Injections of interferon alfa 2b. Interferons and their role in clinical medicine

Interferon alfa-2b was obtained from a clone of Escherichia coli by hybridization of bacterial plasmids with the gene of human leukocytes, which encode the synthesis of interferon. Reacting on the cell surface with specific receptors, the drug initiates a complex chain of changes inside the cell, which include the induction of the formation of certain specific enzymes and cytokines, disrupts the formation of RNA and proteins inside the cells of the virus. As a result of these changes, antiproliferative and nonspecific antiviral activity appears, which is associated with a slowdown in cell proliferation, prevention of virus replication inside the cell, and the immunomodulatory effect of interferon.
Interferon alpha-2b stimulates the phagocytic activity of macrophages, the process of antigen presentation to immunocompetent cells, as well as the cytotoxic activity of natural killer cells and T cells that are involved in the antiviral response. The drug prevents cell proliferation, especially tumor cells. It has an inhibitory effect on the formation of certain oncogenes that lead to inhibition of tumor growth. When administered subcutaneously or intramuscularly, the bioavailability of the drug is 80 - 100%. The maximum concentration in the blood is reached after 4-12 hours, the half-life is 2-6 hours. It is excreted mainly by glomerular filtration by the kidneys. After 16-24 hours after administration, the drug in the blood plasma is not determined. Metabolized in the liver.

Indications

Intravenously, intramuscularly, subcutaneously: as part of complex treatment in adults: chronic viral hepatitis C without signs of liver failure; chronic viral hepatitis B without signs of liver cirrhosis; genital warts, papillomatosis of the larynx; chronic myeloid leukemia; hairy cell leukemia; non-Hodgkin's lymphoma; multiple myeloma; progressive kidney cancer; melanoma; AIDS-related Kaposi's sarcoma.
Local: viral lesions of the mucous membranes and skin of various localization; therapy of SARS and influenza; prevention and complex treatment of stenosing recurrent laryngotracheobronchitis; complex treatment of exacerbations of chronic recurrent and acute herpetic infection of the mucous membranes and skin, including urogenital forms; complex treatment of herpetic cervicitis.
Suppositories, as part of complex treatment: pneumonia (viral, bacterial, chlamydial); SARS, including influenza, including those complicated by a bacterial infection; infectious and inflammatory pathology of newborns, including premature babies: sepsis, meningitis (viral, bacterial), intrauterine infection (herpes, chlamydia, cytomegalovirus infection, candidiasis, including visceral, enterovirus infection, mycoplasmosis); infectious and inflammatory pathology of the urogenital tract (cytomegalovirus infection, chlamydia, ureaplasmosis, gardnerellosis, trichomoniasis, papillomavirus infection, recurrent vaginal candidiasis, bacterial vaginosis, mycoplasmosis); chronic viral hepatitis B, C, D, including in combination with the use of hemosorption and plasmapheresis in chronic viral hepatitis of severe activity, which are complicated by cirrhosis of the liver; recurrent or primary herpetic infection of the mucous membranes and skin, mild to moderate course, localized form, including the urogenital form.

Method of application of interferon alfa-2b and dose

Interferon alpha-2b is administered intramuscularly, intravenously, subcutaneously; used in the form of candles; applied topically in the form of a gel, ointment, drops, spray. The method of administration, dose and regimen of therapy are set depending on the indications, individually.
In patients with pathology of the cardiovascular system, arrhythmia may develop when using interferon alfa-2b. If the arrhythmia does not decrease or increases, then the dose should be reduced by 2 times, or therapy should be discontinued. When using interferon alfa-2b, it is necessary to monitor mental and neurological status. With a strong inhibition of bone marrow hematopoiesis, it is necessary to conduct a regular study of the composition of peripheral blood. Interferon alfa-2b stimulates the immune system and therefore should be used with caution in patients who are prone to autoimmune disease due to an increased risk of autoimmune reactions. In patients receiving interferon alfa-2b preparations, antibodies can be detected in the blood plasma that neutralize the antiviral activity of interferon alfa-2b. Almost always, antibody titers are low, their appearance does not lead to a decrease in the effectiveness of therapy or the development of other autoimmune disorders.

Contraindications for use

Hypersensitivity, a history of severe pathology of the cardiovascular system (recent myocardial infarction, uncontrolled chronic heart failure, marked cardiac arrhythmias), severe hepatic and / and renal failure, epilepsy and / and other severe disorders of the central nervous system, especially manifested suicidal thoughts and attempts, depression (including a history), autoimmune hepatitis and other autoimmune pathologies, as well as the use of immunosuppressive drugs after transplantation, chronic hepatitis with decompensated liver cirrhosis and in patients during or after previous treatment with immunosuppressants (except for conditions after completion of short-term treatment with glucocorticosteroids), thyroid pathology that cannot be controlled by conventional medical methods, diabetes mellitus prone to ketoacidosis, decompensated pulmonary pathology (including chronic obstructive pulmonary disease), hypercoagulability (including pulmonary embolism, thrombophlebitis), severe myelosuppression, breastfeeding period , pregnancy.

Application restrictions

Violations of bone marrow hematopoiesis, kidney function, liver.

Use during pregnancy and lactation

Systemic use of interferon alfa-2b is contraindicated during pregnancy and lactation; topical use is possible only according to indications and only after consulting a doctor.

Side effects of interferon alfa-2b

Flu-like symptoms: chills, fever, pain in the joints, bones, eyes, headache, myalgia, dizziness, increased sweating;
digestive system: loss of appetite, nausea, diarrhea, vomiting, constipation, dry mouth, taste disturbance, mild abdominal pain, weight loss, changes in the functional state of the liver;
nervous system: dizziness, sleep disturbance, mental deterioration, memory impairment, nervousness, anxiety, aggressiveness, depression, euphoria, paresthesia, tremor, neuropathy, drowsiness, suicidal tendencies;
the cardiovascular system: tachycardia, arterial hypertension or hypotension, arrhythmia, coronary heart disease, disorders of the cardiovascular system, myocardial infarction;
respiratory system: cough, chest pain, slight shortness of breath, pulmonary edema, pneumonia;
hematopoietic system: leukopenia, granulocytopenia, thrombocytopenia;
skin reactions: alopecia, rash, itching; other: muscle stiffness, allergic reactions, formation of antibodies to recombinant or natural interferons.
For local use: allergic reactions.

Interferon alpha-2b interaction with other substances

Interferon alfa-2b reduces the clearance of theophylline by inhibiting its metabolism, so it is necessary to control the level of theophylline in the blood plasma and change its dosing regimen, if necessary. Use interferon alfa-2b with caution in conjunction with narcotic analgesics, sedatives, hypnotics, drugs that can have a myelosuppressive effect. When using interferon alfa-2b together with chemotherapeutic antitumor agents (cyclophosphamide, cytarabine, teniposide, doxorubicin), the risk of developing toxic effects increases.

Overdose

No data.

Trade names of drugs with the active substance interferon alfa-2b

Combined drugs:
Interferon alfa-2b + Taurine + Benzocaine: Genferon®;
Interferon alfa-2b + Taurine: Genferon® Light;
Interferon alpha-2b + Sodium hyaluronate: Gyaferon;
Interferon alfa-2b + Loratadine: Allergoferon®;
Interferon alfa-2b + Metronidazole + Fluconazole: Vagiferon®;
Betamethasone + Interferon alfa-2b: Allergoferon® beta;
Interferon alfa-2b + acyclovir + lidocaine: Gerpferon®;

Release form, composition and packaging

Injection transparent, colorless.

Excipients:

0.5 ml - ampoules (5) - blister packs (1) - cardboard packs.
0.5 ml - ampoules (5) - blister packs (2) - cardboard packs.
0.5 ml - bottles (1) - packs of cardboard.
0.5 ml - bottles (5) - blister packs (1) - cardboard packs.
0.5 ml - glass syringes (1) - blister packs (1) - cardboard packs.
0.5 ml - glass syringes (1) - blister packs (3) - cardboard packs.
0.5 ml - glass syringes (3) - blister packs (1) - cardboard packs.
0.5 ml - glass syringes (3) - blister packs (3) - cardboard packs.

Injection transparent, colorless.

Excipients: sodium acetate, sodium chloride, ethylenediamine tetraacetic acid disodium salt, tween-80, dextran 40, water for injection.

1 ml - ampoules (5) - blister packs (1) - cardboard packs.
1 ml - ampoules (5) - blister packs (2) - cardboard packs.
1 ml - bottles (1) - packs of cardboard.
1 ml - vials (5) - blister packs (1) - cardboard packs.
1 ml - glass syringes (1) - blister packs (1) - cardboard packs.
1 ml - glass syringes (1) - blister packs (3) - cardboard packs.
1 ml - glass syringes (3) - blister packs (1) - cardboard packs.
1 ml - glass syringes (3) - blister packs (3) - cardboard packs.

Clinical and pharmacological group

Interferon. Antitumor, antiviral and immunomodulatory drug

pharmachologic effect

Interferon. Altevir ® has antiviral, immunomodulatory, antiproliferative and antitumor effects.

Interferon alpha-2b, interacting with specific receptors on the cell surface, initiates a complex chain of changes inside the cell, including the induction of the synthesis of a number of specific cytokines and enzymes, disrupts the synthesis of viral RNA and viral proteins in the cell. The result of these changes is nonspecific antiviral and antiproliferative activity associated with the prevention of viral replication in the cell, inhibition of cell proliferation and the immunomodulatory effect of interferon. Interferon alpha-2b stimulates the process of antigen presentation to immunocompetent cells, has the ability to stimulate the phagocytic activity of macrophages, as well as the cytotoxic activity of T-cells and "natural killers" involved in antiviral immunity.

Prevents cell proliferation, especially tumor cells. It has a depressing effect on the synthesis of certain oncogenes, leading to inhibition of tumor growth.

Pharmacokinetics

Suction

With s / c or / m administration of interferon alfa-2b, its bioavailability ranges from 80% to 100%. After the introduction of interferon alpha-2b T max in plasma is 4-12 hours, T 1/2 - 2-6 hours. 16-24 hours after administration, recombinant interferon in the blood serum is not detected.

Metabolism

Metabolism is carried out in the liver.

Alpha interferons are able to disrupt oxidative metabolic processes, reducing the activity of microsomal liver enzymes of the cytochrome P450 system.

breeding

It is excreted mainly by the kidneys by glomerular filtration.

Indications for the use of the drug

As part of complex therapy in adults:

- in chronic viral hepatitis B without signs of cirrhosis of the liver;

- in chronic viral hepatitis C in the absence of symptoms of liver failure (monotherapy or combination therapy with ribavirin);

- with papillomatosis of the larynx;

- with genital warts;

- with hairy cell leukemia, chronic myeloid leukemia, non-Hodgkin's lymphoma, melanoma, multiple myeloma, Kaposi's sarcoma on the background of AIDS, progressive kidney cancer.

Dosing regimen

Apply s / c, / m and / in. Treatment must be started by a doctor. Further, with the permission of the doctor, the patient can administer a maintenance dose to himself (in cases where the drug is prescribed s / c or / m).

Chronic hepatitis B: Altevir ® is administered s / c or / m at a dose of 5-10 million IU 3 times a week for 16-24 weeks. Treatment is stopped after 3-4 months of use in the absence of positive dynamics (according to the DNA study of the hepatitis B virus).

Chronic hepatitis C: Altevir ® is administered s / c or / m at a dose of 3 million IU 3 times a week for 24-48 weeks. In patients with a relapsing course of the disease and patients who have not previously received treatment with interferon alfa-2b, the effectiveness of treatment increases with combination therapy with ribavirin. The duration of combination therapy is at least 24 weeks. Altevir therapy should be carried out for 48 weeks in patients with chronic hepatitis C and the 1st genotype of the virus with a high viral load, in which, by the end of the first 24 weeks of treatment, hepatitis C virus RNA is not detected in the blood serum.

Papillomatosis of the larynx: Altevir ® is injected s / c at a dose of 3 million IU / m 2 3 times a week. Treatment begins after surgical (or laser) removal of tumor tissue. The dose is selected taking into account the tolerability of the drug. Achieving a positive response may require treatment for 6 months.

Hairy cell leukemia: The recommended dose of Altevir for subcutaneous administration in patients with or without splenectomy is 2 million IU/m 2 3 times a week. In most cases, the normalization of one or more hematological parameters occurs after 1-2 months of treatment, it is possible to increase the duration of treatment up to 6 months. This dosing regimen should be followed continuously unless there is rapid progression of the disease or symptoms of severe intolerance to the drug.

Chronic myeloid leukemia: the recommended dose of Altevir as monotherapy is 4-5 million IU / m 2 per day s / c daily. To maintain the number of leukocytes, it may be necessary to use a dose of 0.5-10 million IU / m 2. If treatment can achieve control of the number of leukocytes, then to maintain hematological remission, the drug should be used at the maximum tolerated dose (4-10 million IU / m 2 daily). The drug should be discontinued after 8-12 weeks if therapy has not resulted in partial hematological remission or a clinically significant decrease in the number of leukocytes.

Non-Hodgkin's lymphoma: Altevir ® is used as adjuvant therapy in combination with standard chemotherapy regimens. The drug is administered s / c at a dose of 5 million IU / m 2 3 times a week for 2-3 months. The dose must be adjusted depending on the tolerability of the drug.

Melanoma: Altevir ® is used as adjuvant therapy in adults with a high risk of recurrence after tumor removal. Altevir ® is administered intravenously at a dose of 15 million IU/m 2 5 times a week for 4 weeks, then s/c at a dose of 10 million IU/m 2 3 times a week for 48 weeks. The dose must be adjusted depending on the tolerability of the drug.

multiple myeloma: Altevir ® is prescribed during the period of achieving a stable remission at a dose of 3 million IU / m 2 3 times a week s / c.

Kaposi's sarcoma on the background of AIDS: the optimal dose has not been established. The drug can be used in doses of 10-12 million IU / m 2 / day s / c or / m. In case of stabilization of the disease or response to treatment, therapy is continued until the tumor regresses or drug withdrawal is required.

Kidney cancer: the optimal dose and regimen have not been established. It is recommended to use the drug s / c in doses of 3 to 10 million IU / m 2 3 times a week.

Preparation of a solution for intravenous administration

The volume of Altevira solution necessary to prepare the required dose is collected, added to 100 ml of sterile 0.9% sodium chloride solution and administered over 20 minutes.

Side effect

General reactions: very often - fever, weakness (they are dose-dependent and reversible reactions, disappear within 72 hours after a break in treatment or its termination), chills; less often - malaise.

From the side of the central nervous system: very often - headache; less often - asthenia, drowsiness, dizziness, irritability, insomnia, depression, suicidal thoughts and attempts; rarely - nervousness, anxiety.

From the musculoskeletal system: very often - myalgia; less often - arthralgia.

From the digestive system: very often - loss of appetite, nausea; less often - vomiting, diarrhea, dry mouth, change in taste; rarely - abdominal pain, dyspepsia; possibly a reversible increase in liver enzymes.

From the side of the cardiovascular system: often - a decrease in blood pressure; rarely - tachycardia.

Dermatological reactions: less often - alopecia, increased sweating; rarely - skin rash, skin itching.

From the hematopoietic system: possible reversible leukopenia, granulocytopenia, decreased hemoglobin levels, thrombocytopenia.

Others: rarely - weight loss, autoimmune thyroiditis.

Contraindications to the use of the drug

- severe cardiovascular disease in history (uncontrolled chronic heart failure, recent myocardial infarction, marked cardiac arrhythmias);

- severe renal and / or liver failure (including those caused by the presence of metastases);

- epilepsy, as well as severe disorders of the central nervous system, especially expressed by depression, suicidal thoughts and attempts (including history);

- chronic hepatitis with decompensated liver cirrhosis and in patients receiving or recently treated with immunosuppressants (with the exception of a completed short-term course of treatment with corticosteroids);

- autoimmune hepatitis or other autoimmune disease;

- treatment with immunosuppressants after transplantation;

- thyroid disease that cannot be controlled by conventional therapeutic methods;

- decompensated lung diseases (including COPD);

- decompensated diabetes mellitus;

- hypercoagulation (including thrombophlebitis, pulmonary embolism);

- severe myelodepression;

- pregnancy;

- lactation period (breastfeeding);

- Hypersensitivity to the components of the drug.

The use of the drug during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Application for violations of liver function

Application for violations of kidney function

The drug is contraindicated in severe renal and / or hepatic insufficiency (including those caused by the presence of metastases).

special instructions

Prior to treatment with Altevir for chronic viral hepatitis B and C, a liver biopsy is recommended to assess the degree of liver damage (signs of an active inflammatory process and / or fibrosis). The effectiveness of the treatment of chronic hepatitis C is increased with combination therapy with Altavir and ribavirin. The use of Altevira is not effective in the development of decompensated liver cirrhosis or hepatic coma.

In case of side effects during treatment with Altevir, the dose of the drug should be reduced by 50% or the drug should be temporarily discontinued until they disappear. If side effects persist or reappear after a dose reduction, or progression of the disease is observed, then treatment with Altevir should be discontinued.

If the level of platelets is below 50x10 9 /l or the level of granulocytes is below 0.75x10 9 /l, it is recommended to reduce the dose of Altevir by 2 times with a blood test control after 1 week. If these changes persist, the drug should be discontinued.

If the level of platelets is below 25x10 9 /l or the level of granulocytes is below 0.5 x10 9 /l, it is recommended to cancel the drug Altevir ® with a blood test control after 1 week.

In patients receiving interferon alfa-2b preparations, antibodies can be detected in the blood serum that neutralize its antiviral activity. In almost all cases, antibody titers are low, their appearance does not lead to a decrease in the effectiveness of treatment or the occurrence of other autoimmune disorders.

Overdose

Data on an overdose of the drug Altevir ® are not provided.

drug interaction

Drug interactions between Altevir and other drugs have not been fully studied. Altevir ® should be used with caution simultaneously with hypnotics and sedatives, narcotic analgesics and drugs that have a potential myelodepressive effect.

With the simultaneous appointment of Altevir and theophylline, the concentration of the latter in the blood serum should be monitored and, if necessary, the dosage regimen should be changed.

When using Altevir in combination with chemotherapy drugs (cytarabine, cyclophosphamide, doxorubicin, teniposide), the risk of developing toxic effects increases.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children, in accordance with SP 3.3.2-1248-03 at a temperature of 2° to 8°C; do not freeze. Expiry date - 18 months.

Transport at temperatures from 2° to 8°C; do not freeze.

This section presents instructions for use of interferons alfa 2b and alfa 2a the first generation, which are also called linear, simple or short-lived. The only advantage of these preparations is the comparatively low price.

Back in 1943, W. and J. Hale discovered the so-called interference phenomenon. The initial concept of interferon was as follows: a factor that prevents the reproduction of viruses. In 1957, the English scientist Alik Isaacs and the Swiss researcher Gene Lindenman singled out this factor, clearly described it and named it interferon.

Interferon (IFN) is a protein molecule that is produced in the human body. The "recipe" for its synthesis (interferon gene) is encoded in the human genetic apparatus. Interferon is one of the cytokines, signaling molecules that play an important role in the functioning of the immune system.

Over the past half century since the discovery of IFN, dozens of properties of this protein have been studied. From a medical point of view, the main ones are antiviral and antitumor functions.

The human body produces about 20 species - a whole family - of interferons. IFN is divided into two types: I and II.

Type I IFN - alpha, beta, omega, theta - are produced and secreted by most body cells in response to the action of viruses and some other agents. Type II IFN includes interferon gamma, which is produced by cells of the immune system in response to the action of foreign agents.

Initially, interferon preparations were obtained only from donor blood cells; they were called: leukocyte interferons. In 1980, the era of recombinant, or genetically engineered, interferons began. The production of recombinant drugs has become much cheaper than obtaining similar drugs from donated human blood or other biological raw materials; their production does not use donated blood, which can serve as a source of infection. Recombinant drugs do not contain foreign impurities and therefore have fewer side effects. Their therapeutic potential is higher than that of similar natural preparations.

For the treatment of viral diseases, in particular hepatitis C, interferon alfa (IFN-α) is predominantly used. Distinguish between "simple" ("short-lived") interferons alpha 2b and alpha 2a and pegylated (peginterferon alfa-2a and peginterferon alfa-2b). "Simple" interferons are practically not used in the EU and the USA, but in our country, due to their comparative cheapness, they are used quite often. In the treatment of hepatitis C, both forms of "short" IFN-α are used: interferon alfa-2a and interferon alfa-2b (which differ in one amino acid). Injections with simple interferons are usually done every other day (with peginterferons - once a week). The effectiveness of treatment with short-lived IFNs when administered every other day is lower than with peginterferons. Some experts recommend daily injections of "simple" IFN, since the effectiveness of AVT is somewhat higher.

The range of "short" IFN is quite wide. They are produced by different manufacturers under different names: Roferon-A, Intron A, Laferon, Reaferon-EC, Realdiron, Eberon, Interal, Altevir, Alfarona and others.
The most studied (respectively, expensive) are Roferon-A and Intron-A. The effectiveness of treatment with these IFN in combination with ribavirin, depending on the virus genotype and other factors, ranges from 30% to 60%. A list of the main brands of manufacturers of simple interferons and their description are given in the table.

All interferons should be stored refrigerated (+2 to +8 degrees Celsius). They must not be heated or frozen. Do not shake or expose the drug to direct sunlight. It is necessary to transport drugs in special containers.

Included in medications

Included in the list (Decree of the Government of the Russian Federation No. 2782-r dated December 30, 2014):

VED

ONLS

ATH:

L.03.A.B.05 Interferon alfa-2b

Pharmacodynamics:

Interferon. It is a highly purified recombinant with a molecular weight of 19,300 daltons. Derived from a clone Escherichia coli by hybridization of bacterial plasmids with the human leukocyte gene encoding the synthesis of interferon. Unlike interferon, alpha-2a is at position 23.

It has an antiviral effect, which is due to interaction with specific membrane receptors and induction of RNA synthesis and, ultimately, proteins. The latter, in turn, prevent the normal reproduction of the virus or its release.

It has immunomodulatory activity, which is associated with the activation of phagocytosis, stimulation of the formation of antibodies and lymphokines.

It has an antiproliferative effect on tumor cells.

The drug increases the phagocytic activity of macrophages, potentiates the cytotoxic effect of lymphocytes.

Pharmacokinetics:

It penetrates into the systemic circulation through the mucous membrane of the respiratory tract, undergoes decay in the body, and is partially excreted unchanged, mainly through the kidneys. Topical application for the treatment of viral infections provides a high concentration of interferon in the focus of inflammation. It is metabolized by the liver, the half-life is 2-6 hours.

Indications:

chronic hepatitis B;

hairy cell leukemia;

Renal cell carcinoma;

Dermal T -cell lymphoma (mycosis fungoides and Cesari's syndrome);

IN viral hepatitis B;

IN viral active hepatitis C;

Chronic myeloid leukemia;

Kaposi's sarcoma on the background of AIDS;

malignant melanoma;

- primary (essential) and secondary thrombocytosis;

- transitional form of chronic granulocytic leukemia and myelofibrosis;

- multiple myeloma;

kidney cancer;

- reticulosarcoma;

- multiple sclerosis;

- prevention and treatment of influenza and acute respiratory viral infection.

I.B15-B19.B16 Acute hepatitis B

I.B15-B19.B18.1 Chronic viral hepatitis B without delta agent

I.B15-B19.B18.2 Chronic viral hepatitis C

I.B20-B24.B21.0 HIV disease with manifestations of Kaposi's sarcoma

II.C43-C44.C43.9 Malignant melanoma of the skin, unspecified

II.C64-C68.C64 Malignant neoplasm of the kidney other than the renal pelvis

II.C81-C96.C84 Peripheral and cutaneous T-cell lymphomas

II.C81-C96.C84.0 Fungal mycosis

II.C81-C96.C84.1 Cesari's disease

II.C81-C96.C91.4 Hairy cell leukemia (Leukemic reticuloendotheliosis)

II.C81-C96.C92.1 Chronic myeloid leukemia

Contraindications:

D uncompensated cirrhosis of the liver;

P sychosis;

P hypersensitivity to interferon alfa-2 b;

- severe cardiovascular disease;

T I wish depression;

A alcohol or drug addiction;

- autoimmune diseases;

- acute myocardial infarction;

- severe disorders of the hematopoietic system;

-epilepsy and / or other disorders of the central nervous system;

-chronic hepatitis in patients receiving or shortly before receiving immunosuppressant therapy (with the exception of short-term prior treatment with steroids).

Carefully:

-liver disease;

W kidney disease;

-violation of bone marrow hematopoiesis;

-susceptibility to autoimmune diseases;

-prone to suicidal attempts.

Pregnancy and lactation:

FDA category C recommendation. No safety data available. Do not apply! Use during pregnancy is only possible if the potential benefit to the mother outweighs the potential harm to the baby.

During the use of the drug, contraceptive methods should be used.

There is no information about penetration into breast milk. Do not use while breastfeeding.

Dosage and administration:

Enter intravenously or subcutaneously. The dose is set individually depending on the diagnosis and the individual indicators of the patient.

Subcutaneous injection at a dose of 0.5-1 mcg/kg once a week for 6 months. The dose is selected taking into account the expected efficacy and safety. If after 6 months the elimination of virus RNA from the serum occurs, then treatment is continued for up to one year. If adverse reactions occur during treatment, then the dose is reduced by 2 times. If adverse effects persist or reappear after a dose change, treatment is stopped. Reducing the dose is also recommended when the number of neutrophils is less than 0.75×10 9 /l or the number of platelets is less than 50×10 9 /l. Therapy is stopped when the number of neutrophils is less than 0.5×10 9 /l or platelets - less than 25×10 9 /l. In case of severe renal impairment (clearance less than 50 ml / min), patients should be under constant supervision. If necessary, the weekly dose of the drug is reduced. Changing the dose based on age is not required.

Preparation of the solution: the powdered contents of the vial are dissolved in 0.7 ml of water for injection, the vial is gently shaken until the powder is completely dissolved. The finished solution should be inspected before administration; in case of color change, it should not be used. For administration, up to 0.5 ml of the solution is used, the remains are disposed of.

For the treatment of influenza and SARS- aerosol for topical application 100,000 ME, administered 7 times a day, every 2 hours (daily dose - up to 20,000 ME) in the first two days of the disease, then 3 times a day (daily dose - up to 10,000 ME) during five days or until the symptoms disappear completely.

Interferon therapy is carried out against the background of traditional symptomatic therapy, including the use of non-steroidal anti-inflammatory drugs (,) with an increase in temperature above 38.5 ° C, antihistamines (diazolin, suprastin, tavegil), antitussives (codelac), mucolytic drugs (cough mixture,) , fortifying agents (calcium gluconate, vitamins).

Side effects:

From the gastrointestinal tract: decreased appetite, vomiting, constipation, dry mouth, mild abdominal pain, nausea, diarrhea,violation of taste sensations, weight loss, slight changes in liver function tests.

From the nervous system: dizziness, sleep disturbance, anxiety, aggressiveness, depression, neuropathy, suicidal tendencies, mental deterioration,memory impairment, nervousness, euphoria, paresthesia, tremor, drowsiness.

From the circulatory system: arterial hypotension or hypertension, disorders of the cardiovascular system, myocardial infarction, thrombocytopenia, tachycardia,arrhythmia, ischemic heart disease, leukopenia, granulocytopenia.

From the respiratory system: cough, pneumonia, chest pain,slight shortness of breath, pulmonary edema.

From the side of the skin: reversible alopecia, itching.

Others: antibodies to natural or recombinant interferons, muscle stiffness, flu-like symptoms.

Overdose:

No data.

Interaction:

The drug inhibits the metabolism of theophylline.

Special instructions:

During the period of use of the drug, it is necessary to monitor the mental and neurological status of the patient.

In patients with diseases of the cardiovascular system, arrhythmia is possible. If the arrhythmia does not decrease or increases, the dose should be reduced by 2 times, or treatment should be stopped.

With severe inhibition of bone marrow hematopoiesis, a regular study of the composition of peripheral blood is necessary.

Influence on the ability to drive vehicles and other technical devices

The drug in the form of an aerosol does not affect the ability to drive vehicles and maintain moving mechanisms.

Instructions

2018-02-02T17:43:00+03:00

Proven effectiveness of interferon alfa 2b

For the first time, the world learned about interferon - a natural protein of the human body in 1957, when scientists Alik Isaacs and Jean Lindenmann discovered such a phenomenon as interference - a complex mechanism of biological processes, thanks to which the body is able to fight various diseases. But in the last century, they probably did not suspect that this protein would become the main component of many drugs.

Interferons are proteins that are produced by body cells when viruses are introduced into them. Thanks to them, the activation of genes responsible for the synthesis of protective intracellular molecules, which provide an antiviral effect by suppressing the synthesis of virus proteins and preventing its reproduction, occurs. In other words, these proteins (they are also called cytokines) in our body act as powerful defenders who guard health and strictly watch in order to immediately repel the attack of viruses and defeat the disease if necessary.

To protect the organism infected with viruses, interferon is produced by almost all cells of our body. In addition, its formation can be stimulated not only by viruses, but also by bacterial toxins, so this protein is also effective in certain bacterial infections. Thus, it can be concluded that this cytokine is a very important component of the human immune system. Without it, humanity would have long ago defeated numerous viruses and bacteria.

Types of interferons

Interferons are divided into three types: alpha, beta and gamma, which are produced by different cells.

Interferon alpha activates the so-called natural killers - leukocytes, which destroy viruses, bacteria and other "enemy" agents.
Interferon beta is formed in fibroblasts, epithelial cells and macrophages that absorb infectious agents.
Interferon gamma is produced by T-lymphocytes, its main function, as well as other types, is the regulation of immunity.

What proved the effectiveness of interferon in ARVI?

As you know, in their activities when prescribing therapy, doctors rely on their experience and the already established system of knowledge. But medicine is developing rapidly: every year new effective methods of treatment are developed in the world and new drugs are patented. Therefore, there was a need to systematize the latest achievements and discoveries in medicine, resulting in clinical recommendations and treatment standards. These documented algorithms, based on proven clinical experience, describe the instructions for diagnosis, treatment, rehabilitation, disease prevention necessary to carry out, and help the doctor make decisions on the choice of therapy tactics in a given situation.

For example, on the issues of providing medical care to children on the problem of acute respiratory viral infections and influenza, the development team consists of approximately 40 people and includes leading Russian experts in the field of infectious diseases from various institutions and various departments. It is logical that specialists pay special attention to medicines that are able to cope with diseases as quickly as possible and at the same time have a minimum of side effects. Now we are talking about drugs containing interferon, which help fight SARS in adults and children.

As mentioned above, their ability to fight viruses was discovered during the study of interference by scientists Isaacs and Lindenmann. They described interferon as “a protein, much smaller than immunoglobulins, that is produced by body cells after infection with live or inactivated viruses; capable of inhibiting the growth of a variety of viruses at doses that are non-toxic to cells.” To date, it is known that these proteins can be produced by almost all cells of the body in response to the introduction of foreign information, regardless of its etiology (viruses, fungi, bacteria, intracellular pathogens, oncogenes). And their main biological effect lies in the processes of recognition and removal of this alien information. In other words, these protective molecules "know how" to gently and accurately destroy the viruses that have occupied the cells, without damaging the cells themselves. This has been confirmed by numerous scientific studies.

As for the methods of using drugs containing interferons, here it is necessary to mention some of the nuances. One of the main problems of interferon therapy is to "deliver" the effective dose of the drug, while not causing negative consequences. In some cases, intramuscular or intravenous administration of drugs containing interferon leads to side effects in the form of fever, chills, headache and other adverse events. These symptoms are not critical for the body and soon pass, but in the process of treatment they cause discomfort.

The use of suppositories containing interferon alfa-2b made it possible to minimize the side effects of interferon therapy or completely dispense with them. According to scientific research, rectal use of recombinant human interferon in the first days of ARVI reduces the duration of fever, fights the common cold and allows you to quickly defeat the disease 2 . Intranasal use of drugs (when the drug is applied to the nasal mucosa) containing interferon alfa-2b complements the treatment and ensures the optimal effect of therapy. One of the drugs that is suitable for fighting influenza and other acute respiratory viral infections at any stage of the disease is VIFERON. It is available in the form of suppositories (candles), gel and ointment.

Brief instructions for the use and tolerance of drugs containing interferon alfa-2b

Who can take VIFERON preparations:

adults;
children from the first days of life;
pregnant women from the 4th week of gestation.

Recognition by the scientific community

Interferon alfa-2b (VIFERON) is included in three federal standards for the provision of medical care as a recommended drug for the treatment of influenza and SARS, as well as in three Federal Protocols for the treatment of these diseases. 1 If we take into account not only influenza and SARS, but also other diseases, then the number of standards and recommendations regarding this drug is even greater - interferon (VIFERON) is included in 30 federal standards for providing medical care to adults and children approved by the Ministry of Health of the Russian Federation, as well as in 21 Protocol (Clinical guidelines) for the provision of medical care to adults, including pregnant women, and children.

The principle of the drug

Interferon alfa-2b human recombinant, which is part of the drug VIFERON, has antiviral, immunomodulatory properties and inhibits the replication of RNA- and DNA-containing viruses. Antiviral therapy against influenza can be started at any phase of the disease. This will help improve the condition and prevent the development of complications 2 . The VIFERON preparation includes generally recognized highly active antioxidants: in suppositories these are vitamins E and C, in ointment - vitamin E, in the gel - vitamin E, citric and benzoic acids. Against the background of such antioxidant support, an increase in the antiviral activity of interferons is noted.

Drug test results

VIFERON has passed a full cycle of clinical trials for a wide range of different diseases in leading clinics in Russia. The result of the studies was the proof of the therapeutic and prophylactic efficacy of VIFERON in various infectious and inflammatory diseases in adults and children, including newborns, and pregnant women. It has been scientifically proven that the complex composition and form of release provides the drug VIFERON with unique pharmacokinetic characteristics, with prolongation of the action of interferon in the absence of side effects inherent in parenteral preparations of recombinant interferons 3 .

What diseases are interferon-based drugs used for?alpha-2 b

The drug VIFERON in the form of suppositories, gel and ointment is used to treat the following diseases:

SARS, including influenza;
herpes;
papillomavirus infection;
enterovirus infection;
laryngotracheobronchitis;
chronic hepatitis B, C, D, including those complicated by cirrhosis of the liver;
bacterial vaginosis;
candidiasis;
mycoplasmosis;
ureaplasmosis;
gardnerellosis.

The use of the drug VIFERON as part of complex antiviral therapy makes it possible to reduce the therapeutic doses of antibacterial and hormonal drugs, as well as to reduce the toxic effects of this therapy.

General doctor

http://www.rosminzdrav.ru, Order of the Ministry of Health of the Russian Federation, http://www.raspm.ru; http://www.niidi.ru; http://www.pediatr-russia.ru; http://www.nnoi.ru
Nesterova I.V. “Interferon preparations in clinical practice: when and how”, “Attending Doctor”, September 2017.
"VIFERON - a complex antiviral and immunomodulatory drug for the treatment of infectious and inflammatory diseases in perinatology." (Guide for doctors), Moscow, 2014.

Sources used: http://www.lsgeotar.ru