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Rebetol (Ribavirin) - Summary

Rebetol Rx
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Rebetol News
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  • REBETOL monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication (see WARNINGS).
  • The primary toxicity of ribavirin is hemolytic anemia. The 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 (see WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION).
      Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose half-life of 12 days, and so it may persist in nonplasma compartments for as long as 6 months. 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. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS, Information for Patients and Pregnancy Category X sections).
 

REBETOL SUMMARY

REBETOL is Schering Corporation's brand name for ribavirin, a nucleoside analog. The chemical name of ribavirin is 1-(beta)-D-ribofuranosyl-1 H -1,2,4-triazole-3-carboxamide.

REBETOL (ribavirin, USP) Capsules and Oral Solution are indicated in combination with INTRON A (interferon alfa-2b, recombinant) 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 or in patients 18 years of age and older who have relapsed following alpha interferon therapy.

REBETOL Capsules are indicated in combination with PEG-INTRON (peginterferon alfa-2b, recombinant) 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 PEG-INTRON products have not been established.


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REBETOL NEWS HIGHLIGHTS

Media Articles Related to Rebetol (Ribavirin)

Hepatitis C - Phase 3 Clinical Trial Evaluating Thymalfasin Combined With Pegylated Interferon Alpha-2a And Ribavirin
Source: Liver Disease / Hepatitis News From Medical News Today [2008.11.06]

AASLD: Metformin Effective Add-On in HCV Treatment
Source: MedPage Today Gastroenterology [2008.11.06]

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Published Studies Related to Rebetol (Ribavirin)

Pegylated interferon-alpha-2a plus ribavirin for treatment-naive Asian patients with hepatitis C virus genotype 1 infection: a multicenter, randomized controlled trial. [2008.11.15]

Improved outcomes in patients with hepatitis C with difficult-to-treat characteristics: randomized study of higher doses of peginterferon alpha-2a and ribavirin. [2008.10]

Interferon Beta 1a versus Interferon Beta 1a plus Ribavirin for the Treatment of Chronic Hepatitis C in Chinese Patients: A Randomized, Placebo-Controlled Trial. [2008.08]

Early predictors of anemia in patients with hepatitis C genotype 1 treated with peginterferon alfa-2a (40KD) plus ribavirin. [2008.08]

R1626 plus peginterferon Alfa-2a provides potent suppression of hepatitis C virus RNA and significant antiviral synergy in combination with ribavirin. [2008.08]

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Clinical Trials Related to Rebetol (Ribavirin)

Peg-Ifn Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471AM1)(COMPLETED) [Completed]

Extended Treatment With PEG-Intron and Rebetol in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685AM3) [Active, not recruiting]

Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)(COMPLETED) [Completed]

PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy [Completed]

REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy [Completed]

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Page last updated: 2008-11-06

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