Recombinant interferon alpha 2b in solution. Interferons and their role in clinical medicine. From the treatment of influenza to the treatment of complex viral and bacterial infections. Conditions for dispensing from pharmacies

Interferon alpha-2b was obtained from a clone of Escherichia coli by hybridizing bacterial plasmids with the gene of human leukocytes, which encode the synthesis of interferon. By 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 some specific enzymes and cytokines, and disrupts the formation of RNA and proteins inside the virus cells. As a result of these changes, antiproliferative and nonspecific antiviral activity appears, which is associated with slowing down cell proliferation, preventing virus replication within 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 take part in the antiviral response. The drug prevents cell proliferation, especially tumor cells. It has an inhibitory effect on the formation of certain oncogenes, which lead to inhibition of tumor growth. With subcutaneous or intramuscular injection 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. 16–24 hours after administration, the drug is not detected in the blood plasma. Metabolized in the liver.

Indications

Intravenous, intramuscular, subcutaneous: as part of complex treatment in adults: chronic viral hepatitis C without signs liver failure; chronic viral hepatitis B without signs of liver cirrhosis; genital warts, laryngeal papillomatosis; chronic myeloid leukemia; hairy cell leukemia; non-Hodgkin's lymphoma; multiple myeloma; advanced kidney cancer; melanoma; Kaposi's sarcoma due to AIDS.
Locally: viral lesions of mucous membranes and skin various localizations; therapy for ARVI and influenza; prevention and complex treatment of stenotic recurrent laryngotracheobronchitis; complex treatment of exacerbations of chronic recurrent and acute herpetic infections of the mucous membranes and skin, including urogenital forms; complex treatment of herpetic cervicitis.
Suppositories, as part of complex treatment: pneumonia (viral, bacterial, chlamydial); ARVI, including influenza, including those complicated by 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 for chronic viral hepatitis of severe activity, which is complicated by cirrhosis of the liver; recurrent or primary herpetic infection mucous membranes and skin, mild to moderate, localized form, including the urogenital form.

Method of administration 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 gel, ointment, drops, spray. The method of administration, dose and treatment regimen are determined depending on the indications, individually.
In patients with pathology of cardio-vascular system Arrhythmia may develop when using interferon alfa-2b. If the arrhythmia does not decrease or increases, then the dose must be reduced by 2 times, or therapy should be discontinued. When using interferon alfa-2b, it is necessary to monitor mental and neurological status. If bone marrow hematopoiesis is severely suppressed, regular examination of the composition of peripheral blood should be carried out. Interferon alpha-2b stimulates immune system Therefore, it should be used with caution in patients who are prone to autoimmune diseases, due to the increased risk of autoimmune reactions. In patients receiving interferon alfa-2b preparations, antibodies may 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, history of severe pathology of the cardiovascular system (recent myocardial infarction, uncontrolled chronic heart failure, severe heart rhythm disturbances), severe hepatic and/or renal failure, epilepsy and/or others severe violations work of the central nervous system, especially manifested by suicidal thoughts and attempts, depression (including in history), autoimmune hepatitis and other autoimmune pathologies, as well as the use of immunosuppressive drugs after transplantation, chronic hepatitis with decompensated cirrhosis of the liver and in patients with or after previous treatment with immunosuppressants (except for conditions after completion of short-term treatment with glucocorticosteroids), pathology thyroid gland, which cannot be controlled by generally accepted therapeutic methods, diabetes, prone to ketoacidosis, decompensated pulmonary pathology (including chronic obstructive pulmonary disease), hypercoagulability (including thromboembolism pulmonary artery, thrombophlebitis), severe myelosuppression, period breastfeeding, pregnancy.

Restrictions on use

Disturbances of bone marrow hematopoiesis, kidney and liver function.

Use during pregnancy and breastfeeding

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

Side effects of interferon alfa-2b

Flu-like symptoms: chills, fever, pain in joints, bones, eyes, headache, myalgia, dizziness, increased sweating;
digestive system: loss of appetite, nausea, diarrhea, vomiting, constipation, dry mouth, impaired taste, mild abdominal pain, weight loss, changes in liver function indicators;
nervous system: dizziness, sleep disturbance, deterioration of mental activity, memory impairment, nervousness, anxiety, aggressiveness, depression, euphoria, paresthesia, tremor, neuropathy, drowsiness, suicidal tendencies;
the cardiovascular system: tachycardia, arterial hypertension or hypotension, arrhythmia, ischemic disease 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, therefore it is necessary to monitor the level of theophylline in the blood plasma and change its dosage regimen, if necessary. Use interferon alfa-2b with caution in combination with narcotic analgesics, sedatives, sleeping pills, agents that may have a myelosuppressive effect. When using interferon alfa-2b along with chemotherapy antitumor agents(cyclophosphamide, cytarabine, teniposide, doxorubicin) increases the risk of developing toxic effects.

Overdose

No data.

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

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

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

Proven effectiveness of interferon alpha 2b

The world first learned about interferon, a natural protein in the human body, in 1957, when scientists Alik Isaacs and Jean Lindenmann discovered the phenomenon of interference - complex mechanism biological processes through 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 medications.

Interferons are proteins that are produced by body cells when viruses invade them. Thanks to them, genes responsible for the synthesis of protective intracellular molecules are activated, which provide an antiviral effect by suppressing the synthesis of viral proteins and preventing its reproduction. In other words, these proteins (they are also called cytokines) in our body act as powerful defenders who guard our health and keep a strict vigil so that, if necessary, we can immediately repel the attack of viruses and defeat the disease.

To protect the body 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 against some bacterial infections. Thus, we can conclude that this cytokine is a very important component of the human immune system. Without it, humanity would have been defeated long ago by 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 killer cells– leukocytes that destroy viruses, bacteria and other “enemy” agents.
• Interferon beta is produced in fibroblasts, epithelial cells and macrophages, which absorb infectious agents.
• Interferon gamma is produced by T-lymphocytes, its main function, like other types, is the regulation of immunity.

How has the effectiveness of interferon been proven for ARVI?

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

For example, regarding the provision of medical care children on the problem of ARVI and influenza, the development group numbers approximately 40 people and includes leading Russian specialists in the field of infectious diseases from various institutions and departments. It is logical that experts pay special attention medical drugs, which 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 ARVI 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 the body's cells after infection with live or inactivated viruses; capable of inhibiting the growth of a variety of viruses in doses that are non-toxic to cells.” Today 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 foreign information. In other words, these protective molecules “know how” to gently and accurately destroy viruses that have occupied cells, without damaging the cells themselves. This has been confirmed by numerous scientific studies.

As for the methods of using drugs containing interferons, it is necessary to mention some nuances. One of the main problems of interferon therapy is to “deliver” the effective dose of the drug without causing negative consequences. In some cases, intramuscular or intravenous administration medications containing interferon lead to side effects such as fever, chills, headache and other undesirable effects. These symptoms are not critical for the body and soon disappear, but during the treatment process they cause discomfort.

The use of suppositories containing interferon alfa-2b has made it possible to minimize the side effects of interferon therapy or to do without them altogether. According to scientific research, rectal application of recombinant human interferon in the first days of the disease, ARVI reduces the duration of fever, fights the runny nose and allows you to quickly defeat the disease 2. Intranasal use of drugs (when the medicine 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 use and tolerability of drugs containing interferon alfa-2b

Who can take VIFERON drugs:

• 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 of medical care as a recommended drug for the treatment of influenza and ARVI, as well as in three Federal Protocols for the treatment of these diseases. 1 If we take into account not only influenza and ARVI, 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 provision of medical care to adults and children, approved by the Ministry of Health of the Russian Federation, as well as in Protocol 21 ( Clinical guidelines) providing medical care to adults, including pregnant women, and children.

The principle of action of the drug

Human recombinant interferon alpha-2b, which is part of the drug VIFERON, has antiviral, immunomodulatory properties and suppresses the replication of RNA and DNA 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 drug VIFERON includes generally recognized highly active antioxidants: in suppositories these are vitamins E and C, in ointments - vitamin E, in 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 passed a full cycle of clinical trials with wide range various diseases in leading clinics in Russia. The result of the studies was evidence of the therapeutic and prophylactic effectiveness of the drug VIFERON for various infectious and inflammatory diseases in adults and children, including newborns, and pregnant women. It has been scientifically proven that the complex composition and release form 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.

For what diseases are interferon-based drugs used?alpha-2 b

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

• ARVI, 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 therapeutic doses of antibacterial and hormonal drugs. medicines, as well as reduce the toxic effects of this therapy.

General doctor

1. http://www.rosminzdrav.ru, Order of the Ministry of Health Russian Federation, http://www.raspm.ru; http://www.niidi.ru; http://www.pediatr-russia.ru; http://www.nnoi.ru
2. Nesterova I.V. "Interferon preparations in clinical practice: when and how,” “Attending Physician,” September 2017.
3. “VIFERON is 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

substance-solution: packs Reg. No.: LSR-007009/08

Clinical and pharmacological group:

Release form, composition and packaging

substance -solution.

bottles (1) - cardboard packs.

Description of the active components of the drug " Interferon alpha-2b»

pharmachologic effect

Interferon. It is a highly purified recombinant protein with molecular weight 19,300 daltons. Obtained from an Escherichia coli clone by hybridizing bacterial plasmids with the human leukocyte gene encoding the synthesis of interferon. Unlike interferon, alpha-2a has arginine 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.

Has an antiproliferative effect on tumor cells.

Indications

Acute hepatitis B, chronic hepatitis B, chronic hepatitis C.

Hairy cell leukemia, chronic myeloid leukemia, renal cell carcinoma, Kaposi's sarcoma due to AIDS, cutaneous T-cell lymphoma (mycosis fungoides and Sézary syndrome), malignant melanoma.

Dosage regimen

Administered intravenously or subcutaneously. The dose and treatment regimen are set individually, depending on the indications.

Side effect

Flu-like symptoms: often - fever, chills, pain in bones, joints, eyes, myalgia, headache, increased sweating, dizziness.

From the outside digestive system: possible decreased appetite, nausea, vomiting, diarrhea, constipation, impaired taste, dry mouth, weight loss, mild abdominal pain, slight changes in liver function tests (usually normalized after treatment).

From the central nervous system and peripheral nervous system: rarely - dizziness, deterioration of mental activity, sleep disturbance, memory impairment, anxiety, nervousness, aggressiveness, euphoria, depression (after long-term treatment), paresthesia, neuropathy, tremor; in some cases - suicidal tendencies, drowsiness.

From the cardiovascular system: possible - tachycardia (with fever), arterial hypotension or hypertension, arrhythmia; in some cases - disorders of the cardiovascular system, coronary artery disease, myocardial infarction.

From the outside respiratory system: rarely - chest pain, cough, slight shortness of breath; in some cases - pneumonia, pulmonary edema.

From the hematopoietic system: possible slight leukopenia, thrombocytopenia, granulocytopenia.

Dermatological reactions: possible itching, reversible alopecia.

Others: rarely - muscle stiffness; in isolated cases - antibodies to natural or recombinant interferons.

Contraindications

Heavy cardiovascular diseases, decompensated cirrhosis of the liver, severe depression, psychosis, alcohol or drug addiction, increased sensitivity to interferon alpha-2b.

Pregnancy and lactation

Use during pregnancy is possible only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

It is not known whether interferon alfa-2b is excreted in breast milk. If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.

Women of childbearing age should use reliable contraception during treatment.

Use for liver dysfunction

Contraindicated in decompensated liver cirrhosis. Use with caution in patients with impaired liver function.

Use for renal impairment

Use with caution in patients with impaired renal function.

special instructions

Use with caution in patients with impaired renal, liver, bone marrow hematopoiesis, or with a tendency to suicide attempts.

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.

During the treatment period, monitoring of neurological and mental status is necessary.

In cases of severe suppression of bone marrow hematopoiesis, regular examination of the composition of peripheral blood is necessary.

Interferon alfa-2b has a stimulating effect on the immune system and should be used with caution in patients prone to autoimmune diseases due to an increased risk of autoimmune reactions.

Drug interactions

Drug interactions

Interferon alfa-2b inhibits the metabolism of theophylline and reduces its clearance.

The drug is synthesized by bacterial cells of the Escherichia coli strain SG-20050/pIF16, in the genetic apparatus of which the human interferon alpha-2b gene is integrated. The drug is a protein that contains 165 amino acids; it is identical in properties and characteristics to human leukocyte interferon alpha-2b. The antiviral effect manifests itself during virus reproduction; the drug is actively involved in the metabolic processes of cells. Reacting with specific receptors on the surface of cells, the drug initiates a number of intracellular changes, including the production of specific enzymes (protein kinase and 2-5-adenylate synthetase) and cytokines, the action of which slows down the synthesis of viral ribonucleic acid in the cell and viral protein. Increases the phagocytic activity of macrophages, enhances the specific cytotoxic effect of lymphocytes on target cells. Changes the functional activity of immunocompetent cells, the qualitative and quantitative composition of excreted cytokines, the formation and secretion of intracellular proteins. Suppresses the proliferation of tumor cells and the formation of certain oncogenes, which inhibits tumor growth.
The maximum concentration of the drug when administered parenterally is achieved after 2 - 4 hours. 20 - 24 hours after administration, the drug is not detected in the blood plasma. The concentration of the drug in the blood serum directly depends on the frequency and dose of administration. Metabolized in the liver, excreted mainly through the kidneys, partly unchanged.

Indications

Therapy and prevention of influenza and acute respiratory viral infections; emergency prevention tick-borne encephalitis together with anti-tick immunoglobulin; atopic diseases, allergic rhinoconjunctivitis, bronchial asthma when carrying out specific immunotherapy.
Complex treatment in adults: acute viral hepatitis B (moderate and severe forms at the beginning of the jaundice period until the fifth day of jaundice (in late dates the drug is less effective; in case of cholestatic course of the disease and developing hepatic coma, the drug is not effective); acute protracted hepatitis B and C, chronic active hepatitis B and C, chronic hepatitis B with delta agent; hairy cell leukemia, stage IV kidney cancer, malignant skin lymphomas (primary reticulosis, mycosis fungoides, reticulosarcomatosis), basal cell and squamous cell carcinoma intestines, Kaposi's sarcoma, subleukemic myelosis, keratoacanthoma, Langerhans cell histiocytosis, chronic myeloid leukemia, essential thrombocythemia; viral conjunctivitis, keratitis, keratoconjunctivitis, keratouveitis, keratoiridocyclitis; urogenital chlamydial infection; febrile and meningeal form of tick-borne encephalitis.
Complex treatment for children from 1 year of age: respiratory papillomatosis of the larynx, starting with next day after removal of papillomas; acute lymphoblastic leukemia in remission after the end of induction chemotherapy (at 4-5 months of remission).

Method of use of human recombinant interferon alpha-2b and dose

Human recombinant interferon alpha-2b is administered intramuscularly, subcutaneously, into the lesion, subconjunctivally, taken orally, and used topically. The method of administration, dose, regimen and duration of treatment are established individually depending on the indications, age, condition of the patient, and tolerability of the drug.
During treatment, general clinical blood tests must be performed every 2 weeks, biochemical tests - every 4 weeks. If the absolute number of neutrophils decreases to less than 0.50 X 10^9/l, and the number of platelets less than 25 X 10^9/l, therapy should be discontinued. If the absolute number of neutrophils decreases to less than 0.75 X 10^9/l, and the number of platelets less than 50 X 10^9/l, it is recommended to temporarily reduce the dose of the drug by 2 times and repeat the analysis after 1 - 2 weeks; If changes persist, it is recommended to discontinue therapy.
The patient should be closely monitored if signs of liver dysfunction appear. Use of the drug should be discontinued if symptoms progress.
When reactions develop hypersensitivity (angioedema, urticaria, anaphylaxis, bronchospasm), the drug is discontinued and appropriate drug treatment is immediately prescribed.
Must be carefully monitored functional state kidneys in the presence of mild to moderate renal dysfunction.
With prolonged use of the drug, the development of pneumonia and pneumonitis is possible. Relief of pulmonary syndromes is facilitated by timely discontinuation of the drug and the prescription of glucocorticosteroids.
If changes occur in the central nervous system and/or psyche, including depression, observation by a psychiatrist is necessary during treatment and for six months after its completion. After cessation of treatment, these disorders are usually quickly reversible, but sometimes it takes up to 3 weeks for them to completely reverse. It is recommended to consult a psychiatrist and discontinue drug therapy if aggressive behavior directed at other people or suicidal thoughts appear, symptoms of a mental disorder worsen or do not regress. Suicidal thoughts and attempts are more common in children and adolescents than in adults. If treatment with the drug is considered necessary in adult patients with serious mental disorders (including a history), it should only be started if treatment for the mental disorder and appropriate individual screening are carried out. The use of the drug in patients under 18 years of age with serious mental disorders (including a history) is contraindicated.
In patients with thyroid pathology, before starting therapy, it is necessary to determine the level thyroid-stimulating hormone, in the future, its content should be monitored at least once every 6 months, as well as when signs of dysfunction of the thyroid gland appear. The use of the drug in such patients should be carried out under the supervision of an endocrinologist. If thyroid dysfunction occurs or existing diseases that cannot be treated worsen, the drug must be discontinued.
With prolonged use of the drug, visual disturbances are possible. It is recommended to conduct an ophthalmological examination before starting treatment. For any complaints from the organ of vision, immediate consultation with an ophthalmologist is necessary. Patients with diseases that may cause changes in the retina (arterial hypertension, diabetes mellitus, etc.) must undergo an ophthalmological examination at least once every six months. If visual disturbances worsen or appear, discontinuation of therapy should be considered.
Patients with progressive oncological diseases and/or pathology of the cardiovascular system requires careful observation and monitoring of the electrocardiogram. If hypotension occurs, appropriate treatment and adequate hydration should be provided.
In elderly patients who receive the drug in high doses, coma, disturbances of consciousness, encephalopathy, and convulsions are possible. If these disorders develop and dose reduction is ineffective, therapy is discontinued.
With prolonged use of the drug, some patients may develop antibodies to interferon. Typically, antibody titers are low, and their appearance does not reduce the effectiveness of treatment.
In transplant patients, drug immunosuppression may be less effective because interferon stimulates the immune system.
Prescribe with caution to patients with a predisposition to autoimmune diseases. If symptoms of an autoimmune disease develop, it is necessary to conduct a thorough examination and evaluate the possibility of continuing interferon treatment. Sometimes treatment with the drug is associated with exacerbation or the occurrence of psoriasis and sarcoidosis.
During treatment, caution should be exercised when engaging in potentially hazardous activities where increased attention and speed of psychomotor reactions (including driving), and with the development of fatigue, drowsiness, disorientation or other adverse reactions such activities must be abandoned.

Contraindications for use

Hypersensitivity, severe diseases of the cardiovascular system (recent myocardial infarction, heart failure in the stage of decompensation, severe heart rhythm disturbances), severe allergic diseases, severe liver or/kidney failure, autoimmune hepatitis, chronic hepatitis with decompensated liver cirrhosis, mental illness and disorders in children and adolescents, epilepsy and other disorders of the central nervous system, autoimmune diseases history, use of immunosuppressants after transplantation, pathology of the thyroid gland that cannot be controlled by generally accepted therapeutic methods; pregnancy, breastfeeding period, use in men whose partners are pregnant.

Restrictions on use

Severe myelosuppression, liver and/or renal failure, thyroid disease, psoriasis, sarcoidosis, chronic obstructive pulmonary disease, diabetes mellitus, tendency to ketoacidosis, bleeding disorders, mental disorders, especially expressed by depression, suicidal thoughts and attempts in the anamnesis.

Use during pregnancy and breastfeeding

The use of the drug is contraindicated during pregnancy and breastfeeding.

Side effects of human recombinant interferon alpha-2b

Cardiovascular system and blood: transient reversible cardiomyopathy, arrhythmias, arterial hypotension, myocardial infarction, leukopenia, lymphopenia, thrombocytopenia, anemia.
Digestive system: dry mouth, abdominal pain, nausea, dyspepsia, weight loss, appetite disturbances, diarrhea, vomiting, pancreatitis, hepatotoxicity, increased activity of alanine aminotransferase, alkaline phosphatase.
Nervous system and sensory organs: irritability, depression, nervousness, asthenia, anxiety, insomnia, impaired ability to concentrate, aggressiveness, suicidal thoughts, neuropathies, psychosis, hearing impairment, swelling of the conjunctiva of the lower fornix, hyperemia and single follicles mucous membrane of the eye, focal changes fundus, decreased visual acuity, neuritis optic nerve, retinal hemorrhages, thrombosis of retinal arteries and veins, papilledema.
Skin: increased sweating, rash, itching, hair loss, local inflammatory reaction.
Endocrine system: changes in the thyroid gland, diabetes mellitus.
Musculoskeletal system: rhabdomyolysis, back pain, leg cramps, myositis, myalgia.
Respiratory system: pharyngitis, dyspnea, cough, pneumonia.
Urinary system: renal failure, increased concentrations of creatinine, urea.
The immune system: autoimmune pathology ( rheumatoid arthritis, vasculitis, lupus-like syndrome), sarcoidosis, anaphylaxis, angioedema, allergic edema, facial edema.
Others: flu-like syndrome (fever, chills, asthenia, fatigue, tiredness, arthralgia, myalgia, headaches).

Interaction of human recombinant interferon alpha-2b with other substances

The drug reduces clearance and doubles the concentration of aminophylline in plasma.
When used together with amphotericin B, the risk of developing kidney damage, hypotension, and bronchospasm increases; with busulfan - veno-occlusive liver disease; with dacarbazine - hepatotoxicity; with zidovudine - neutropenia.
The drug increases the toxicity of doxorubicin.
When used together with levothyroxine sodium, the effect changes and dose adjustment may be required.
When used together with pegaspargase, the risk of side effects mutually increases.
The drug can reduce the activity of cytochrome P-450 isoenzymes and, thereby, affect the metabolism of phenytoin, cimetidine, chimes, diazepam, warfarin, theophylline, propranolol, and some cytostatics.
May enhance the myelotoxic, neurotoxic, cardiotoxic effects of drugs that were previously prescribed or co-administered.
Avoid simultaneous use with drugs that depress the central nervous system, immunosuppressive drugs (including glucocorticosteroids).
Alcohol consumption is not recommended during therapy.
When used together with hydroxyurea, the incidence of cutaneous vasculitis may increase.
When used together with theophylline, it is necessary to monitor the concentration of theophylline in the blood plasma and, if necessary, adjust the dosage regimen.

Overdose

In case of drug overdose, they intensify side effects. It is necessary to discontinue the drug and carry out symptomatic and supportive treatment.

Trade names of drugs with the active substance interferon alpha-2b human recombinant

Combined drugs:
Interferon alpha-2b human recombinant + Diphenhydramine: Ophthalmoferon®.