ALPHARONA Prescribing Information (injectable)

Has antiviral, antitumor, immunomodulating activity. ALPHARONA, when administered parenterally, undergoes degradation, partially eliminated uncganged, mainly, through kidneys. The drug, like all interferons, may cause appearance of antibodies to interferon and, consequently, a decrease in therapeutic effect of the drug.

In combined therapy of adults:

• for acute viral hepatitis В - moderate and severe forms in the beginning of icteritous period up to the 5th day of icterus (later administration of the drug is less effective; it is not effective for developing hepatic coma and cholestatic course of disease);
• for acute prolonged hepatitis B, chronic active hepatitis В and D without signs of cirrhosis and when signs of hepatic cirrhosis appear;
• for chronic viral hepatitis C;
• for viral (influenza-like, adenoviral, enteroviral, herpetic, parotitic), viral and bacterial and mycoplasmal encephalomeningitis. Drug administration is the most efficient in the first 4 days of the disease;
• for viral conjunctivitis, keratoconjunctivitis, keratitis, keratouveitis;
• for stage IV kidney cancer, hairy-cell leukemia, malignant skin lymphadenosis (mycosis fungoidea, polymorphic reticulosis), Kaposi's sarcoma, basal cell and squamous cell carcinoma of the skin, keratoacanthoma, chronic myelogenous leukemia, histiocytosis-X, subleukemic myelosis, essential thrombocytopenia;
• for disseminated sclerosis.

In combined therapy of children:

• for acute lymphoblastic leucosis in remission period after completion of inductive chemotherapy (in 4-5 months of remission);
• for respiratory laryngeal papillomatosis, starting from the day following papilloma removal.

Severe forms of allergic diseases; pregnancy.

Intramuscularly, subcutaneously, into or under lesion focus, subconjunctivally or locally. Immediately before use, content of a vial should be dissolved with water for injections (1,000,000 for intramuscular injection and injection into the lesion, 5,000,000 for subconjunctival and local administration). Drug solution shall be transparent and shall not contain foreign particles. Dissolution period shall not exceed 4 minutes. Dissolved drug shall not be stored.

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.   

In case of parenteral administration, chills, rise of temperature, fatigue, cutaneous eruption and itching, and leuco- and thrombocytopenia are possible, in case of the latter two, blood count is required 2-3 times a week. In case of injections around lesion focus - local inflammatory response. These adverse effects are not the obstacle for continued administration of the drug.

In case of local application on conjunctiva, conjunctival infection, conjunctival hyperemia, singular follicles, oedema of the lower fornix conjunctiva are possible. In case of strongly pronounced local and systemic adverse effects, administration of the drug shall be stopped.

Lyophilizate for preparation of solution for injections and local application 500,000 IU, 1,000,000 IU, 3,000,000 IU, 5,000,000 IU of active ingredient per 1 vial. 1, 5,10 or 20 vials of the drug with application instructions are put into cardboard package or 1, 5,10 or 20 vials of the drug in contour cellular package or in cassette contour package with application instructions are put into cardboard package.

Keep in dry dark place out of the reach of children at a temperature of 10°С maximum. Shelf life - 2 years.

Manufacturer:
Pharmaklon RPE, LLC, Russia

Legal address:
30/34 Chekhov street, Serpukhov, Moscow region, Russia, 142200

Мanufacturer's address:
Biomed named after Mechnikov, Petrovo-Dalnee, Krasnogorsk district, Moscow region, Russia, 143422

Phone/fax:+7 (4967) 36-07-71, +7 (495) 120-12-47

E-mail: info@pharmaclon.ru

www.pharmaclon.ru