Select therapeutic use:
Indications for PEG-INTRON:
Chronic hepatitis C with compensated liver disease.
Give SC once weekly (same day each week). ≥18yrs: Monotherapy: initially 1mcg/kg/week. Treat for 1 year; consider discontinuing if inadequate response after 6 months. Combination with ribavirin: 1.5mcg/kg/week. Alpha-naive patients: Genotype 1: treat for 48 weeks. Discontinue therapy if treatment Week 12 HCV-RNA drops <2 log10 or at 24 weeks if HCV-RNA are detectable. Genotype 2/3: treat for 24 weeks. Prior treatment failure: add HCV NS3/4A protease inhibitor (unless contraindicated); treat for 48 weeks. Consider discontinuing if patient fails to achieve undetectable HCV-RNA at Week 12 or 24. Reduce dose if serious adverse reaction develops (discontinue if persists). Neutropenia, thrombocytopenia, depression: see full labeling. Renal impairment: CrCl 30–50mL/min: reduce dose by 25%; CrCl 10–29mL/min, hemodialysis: reduce dose by 50%.
<3yrs: not established. Give by SC inj. Combination w. ribavirin: ≥3yrs: 60mcg/m2/week. Genotype 1: Discontinue therapy at 12 weeks if treatment Week 12 HCV-RNA drops <2 log10 compared to pretreatment or at 24 weeks if HCV-RNA are detectable. Genotype 2/3: treat for 24 weeks. Reduce dose if serious adverse reaction develops (discontinue if persists). Neutropenia, thrombocytopenia, depression: see full labeling. Renal impairment: CrCl 30–50mL/min: reduce dose by 25%; CrCl 10–29mL/min, hemodialysis: reduce dose by 50%.
Hepatic decompensation (Child-Pugh score >6 [Class B and C]) before or during treatment. Autoimmune hepatitis. Combination with ribavirin contraindicated in pregnancy, men with pregnant partners, hemoglobinopathies, and CrCl <50mL/min.
Risk of serious disorders and ribavirin-associated effects.
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. Autoimmune disorders. 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.
Caution with drugs metabolized by CYP1A2 (eg, caffeine) or CYP2D6 (eg, thioridazine). May potentiate methadone, thioridazine, theophylline; monitor. Monitor with myelosuppressives (eg, zidovudine) or immunosuppressive agents (eg, cyclosporine, sirolimus, tacrolimus). Concomitant nucleoside analogues: closely monitor for toxicities; discontinue interferon, ribavirin, or both with worsening toxicities (see full labeling).
Flu-like symptoms (fever, headache, myalgia, fatigue); hepatic, hematologic, respiratory, skin, genitourinary system, CNS, cardiovascular, endocrine (esp. thyroid), dental/periodontal, or visual disorders, inj site reactions, anxiety/emotional lability/irritability, nausea; hemorrhagic colitis, hypertriglyceridemia, pancreatitis, antibody formation, infections; Others (see full labeling). Children: weight loss, growth inhibition, pyrexia, headache, vomiting, neutropenia, anorexia, inj site erythema.
See Rebetol entry for more information on ribavirin.
Pwd in vials (0.5mL)—1 (w. diluent, supplies); Redipen (0.5mL)—1, 4 (w. supplies)