These highlights do not include all the information needed to use REBETOL safely and effectively. See full prescribing information for REBETOL.
REBETOL® (ribavirin USP) capsules, for oral use
REBETOL® (ribavirin USP) oral solution
Initial U.S. Approval: 1998
WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS
See full prescribing information for complete boxed warning.
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REBETOL monotherapy is not effective for the treatment of chronic hepatitis C (5.10).
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The hemolytic anemia associated with REBETOL therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL (2.4, 5.2, 6.1).
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Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Therefore, REBETOL therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking REBETOL therapy (4, 5.1, 8.1, 13.1, 17.2).
RECENT MAJOR CHANGES
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Dosage and Administration |
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REBETOL/PegIntron Combination Therapy (2.1) |
05/2013 |
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Dose Modifications (2.4) |
05/2013 |
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Warnings and Precautions |
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Impact on Growth – Pediatric Use (5.9) |
11/2013 |
INDICATIONS AND USAGE
REBETOL is a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1)
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Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.
DOSAGE AND ADMINISTRATION
REBETOL is administered according to body weight. (2.1, 2.2)
Dose reduction or discontinuation is recommended in patients experiencing certain adverse reactions or renal dysfunction. (2.4, 2.5, 12.3)
DOSAGE FORMS AND STRENGTHS
REBETOL Capsules 200 mg (3)
REBETOL Oral Solution 40 mg per mL (3)
CONTRAINDICATIONS
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Pregnant women and men whose female partners are pregnant (4, 8.1)
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Known hypersensitivity reactions such as Stevens-Johnson syndrome, toxic, epidermal necrolysis, and erythema multiforme to ribavirin or any component of the product (4)
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Autoimmune hepatitis (4)
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Hemoglobinopathies (4)
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Creatinine clearance less than 50 mL/min (4)
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Coadministration with didanosine (4, 7.1)
WARNINGS AND PRECAUTIONS
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Pregnancy Category X (5.1, 8.1, 8.3)
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Birth defects and fetal death with ribavirin: Patients must have a negative pregnancy test prior to therapy; use at least 2 forms of contraception and undergo monthly pregnancy tests.
Patients exhibiting the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy:
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Monotherapy with ribavirin is not permitted. (5.10)
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Hemolytic anemia may occur with a significant initial drop in hemoglobin. (5.2)
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Pancreatitis. (5.3)
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Pulmonary infiltrates or pulmonary function impairment. (5.4)
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New or worsening ophthalmologic disorders. (5.5)
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Severe decreases in neutrophil and platelet counts, and hematologic, endocrine (e.g., TSH), and hepatic abnormalities. (5.6)
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Dental/periodontal disorders reported with combination therapy. (5.7)
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Concomitant administration of azathioprine. (5.8)
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Weight loss and growth inhibition reported during combination therapy in pediatric patients. Long-term growth inhibition (height) reported in some patients. (5.9)
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