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 Roferon-A
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L. Hudson Lori
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Brand Name:Roferon-A Trade Name:Interferon alfa-2a
FDA Approved For:Roferon-A is indicated for the treatment of chronic hepatitis C, hairy cell leukemia and AIDS-related Kaposi's sarcoma in patients 18 years of age or older. In addition, it is indicated for chronic phase, Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) patients who are minimally pretreated (within 1 year of diagnosis). For Patients With Chronic Hepatitis C Roferon-A is indicated for use in patients with chronic hepatitis C diagnosed by HCV antibody and/or a history of exposure to hepatitis C who have compensated liver disease and are 18 years of age or older...For Patients With AIDS-Related Kaposi's Sarcoma Roferon-A is indicated for the treatment of AIDS-related Kaposi's sarcoma in a select group of patients... Pediatric Use:Pediatric Use Use of Roferon-A in children with Ph-positive adult-type CML is supported by evidence from adequate and well-controlled studies of Roferon-A in adults with additional data from the literature on the use of alfa interferon in children with CML. A published report on 15 children with Ph-positive adult-type CML suggests a safety profile similar to that seen in adult CML; clinical responses were also observed (see DOSAGE AND ADMINISTRATION). For all other indications, safety and effectiveness have not been established in patients below the age of 18 years. The injectable solutions are not indicated for use in neonates or infants and should not be used by patients in that age group. There have been rare reports of death in neonates and infants associated with excessive exposure to benzyl alcohol (see warnings).
Carcinogen:Roferon-A has not been tested for its carcinogenic potential.Mutagen:Mutagenesis: A. Internal Studies - Ames tests using six different tester strains, with and without metabolic activation, were performed with Roferon-A up to a concentration of 1920 µg/plate. There was no evidence of mutagenicity. Human lymphocyte cultures were treated in vitro with Roferon-A at noncytotoxic concentrations. No increase in the incidence of chromosomal damage was noted. B. Published Studies - There are no published studies on the mutagenic potential of Roferon-A. However, a number of studies on the genotoxicity of human leukocyte interferon have been reported. A chromosomal defect following the addition of human leukocyte interferon to lymphocyte cultures from a patient suffering from a lymphoproliferative disorder has been reported. In contrast, other studies have failed to detect chromosomal abnormalities following treatment of lymphocyte cultures from healthy volunteers with human leukocyte interferon. It has also been shown that human leukocyte interferon protects primary chick embryo fibroblasts from chromosomal aberrations produced by gamma rays.
Manufacturer and/or Distributor:Hoffmann-La Roche  

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EditText of this page (last edited August 23, 2008)

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