Ribavirin Tablets

— THERAPEUTIC CATEGORIES —
  • Viral infections

Ribavirin Tablets Generic Name & Formulations

General Description

Ribavirin 200mg, 400mg, 500mg, 600mg.

Pharmacological Class

Nucleoside analogue.

How Supplied

Contact supplier

Ribavirin Tablets Indications

Indications

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.

Ribavirin Tablets Dosage and Administration

Adult

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.

Children

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

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.

Ribavirin Tablets Boxed Warnings

Boxed Warning

Risk of serious disorders and ribavirin-associated effects.

Ribavirin Tablets Warnings/Precautions

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 Pharmacokinetics

See Literature

Ribavirin Tablets Interactions

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.

Ribavirin Tablets Adverse Reactions

Adverse Reactions

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).

Ribavirin Tablets Clinical Trials

See Literature

Ribavirin Tablets Note

Notes

Formerly known under the brand name Copegus.

Ribavirin Tablets Patient Counseling

See Literature