Monograph Details
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Immune System
> Immunomodulators
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PEGASYS |
| Manufacturer |
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Roche Laboratories |
| Legal Classification |
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Rx
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| Generic Name |
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Peginterferon alfa-2a (polyethylene glycol/recombinant alfa interferon conjugate) 180micrograms/mL (vials), 180micrograms/0.5mL (prefilled syringe); soln for SC inj; contains benzyl alcohol. |
| Indications |
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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. |
| Children |
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<18 years: not recommended. |
| Adults |
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≥18 years: monotherapy for chronic hep C monoinfection, hep B monoinfection, or chronic hep C and HIV coinfection: 180micrograms SC once weekly for 48 weeks. With ribavirin for hep C with or without HIV coinfection: see literature. ESRD on hemodialysis: 135micrograms SC once weekly. Reevaluate 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). |
| Contraindications |
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Autoimmune hepatitis. Decompensated liver disease. Neonates. Infants. Combination with ribavirin contraindicated in pregnancy, men with pregnant partners, and in hemoglobinopathies. |
| Precautions |
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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 |
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May potentiate theophylline, methadone. Caution with NRTIs; monitor for toxicities. |
| Adverse Reactions |
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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. |
| Extra Text |
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Note: See Copegus entry in Antivirals section for information on ribavirin. |
| How Supplied |
Vial single-use—1
Vials single-use—4 (w. syringes)
Prefilled syringe—4 (w. supplies) |
| Additional Resources |
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• Related Prescribing Note |
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