interferon alfa-2b | Reaferon-EU 1,000,000 IU bottles 5 pcs.

Release form

Lyophilisate for solution for injection and topical use.

Packaging

In ampoules or glass vials of 1 million IU, 5 ampoules per cell made of PVC film.

Pharmacological action

The drug has antiviral, antitumor, immunomodulating activity.

Interferon alpha-2b human recombinant, which is the active ingredient in the preparation, is synthesized by bacterial cells of the Escherichia coli strain SG-20050 / pIF16, the genetic apparatus of which contains the human interferon alpha-2b gene. It is a protein containing 165 amino acids, and is identical in characteristics and properties to human leukocyte interferon alpha-2b.

The antiviral effect of interferon alpha-2b is manifested during the reproduction of the virus by active inclusion in the metabolic processes of cells. Interferon, interacting with specific receptors on the cell surface, initiates a number of intracellular changes, including the synthesis of specific cytokines and enzymes (2-5-adenylate synthetases and protein kinases), the action of which inhibits the formation of viral protein and viral ribonucleic acid in the cell.

The immunomodulatory effect of interferon alpha-2b is manifested in an increase in the phagocytic activity of macrophages, an increase in the specific cytotoxic effect of lymphocytes on target cells, a change in the quantitative and qualitative composition of secreted cytokines, a change in the functional activity of immunocompetent cells, and a change in the production and secretion of intracellular proteins.

The antitumor effect of the drug is realized by suppressing the proliferation of tumor cells and the synthesis of certain oncogenes, leading to inhibition of tumor growth.

Indications

In complex therapy in adults:

in acute viral hepatitis B - moderate and severe forms at the beginning of the icteric period up to the 5th day of jaundice (in later terms, drug administration is less effective in developing hepatic coma and cholestatic disease)

in acute protracted hepatitis B and C , chronic active hepatitis B and C, chronic hepatitis B with a delta agent, without signs of cirrhosis and with signs of liver cirrhosis

with stage IV kidney cancer, hairy cell leukemia, malignant skin lymphomas (gr ovidny mycosis primary reticulosis, retikulosarkomatoze), Kaposi's sarcoma, basal and squamous cell cancers of the skin, keratoacanthoma, chronic myeloid leukemia, Langerhans cell histiocytosis, subleukemic mieloze, essential thrombocythemia

viral conjunctivitis, keratoconjunctivitis, keratitis, keratoiridocyclitis, keratouveitis

In complex therapy in children from 1 year old:

in acute lymphoblastic leukemia in the remission period after induction chemotherapy (at 4-5 months of remission)

with papillomavirus respiratory removal after the next day .

Contraindications

Hypersensitivity to the components of the drug

Severe forms of allergic diseases

Severe diseases of the cardiovascular system - heart failure in the decompensation stage, recent myocardial infarction, severe heart rhythm

, severe or severe the presence of metastases, chronic hepatitis with decompensated cirrhosis, autoimmune hepatitis

Epilepsy and other disorders of the central nervous system, mental illness and disorder in children and adolescents

History of autoimmune disease

Use of immunosuppressants after

transplantation Thyroid diseases that are not controlled by conventional therapeutic methods

Creatinine clearance below 50 ml / min (when used in combination with rib) with ribavirin, the contraindications indicated in the instructions for use of ribavirin

should also be considered. Use in men whose partners are pregnant

Pregnancy s and during breastfeeding.

Precautions

Renal and / or liver failure, severe myelosuppression. Mental disorders, especially expressed by depression, suicidal thoughts and attempts in history. Patients with psoriasis, sarcoidosis.

Use during pregnancy and during breastfeeding

The drug is contraindicated for use during pregnancy and during breastfeeding.

Special instructions

In order to timely detect abnormalities in laboratory parameters that may occur during therapy, general clinical blood tests must be repeated every 2 weeks, and biochemical tests every 4 weeks.

When reducing the number of platelets to less than 50 · 109 / l, the absolute number of neutrophils is less than 0.75 · 109 / l, it is recommended that a temporary dose reduction of 2 times and a repeat of the analysis after 1-2 weeks. If changes persist, treatment is recommended to be discontinued.

When reducing the number of platelets to a value less than 25 · 109 / l, the absolute number of neutrophils less than 0.50 · 109 / l, it is recommended to stop treatment.

In the case of the development of immediate hypersensitivity reactions (urticaria, angioedema, bronchospasm, anaphylaxis), the drug is canceled and appropriate medication is prescribed immediately. Transient skin rash does not require discontinuation of therapy.

In the event of signs of impaired liver function, it is necessary to carefully monitor the patient. With the progression of symptoms, the drug should be discontinued.

With mild to moderate impaired renal function, their functional state must be carefully monitored.

Use with caution in patients with severe chronic diseases such as chronic obstructive pulmonary diseases, diabetes mellitus with a tendency to ketoacidosis, in patients with bleeding disorders expressed by myelosuppression. In patients receiving Reaferon-EC for a long time, in rare cases, pneumonitis and pneumonia are observed. Timely cancellation of interferon alfa and the appointment of glucocorticosteroid therapy contribute to the relief of pulmonary syndromes.

In patients with thyroid disease, before starting treatment, it is necessary to determine the concentration of thyroid stimulating hormone, it is recommended to control its level at least 1 time in 6 months. If there is a violation of the thyroid gland function or a deterioration in the course of existing diseases that are not amenable to adequate medical correction, it is necessary to cancel the drug.

In the event of changes in the mental sphere and / or central nervous system, including the development of depression, it is recommended that the psychiatrist be monitored during treatment, and also within 6 months after its completion. These disorders are usually rapidly reversible after discontinuation of therapy, however, in some cases, up to 3 weeks are necessary for their complete reverse development. If the symptoms of a mental disorder do not regress or worsen, suicidal thoughts or aggressive behavior directed at other people appear, It is recommended to discontinue treatment with Reaferon-EU and provide a consultation with a psychiatrist. Suicidal thoughts and attempts are more often observed in children, primarily adolescents (2.4%), than in adults (1%). If therapy using interferon alfa-2b is deemed necessary in adult patients with serious mental disorders (including a history), it should be started only if appropriate individual screening and therapy for mental disorders are carried out. The use of interferon alfa-2b in children and adolescents with serious mental disorders (including a history) is contraindicated.

With prolonged use, usually after several months of treatment, visual disturbances are possible. Before starting therapy, an ophthalmic examination is recommended. In case of complaints of any ophthalmic disorders, an immediate consultation with an oculist is necessary. Patients with diseases in which changes in the retina may occur, for example, diabetes mellitus or arterial hypertension, must undergo an ophthalmological examination at least 1 time in 6 months. If visual disturbances occur or worsen, consideration should be given to discontinuing Reaferon-EU therapy.

In elderly patients receiving the drug in high doses, impaired consciousness, coma, convulsions, encephalopathy are possible. In the event of the development of such disorders and the ineffectiveness of dose reduction, treatment should be discontinued.

Patients with diseases of the cardiovascular system and / or advanced oncological diseases require careful observation and monitoring of the ECG. With the development of arterial hypotension, it is recommended to provide adequate hydration and appropriate therapy.

In patients after transplantation (for example, a kidney or bone marrow), drug immunosuppression may be less effective, since interferon has a stimulating effect on the immune system.

With prolonged use, the preparation of interferon alfa may cause antibodies to interferon in individuals. As a rule, antibody titers are low, their appearance does not reduce the effectiveness of treatment.

Use with caution in patients with a predisposition to autoimmune diseases. When symptoms of an autoimmune disease appear, a thorough examination should be carried out and the possibility of continuing treatment with interferon should be assessed. Rarely, interferon alfa therapy is associated with the onset or exacerbation of psoriasis, sarcoidosis.

During the period of use of the drug, patients experiencing fatigue, drowsiness or disorientation should refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Influence on the ability to drive vehicles and mechanisms

During the period of use of the drug, patients experiencing fatigue, drowsiness or disorientation should refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Composition of

In one ampoule or in one vial contains:

Active ingredient - interferon alfa-2b human recombinant 1 million IU

Excipients: albumin, solution for infusion 10% - 4.50 mg, sodium chloride - 8.96 mg, sodium dodecahydrate hydrogen phosphate - 2.86 mg, sodium dihydrogen phosphate dihydrate - 0.40 mg.

Dosage and administration

The drug is administered intramuscularly, subcutaneously, in or under the lesion, subconjunctival and topical. Immediately before use, the contents of the ampoule or vial are dissolved in water for injection or 0.9% sodium chloride solution (in 1 ml for intramuscular, subcutaneous and focal injection, in 5 ml for subconjunctival and local administration). The solution of the drug should be colorless, transparent or with weak opalescence, without sediment and impurities. Dissolution time should be about 3 minutes.

Intramuscular and subcutaneous administration of

In acute viral hepatitis B, the drug is administered 1 million IU 2 times a day for 5-6 days, then the dose is reduced to 1 million IU per day and administered for another 5 days. If necessary (after control biochemical blood tests), the course of treatment can be continued at 1 million IU 2 times a week for 2 weeks. The course dose is 15-21 million IU.

In acute protracted and chronic viral hepatitis B with the exception of the delta agent and without signs of cirrhosis, the drug is administered 1 million IU 2 times a week for 1-2 months. If there is no effect, treatment should be extended to 3-6 months or after the end of 1-2 months of treatment, 2-3 similar courses should be taken with an interval of 1-6 months.

In chronic viral hepatitis B with a delta agent without signs of liver cirrhosis, the drug is administered at 500 thousand to 1 million IU per day 2 times a week for 1 month. A second course of treatment after 1-6 months.

In chronic viral hepatitis B with a delta agent and signs of liver cirrhosis, the drug is administered at 250-500 thousand IU per day 2 times a week for 1 month. When signs of decompensation appear, similar courses are repeated at intervals of at least 2 months.

In acute protracted and chronic active hepatitis C without signs of liver cirrhosis, the drug is administered at 3 million IU 3 times a week for 6-8 months. In the absence of effect, treatment should be extended to 12 months. A second course of treatment after 3-6 months.

In kidney cancer, the drug is used in 3 million IU daily for 10 days. Repeated courses of treatment (3-9 or more) are carried out at intervals of 3 weeks. The total amount of the drug is from 120 million IU to 300 million IU or more.

With hairy cell leukemia, the drug is administered daily at 3-6 million IU for

for 2 months. After the normalization of the clinical blood test, the daily dose of the drug is reduced to 1-2 million IU. Then prescribe maintenance therapy at 3 million IU 2 times a week for 6-7 weeks. The total amount of the drug is 420-600 million IU or more.

In acute lymphoblastic leukemia in children in remission after induction chemotherapy (at 4-5 months of remission) - 1 million IU 1 time per week for 6 months, then 1 time in 2 weeks for 24 months. At the same time, maintenance chemotherapy is performed.

In malignant lymphomas and Kaposiӳ sarcoma, the drug is administered at 3 million IU per day daily for 10 days in combination with cytostatics (prosidium chloride, cyclophosphamide) and glucocorticosteroids. In the tumor stage of fungoid mycosis, primary reticulosis and reticulosarcomatosis, it is advisable to alternate the intramuscular injection of the drug at 3 million IU and the intrafocal - at 2 million IU for 10 days.

In patients with the erythrodermic stage of mushroom mycosis, when the temperature rises above 39 РC and in case of exacerbation of the process, the drug should be discontinued. With insufficient therapeutic effect, after 10-14 days, a second course of treatment is prescribed. After achieving the clinical effect, maintenance therapy is prescribed at 3 million IU once a week for 6-7 weeks.

In chronic myelogenous leukemia, the drug is administered in 3 million IU daily or 6 million IU every other day. The duration of treatment is from 10 weeks to 6 months.

With histiocytosis from Langerhans cells, the drug is administered at 3 million IU daily for 1 month. Repeated courses at 1-2-month intervals for 1-3 years.

In case of subleukemic myelosis and essential thrombocythemia for the correction of hyperthrombocytosis - 1 million IU daily or after 1 day for 20 days.

In case of respiratory laryngeal papillomatosis, the drug is administered at 100-150 thousand IU per kilogram of body weight daily for 45-50 days, then at the same dosage 3 times a week for 1 month. The second and third courses are carried out with an interval of 2-6 months.

In individuals with a high pyrogenic reaction (39 РC and above), the simultaneous use of paracetamol or indomethacin is recommended.

Perifocal administration of

In case of basal cell and squamous cell carcinoma, keratoacanthoma, the drug is administered under the lesion of 1 million IU once daily for 10 days. In the case of severe local inflammatory reactions, administration under the lesion is carried out after 1-2 days. At the end of the course, if necessary, conduct cryodestruction.

Subconjunctival administration of

In stromal keratitis and keratoiridocyclitis, subconjunctival injections of the drug are prescribed in a dose of 60 thousand IU in a volume of 0.5 ml daily or every other day, depending on the severity of the process. Injections are performed under local anesthesia with a 0.5% dicaine solution. The course of treatment is from 15 to 25 injections.

Topical application

For topical application, the contents of the ampoule are dissolved in 5.0 ml of 0.9% sodium chloride solution for injection. In the case of storing a solution of the drug, it is necessary, following the rules of asepsis and antiseptics, transfer the contents of the ampoule to a sterile vial and store the solution in the refrigerator at 4-10 РC for no more than 12 hours.

In conjunctivitis and superficial keratitis, 2 drops of solution are applied to the conjunctiva of the affected eye 6-8 times a day. As the inflammatory phenomena disappear, the number of instillations is reduced to 3-4. The course of treatment is 2 weeks.

Side effects

The frequency of adverse reactions is according to the WHO classification: “very frequent” - 1/10, “frequent” - more than 1/100, but less than 1/10, “infrequent” - more than 1/1000, but less than 1/100, “rare” - more than 1/10000, but less than 1/1000 and “very rare” with a frequency of less than 1/10000, including individual messages.

When using Reaferon-EC (in clinical trials and outside of clinical trials) the following undesirable effects were observed:

Often with parenteral administration of the drug there is a flu-like syndrome (chills, fever, asthenia, fatigue, fatigue, myalgia, arthralgia, headaches), partially stopped by paracetamol, indomethacin. As a rule, the flu-like syndrome appears at the beginning of treatment and decreases with continuation.

From the cardiovascular system: rarely - arrhythmias, transient reversible cardiomyopathy, very rarely - arterial hypotension, myocardial infarction.

From the digestive system: rarely - dry mouth, nausea, abdominal pain, dyspepsia, loss of appetite, weight loss, vomiting, diarrhea, very rarely - pancreatitis, hepatotoxicity.

From the central nervous system: rarely - irritability, nervousness, depression, asthenia, insomnia, anxiety, impaired ability to concentrate, suicidal thoughts, aggressiveness, very rarely - neuropathies, psychosis.

From the skin: rarely - skin rashes and itching, increased sweating, hair loss. When injected into or under the lesion, a local inflammatory reaction is rare. These side effects are usually not an obstacle to the continued use of the drug.

From the endocrine system: against the background of prolonged use of the drug, changes in the thyroid gland are possible. Very rarely - diabetes.

On the part of laboratory parameters: when using the drug, abnormalities in laboratory parameters are possible, manifested by leukopenia, lymphopenia, thrombocytopenia, anemia, increased activity of alanine aminotransferase, alkaline phosphatase, creatinine, urea concentration. As a rule, these changes are usually minor, asymptomatic and reversible.

From the musculoskeletal system: rarely - rhabdomyolysis, leg cramps, back pain, myositis, myalgia.

From the respiratory system: rarely - pharyngitis, cough, dyspnea, pneumonia.

From the urinary system: very rarely - renal failure.

On the part of the immune system: rarely - autoimmune pathology (vasculitis, rheumatoid arthritis, lupus-like syndrome), very rarely - sarcoidosis, angioedema, allergic edema, anaphylaxis, facial edema.

From the side of the organs of vision: with topical administration of the drug on the mucous membrane of the eye, hyperemia, single follicles, swelling of the conjunctiva of the lower arch are possible. Rarely, hemorrhages in the retina, focal changes in the fundus, thrombosis of arteries and veins of the retina, decreased visual acuity, optic neuritis, edema of the optic nerve head.

On the part of the hearing organs: rarely - hearing impairment.

In case of pronounced local and general adverse reactions, the drug should be discontinued.

Drug interaction

Interferon alfa-2b is able to reduce the activity of isoenzymes of cytochrome P-450 and, therefore, affect the metabolism of cimetidine, phenytoin, curantyl, theophylline, diazepam, propranolol, warfarin, and some cytostatics. May enhance the neurotoxic, myelotoxic, or cardiotoxic effects of drugs previously prescribed or at the same time. Avoid co-administration with drugs that depress the central nervous system, immunosuppressive drugs (including oral and parenteral forms of glucocorticosteroids).

Interferons can affect oxidative metabolic processes. This should be considered with simultaneous use with drugs, metabolized by oxidation (including with xanthine derivatives - aminophylline and theophylline). With the simultaneous use of Reaferon-EC with theophylline, it is necessary to control the concentration of theophylline in the blood serum and, if necessary, adjust the dosage regimen.

With the combined use of Reaferon-EC and hydroxyurea, the incidence of cutaneous vasculitis may increase.

Drinking alcohol during treatment is not recommended.

Overdose

There have been no cases of overdose. Given that the active substance is interferon alfa-2b, an overdose may increase the severity of dose-dependent side effects.

Treatment: withdrawal of the drug if necessary, conduct symptomatic therapy.

Storage conditions

Store in a dark place at a temperature not exceeding 8 РC.

Keep out of the reach and sight of children.

The Expiration of

is 3 years.

lekarstvennaja form

Solution for

Indications

Conjunctivitis, Hepatitis, HPV

Possible product names

Reaferon-EU 1,000,000 IU bottles 5 pcs.