Generic Name and Formulations:
Peginterferon alfa-2a (polyethylene glycol/recombinant alfa interferon conjugate) 180mcg/mL (vials), 180mcg/0.5mL (prefilled syringe); soln for SC inj; contains benzyl alcohol.

Company:
Roche Laboratories

Indications for PEGASYS:

Chronic hepatitis C (hep C), alone or with ribavirin (Copegus), in patients with compensated liver disease (including compensated cirrhosis) not previously treated with interferon alfa. HBeAg (+) or HBeAg (–) chronic hepatitis B (hep B), in patients with compensated liver disease and evidence of viral replication and liver inflammation.

Adult:

≥18 years: monotherapy for chronic hep C monoinfection, hep B monoinfection, or chronic hep C and HIV coinfection: 180mcg SC once weekly for 48 weeks. With ribavirin for hep C with or without HIV coinfection: see literature. ESRD on hemodialysis: 135mcg SC once weekly. Reeva luate if inadequate response after 24 weeks. Reduce dose and/or discontinue if ALT increases progressively, if bilirubin increases, or if neutropenia, thrombocytopenia, or depression occurs (see literature).

Children:

<18yrs: not recommended.

Contraindications:

Autoimmune hepatitis. Hepatic decompensation (Child-Pugh B and C) in cirrhotic patients or cirrhotic CHC patients coinfected with HIV. Neonates. Infants. Combination with ribavirin contraindicated in pregnancy, men with pregnant partners, and in hemoglobinopathies.

Warnings/Precautions:

May worsen neuropsychiatric, autoimmune, endocrine, ischemic, ophthalmic, pulmonary, or infectious disorders: monitor closely, discontinue if severe or persistently worsens. Cardiovascular or renal (CrCl <50mL/min) disease. Severe myelosuppression. Discontinue if severe hypersensitivity reactions, colitis or pancreatitis develops. Monitor CBC, thyroid, visual, and hepatic function before and during therapy. Transplant recipients. CD4 cell count <100 cells/microliter. HBV or HCV co-infection. Elderly. Pregnancy (Cat.C); may have abortifacient effects. Nursing mothers: not recommended.

Interactions:

May potentiate theophylline, methadone. Caution with NRTIs; monitor for toxicities.

Adverse Reactions:

Flu-like symptoms, psychiatric/CNS effects (depression, irritability, suicidal ideation, headache, insomnia), alopecia, GI upset, decreased CD4, CD8 counts; cardiovascular, hepatic, hematologic (eg, decreased WBCs, platelets), respiratory, thyroid, visual abnormalities, infections, anorexia, ALT elevations.

Note:

Note: See Copegus entry in Antivirals section for information on ribavirin.

How Supplied:

Vial single-use—1; Prefilled syringe—4 (w. supplies)