Index of drugs

Treatment of hairy cell leukemia. Treatment of patients with AIDS with progressive Kaposi's sarcoma, without generalized symptoms, in whom the CD4 cell count is> 250 cells / mm³. Treatment of chronic phase myeloid leukemia with the presence of the Philadelphia chromosome (treatment with Interferon alpha-2a chronic myelogenous leukemia is not an alternative treatment option in patients with HLA-compatible donors and for which allogeneic bone marrow transplantation is planned or possible in the near future; it is still unclear whether the use of the preparation can be considered as a treatment method to obtain a cure in this indication). Treatment of cutaneous T lymphocytes (interferon alfa-2a may be active in patients with progressive disease who are resistant to treatment or who are not eligible for conventional therapy). Treatment of adult patients with histologically confirmed hepatitis B virus in whom viral replication markers are present, i.e. positive HBV DNA or HbeAg assays. Treatment of adult patients with histologically confirmed hepatitis C in whom anti-HCV or HCV RNA tests are positive and have increased ALT in the blood without decompensation of liver function (efficacy of interferon alfa-2a in the treatment of hepatitis C is increased when combined with Ribavirin, interferon alfa-2a monotherapy should be used if Ribavirin intolerance or contraindications to its use). Treatment of follicular type follicular lymphomas. Treatment of advanced stage of renal cancer. Treatment of patients with malignant melanoma in stage II according to AJCC (thickness of Breslov infiltration> 1.5 mm, no lymph node involvement or spreading in the skin), in whom no signs of disease are found after surgical treatment.

1 pre-filled syringe of 0.5 ml (for single administration) contains 3 million, 6 million or 9 million IU interferon alfa-2a. The drug contains benzyl alcohol (10 mg / ml).

Recombinant interferon alfa-2a - has many properties of natural, human alpha-interferon. It exerts antiviral activity by inducing in the cells a state of resistance to infection by viruses and modulating the effector part of the immune system responsible for neutralizing viruses or eliminating virus-infected cells. The mechanism of antitumor activity of the preparation has not been known yet. In HT 29 cells it reduces the synthesis of DNA, RNA and proteins. It also has antiproliferative activity against many human cancer cells. The bioavailability of the preparation after intramuscular or subcutaneous administration is over 80%. The maximum concentration in the blood after intramuscular administration occurs after about 3.8 hours, and after subcutaneous administration - after about 7.3 hours. Renal catabolism is the main route of elimination of the drug. Biliary excretion and hepatic metabolism play a smaller role in excretion.

Hypersensitivity to recombinant interferon alfa-2a or other components of the preparation. Severe heart disease now or in the past. Severe renal, liver or bone marrow failure. Seizure disorders that can not be cured and / or impaired by o.u.n. Chronic hepatitis with advanced, decompensated liver failure or cirrhosis. Chronic hepatitis, which is currently or has recently been treated with immunosuppressive drugs. Newborns and children <3 years, due to the presence of benzyl alcohol in the preparation. If you are planning a combination therapy with ribavirin, you should also check the contraindications for the use of ribavirin in its SmPC.

When planning combination therapy with interferon alfa-2a and ribavirin, the SmPC for ribavirin should also be consulted. Caution in patients with hyperglycaemia (regularly monitor blood Glucose levels, it may be necessary to modify the antidiabetic treatment); with severe myelosuppression (risk of myelosuppression); with previous or existing autoimmune disorders (monitor the clinical symptoms associated with autoimmune disease and control the concentration of autoantibodies and TSH levels, discontinue treatment if necessary). All patients should be periodically monitored for peripheral blood counts, both before and during the treatment.In the case of slight or moderate renal, hepatic or marrow dysfunctions, the parameters determining the function of these organs should be closely monitored. All patients should be closely monitored for signs of psychiatric disorders; in the event of such disorders, psychiatric intervention and / or discontinuation of interferon alfa-2a should be considered. Every patient reporting eye disorders during therapy should be referred for ophthalmologic examination; administration of interferon alfa-2a should be discontinued in the event of new or worsening of existing visual disorders. In patients with diabetes and / or hypertension, an ophthalmologic examination should be performed before starting treatment. In case of fever during therapy, exclude other causes of fever than the syndrome of flu-like symptoms, in particular severe infections, especially in patients with neutropenia; if serious bacterial, viral or fungal infections are diagnosed, appropriate treatment of infection should be initiated immediately and consideration should be given to termination of interferon alfa-2a therapy. Due to the immunostimulatory effect of the preparation, the effectiveness of immunosuppressive drugs used after organ transplants can be reduced (cases of transplant rejection have been reported). The effectiveness of the medicine has not been demonstrated in patients with hepatitis B or C who are undergoing hemodialysis, have haemophilia or concomitant HIV infection. Because of the risk of developing lactic acidosis, take special care with combination therapy with interferon alfa-2a and ribavirin in patients with concomitant HIV infection who receive intensive antiretroviral therapy (HAART). Patients with HIV infection and advanced cirrhosis who are simultaneously treated with HAART may have an increased risk of developing decompensated liver failure and death; adding alpha interferons to treatment with monotherapy or in combination with ribavirin may increase the risk in this group of patients. The product is not recommended in children (the efficacy and safety of use in this age group have not been established).

Men and women treated with the product should use effective contraception. In pregnancy, the medicine should only be used if the benefits of using it for a woman justify the potential risk to the fetus (the risk of fetal harm can not be excluded). It is not known whether the drug is excreted in breast milk; making a decision to stop breastfeeding or discontinuation of the drug must result from the potential benefits of using the drug for the mother.
Combination therapy with ribavirin: ribavirin is teratogenic and / or embryotoxic. In pregnant women, treatment with ribavirin is contraindicated. Women of child-bearing age and their partners must use effective contraception measures during treatment and for 4 months after treatment. Patients and their partners must use effective contraceptive measures during treatment and for 7 months after treatment (see ribavirin SPC).

Very common: leukopenia, anorexia, nausea, slight hypocalcemia, headache, diarrhea, alopecia (reversible after discontinuation of the drug, increased baldness can last for several weeks after treatment), increased sweating, muscle pain, joint pain, flu-like symptoms, decreased appetite , fever, chills, tiredness. Common: thrombocytopenia, anemia, dysgeusia, cardiac arrhythmias (including atrioventricular block), palpitations, cyanosis, vomiting, abdominal pain, nausea, dry mouth, chest pain, edema, weight loss. Uncommon: dehydration, electrolyte imbalance, depression, anxiety, changes in mental performance, confusion, behavioral disorders, nervousness, memory disorders, sleep disorders, neuropathy, dizziness, hypoaesthesia, paresthesia, tremor, drowsiness; conjunctivitis, blurred vision, conjunctivitis, dizziness, hypertension, hypotension, exacerbation or psoriasis, pruritus, proteinuria and increased number of cells in the urine, increased ALT activity, increased transaminases, increased alkaline phosphatase activity in the blood. Rarely: pneumonia, herpes infection (including herpes labialis exacerbation), agranulocytosis, hemolytic anemia, autoimmune disorders, acute hypersensitivity reactions (e.g.urticaria, angioneurotic edema, bronchospasm and anaphylaxis), hypothyroidism or hyperthyroidism, thyroid dysfunction, diabetes, hyperglycemia, suicide, suicide attempts, suicidal thoughts, coma, cerebrovascular events, seizures, transient erectile dysfunction, ischemic retinopathy, cardiac arrest and breathing, myocardial infarction, congestive heart failure, pulmonary edema, vasculitis, dyspnoea, cough, pancreatitis, increased intestinal motility, constipation, indigestion, bloating, liver failure, hepatitis, liver dysfunction, skin rash, dry skin, nosebleeds, dry mucous membranes, watery nasal discharge, systemic lupus erythematosis, arthritis, acute renal failure (mainly in patients with cancer associated with kidney disease), renal dysfunction, increased creatinine, urea, uric acid and bilirubin in the blood, increased activity of lactate dehydrogenase in the blood. Very rare: idiopathic thrombocytopenic purpura, sarcoidosis, hypertriglyceridemia, hyperlipidemia, encephalopathy, retinal artery thrombosis, optic neuropathy, retinal haemorrhage, retinal vein thrombosis, retinal exudates, retinopathy, optic disc edema, ulcer recurrence, non-life threatening bleeding with gastrointestinal tract, necrosis at the injection site, injection site reaction. Not known (post-marketing): transplant rejection. Pancytopenia may occur; cases of aplastic anemia have been reported very rarely. Some patients may develop neutralizing antibodies against interferons.

Administration of the drug should be carried out under the supervision of a doctor who has experience in the treatment of diseases that indicate the use of the drug. Adults.Hairy cell leukemia: initial dose - 3 million IU daily for subcutaneous injections 16-24 weeks. If you notice intolerance, reduce the dose to 1.5 million IU. daily or reduce the frequency of administration up to 3 times a week. Maintenance dose - 3 million IU 3 times a week. In the case of intolerance, the dose should be reduced to 1.5 million IU. 3 times per week. The treatment time needed to assess the effectiveness of treatment is about 6 months. Treatment should be stopped if there is no improvement or continue in patients with a response to treatment. The treatment was continued for a maximum of 20 consecutive months. The optimal duration of application of the drug or the minimum effective dose was not determined.Kaposi's sarcoma associated with AIDS: subcutaneously for 10-12 weeks in a dose gradually increased to at least 18 million IU daily, and if possible up to 36 million IU. per day. The following dose escalation schedule is recommended: days 1-3 - 3 million IU / day; days 4-6 - 9 million IU / day; days 7-9 - 18 million units daily, and if the patient tolerates this dose, increase to 36 million IU / day on days 10-84. Maintenance dose - 3 times a week in the maximum dose tolerated by the patient, but not more than 36 million IU The duration of treatment needed to assess the effectiveness of treatment is at least 10, preferably 12 weeks. Treatment should be discontinued if there is no improvement or continue in patients with a response to treatment. Treatment with the preparation was continued for up to 20 consecutive months. Once a response has been obtained, treatment should be continued until the tumor has resolved. The optimal treatment time has not been determined. Interferon alfa-2a should not be used in combination with protease inhibitors; with the exception of zidovudine, there is no data on the safety of interferon alfa-2a in combination with reverse transcriptase inhibitors. After the end of treatment, Kaposi's sarcoma often recurs.Chronic myelogenous leukemia: application of the preparation allows to achieve haematological remission in 60% of patients in the chronic phase of CML, regardless of previous treatment; 2/3 of these patients have a complete haematological response that can occur up to 18 months after the start of treatment. Interferon alfa-2a allows to obtain a sustained cytogenetic response, persisting for over 40 months. The drug is administered by subcutaneous injection for 8-12 weeks. Recommended dosage regimen: days 1-3 - 3 million IU / day; days 4-6 - 6 million IU / day; days 7-84 - 9 million IU / day. The treatment time needed to assess the effectiveness of treatment is at least 8 weeks, and preferably at least 12 weeks. Treatment should be discontinued if there is no improvement.In patients who have responded to treatment, they should be continued until complete hematological remission or for a maximum of 18 months. All patients in whom a complete haematological response has been achieved should continue treatment at a dose of 9 million IU / day (optimal dose). or 9 million IU 3 times a week (minimum dose). The optimal duration of treatment was not determined, although the occurrence of cytogenetic remission was observed after 2 years from the beginning of therapy.Cutaneous T-cell lymphomas (CTCL): the drug is used in the case of resistance to standard therapy or the existence of contraindications to it. Subcutaneously for 12 weeks in a dose gradually increased to 18 million IU. per day. The following dose escalation schedule is recommended: days 1-3 - 3 million IU / day; days 4-6 - 9 million IU / day; days 7-84 - 18 million IU / day. Maintenance dose: 3 times a week in the maximum tolerated by the patient, but not more than 18 million IU / day. The duration of treatment needed to assess the effectiveness of treatment is at least 8 weeks, and preferably 12 weeks. Treatment should be discontinued if there is no improvement or continue in patients with a response to treatment. The minimum duration of treatment for patients who received a response should be 12 months. The treatment was continued for up to 40 consecutive months. The optimal duration of treatment has not been determined.Chronic hepatitis B: no optimal dosing schedule has been established; a dose of 2.5-5 million IU is usually used² pc, subcutaneously 3 times a week for 4-6 months. The dose is then adjusted depending on the patient's tolerance. In the absence of improvement after 3-4 months of treatment, consideration should be given to discontinuing treatment. Children were given a medicine at a dose of up to 10 million IU / m² pc. with good tolerability, but the effectiveness of the therapy has not been demonstrated.Chronic hepatitis C. Combination therapy with ribavirin. Patients with relapse: interferon alfa-2a subcutaneously at a dose of 4.5 million IU 3 times a week for 6 months; ribavirin at a dose of 1000-1200 mg daily in 2 doses (please refer to the Smarm ribavirin report). Untreated patients: interferon alfa-2a subcutaneously at a dose of 3-4.5 million IU 3 times per week for a period of at least 6 months. Treatment should be continued for the Next 6 months in those patients who have a negative HCV RNA test at 6 months of treatment and those who are infected with genotype 1 and they have high viral load before starting therapy. The dose of ribavirin: as above. Other unfavorable prognostic factors should be taken into account when deciding to extend treatment to 12 months (age> 40 years, male gender, liver bridge fibrosis). Patients who do not receive a virological response after 6 months of treatment usually do not receive a consistent response.Interferon alfa-2a monotherapy(used mainly in the case of ribavirin intolerance or contraindications to its use): initial dose - 3-6 million IU subcutaneously 3 times a week for 6 months as an induction treatment, if the drug is well tolerated. In patients who have not responded after 3-4 months of treatment, treatment with interferon alfa-2a should be considered. Maintenance dose: patients who have achieved normalization of ALT in the blood and / or HCV-RNA are undetectable, require maintenance therapy with interferon alfa-2a at a dose of 3 million IU. 3 times a week for the next 6 months or longer to consolidate the total answer. The optimal treatment time has not been established, treatment is recommended for at least 12 months. In the majority of patients, recurrence of the disease, with proper treatment with interferon alfa-2a as monotherapy, occurred within 4 months of the end of treatment.Non-Hodgkin's lymphoid type: interferon alfa-2a should be administered concurrently with CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisolone) at a dose of 6 million IU / m² pc. subcutaneously from day 22 to day 26 of each 28-day treatment cycle.Advanced stage of kidney cancer. Combination therapy with vinblastine: interferon alfa-2a subcutaneously at a dose of 3 million IU 3 times a week for the first week; 9 million IU 3 times a week in the second week and 18 million IU 3 times a week in the following weeks. Vinblastine intravenously, according to the manufacturer's instructions (at a dose of 0.1 mg / kg once per 3 weeks) - see SmPC of vinblastine. If the dose of interferon alfa-2a 18 million IU 3 times a week is not tolerated by the patient, it can be reduced to 9 million IU. 3 times a week. Treatment should last at least 3 months, up to 12 months, or until the disease progresses. For patients who have achieved complete response, treatment can be terminated in 3 months after a lasting response.Combination therapy with bevacizumab: interferon alfa-2a subcutaneously at a dose of 9 million IU 3 times per week until the disease has progressed or for up to 12 months. The safety and efficacy of interferon alfa-2a administered for more than 12 months has not been evaluated. Interferon alfa-2a treatment may be initiated at a lower dose (3 or 6 million IU) , however, the recommended dose of 9 million IUshould be reached within the first 2 weeks of treatment. If a dose intolerance of 9 million IU occurs. Three times a week, the dose should be reduced to a minimum dose of 3 million IU. 3 times a week Interferon alfa-2a should be given after the completion of bevacizumab infusion (please refer to the Bewacyzumab SPC).Malignant melanoma after surgical treatment: under the skin at a dose of 3 million IU 3 times a week for 18 months, and the treatment should be started no later than 6 weeks after surgery. If treatment intolerance occurs, the dose should be reduced to 1.5 million IU. 3 times a week