Viral infections:

Indications for: REBETOL

Chronic hepatitis C: in combination with interferon alfa-2b (pegylated and nonpegylated), in patients ≥3 years of age with compensated liver disease.

Adult Dosage:

Swallow caps whole. Take with food. With PEG-Intron: <66kg: 400mg twice daily (AM & PM); 66–80kg: 400mg in AM and 600mg in PM; 81–105kg: 600mg twice daily (AM & PM); >105kg: 600mg in AM and 800mg in PM. Interferon alpha-naive patients: Genotype 1: treat for 48 weeks. Discontinue therapy if treatment Week 12 HCV-RNA not achieve at least a 2 log10 drop or loss, or at 24 weeks if HCV-RNA remains detectable. Genotype 2/3: treat for 24 weeks. Re-treatment of prior treatment failures: treat for 48 weeks, regardless of genotypes. Consider discontinuing if patient fails to achieve undetectable HCV-RNA at Week 12 or 24. With Intron A: ≥18yrs (≤75kg): 400mg in AM and 600mg in PM; >75kg: 600mg twice daily (AM & PM). Dose adjustments: see full labeling.

Children Dosage:

<3yrs: not established. Swallow caps whole. Take with food. With PEG-Intron: 3–17yrs (<47kg): 15mg/kg per day in divided doses (AM & PM); 47–59kg: 400mg twice daily (AM & PM); 60–73kg: 400mg in AM and 600mg in PM; >73kg: 600mg twice daily (AM & PM). Genotype 1: treat for 48 weeks (reevaluate after 24 weeks). Genotype 2/3: treat for 24 weeks. Dose adjustments: see full labeling.

REBETOL Contraindications:

Autoimmune hepatitis. Hemoglobinopathies (eg, thalassemia major, sickle-cell anemia). Renal impairment (CrCl <50mL/min). Pregnancy. Male partners of pregnant women. Concomitant didanosine.

Boxed Warning:

Embryo-fetal toxicity. Hemolytic anemia. Monotherapy not recommended.

REBETOL Warnings/Precautions:

Not for use as monotherapy. Risk of embryo-fetal toxicity. Women of childbearing potential: obtain negative pregnancy test immediately prior to initiation, during therapy, and during the 9-month period after completion. Advise to use effective contraception during and for 9 months (females of reproductive potential) or for 6 months (males w. female partners) post-therapy period. Risk of hemolytic anemia. Significant or unstable cardiac disease: not recommended. Do baseline CBC (and at weeks 2 and 4 or more often if needed), WBCs with differential, platelets, blood chemistry, and thyroid function tests. Reduce dose or discontinue if hemolytic anemia with significant initial drop in hemoglobin, pancreatitis, pulmonary infiltrates, pulmonary function impairment, new or worsening ophthalmologic disorders, severe decreases in neutrophils and platelets, hematologic, endocrine (eg, TSH), and hepatic abnormalities, dental/periodontal disorders, or weight loss and growth inhibition in children occur. Pre-existing cardiac disease: do ECGs prior to initiation and monitor during therapy. Discontinue if cardiovascular status deteriorates. Psychiatric disorders: temporarily reduce dose if mild depression occurs; discontinue if severe depression or suicidal ideation/attempt occurs. Pulmonary disorders. Autoimmune disorders. Organ transplant. Evaluate for ophthalmologic disorders. Decompensated hepatitis C. Nonresponders to interferon. Co-infection with hepatitis B virus or HIV infection. Maintain adequate hydration. Elderly. Nursing mothers.

See Also:

    REBETOL Classification:

    Nucleoside analogue.

    REBETOL Interactions:

    See Contraindications. May antagonize stavudine, zidovudine. Concomitant azathioprine; may induce severe pancytopenia and increase risk of myelotoxicity (monitor CBCs).

    Adverse Reactions:

    Inj site reactions, fatigue/asthenia, headache, rigors, fever, nausea, myalgia, anxiety/emotional lability/irritability; hemolytic anemia, cardiac and pulmonary events (discontinue if occur), psychiatric effects, pancreatitis, dental and periodontal disorders. In children: also neutropenia, anorexia, vomiting; growth inhibition.

    Generic Drug Availability:


    How Supplied:

    Caps—56, 70, 84