Indications for PEGINTRON:
Chronic hepatitis C (CHC) with compensated liver disease.
Give by SC inj once weekly. ≥18yrs: Monotherapy (see full labeling): 1mcg/kg/week on same day of the week for 1 year. Consider discontinuing if treatment Week 12 HCV-RNA not achieve <2 log10 drop or at 24 weeks if HCV-RNA remains detectable. Combination w. ribavirin: 1.5mcg/kg/week. Interferon alpha-naive patients: Genotype 1: treat for 48 weeks. Discontinue therapy if treatment Week 12 HCV-RNA not achieve <2 log10 drop or at 24 weeks if HCV-RNA remains detectable. Genotype 2/3: treat for 24 weeks. Re-treatment of prior treatment failures: if Genotype 1: only use without an HCV NS3/4A protease inhibitor if contraindicated. Treatment duration: regardless of genotypes, treat for 48 weeks. Consider discontinuing if patient fails to achieve undetectable HCV-RNA at Week 12 or 24. Renal impairment: CrCl 30–50mL/min: reduce dose by 25%; CrCl 10–29mL/min, hemodialysis: reduce dose by 50%. Dose modifications: see full labeling.
<3yrs: not established. Give by SC inj once weekly. ≥3yrs: Combination w. ribavirin: 60mcg/m2/week. Genotype 1: treat for 48 weeks. Discontinue therapy at 12 weeks if treatment Week 12 HCV-RNA not achieve <2 log10 drop compared to pretreatment or at 24 weeks if HCV-RNA are detectable. Genotype 2/3: treat for 24 weeks. Renal impairment: CrCl 30–50mL/min: reduce dose by 25%; CrCl 10–29mL/min, hemodialysis: reduce dose by 50%. Dose modifications: see full labeling.
Hepatic decompensation (Child-Pugh score >6 [Class B and C]) in cirrhotic CHC patients before or during treatment. Autoimmune hepatitis. When co-administered with ribavirin, its contraindications also apply to this combination regimen (eg, pregnancy, CrCl <50mL/min).
Risk of serious disorders.
May cause or exacerbate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen. Psychiatric disorders or history of (esp. depression). Substance abuse. Cardiovascular disease. History of significant or unstable cardiac disease: avoid combination therapy. Pulmonary disease. Uncontrolled thyroid abnormalities. Diabetes. Autoimmune disorders. Discontinue if severe myelosuppression, colitis, pancreatitis, hypersensitivity reactions, cutaneous eruptions, pulmonary dysfunction, new or worsening eye disorders occur. Maintain adequate hydration. Monitor blood, triglycerides, thyroid, visual and liver function before and during therapy; EKG in cardiovascular disease. Renal dysfunction (CrCl <50mL/min). Organ transplant recipients. Hepatitis C virus with HIV or HBV coinfection. Elderly. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥10 days after last dose. Nursing mothers: not recommended with ribavirin.
Caution with drugs metabolized by CYP1A2 (eg, caffeine) or CYP2D6 (eg, thioridazine). May potentiate methadone (reduce dose), thioridazine, theophylline; monitor. Monitor with myelosuppressives (eg, zidovudine) or immunosuppressive agents (eg, cyclosporine, sirolimus, tacrolimus). Concomitant nucleoside analogues: closely monitor for toxicities (esp. hepatic decompensation, anemia); discontinue interferon, ribavirin, or both with worsening toxicities (see full labeling). Neutropenia potentiated by ribavirin. Peripheral neuropathy with concomitant telbivudine. Avoid concurrent ribavirin and didanosine.
Inj site reactions, fatigue/asthenia, headache, rigors, fever, nausea, myalgia, anxiety/emotional lability/irritability; colitis, hypertriglyceridemia, pancreatitis, cardiovascular effects, thyroid disorders, hyperglycemia, myelosuppression, dental/periodontal or visual disorders. Children: pyrexia, headache, neutropenia, fatigue, anorexia, inj site erythema, vomiting, weight loss, growth inhibition.
See Rebetol entry for more information on ribavirin.
Single-use vial—1 (w. diluent, supplies); Single-use Redipen—1, 4 (w. supplies)