Rebetol

2009-02-26T02:17:00.000-08:00

INDICATIONS
Adult Use

REBETOL (ribavirin, USP) Capsules and Oral Solution are indicated in combination with INTRON A (interferon alfa-2b, recombinant) for Injection

for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha

interferon and in patients 18 years of age and older who have relapsed following alpha interferon therapy.

REBETOL Capsules are indicated in combination with PegIntron (peginterferon alfa-2b,) Injection for the treatment of chronic hepatitis C in

patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.

The safety and efficacy of REBETOL Capsules or Oral Solution with interferons other than INTRON A or PegIntron products have not been

established.
Pediatric Use

REBETOL (ribavirin, USP) Capsules are indicated in combination with INTRON A for Injection for the treatment of chronic hepatitis C in patients

5 years of age and older with compensated liver disease previously untreated with alpha interferon and in patients who have relapsed following

alpha interferon therapy.

REBETOL (ribavirin, USP) Oral Solution is indicated in combination with INTRON A for Injection for the treatment of chronic hepatitis C in

patients 3 years of age and older with compensated liver disease previously untreated with alpha interferon and in patients who have relapsed

following alpha interferon therapy.

Evidence of disease progression, such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral

load, should be considered when deciding to treat a pediatric patient. The benefits of treatment should be weighed against the safety findings

observed (see PRECAUTIONS Pediatric Use) for pediatric subjects in the clinical trials.
DOSAGE AND ADMINISTRATION

(see CLINICAL PHARMACOLOGY, Special Populations; see WARNINGS)
REBETOL/INTRON A Combination Therapy
Adults

The recommended dose of REBETOL Capsules depends on the patient\'s body weight. The recommended dose of REBETOL is provided in

TABLE 11.

The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be

individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen. (See

Description of Clinical Studies and ADVERSE REACTIONS.) After 24 weeks of treatment virologic response should be assessed. Treatment

discontinuation should be considered in any patient who has not achieved an HCV RNA below the limit of detection of the assay by 24 weeks.

There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.

In patients who relapse following non-pegylated interferon monotherapy, the recommended duration of treatment is 24 weeks. There are no

safety and efficacy data on treatment for longer than 24 weeks in the relapse patient population.

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