REBETOL ORAL SOLUTION Rx

Indications for REBETOL ORAL SOLUTION:

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

Adult:

Genotype 1: treat for 48 weeks (reevaluate after 24 weeks). Genotype 2/3: treat for 24 weeks. Swallow caps whole. Give consistently with regard to food. With Intron A: >18yrs (≤75kg): 400mg in AM and 600mg in PM; >75kg: 600mg twice daily (AM & PM). 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. Dose adjustments: see full labeling.

Children:

Genotype 1: treat for 48 weeks (reevaluate after 24 weeks). Genotype 2/3: treat for 24 weeks. Swallow caps whole. Give consistently with regard to food. <3yrs: not established. 3–18yrs (<47kg): 15mg/kg per day in divided doses (AM & PM); use oral soln if <47kg or cannot swallow caps; 47–59kg: 400mg twice daily (AM & PM); 60–73kg: 400mg in AM and 600mg in PM; >73kg: 600mg twice daily (AM & PM). Dose adjustments: see full labeling.

Contraindications:

Autoimmune hepatitis. Hemoglobinopathies (eg, thalassemia major, sickle-cell anemia): not recommended. Renal impairment (CrCl <50mL/min). Male partners of pregnant women. Pregnancy (Cat.X). Concomitant didanosine.

Boxed Warning:

Risk of serious disorders and ribavirin-associated effects.

Warnings/Precautions:

Significant or unstable cardiac disease: not recommended. Women of childbearing potential: obtain negative pregnancy test immediately before starting therapy. Women of childbearing potential and men: use 2 forms of effective contraception during and for 6 months following treatment. Do baseline CBC (and at weeks 2 and 4 or more often if needed), WBCs with differential, platelets, blood chemistry, thyroid, and monthly pregnancy tests (during and for 6 months after treatment). Reduce dose or discontinue if severe reactions or hematologic abnormalities 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. Pancreatitis (discontinue if occurs). 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: not recommended.

See Also:

REBETOL

Pharmacological Class:

Nucleoside analogue.

Interactions:

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

Adverse Reactions:

Anemia, other hematological disorders, flu-like symptoms, cardiac and pulmonary events (discontinue if occur), psychiatric effects, dizziness, nausea, vomiting, alopecia, rash, pruritus, diabetes, fatigue/asthenia, headache, rigors, myalgia, pyrexia, pancreatitis, dental and periodontal disorders.

How Supplied:

Caps—56, 70, 84; Soln—100mL