Combined regimen with interferon alpha-2b + interferon gamma. Interferon alpha-2b (ALPHARONA®) in dosage of 5 mln IU and interferon gamma (INGARON®) in dosage of 500 thous IU intramuscularly or subcutaneously daily for 6 months (efficiency has been proven in the course of clinical studies performed in specialized clinic of the State Institution, Scientific and Research Institute of Influenza of the Russian Academy of Medical Sciences, St.Petersburg, under the supervision of E.V. Esaulenko, M.D, and in the infectious diseases department with course of tropical medicine of the State Educational Institution for Higher Vocational Education "Saint Petersburg State Medical Academy named after I.I. Mechnikov" under the supervision of professor T.V. Sologub, M.D).
Recommendations. Monthly measured ALT, AST, bilirubin, hemogram control. Additionally, at least once each 3 months, quantitative PCR for HBV DNA and test for thyroid hormones; advisable, once each 3 months perform test for autoimmune markers (cryoglobulin, АНА, АМА, AGA). Criteria used for evaluation of treatment efficiency are the following: normalization of serum ALT and AST, absence of HBV DNA in blood serum, disappearance of HBeAg (in case of HBeAg- positive hepatitis). In case of pronounced adverse events associated with use of interferons (flu-like syndrome, apparent emotional lability, depression, sharp weight loss), drug dosing regimen may be adjusted under control of the above laboratory indicators: interferon alpha-2b (ALPHARONA®) in dosage of 5 mln IU and interferon gamma (INGARON®) in dosage of 500 thous IU intramuscularly or subcutaneously every second day at least for 6 months. (Efficiency has been proven in the course of clinical studies performed in specialized clinic of infectious diseases department with course of tropical medicine of the State Educational Institution for Higher Vocational Education "Saint Petersburg State Medical Academy" named after I.I. Mechnikov" under the supervision of professor T.V. Sologub, M.D.).Standard regimen. Interferon alpha-2b (ALPHARONA®) in dosage of 3 mln IU intramuscularly or subcutaneously every second day and ribavirin (Ribamidil® manufactured by Biopharma JSC, Russia) 15 mg per kg of the patient's body weight orally daily. Duration of the therapy depends on genotype of HCV: for 12 months for patients with 1 genotype and 6 months when patients with non-1 genotype of the virus (efficiency has been proven in the course of clinical studies performed in specialized clinic of State Institution, Scientific and Research Institute of Influenza of the Russian Academy of Medical Sciences, St.Petersburg, under the supervision of E.V. Esaulenko, M.D., and at ithe nfectious diseases department of the State Educational Institution for Higher Vocational Education "Bashkir State Medical University of Roszdrav", Ufa, under the supervision of professor D.A. Valishin, M.D).
Regimen for 1 genotype of HCV.
1st stage: interferon alpha-2b (ALPHARONA®) in dosage of 3 mln IU intramuscularly or subcutaneously every second day, ribavirin (Ribamidil® manufactured by Biopharma JSC, Russia) 15 mg per kg of the patient's body weight orally daily, and interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously on the days of administration of interferon alpha-2b for 6 months.
2nd stage: Interferon alpha-2b (ALPHARONA®) in dosage of 3 mln IU intramuscularly or subcutaneously every second day and ribavirin (Ribamidil® manufactured by Biopharma JSC, Russia) 15 mg per kg of the patient's body weight orally daily for 6 months.
(Efficiency has been proven in the course of clinical studies performed in specialized clinic of the infectious diseases department with course of tropical medicine of the State Educational Institution for Higher Vocational Education "Saint Petersburg State Medical Academy named after I.I. Mechnikov" under the dupervision of professor T.V. Sologub, M.D.)
Regimen for non-1 genotype of HCV.
1st stage: interferon alpha-2b (ALPHARONA®) in dosage of 3 mln IU intramuscularly or subcutaneously every second day, ribavirin (Ribamidil® manufactured by Biopharma JSC, Russia) 15 mg per kg of the patient's body weight orally daily, and interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously on the days of administration of interferon alpha-2b for 3 months.
2nd stage: Interferon alpha-2b (ALPHARONA®) in dosage of 3 mln IU intramuscularly or subcutaneously every second day and ribavirin (Ribamidil® manufactured by Biopharma JSC, Russia) 15 mg per kg of the patient's body weight orally daily for 3 months.
(Efficiency has been proven in the course of clinical studies performed in specialized clinic of the infectious diseases department with course of tropical medicine of the State Educational Institution for Higher Vocational Education "Saint Petersburg State Medical Academy named after I.I. Mechnikov of the Ministry of Health" under the supervision of professor T.V. Sologub, M.D.)
Recommendations. Monthly measurement of ALT, AST, bilirubin, hemogram control. Additionally, at least once each 3 months, quantitative PCR for VHC RNA and test for thyroid hormones; advisable, once each 3 months perform test for autoimmune markers (cryoglobulin, АНА, АМА, AGA). In case if the therapy in not efficient (3 months later, viral load has decreased for less than 2 logarithms), treatment regimen will be adjusted in each specific case individually.Regimen with interferon alpha-2b and interferon gamma. As part of combined therapy, course of interferon alpha-2b (ALPHARONA®) in dosage of 3 mln IU and interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously daily. Considering high tolerability of the drugs, course of treatment may be extended up to 3 months (Efficiency has been proven in the course of clinical studies performed at the premises of the 5th department of the Saint Petersburg Municipal Tuberculosis Hospital No.2 under the supervision of professor T.V. Sologub, M.D.)
Recommendations. For patients with CD4+ level lower than 350 cells/μl, immunocorrecting therapy with interferons is not recommended. Control of therapy efficiency will be performed considering clinical, bacteriological and X-ray examination.
Intramuscular and subcutaneous injection. For acute hepatitis B 1,000,000 IU are injected twice a day for 5-6 days, then the dose shall be reduced to 1,000,000 IU once a day for 5 more days. If necessary (after control blood chemistry), the course of treatment may be continued by 1,000,000 IU twice a week for 2 weeks. Course dose is 15,000,000 - 21,000,000 IU.
For acute prolonged and chronic active hepatitis B, with delta infection excluded and without signs of hepatic cirrhosis, 1,000,000 IU are injected twice a week for 1-2 months. In case of lack of efficiency, treatment should be extended up to 3-6 months or after completion of 1-2 month course of treatment, 2-3 similar courses should be administered with 1-6 month interval.
For chronic active hepatitis D without signs of hepatic cirrhosis, 500,000 - 1,000,000 IU of the drug are injected twice a week for 1 month. Repeat the course of treatment after 1-6 months.
For chronic active hepatitis B and D with signs of hepatic cirrhosis, 250,000 - 500,000 IU are injected daily twice a week for 1 month. If decompensation signs appear, similar courses should be repeated with minimum 2 month interval.
For chronic viral hepatitis C: adults - 3,000,000 IU intramuscularly or subcutaneously 3 times a week for 9 months. Children - 3,000,000 IU/sq.m (maximum dose is 3,000,000 IU) 3 times a week for 9 months.
In case of kidney cancer, 3,000,000 IU is used daily for 10 days. Course of treatment (3-9 and more) should be repeated at 3-week interval. Total amount of the drug is 120,000,000 IU to 300,000,000 IU and more.
In case of hairy-cell leukemia, 3,000,000 IU - 6,000,000 IU are injected daily for 2 months. After normalization of hemogram, daily dose should be reduced to 1,000,000 - 2,000,000 IU. Then supporting therapy should be administered with 3,000,000 IU twice a week for 6-7 weeks. Total amount of the drug is 420,000,000 IU to 600,000,000 IU and more.
In case of acute lymphoblastic leucosis of children, in remission period after completion of inductive chemotherapy (in 4-5 months of remission) - 1,000,000 IU once a week for 6 months, then once every second week for 24 months. Supporting chemotherapy should be carried out simultaneously.
In case of chronic myelogenous leukemia, 3,000,000 each day or 6,000,000 every second day.
Treatment period is from 10 weeks to 6 months.
In case of histiocytosis-X, 3,000,000 IU daily for 1 month. Repeated courses with 1-2 month intervals for 1-3 years.
In case of subleukemic myelosis and essential thrombocytopenia for correction of hyperthrombocytosis, 1,000,000 IU daily or every second day for 20 days.
In case of malignant lymphoma and Kaposi's sarcoma, 3,000,000 IU are injected daily for 10 days combined with cytostatic drugs (prospidinum, cyclophosphan) and glucocorticosteroids. In case of tumorous stage of mycosis fungoidea and reticulosarcomatosis, it is reasonable to alternate intramuscular injection of 3,000,000 IU of the drug and intralesional injection of 2,000,000 IU for 10 days.
For patients with erythrodermical stage of mycosis fungoidea, if temperature has risen over 39ºС and if the process has worsened, administration of the drug shall be stopped. If therapeutic effect is insufficient after 10-14 days, repeated treatment course should be administered. Once clinical effect is achieved, supporting therapy should be administered with 3,000,000 IU once a week for 6-7 weeks.
In case of respiratory laryngeal papillomatosis, 100,000 - 150,000 IU of the drug per 1 kg of body weight should be injected daily for 45-50 days, then the same dose 3 times a week for 1 month. Second and third courses should be carried out at 2-6 month interval.
In case of disseminated sclerosis, 1,000,000 IU is administered: in case of pyramidal syndrome, 3 times a day, in case of cerebellar syndrome, 1-3 times a day for 10 days with consequent injection of 1,000,000 once a week for 5-6 months. Total amount of the drug is 50,000,000 IU to 60,000,000 IU.
For persons with high pyrogenic (39°С and higher) response to the drug, simultaneous use of indometacin is recommended.
Perifocal introduction. In case of basal cell and squamous cell carcinoma of the skin, keratoacanthoma, 1,000,000 IU should be injected under the lesion focus once a day for 10 days. In case of pronounced local inflammatory response, injection under the lesion focus should be carried out every second or third day. Upon completion of the course, if necessary, cryolysis should be carried out.
Subconjunctival injection. In case of stromal keratitis and keratoiridocyclitis, subconjunctival injections should be administered in dosage of 60,000 IU in 0.5 ml daily or every second day, depending on process severity. Injections should be carried out under local anesthesia using 0.5% dicaine solution. Course of treatment is 15 to 25 injections.
Local application. For local application, dissolve the content of a vial in 5 ml of 0.9% sodium chloride solution for injections. In case if the drug solution is stored, content of the vial shall be transfered into sterile vial, observing the rules for aseptics and antiseptics, and keep the solution in refrigerator at a temperature of 4-10ºС not longer than 12 hours.
In case of conjunctivitis and interfacial keratitis, 2 drops should be applied to conjunctiva of the affected eye 6-8 times a day. As far as inflammatory events disappear, number of instillations shall be decreased to 3-4. Course of treatment is 2 weeks.
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