WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS
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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 and Precautions].
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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 Dosage and Administration, Warnings and Precautions, and
Adverse Reactions].
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Significant teratogenic and 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 post-treatment follow-up period [see Contraindications (4), Warnings and Precautions, Use in Specific Populations, Nonclinical Toxicology, and Patient Counseling Information].
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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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NEWS HIGHLIGHTS
Published Studies Related to Rebetol (Ribavirin)
The combination of MK-5172, peginterferon, and ribavirin is effective in
treatment-naive patients with hepatitis C virus genotype 1 infection without
cirrhosis. [2014]
without cirrhosis... CONCLUSIONS: Once-daily MK-5172 (100 mg) with PR for 24 or 48 weeks was highly
[Efficacy and safety of ribavirin aerosol in children with hand-foot-mouth
disease]. [Article in Chinese] [2014]
with hand-foot-mouth disease (HFMD)... CONCLUSIONS: Ribavirin aerosol can be effectively and safely used for treating
[Effects of ribavirin aerosol on viral exclusion of patients with hand-foot-mouth
disease]. [Article in Chinese] [2014]
treatment of hand-foot-mouth disease (HFMD)... CONCLUSIONS: Ribavirin aerosol has multiple advantages of lower dose, quicker
Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese
patients infected with hepatitis C genotype 1. [2014]
infection... CONCLUSIONS: Daclatasvir combined with alfa-2a/ribavirin in treatment-naive
A randomized trial of daclatasvir with peginterferon alfa-2b and ribavirin for
HCV genotype 1 infection. [2014]
infection... CONCLUSIONS: Daclatasvir 60 mg combined with peginterferon alfa-2b and ribavirin
Clinical Trials Related to Rebetol (Ribavirin)
Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252) [Completed]
Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles,
anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur
during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue
their treatment early. The goal of this study is to assess whether a psychotherapy support
program may contribute to a better adherence rate.
Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671) [Completed]
Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C.
Patients in the first one will receive a patient assistance program, and patients in the
second group will not. All patients will receive PegIntron and Rebetol according to label.
Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471) [Completed]
The objective is to compare the safety and efficacy of the following three treatment
regimens in previously untreated adult subjects with chronic hepatitis C infected with
Genotype 1: (1) PegIntron 1. 5 µg/kg/wk in combination with weight based REBETOL (800-1400
mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day);
and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212) [Terminated]
This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy
with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1
chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian
patients with genotype 1 chronic hepatitis C. This study is also designed to provide a
randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin
in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained
virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in
serum at 24 weeks after therapy completion.
Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206) [Terminated]
Patients receiving a patient assistance program during therapy for Hepatitis C will be
enrolled into this study. All patients will receive PegIntron and Rebetol (according to the
label) and the patient assistance program, which includes (1) medications used for treatment
(psychiatric medications); (2) other interventions (nurse support); and (3) educational
literature. This study will be compared to similar studies from other clinics using various
patient support programs for the purpose of designing future comparative phase IV studies.
Reports of Suspected Rebetol (Ribavirin) Side Effects
Anaemia (270),
Rash (142),
Nausea (125),
Decreased Appetite (115),
Haemoglobin Decreased (112),
Pyrexia (104),
Fatigue (88),
Pruritus (79),
Vomiting (79),
Malaise (77), more >>
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Page last updated: 2015-08-10
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