG INTERACTIONS

Interactions between hormonal contraceptives and other medicinal products may result in breakthrough bleeding and/or loss of the contraceptive effect.

With the simultaneous use of NovaRing with drugs that induce microsomal liver enzymes (phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, St. John's wort), the metabolism of sex hormones increases and the contraceptive effect of NovaRing decreases.

The effectiveness of NuvaRing may also be reduced while taking some antibiotics, such as penicillins and tetracyclines. These drugs reduce the enterohepatic circulation of estrogen, which leads to a decrease in the concentration of ethinyl estradiol.

The effect on the contraceptive effect and safety of NovaRing antifungal drugs and spermicidal agents administered intravaginally is unknown.

No direct interactions of etonogestrel with co-administered ethinyl estradiol have been found.

TERMS AND CONDITIONS OF DISCOUNT FROM PHARMACIES

NuvaRing is a prescription drug.

TERMS AND CONDITIONS OF STORAGE

NuvaRing should be stored out of the reach of children at a temperature of 2° to 8°C. Shelf life - 3 years.

Combined hormonal contraceptive preparation containing etonogestrel and ethinyl estradiol.

Etonogestrel is a progestogen (a derivative of 19-nortestosterone) that binds with high affinity to progesterone receptors in target organs. Ethinylestradiol is an estrogen and is widely used in the manufacture of contraceptives.

The contraceptive effect of NovaRing ® is due to a combination of various factors, the most important of which is the suppression of ovulation.

Efficiency

In clinical studies, it was found that the Pearl Index (an indicator that reflects the frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years for the drug NovaRing ® was 0.96 (95% CI: 0.64-1.39) and 0.64 (95% CI: 0.35-1.07) in statistical analysis of all randomized participants (ITT analysis) and analysis of participants in studies that completed them according to the protocol (PP analysis), respectively. These values were similar to Pearl Index values obtained in comparative studies of combined oral contraceptives (COCs) containing levonorgestrel/ethinylestradiol (0.150/0.030 mg) or drospirenone/ethinylestradiol (3/0.30 mg).

Against the background of the use of the drug NovaRing ®, the cycle becomes more regular, the pain and intensity of menstrual bleeding decreases, which helps to reduce the incidence of iron deficiency. There is evidence of a reduced risk of endometrial and ovarian cancer with the use of the drug.

The nature of bleeding

Comparison of bleeding patterns over one year in 1000 women who used NovaRing ® and COCs containing levonorgestrel / ethinyl estradiol (0.150 / 0.030 mg) showed a significant reduction in the frequency of breakthrough bleeding or spotting when using NovaRing ® compared with COCs . In addition, the frequency of cases when bleeding occurred only during a break in the use of the drug was significantly higher among women who used NovaRing®.

Effect on bone mineral density

A comparative two-year study of the effect of NovaRing (n=76) and a non-hormonal intrauterine device (n=31) showed no effect on bone mineral density in women.

The safety and efficacy of NovaRing ® for adolescent girls under the age of 18 has not been studied.

Pharmacokinetics

Etonogestrel

Suction

Etonogestrel, released from the NovaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. C max etonogestrel in plasma, which is about 1700 pg / ml, is achieved approximately 1 week after the introduction of the ring. Plasma concentration varies in a small range and slowly decreases to about 1600 pg / ml after 1 week, 1500 pg / ml after 2 weeks and 1400 pg / ml after 3 weeks of use. Absolute bioavailability is about 100%, which exceeds the oral bioavailability of etonogestrel. According to the results of measuring the concentrations of etonogestrel in the cervix and inside the uterus in women using the drug NovaRing ®, and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed values of etonogestrel concentrations were comparable.

Distribution

Etonogestrel binds to serum albumin and sex hormone-binding globulin (SHBG). The apparent V d of etonogestrel is 2.3 l / kg.

Metabolism

Biotransformation of etonogestrel occurs by known pathways of sex hormone metabolism. The apparent plasma clearance is about 3.5 l/h. Direct interaction with ethinyl estradiol, taken simultaneously, has not been identified.

breeding

The plasma concentration of etonogestrel decreases in two phases. In the terminal phase, T 1/2 is about 29 hours. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines with bile in a ratio of 1.7:1. T 1/2 metabolites is approximately 6 days.

Ethinylestradiol

Suction

Ethinyl estradiol, released from the NovaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. C max in plasma, which is about 35 pg / ml, is reached 3 days after the introduction of the ring and decreases to 19 pg / ml after 1 week, to 18 pg / ml after 2 weeks and 18 pg / ml after 3 weeks of use. Absolute bioavailability is approximately 56% and is comparable to that of oral administration of ethinyl estradiol. According to the results of measuring the concentrations of ethinylestradiol in the cervical region and inside the uterus in women using NovaRing ® and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinylestradiol, the observed values of ethinylestradiol concentrations were comparable.

The concentration of ethinylestradiol was studied during a comparative randomized study of the drug NovaRing ® (daily release of ethinylestradiol in the vagina 0.015 mg), transdermal patch (norelgestromin / ethinylestradiol; daily release of ethinylestradiol 0.020 mg) and COC (levonorgestrel / ethinylestradiol; daily release administration of ethinylestradiol 0.030 mg) during one cycle in healthy women. Monthly systemic exposure to ethinylestradiol (AUC 0-∞) for NovaRing® was statistically significantly lower than that of the patch and COC, and amounted to 10.9, 37.4 and 22.5 ngh/ml, respectively.

Distribution

Ethinylestradiol binds to serum albumin. The apparent V d is about 15 l/kg.

Metabolism

Ethinylestradiol is metabolized by aromatic hydroxylation. During its biotransformation, a large number of hydroxylated and methylated metabolites are formed, which circulate both in the free state and in the form of glucuronide and sulfate conjugates. The apparent clearance is approximately 3.5 l / h.

breeding

The concentration of ethinylestradiol in plasma decreases in two phases. T 1/2 in the terminal phase varies widely; the median is about 34 hours. Ethinylestradiol is not excreted unchanged; its metabolites are excreted by the kidneys and through the intestines in a ratio of 1.3:1. T 1/2 of metabolites is about 1.5 days.

Special patient groups

The pharmacokinetics of NovaRing ® in healthy adolescent girls under the age of 18 years who have already begun menstruation has not been studied.

Impaired kidney function

The effect of kidney disease on the pharmacokinetics of NovaRing® has not been studied.

Impaired liver function

The effect of liver disease on the pharmacokinetics of NovaRing® has not been studied.

However, in patients with impaired liver function, the metabolism of sex hormones may be impaired.

ethnic groups

The pharmacokinetics of the drug in representatives of ethnic groups has not been specifically studied.

Release form

The vaginal ring is smooth, transparent, colorless or almost colorless, without large visible damage, with a transparent or almost transparent area at the junction.

Excipients: ethylene and vinyl acetate copolymer (28% vinyl acetate) - 1677 mg, ethylene and vinyl acetate copolymer (9% vinyl acetate) - 197 mg, magnesium stearate - 1.7 mg.

1 PC. - aluminum foil waterproof bags (1) - cardboard packs.
1 PC. - aluminum foil waterproof bags (3) - cardboard packs.

Dosage

NovaRing ® is injected into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week that it was placed in the vagina; after a week break, a new ring is introduced. For example: if the NovaRing ® ring was installed on Wednesday at about 22.00, then it should be removed on Wednesday after 3 weeks at about 22.00; on the next Wednesday, a new ring is introduced.

Bleeding associated with the discontinuation of the effect of the drug usually begins 2-3 days after the removal of NovaRing ® and may not completely stop until a new ring is installed.

Hormonal contraceptives were not used in the previous menstrual cycle

NovaRing ® should be administered on the first day of the cycle (i.e. the first day of menstruation). It is allowed to install the ring on the 2nd-5th days of the cycle, however, in the first cycle, in the first 7 days of using NovaRing ®, additional use of barrier methods of contraception is recommended.

Switching from taking combined oral contraceptives

NovaRing ® should be administered on the last day of the usual interval between cycles of combined hormonal contraceptives (tablets or patches). If a woman has been taking the combined hormonal contraceptive correctly and regularly and is sure that she is not pregnant, she can switch to using the vaginal ring on any day of the cycle.

Switching from progestogen-only drugs (mini-pill, progestin-only oral contraceptives, implants, injectable forms, or hormone-containing intrauterine systems - IUDs)

A woman taking mini-pills can switch to NovaRing ® any day. The ring is inserted on the day the implant or IUD is removed. If the woman received injections, then the use of the drug NovaRing ® begins on the day when the next injection should have been made. In all these cases, the woman must use a barrier method of contraception during the first 7 days after the introduction of the ring.

After an abortion in the first trimester of pregnancy

The use of NuvaRing ® can be started immediately after an abortion. In this case, there is no need for additional use of other contraceptives. If the use of NovaRing ® immediately after an abortion is undesirable, the use of the ring should be carried out in the same way as if hormonal contraceptives were not used in the previous cycle. At interval, the woman is recommended an alternative method of contraception.

After childbirth or abortion in the second trimester of pregnancy

The use of NuvaRing ® should begin within the 4th week after childbirth (if the woman is not breastfeeding) or abortion in the second trimester. If the use of NovaRing ® is started at a later date, then additional use of barrier methods of contraception is necessary in the first 7 days of using NovaRing ® . However, if during this period sexual intercourse has already taken place, then before using the drug NovaRing ®, it is necessary to exclude pregnancy or wait for the first menstruation.

The contraceptive effect and cycle control may be impaired if the patient does not comply with the recommended regimen. To avoid the loss of the contraceptive effect in case of deviation from the regimen, the following recommendations must be followed.

Extension of the break in the use of the ring

If during the break in the use of the ring there were sexual intercourse, pregnancy should be excluded. The longer the break, the higher the chance of pregnancy. If pregnancy is ruled out, insert a new ring into the vagina as soon as possible. An additional barrier method of contraception, such as a condom, may be used for the next 7 days.

If the ring has been temporarily removed from the vagina

If the ring was left outside the vagina for less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible (no later than 3 hours later).

If the ring was outside the vagina for more than 3 hours during the first or second week of use, then the contraceptive effect may be reduced. The ring should be placed in the vagina as soon as possible. For the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring has been out of the vagina and the closer this period is to the 7-day break in the use of the ring, the higher the likelihood of pregnancy.

If the ring was outside the vagina for more than 3 hours during the third week of use, then the contraceptive effect may be reduced. The woman should discard this ring and choose one of the two following methods.

1. Immediately install a new ring. Keep in mind that a new ring can be used within the next 3 weeks. In this case, there may be no bleeding associated with the cessation of the drug. However, spotting of blood or bleeding in the middle of the cycle is possible.

2. Wait for bleeding associated with the termination of the drug, and introduce a new ring no later than 7 days after removing the previous ring. This option should only be selected if the ring has not been previously broken during the first 2 weeks.

Extended use of the ring

If the drug NovaRing ® was used for no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. You can take a week off from using the ring, and then introduce a new ring. If NovaRing ® remained in the vagina for more than 4 weeks, then the contraceptive effect may worsen, so pregnancy must be excluded before the introduction of a new ring.

How to move or delay the onset of menstrual bleeding

To delay menstrual-like withdrawal bleeding, a new ring can be inserted without a week break. The next ring must be used within 3 weeks. This may cause bleeding or spotting. Further, after the usual weekly break, you should return to the regular use of NovaRing ®.

To move the onset of bleeding to another day of the week, it may be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the break in ring use, the more likely it is that there will be no bleeding after ring removal and that bleeding or spotting will occur while the next ring is in use.

Ring damage

In rare cases, when using NuvaRing ®, a rupture of the ring was observed. The core of the NovaRing ® ring is solid, so its contents remain intact and hormone secretion does not change significantly. If the ring breaks, it usually falls out of the vagina. If the ring breaks, a new ring must be inserted (following the recommendations above "If the ring has been temporarily removed from the vagina").

Ring drop

Sometimes there was a loss of NovaRing ® from the vagina, for example, when it was inserted incorrectly, when a tampon was removed, during intercourse, or against the background of severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NovaRing ® ring in the vagina. If the ring falls out of the vagina, the above recommendations "If the ring was temporarily removed from the vagina" should be followed.

Rules for using NuvaRing ®

A woman can independently insert NovaRing ® into the vagina. To introduce the ring, a woman should choose the most comfortable position for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing ® must be squeezed and passed into the vagina until the ring is in a comfortable position. The exact position of NovaRing ® in the vagina is not decisive for the contraceptive effect.

After insertion, the ring must remain in the vagina continuously for 3 weeks. If the ring is accidentally removed, it must be rinsed with warm (not hot) water and inserted into the vagina immediately.

To remove the ring, you can pick it up with your index finger or squeeze it between your index and middle fingers and pull it out of the vagina. The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded.

Overdose

Serious consequences of an overdose of hormonal contraceptives are not described.

Suggested symptoms: nausea, vomiting, slight vaginal bleeding in young girls.

Treatment: carry out symptomatic therapy. There are no antidotes.

Interaction

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and / or contraceptive failure.

The following interactions with combined oral contraceptives are described in the literature in general.

Possible interaction with drugs that induce microsomal liver enzymes, which can lead to an increase in the clearance of sex hormones. Interactions with the following drugs have been established: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort.

When treating any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with NovaRing ® or choose another method of contraception. During the concomitant use of drugs that cause the induction of microsomal liver enzymes, and within 28 days after their withdrawal, barrier methods of contraception should be used.

If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

A decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with the concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, ingestion of amoxicillin (875 mg 2 times / day) or doxycycline (200 mg / day, and then 100 mg / day) for 10 days during the use of the drug NovaRing ® had little effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (excluding amoxicillin and doxycycline), you should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics. If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

Hormonal contraceptives can cause a violation of the metabolism of other drugs. Accordingly, their plasma and tissue concentrations may increase (eg, cyclosporine) or decrease (eg, lamotrigine).

To exclude a possible interaction, it is necessary to study the instructions for use of other drugs.

Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NovaRing ® vaginal ring. In rare cases, the ring may be accidentally removed when the tampon is removed.

Side effects

Determining the frequency of side effects: often (≥1 / 100), infrequently (<1/100, ≥1/1000), редко (<1/1000, ≥1/10 000).

Often	Infrequently	Rarely	Post-marketing data 1
Infections and infestations
vaginal infection	Cervicitis, cystitis, urinary tract infections
From the side of the immune system
			Hypersensitivity
From the side of metabolism
Weight gain	Appetite increase
Mental disorders
Depression, decreased libido	Mood change
From the side of the nervous system
Headache, migraine	Dizziness, hypoesthesia
From the organ of vision
	visual impairment
From the side of the cardiovascular system
	Hot flashes, increased blood pressure	Venous thromboembolism 2
From the digestive system
Abdominal pain, nausea	Bloating, diarrhea, vomiting, constipation
From the side of the skin
acne	alopecia, eczema, skin itching, rash		Hives
From the musculoskeletal system
	Back pain, muscle spasms, pain in limbs
From the urinary system
	Dysuria, urinary urgency, pollakiuria
From the genital organs and mammary gland
Breast engorgement and tenderness, genital itching in women, painful menstrual bleeding, pelvic pain, vaginal discharge	Absence of menstrual-like bleeding, discomfort in the mammary glands, enlargement of the mammary glands, lumps in the mammary glands, cervical polyps, contact (during intercourse) spotting (bleeding), pain during intercourse, ectropion of the cervix, fibrocystic mastopathy , heavy menstrual-like bleeding, acyclic bleeding, discomfort in the pelvic area, premenstrual-like syndrome, burning sensation in the vagina, vaginal odor, painful sensations in the vagina, discomfort and dryness of the vulva and vaginal mucosa		Local reactions in partner 3 galactorrhea
From the body as a whole
	Fatigue, irritability, malaise, swelling
Other
Discomfort when using the vaginal ring, prolapse of the vaginal ring	Difficulties in using a contraceptive, rupture (damage) of the ring, sensation of a foreign body in the vagina

1 The list of side effects is based on data obtained from spontaneous reports. It is not possible to accurately determine the frequency.

2 Observational cohort data: ≥1/10,000 -<1/1000 женщин-лет.

3 Local partner reactions include reports of local penile reactions (eg, pain, flushing, bruising, and abrasions).

Side effects that occurred when taking combined hormonal contraceptives: pancreatitis, cholecystitis, cerebrovascular disorders, benign and malignant liver tumors, chloasma, changes in insulin resistance.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.

Indications

Contraception.

Contraindications

thrombosis (arterial or venous) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;
predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);
migraine with focal neurological symptoms at present or in history;
diabetes mellitus with vascular damage;
pronounced or multiple risk factors for venous or arterial thrombosis: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), arterial hypertension, lesions of the valvular apparatus of the heart, atrial fibrillation, extended surgery, prolonged immobilization, extensive trauma, obesity (BMI> 30 kg / m 2), smoking in women over 35 years of age;
pancreatitis (including history) in combination with severe hypertriglyceridemia;
severe liver disease;
liver tumors, malignant or benign (including history);
established or suspected hormone-dependent malignant tumors (for example, genital or breast);
vaginal bleeding of unknown etiology;
pregnancy (including intended);
breastfeeding period;
hypersensitivity to any of the active or auxiliary substances of the drug NovaRing ®.

The safety and efficacy of NovaRing® in adolescent girls under 18 years of age have not been studied.

In the event of any of the above conditions, you should immediately stop using the drug.

With caution, the drug should be prescribed in the presence of any of the following diseases, conditions or risk factors; in such cases, the doctor must carefully weigh the benefit-risk ratio of using NovaRing®:

the presence of risk factors for the development of thrombosis and thromboembolism: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, valve disease heart, cardiac arrhythmias, prolonged immobilization, major surgical interventions;
thrombophlebitis of superficial veins;
dyslipoproteinemia;
heart valve disease;
adequately controlled arterial hypertension;
diabetes mellitus without vascular complications;
acute or chronic liver dysfunction;
jaundice and/or itching caused by cholestasis;
cholelithiasis;
porphyria;
systemic lupus erythematosus;
hemolytic-uremic syndrome;
chorea of Sydenham (small chorea);
hearing loss due to otosclerosis;
angioedema (hereditary) edema;
chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis);
sickle cell anemia;
chloasma;
conditions that make it difficult to use the vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

In the event of an exacerbation of diseases, a deterioration in the condition, or the occurrence of any of the listed conditions for the first time, you should consult a doctor to decide on the possibility of further use of the drug NovaRing ®.

Application features

Use during pregnancy and lactation

NovaRing ® is intended to prevent pregnancy. If a woman wants to stop using the drug in order to become pregnant, it is recommended to conceive until the restoration of the natural cycle, because. this will help to correctly calculate the date of conception and childbirth.

The use of the drug NovaRing ® during pregnancy is contraindicated. If pregnancy occurs, the ring should be removed. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took COCs in early pregnancy without knowing about it. Although this applies to all PDAs, it is not known if this also applies to NovaRing®. A clinical study in a small group of women showed that, despite the fact that NovaRing ® is administered into the vagina, the concentrations of contraceptive hormones inside the uterus when using NovaRing ® are similar to those when using PDA. Pregnancy outcomes in women who used the drug NovaRing ® during a clinical study are not described.

The use of the drug NovaRing ® during breastfeeding is contraindicated. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and / or their metabolites can be excreted in breast milk, but there is no evidence of their negative effect on the health of children.

Application for violations of liver function

Contraindicated in severe liver disease (before the normalization of function indicators).

Use in children

The safety and efficacy of NovaRing ® for adolescents under the age of 18 has not been studied.

special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits of using NovaRing ® and the possible risks for each individual woman should be evaluated before she starts using NovaRing ®. In the event of an exacerbation of diseases, a deterioration in the condition, or the occurrence of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NovaRing ®.

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes with a fatal outcome.

The use of any COC increases the risk of developing venous thromboembolism (VTE) compared with the risk of developing VTE in patients who do not use COCs. The greatest risk of developing VTE occurs in the first year of COC use. Data from a large prospective cohort study on the safety of various COCs suggest that the greatest increase in risk, compared with the level of risk in women who do not use COCs, occurs in the first 6 months after starting the use of COCs or resuming their use after a break (4 weeks or more) . In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 cases per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE is from 3 to 9 cases per 10,000 VL. However, the risk increases to a lesser extent than during pregnancy, when it is 5-20 cases per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in standard studies; when converted to a pregnancy of 9 months, the risk is from 7 to 27 cases per 10,000 YL). In women in the postpartum period, the risk of developing VTE is 40 to 65 cases per 10,000 VL. VTE is fatal in 1-2% of cases.

According to the results of studies, the increased risk of developing VTE in women using NovaRing ® is similar to that in women using COCs (adjusted risk ratio is presented in the table below). A large prospective observational study, TASC (Transatlantic Active Study on the Cardiovascular Safety of NovaRing ®), assessed the risk of VTE in women who started using NovaRing ® or COC, switched to NovaRing ® or COC from other contraceptives or resumed the use of the drug NovaRing ® or PDA, in a population of typical users. Women were followed up for 24-48 months. The results showed a similar level of risk of developing VTE in women using NovaRing ® (frequency 8.3 cases per 10,000 LL) and in women using PDA (frequency 9.2 cases per 10,000 LL). For women using COCs, except those containing desogestrel, gestodene and drospirenone, the incidence of VTE was 8.5 cases per 10,000 VL.

A retrospective cohort study initiated by the FDA showed that the incidence of VTE in women who started using NovaRing ® is 11.4 cases per 10,000 VL, while in women who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10 000 JL.

Assessment of the risk (risk ratio) of developing VTE in women using NovaRing ®, compared with the risk of developing VTE in women using COCs

Epidemiological study, population	Comparator(s)	Risk ratio (RR) (95% CI)
TASC (Dinger, 2012) Women who started using the drug (including again, after a break) and switched from other contraceptives.	All available PDAs during study 1	RR 2: 0.8 (0.5-1.5)
	Available PDAs, except those containing desogestrel, gestodene, drospirenone	RR 2: 0.9 (0.4-2.0)
"FDA Initiated Study" (Sydney, 2011) Women who started using combined hormonal contraceptives (CHCs) for the first time during the study period.	PDAs available during study period 3	RR 4: 1.09 (0.55-2.16)
	Levonorgestrel /0.03 mg ethinylestradiol	RR 4: 0.96 (0.47-1.95)

1 Incl. low-dose COCs containing the following progestogens: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethinodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate, or norgestrel.

2 Based on age, BMI, duration of use, history of VTE.

3 Incl. low-dose COCs containing the following progestogens: norgestimate, norethindrone or levonorgestrel.

4 Taking into account age, place and year of inclusion in the study.

Extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) are known with the use of COCs. It is not known whether these cases are associated with the use of PDAs.

Possible symptoms of venous or arterial thrombosis may include unilateral edema and/or pain in the lower extremity, localized fever in the lower extremity, redness or discoloration of the skin of the lower extremity; sudden severe chest pain, possibly radiating to the left arm; an attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, with or without focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; "sharp" abdomen.

Risk factors for the development of venous thrombosis and embolism:

age;
the presence of diseases in the family history (venous thrombosis and embolism in brothers / sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting any hormonal contraceptive;
prolonged immobilization, major surgery, any surgery to the lower extremities, or major trauma. In such situations, it is recommended to stop using the drug (in the case of a planned operation, at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after the full restoration of motor activity;
with obesity (BMI over 30 kg / m 2);
possibly thrombophlebitis of superficial veins and varicose veins.

There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

age;
smoking (with heavy smoking and with age, the risk increases even more, especially in women over 35 years old);
dyslipoproteinemia;
obesity (BMI over 30 kg/m2);
arterial hypertension;
migraine;
heart valve disease;
atrial fibrillation;
the presence of diseases in a family history (arterial thrombosis in brothers / sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting the use of any hormonal contraceptives.

Biochemical factors that may indicate a hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (anti-cardiolipin antibodies, lupus anticoagulant).

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

Women using COCs should be advised to consult a doctor if symptoms of thrombosis appear. If thrombosis is suspected or confirmed, COC use should be discontinued. In this case, it is necessary to use effective contraceptives, since anticoagulants (coumarins) have a teratogenic effect.

The risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term COC use leads to an additional increase in this risk, but it remains unclear how much this is due to other factors such as more frequent cervical smears and differences in sexual behavior, incl. use of barrier contraceptives. It remains unclear how this effect is associated with the use of NovaRing®.

A meta-analysis of the results of 54 epidemiological studies revealed a slight increase (1.24) in the relative risk of developing breast cancer in women taking COCs. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under the age of 40, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women using COCs is clinically less pronounced than cancer detected in women who have never used COCs. The increased risk of developing breast cancer may be due to both the fact that in women taking COCs, the diagnosis of breast cancer is established earlier, and the biological effects of COCs, or a combination of both of these factors.

In rare cases, women who took COCs have experienced cases of benign, and even more rarely, malignant liver tumors. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NuvaRing ® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia or a family history of hypertriglyceridemia have an increased risk of developing pancreatitis when taking hormonal contraceptives.

Many women taking hormonal contraceptives have a slight increase in blood pressure, but a clinically significant increase in blood pressure is rare. A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established. If during the use of the drug NovaRing ® there is a constant increase in blood pressure, you should contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate control of blood pressure with antihypertensive drugs, it is possible to resume the use of the drug NovaRing ®.

During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been fully established: jaundice and / or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, angioedema (hereditary) edema.

Acute or chronic violations of liver function may serve as a basis for discontinuation of the drug NovaRing ® until the normalization of liver function parameters. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex steroid preparations, requires discontinuation of the drug NovaRing ®.

Although estrogens and progestogens may affect peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using NovaRing®, especially in the first months of contraception.

There is evidence of worsening of the course of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

The following conditions may prevent proper insertion of the ring or cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.

In very rare cases, women have inadvertently inserted the NovaRing ® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, the possibility of incorrect insertion of the ring must be considered.

Cases of vaginitis during the use of the drug NovaRing ® are described. There is no evidence that the treatment of vaginitis affects the effectiveness of the use of the drug NovaRing ®, as well as evidence of the effect of the use of the drug NovaRing ® on the effectiveness of the treatment of vaginitis.

Very rare cases of difficult removal of the ring have been described, requiring its removal by a healthcare professional.

Medical examination/consultation

Before you prescribe the drug NovaRing ® or resume its use, you should carefully review the medical history (including family history) of the woman and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions and follow all recommendations. The woman should be informed that NovaRing ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug NovaRing ® may decrease if the regimen is not followed or if concomitant therapy is carried out.

Changes in the nature of menstruation

During the use of the drug NovaRing ®, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles against the background of the correct use of the drug NovaRing ®, you should contact your gynecologist for the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. Diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If the drug NuvaRing ® was used in accordance with the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after the removal of the ring, as well as in the absence of bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinylestradiol and etonogestrel on the sexual partner

The possible pharmacological effects and degree of exposure of ethinyl estradiol and etonogestrel to male sexual partners due to absorption through the tissues of the penis have not been studied.

Laboratory research

The use of hormonal contraceptives may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma concentrations of transport proteins (for example, corticosteroid-binding globulin and sex hormone-binding globulin globulin), lipid/lipoprotein fractions, carbohydrate metabolism and indicators of coagulability and fibrinolysis. Indicators, as a rule, change within normal values.

Influence on the ability to drive vehicles and control mechanisms

Based on information about the pharmacodynamic properties of the drug NovaRing ® , it can be expected that it does not affect the ability to drive vehicles and work with mechanisms.

Of great importance among the methods of pregnancy planning is given to the prevention of unwanted conception. For this purpose, various means of contraception are used: condoms, pills, spirals. But there are also quite exotic pharmacological forms, for example, a vaginal contraceptive ring called NovaRing (or Nova Ring). Many women hear about this for the first time, so it is necessary to pay attention to the consideration of the features, method of application, indications and limitations of this remedy.

Characteristics

The pharmacological form is a flexible ring made of latex, which contains two active ingredients: estrogen and progestogen. Therefore, NovaRing refers to combined hormonal contraceptives with a predominantly local mechanism of action. The gestagen is etonogestrel, and the group of estrogens is ethinylestradiol, synthetic analogues of the natural hormones of the female body. The ring is 5.4 cm in diameter and only 4 mm thick. These sizes are suitable for most women, which is ensured by the flexibility of the form and its adjustment to the individual characteristics of the genitals.

The effects of the contraceptive ring are due to the action of the active substances that make up its composition.

Etonogestrel and ethinylestradiol bind to their respective receptors, thereby blocking the local effects of natural hormones - estrogens and progesterone. This is mainly manifested in the suppression of ovulation and the inhibition of the secretory transformation of the endometrium.

As soon as the ring is inserted into the vagina, its shell takes on the temperature of the human body, becoming permeable to the substances inside. Medicinal components are contained in low doses, they act mainly on the uterus and ovaries, without affecting other systems and organs. Based on the mechanism of action of etonogestrel and ethinylestradiol, the conception of a child becomes impossible. The egg does not mature and remains in the follicle, and the thin mucous membrane of the uterus prevents the implantation of the embryo.

Distribution in the body

Substances in the ring are actively released from it and absorbed through the vaginal mucosa. They enter the bloodstream, where they reach their maximum concentration after about three days (ethinylestradiol) and a week (etonogestrel) from the start of use. Bioavailability is high, comparable with the use of tableted contraceptives. Once in the blood plasma, the active substances bind to proteins (mainly albumin) and in this form are transferred to target organs. Metabolism occurs in the liver, the half-life of drugs ranges from 29 to 36 hours, and excretion from the body is carried out by the kidneys (with urine) and intestines (with bile).

Indications

The NovaRing ring is used as a planned contraceptive. But it also has medicinal properties, which makes it possible to use this pharmacological form for some gynecological diseases. We are talking about menstrual dysfunction, when the cycle is irregular, and menstruation is painful.

Using the ring to prevent unwanted conception, you can be sure of its reliability and high performance. The probability of pregnancy during the year of using a contraceptive does not exceed 0.9. This is a high rate, comparable to taking hormonal pills. But, in addition to this, the NuvaRing ring has other advantages:

Ease of use (replacement is carried out once a month).
Provides a predominantly local effect on the genitals.
There is no chance of weight gain.
The menstrual cycle is normalized.
Reduces the risk of cancer of the uterus and ovaries.
The ring does not affect the sensations during sexual intimacy.
Rapid resumption of fertility (4 weeks after extraction).

A wide list of positive qualities should increase the adherence of patients to this method of protection. But, in comparison with other means of contraception, it has a number of disadvantages. Firstly, the use of the ring is quite unusual for a woman. Secondly, it does not protect against genital infections (unlike a condom). And thirdly, there are many contraindications and restrictions for using NovaRing.

As a contraceptive, the ring has many advantages. But there are certain disadvantages that limit its use.

Usage

Before using the ring, a woman should consult a gynecologist. The doctor will conduct an examination, based on the results of which he will say whether she can use such a contraceptive. The specialist should explain how and when it is better to introduce it and what can be expected in the long term.

Acting according to the instructions, a woman can put the NuvaRing ring herself. To do this, she must first choose a suitable position: lying on her back, squatting or standing with her leg elevated. Squeezing the contraceptive with two fingers, she introduces it. The position of the ring in the vagina should be comfortable, and the contraceptive effect does not depend on its accuracy.

The time when you start using the ring is important. The optimal timing of administration is determined by several factors:

Other contraceptives were not used - on the first day of the menstrual cycle.
After taking combined estrogen-gestagenic drugs (tablets or patches) - on the last day of the interval between their appointment.
The transition from monocomponent progestogens - at any time of the cycle.
With early abortion - immediately after the termination of pregnancy.
In the postpartum period or during an abortion in the second trimester - after 1 month.

The ring is in the vagina for 3-4 weeks. Use beyond this period reduces the contraceptive effect. In case of spontaneous loss of NuvaRing, it is necessary to insert it back as soon as possible. If the ring was in the external environment for more than 3 hours, then its effect also decreases. In the intervals between the installation of a contraceptive, as well as in the first 7 days of its use, an additional condom should be used (this is not necessary after childbirth or abortion).

Side effects

The NovaRing contraceptive ring has a number of side effects. They occur with varying frequency and not in all women. Much depends on the individual characteristics of the organism. During the use of the ring, the following undesirable phenomena may occur:

Gynecological: inflammatory processes (cervicitis), vaginal discharge, itching, burning and dryness in the vagina, scanty bleeding (including contact and acyclic), discomfort during intercourse, ectropion, cervical polyps; swelling and soreness of the mammary glands, mastopathy.
Urological: cystitis, dysuric disorders (frequent urge).
Digestive: nausea, decreased appetite, abdominal pain, flatulence, constipation.
Neuropsychiatric: migraine headaches, visual disturbances, dizziness, weakness and fatigue, irritability, decreased sexual desire, depression.
Skin-allergic: itching, punctate rash, urticaria, acne.
Vascular: sensation of heat, thrombotic conditions.

In addition to the effects due to the content of the active components, the ring can simply fall out of the vagina, break or cause discomfort due to the form itself. But in order to minimize the risk of any side effects, it should be used only after consulting a doctor and an appropriate examination. Compliance with all the recommendations and requirements of the instructions will minimize adverse events.

The use of the NuvaRing ring may be associated with various unpleasant symptoms. But their probability can be reduced due to the strict observance of all conditions of use.

Restrictions and contraindications

Like any drug, the ring with etonogestrel and ethinyl estradiol has certain limitations that make the use of NovaRing impossible or highly undesirable. All such conditions must be taken into account by the doctor at the examination stage.

The considered contraceptive has a number of contraindications. In the NuvaRing contraceptive ring, the instructions indicate that it cannot be used in the following cases:

Thrombotic conditions, including predisposition to them.
Associated migraine (combined with neurological disorders).
Diabetes complicated by angiopathy.
Severe hepatic pathology (including oncology).
Hormone-sensitive tumors of the gynecological sphere.
Metrorrhagia with unknown cause.
Pregnancy (confirmed and probable).
Individual hypersensitivity to the components of the ring.

Caution should be taken in such conditions as hypertension, dyslipidemia, heart defects, systemic connective tissue diseases, inflammatory bowel disease, sickle cell anemia. Some restrictions relate to difficulties with the introduction of a contraceptive into the vagina, which can be observed with uterine prolapse, constipation, rectal diverticula, hernial protrusion of the bladder wall.

special instructions

If pregnancy develops during the use of NovaRing, the ring will have to be removed immediately. Studies confirming the safety of local combined contraceptives for the fetus are not enough to unequivocally speak about the absence of undesirable consequences. During breastfeeding, you should also not use this method. The effectiveness of the ring in adolescent girls is unknown.

In women who used combinations of estrogens and progestins as a contraceptive, there were cases of increased blood pressure, but a direct relationship between these events has not yet been established. With the correct intake of antihypertensive drugs, this effect is leveled. There are indications of the effect of the active substances that make up the ring on carbohydrate tolerance. But this does not require any changes in hypoglycemic therapy.

The components of NovaRing may have a certain effect on the results of some laboratory tests: liver tests, thyroid and adrenal hormones, indicators of kidney function, lipid spectrum, coagulogram. But all changes are within the reference values. The use of tampons does not affect the effectiveness of the ring in any way.

If, during the use of the remedy in question, a woman has any symptoms described as side effects or others that are alarming, you should immediately consult a doctor. Mild reactions do not require removal of the ring, but in some cases it should still be discontinued and switched to other contraceptives.

Every woman should be aware of contraindications and other restrictions that can become an obstacle to the use of NuvaRing.

Interaction

Estrogen-progestin contraceptives, including NovaRing, may interact with other medicines. The acceleration of metabolism, and hence the decrease in the contraceptive effect, can be observed with the parallel intake of inducers of microsomal oxidation in the liver. Such drugs include barbiturates, rifampicin, carbamazepine, ritonavir, St. John's wort-based preparations. The action of the ring is inhibited against the background of taking antibiotics from the group of ampicillin and tetracycline. Therefore, the patient should inform the doctor about all medications taken.

The NovaRing ring is a highly effective contraceptive of hormonal origin. Due to its shape, it has a predominantly local effect on the genitals. There are other positive qualities that contribute to the widespread use of the ring. But it can be used only in strict accordance with medical recommendations and instructions. This allows you to minimize the risk of adverse events and achieve a stable result.

Novaring - a new description of the drug, you can see the pharmacological action, indications for use, Novaring. Reviews about Nuvaring -

Hormonal contraceptive for intravaginal use.
Preparation: NovaRing®
The active substance of the drug: ethinylestradiol, etonogestrel
ATX encoding: G02BB01
CFG: Hormonal contraceptive for intravaginal administration
Registration number: P No. 015428/01
Date of registration: 25.12.03
The owner of the reg. credit: ORGANON N.V. (Netherlands)

The vaginal ring is smooth, transparent, colorless or almost colorless, without large visible damage, with a transparent or almost transparent area at the junction.
vaginal ring
1 ring
ethinylestradiol
2.7 mg
etonogestrel
11.7 mg

Excipients: ethylene vinyl acetate copolymer (28% vinyl acetate), ethylene vinyl acetate copolymer (9% vinyl acetate), magnesium stearate, purified water.

1 PC. - aluminum foil bag (1) - cardboard boxes.

The description of NuvaRing is based on officially approved instructions for use.

Pharmacological action Novaring

The contraceptive effect of NovaRing is based on various mechanisms, the most significant of which is inhibition of ovulation. The Pearl Index of NuvaRing is 0.765.

Pharmacokinetics of the drug.

Etonogestrel

Suction

Etonogestrel released from NovaRing is rapidly absorbed by the vaginal mucosa. Cmax etonogestrel, equal to approximately 1700 pg / ml, is achieved approximately one week after the introduction of the ring. Serum concentration fluctuates slightly and slowly reaches the level of 1400 pg / ml after 3 weeks. Absolute bioavailability is about 100%.

Distribution

Etonogestrel binds to serum albumin and sex hormone-binding globulin (SHBG). Vd etonogestrel 2.3 l / kg.

Metabolism

Etonogestrel is metabolized by hydroxylation and reduction to sulfate and glucuronide conjugates. Serum clearance is about 3.5 l / h.

breeding

The decrease in serum etonogestrel concentration is biphasic. T1 / 2 -phase is about 29 hours. Etonogestrel and its metabolites are excreted in the urine and bile in a ratio of 1.7:1. T1 / 2 metabolites about 6 days.

Ethinylestradiol

Suction

Ethinylestradiol released from NovaRing is rapidly absorbed by the vaginal mucosa. Cmax is about 35 pg / ml, is reached by the 3rd day after the introduction of the ring and decreases to 18 pg / ml after 3 weeks. The absolute bioavailability is about 56%, which is comparable to oral bioavailability.

Metabolism

breeding

The decrease in the concentration of ethinylestradiol in serum is biphasic. T1 / 2 -phase is characterized by large individual differences, and, on average, is about 34 hours. Ethinylestradiol is not excreted unchanged; its metabolites are excreted in the urine and bile in a ratio of 1.3:1. T1 / 2 metabolites is about 1.5 days.

Indications for use:

Contraception.

Dosage and method of application of the drug.

Hormonal contraceptives were not used in the previous menstrual cycle

Switching from taking combined oral contraceptives

Switching from progestogen-based contraception (mini-pill, implant, or injectable contraception) or progestogen-releasing intrauterine device (IUD)

After an abortion in the first trimester of pregnancy

After childbirth or abortion in the second trimester of pregnancy

In the event of an extended interruption in the use of the ring, a new ring should be placed in the vagina as soon as possible. Additionally, a barrier method of contraception must be used for the next 7 days. If during the break in the use of the ring there were sexual contacts, the possibility of pregnancy should be considered. The longer the break, the higher the risk of pregnancy.

If the ring was accidentally removed and left outside the vagina for less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible. If the ring has been outside the vagina for more than 3 hours, the contraceptive effect may be reduced. The ring should be placed in the vagina as soon as possible, after which it should be permanently in the vagina for at least 7 days, and an additional barrier method of contraception should be used during these 7 days. If the ring was out of the vagina for more than 3 hours during the third week of its use, then its use should be extended beyond the prescribed three weeks (until the end of 7 days after the re-insertion of the ring). After that, the ring should be removed, and a new one placed after a week break. If the removal of the ring from the vagina for more than 3 hours occurs during the first week of using the ring, the possibility of pregnancy should be considered.

In the case of prolonged use of the ring, but not longer than 4 weeks, the contraceptive effect is preserved. You can take a week break and then place a new ring. If NuvaRing has been in the vagina for more than 4 weeks, the contraceptive effect may decrease, and pregnancy must be excluded before using a new NuvaRing ring.

To delay the onset of menstruation, you can start using a new ring without a week break. The next ring should also be used within 3 weeks. This may cause bleeding or spotting. Further, after the prescribed weekly break, you should return to the regular use of NuvaRing.

Rules for using NovaRing

SIDE EFFECTS NovaRing

From the side of the central nervous system: headache, migraine, depression, emotional lability, dizziness, anxiety, fatigue.

From the digestive system: nausea, abdominal pain, diarrhea, vomiting, decreased libido.

From the endocrine system: increase or decrease in body weight.

From the reproductive system: vaginal discharge ("whites"), vaginitis, cervicitis, soreness, tension and enlargement of the mammary glands, dysmenorrhea.

From the urinary system: urinary tract infections (including cystitis).

Local reactions: loss of the ring, discomfort during intercourse in women and men, sensation of a foreign body in the vagina.

CONTRAINDICATIONS NovaRing

Venous or arterial thrombosis / thromboembolism (including history);

Thrombosis risk factors (including history);

Migraine with focal neurological symptoms;

Diabetic angiopathy;

Pancreatitis (including history) in combination with a high degree of hypertriglyceridemia (LDL concentration more than 500 mg / dl);

Severe liver disease (before normalization of function indicators);

Tumors of the liver (benign or malignant, including in history);

Hormone-dependent malignant tumors (established or suspected, for example, tumors of the genital organs or mammary glands);

Vaginal bleeding of unknown etiology;

Pregnancy or suspicion of it;

lactation period;

Hypersensitivity to the components of the drug.

With caution, the drug should be prescribed for diabetes mellitus, obesity (body mass index over 30 kg / m2), arterial hypertension, atrial fibrillation, heart valve disease, dyslipoproteinemia, liver or gallbladder disease, Crohn's disease or ulcerative colitis, sickle cell anemia, SLE, hemolytic uremic syndrome, epilepsy, smoking in combination with the age of more than 35 years, with prolonged immobilization, major surgical interventions, fibrocystic mastopathy, uterine fibroids, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome), chloasma (avoid exposure to ultraviolet rays ), as well as conditions that make it difficult to use the vaginal ring (cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation).

Use during pregnancy and lactation.

The use of NovaRing during pregnancy, suspected pregnancy and lactation is contraindicated.

Special instructions for the use of Nuvaring.

The effectiveness of NovaRing may be reduced in case of non-compliance with the regimen or the concomitant use of other drugs.

Against the background of pregnancy or taking oral hormonal contraceptives, conditions such as herpes pregnant, hearing loss, Sydenham's chorea (chorea minor), porphyria may occur.

The patient should be informed that NovaRing does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

During the use of NuvaRing, irregular bleeding (minor discharge or sudden bleeding) may occur.

The degree of exposure and possible pharmacological effects of ethinyl estradiol and etonogestrel on sexual partners through their absorption through the skin of the penis have not been studied.

Drug overdose:

Cases of overdose are unknown.

Expected symptoms: nausea, vomiting, vaginal bleeding.

Treatment: carry out symptomatic therapy. There are no antidotes.

Interaction of Nuvaring with other drugs.

Interactions between hormonal contraceptives and other medicinal products may result in breakthrough bleeding and/or loss of the contraceptive effect.

The effect on the contraceptive effect and safety of NovaRing antifungal drugs and spermicidal agents administered intravaginally is unknown.

No direct interactions of etonogestrel with co-administered ethinyl estradiol have been found.

Conditions of sale in pharmacies.

NuvaRing is a prescription drug.

Terms of the storage conditions of the drug Nuvaring.

NuvaRing should be stored out of the reach of children at a temperature of 2° to 8°C. Shelf life - 3 years.

Ethinylestradiol* + Etonogestrel* (Ethinylestradiol* + Etonogestrel*)

ATX

G02BB01 Intravaginal progestogen- and estrogen-containing rings

Pharmacological group

Combined contraceptive (estrogen + gestagen) [Estrogens, gestagens; their homologues and antagonists in combinations]

The contraceptive ring is a vaginal female hormonal agent of a new generation. Contraceptive ring novaring

Pharmacokinetics

Release form

Dosage

Overdose

Interaction

Side effects

Indications

Contraindications

Application features

Use during pregnancy and lactation

Application for violations of liver function

Use in children

special instructions

Characteristics

Distribution in the body

Indications

Usage

Side effects

Restrictions and contraindications

special instructions

Interaction

Pharmacological action Novaring

Pharmacokinetics of the drug.

Indications for use:

Dosage and method of application of the drug.

Use during pregnancy and lactation.

Special instructions for the use of Nuvaring.

Drug overdose:

Interaction of Nuvaring with other drugs.

Conditions of sale in pharmacies.

Terms of the storage conditions of the drug Nuvaring.

ATX

Pharmacological group

Compound

Description of the dosage form

pharmachologic effect

Pharmacodynamics

Use during pregnancy and lactation

Side effects

Interaction

Dosage and administration

Overdose

special instructions