Monograph Details
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Immune System
> Immunomodulators
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PEG-INTRON |
| Manufacturer |
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Schering Corporation |
| Legal Classification |
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Rx
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| Generic Name |
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Peginterferon alfa-2b (polyethylene glycol/recombinant alfa interferon conjugate) 100micrograms/mL, 160micrograms/mL, 240micrograms/mL, 300micrograms/mL; per single-use pen or per vial after reconstitution; pwd for SC inj after reconstitution/dilution. |
| Indications |
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Chronic hepatitis C with compensated liver disease not previously treated with interferon alpha, as monotherapy or with ribavirin. |
| Children |
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<18yrs: not recommended. |
| Adults |
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Give SC once weekly (same day each week ). ≥18yrs: Monotherapy: initially 1microgram/kg per week. Treat for 1 year; consider discontinuing if inadequate response after 6 months. Combination with ribavirin: 1.5microgram/kg per week. Genotype 1: treat for 48 weeks. Genotype 2/3: treat for 24 weeks. Reduce dose if serious adverse reaction develops; discontinue if persists. Neutropenia, thrombocytopenia, depression: see literature. Renal impairment: CrCl 30–50mL/min: reduce dose by 25%; CrCl 10–29mL/min, hemodialysis: reduce dose by 50%. |
| Contraindications |
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Hepatic decompensation before or during treatment. Autoimmune hepatitis. |
| Precautions |
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May cause or exacerbate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen. Severe psychiatric disorders (esp. depression). Cardiovascular or pulmonary disease. Severe myelosuppression, colitis, pancreatitis: discontinue if occurs. Uncontrolled thyroid abnormalities. Diabetes. Coagulation disorders. Maintain adequate hydration. Monitor blood, thyroid, visual and liver function before and during therapy; EKG in cardiovascular disease. Psoriasis. Renal dysfunction (CrCl <50mL/min). Transplant recipients. Hepatitis C virus with HIV or HBV coinfection. Elderly. Debilitated. Pregnancy (Cat.C); use adequate contraception. Nursing mothers: not recommended. |
| Interactions |
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Caution with myelosuppressives, and drugs that can exacerbate depression. May potentiate theophylline (may double its levels), methadone (monitor). Caution with drugs metabolized by CYP2C8/9 (eg, warfarin, phenytoin), or CYP2D6 (eg, flecainide). |
| Adverse Reactions |
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Flu-like symptoms (fever, headache, myalgia, fatigue); hepatic, hematologic, respiratory, skin, genitourinary system, CNS, cardiovascular, endocrine (esp thyroid), GI, or visual disorders; hemorrhagic colitis, hypertriglyceridemia, pancreatitis, antibody formation, infections, injection site reactions; Others (see literature). |
| How Supplied |
Pwd in vials (0.5mL)—1 (w. diluent, supplies)
Redipen (0.5mL)—1, 4 (w. supplies) |
| Additional Resources |
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• Related Prescribing Note |
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