ROFERON-A PREFILLED SYRINGE FOR INJECTION 3 MIU/0.5ml FOR SUBCUTANEOUS, INTRAMUSCULAR USE

Product Information

Registration Status: Active

ROFERON-A PREFILLED SYRINGE FOR INJECTION 3 MIU/0.5ml is approved to be sold in Singapore with effective from 1998-10-23. It is marketed by ROCHE SINGAPORE PTE LTD, with the registration number of SIN10296P.

This product contains Interferon Alfa-2A 3 MIU/0.5ml in the form of INJECTION. It is approved for SUBCUTANEOUS, INTRAMUSCULAR use.

This product is manufactured by F HOFFMANN-LA ROCHE LTD in SWITZERLAND.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Description

Interferon a (human leukocyte protein moiety reduced). A type I interferon consisting of 165 amino acid residues with lysine in position 23. This protein is produced by recombinant DNA technology and resembles interferon secreted by leukocytes. It is used extensively as an antiviral or antineoplastic agent. An oral form is being developed by Amarillo Biosciences.

Indication

For the treatment of chronic hepatitis C, hairy cell leukemia, AIDS-related Kaposi's sarcoma, and chronic myelogenous leukemia. Also for the treatment of oral warts arising from HIV infection.

Mechanism of Action

Interferon alpha binds to type I interferon receptors (IFNAR1 and IFNAR2c) which, upon dimerization, activate two Jak (Janus kinase) tyrosine kinases (Jak1 and Tyk2). These transphosphorylate themselves and phosphorylate the receptors. The phosphorylated INFAR receptors then bind to Stat1 and Stat2 (signal transducers and activators of transcription)which dimerize and activate multiple (~100) immunomodulatory and antiviral proteins. Interferon alpha binds less stably to type I interferon receptors than interferon beta.

Pharmacokinetics

Absorption: Absorption is high (greater than 80%) when administered intramuscularly or subcutaneously.
Distribution: * 0.223 to 0.748 L/kg [healthy people]
Metabolism
Elimination

Clearance

* 2.14 - 3.62 mL/min/kg [healthy]

Toxicity

Interferon alfa-2 may cause serious adverse effects such as anemia; autoimmune diseases, including vasculitis, arthritis, hemolytic anemia, and erythematosus syndrome; cardiotoxicity; hepatotoxicity; hyperthyroidism or hypothyroidism; transient ischemic attacks; leukopenia; neurotoxicity; peripheral neuropathy; and thrombocytopenia. Some lesser side effects that may not need medical attention include blurred vision, change in taste or metallic taste, cold sores or stomatitis, diarrhea, dizziness, dry mouth, dry skin or itching, flu-like syndrome, increased sweating, leg cramps, loss of appetite, nausea or vomiting, skin rash, unusual tiredness, weight loss, and partial loss of hair.

Active Ingredient/Synonyms

Source of information: Drugbank (External Link). Last updated on: 3^rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.