Indications for: Ribavirin Tablets
Chronic hepatitis C, in combination with peginterferon alfa-2a, in patients ≥5yrs of age with compensated liver disease previously untreated with interferon alpha, including patients co-infected with HIV.
Take with food in 2 divided doses, with peginterferon alfa-2a. ≥18yrs: Genotype 1, 4: (<75kg): 1g/day for 48 weeks; (≥75kg): 1.2g/day for 48 weeks. Genotype 2, 3: 800mg/day for 24 weeks. HIV co-infection: 800mg/day for 48 weeks. Renal impairment (CrCl 30–50mL/min): 200mg and 400mg alternating every other day; (CrCl <30mL/min) or hemodialysis: 200mg/day. Reduce dose or discontinue if severe reactions or hematologic abnormalities occur; see full labeling.
Take with food in 2 divided doses, with peginterferon alfa-2a. <5yrs: not established. ≥5yrs (23–33kg): 400mg/day; (34–46kg): 600mg/day; (47–59kg): 800mg/day; (60–74kg): 1g/day; (≥75kg): 1.2g/day. Treat for 48 weeks (Genotype 1, 4) or 24 weeks (Genotype 2, 3). Reduce dose or discontinue if severe reactions or hematologic abnormalities occur; see full labeling.
Ribavirin Tablets Contraindications:
Hemoglobinopathies (eg, thalassemia, sickle-cell anemia). Pregnancy. Male partners of pregnant women. Concomitant didanosine. With peginterferon alfa-2a: autoimmune hepatitis, hepatic decompensation in cirrhotic patients before therapy.
Risk of serious disorders and ribavirin-associated effects.
Ribavirin Tablets Warnings/Precautions:
Not for use as monotherapy. Risk of embryo-fetal toxicity. Females of reproductive potential: obtain negative pregnancy test immediately prior to initiating therapy. Advise females of reproductive potential and males (w. female partners) to use 2 forms of effective contraception during and for 6 months post treatment period. Risk of severe hemolytic anemia. Significant or unstable cardiac disease: not recommended. Assess for underlying cardiac disease prior to initiation. Pre-existing cardiac disease: do ECG prior to therapy and monitor. Do baseline CBC (and at weeks 2 and 4 or more often if needed), WBCs with differential, platelets, blood chemistry, renal function, thyroid, and monthly pregnancy tests (during and for 6 months after treatment). Monitor hepatic function during therapy. Discontinue if cardiovascular status deteriorates, hepatic decompensation, pulmonary disorders, severe hypersensitivity or skin reactions, or pancreatitis occurs. Psychiatric disorders. Organ transplant. Nonresponders to interferon. Maintain adequate hydration. Nursing mothers: not recommended.
Ribavirin Tablets Classification:
Ribavirin Tablets Interactions:
Caution with NRTIs (eg, lamivudine, stavudine, zidovudine); monitor for toxicities. Concomitant azathioprine; may induce severe pancytopenia and increase risk of myelotoxicity (monitor CBCs). Avoid alcohol.
Fatigue/asthenia, pyrexia, nausea, vomiting, myalgia, headache; hemolytic anemia, bone marrow suppression, cardiac events, pulmonary events, psychiatric effects, skin disorders, hepatic failure, pancreatitis, growth inhibition (children).
Formerly known under the brand name Copegus.