Uses: Treatment of Chronic Hepatitis B and C.

Dosage and Administration: Chronic Hepatitis B: the recommended dosage is usually in the range of 5.0 million IU daily or 10.0 million IU three times per week administered subcutaneously for a period of four to six months. Chronic Hepatitis C: the recommended dose is 3 million IU administered three times a week. Most of the patients who received Interferon Alfa-2b for 6 – 12 months, responded demonstrate improvement in ALT levels within 12-16 weeks. Contraindications, Warnings, Precautions, etc.

Contraindications: A history of hypersensitivity to recombinant interferon Alfa – 2b or components of HEBERON ALFA R injection contraindicate its use; severe pre-exiting cardiac disease, severe renal or hepatic dysfunction; epilepsy and/or compromised central nervous system function; chronic hepatitis with advanced decompensated cirrhosis of the liver; chronic hepatitis patients who are being or have been recently treated with immunosuppressive agents excluding short-term corticosteroid withdrawal. Autoimmune hepatitis or history or autoimmune disease, pre-existing thyroid disease not controlled by conventional therapy.

Warnings and Precautions: Use with caution in patients with a history of pulmonary disease, coagulation disorders or severe myelosuppression. Moderate to severe adverse effects experiences may require reduction of dosage or termination of HEBERON ALFA R therapy. Patients with chronic Hepatitis B with evidence of decreasing hepatic synthetic function may be at increased risk of clinical decompensation if a flare of aminotransferases occurs during treatment. Patients with a recent history of cardiovascular events should be closely monitored as adverse cardiovascular events including hypotension and cardiac arrhytimas have been observed. Adequate hydration of patients should be maintained during treatment. Pulmonary infiltrates, pneumonitis and pneumonia, including fatality, have been observed rarely. Reversible CNS effects commonly manifested by confusion have been seen, usually at high doses. Infrequently, patients treated for chronic Hepatitis C developed thyroid abnormalities, either hypothyroid or hyperthyroid. HEBERON ALFA R may exacerbate pre-existing psoriatic disease. Ocular adverse events have been reported. Combinant narcotics or sedatives should be administered with caution. Patients taking xanthine derivates should be monitored and dosage adjusted as necessary. No information is available on the use of interferon in human pregnancy or its effect on human lactation. HEBERON ALFA R should only be given if the benefits clearly outweigh the potential hazard to the foetus or nursing infant.

Side Effects: Elevated live function tests, reduction in white blood cell, granulocyte and platelet counts have been observed especially at higher doses. Retinal haemorrhages, cotton wool spots and retinal artery or vein obstruction have been observed rarely. The most common adverse effects are ‘flu-like’ symptoms, leucopenia thrombocytopenia and CNS effects, which are generally dose-related and reversible and can be alleviated by the use of paracetamol.