Roferon-A alfa-2b
PEG-IntronÒ
(Peginterferon alfa-2b)
Powder for Injection
Alpha interferons, including PEG-Intron, may cause or aggravate fatal or life-threatening neuropsychi-atric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with peri-odic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symp-toms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEG-Intron therapy. See WARNINGS, ADVERSE REACTIONS.
Use with Ribavirin. Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen. (See REBETOL package insert for additional information and other warnings.)
DRUG DESCRIPTION
PEG-IntronÒ , peginterferon alfa-2b, Powder for Injection is a covalent conjugate of recombinant alfa-2b interfer-on with monomethoxy polyethylene glycol (PEG). The average molecular weight of the PEG portion of the molecule is 12,000 daltons. The average molecular weight of the PEG-Intron molecule is approximately 31,000 daltons. The specific activity of peginterferon alfa-2b is approximately 0.7 x 108 IU/mg protein.
Interferon alfa-2b, is a water-soluble protein with a molecular weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of Escherichia coli bearing a genetically engineered plasmid containing an interferon gene from human leukocytes.
PEG-Intron is supplied in both vials and the RedipenÒ for subcutaneous use.
Vials
Each vial contains either 74 mg, 118.4 mg, 177.6 mg, or 222 mg of PEG-Intron as a white to off-white tablet-like solid, that is whole/in pieces or as a loose powder, and 1.11 mg dibasic sodium phosphate anhydrous, 1.11 mg monobasic sodium phosphate dihydrate, 59.2 mg sucrose and 0.074 mg polysorbate 80. Following reconstitution with 0.7 mL of the supplied Sterile Water for Injection, USP, each vial contains PEG-Intron at strengths of either 50 mg per 0.5 mL, 80 mg per 0.5 mL, 120 mg per 0.5 mL, or 150 mg per 0.5 mL.
RedipenÒ
RedipenÒ is a dual-chamber glass cartridge containing lyophilized PEG-Intron as a white to off-white tablet or pow-der that is whole or in pieces in the sterile active chamber and a second chamber containing Sterile Water for Injection, USP. Each PEG-Intron RedipenÒ contains either 67.5 mg, 108 mg, 162 mg, or 202.5 mg of PEG-Intron, and 1.013 mg dibasic sodium phosphate anhydrous, 1.013 mg monobasic sodium phosphate dihydrate, 54 mg sucrose and 0.0675 mg polysorbate 80. Each cartridge is reconstituted to allow for the administration of up to 0.5 mL of solution. Following reconstitution, each RedipenÒ contains PEG-Intron at strengths of either 50 mg per 0.5 mL, 80 mg per 0.5 mL, 120 mg per 0.5 mL, or 150 mg per 0.5 mL for a single use. Because a small volume of reconstituted solution is lost during preparation of PEG-Intron, each RedipenÒ contains an excess amount of PEG-Intron powder and diluent to ensure delivery of the labeled dose.
Generic Name: Peginterferon alfa-2b
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Roferon-A alfa-2b
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