Rebetol (ribavirin)
Company: Schering-Plough
Approval Status: Approved July 2001
Treatment for: Hepatitis C
Areas: Gastroenterology; Immunology/Infectious Diseases
| General Information | Side Effects | Mechanism of Action | Additional Information |
General Information
Rebetol (ribavirin) capsules have been approved as a separately marketed product for use in combination with Intron A (interferon alfa-2b) injection. This drug is designed as a treatment for chronic hepatitis C in patients with compensated liver disease who have not had previous alpha interferon therapy or who have relapsed following successful therapy.
Rebetol has been approved in the United States since 1998 as part of a single-package combination therapy (known as Rebetron) that includes Rebetol capsules and Intron A injection. The new stand-alone package of Rebetol capsules provides patients and physicians with the option of individualized ribavirin and interferon-based therapies.
Hepatitis C is a potentially life-threatening viral infection that can lead to liver inflammation, liver disease, cirrhosis or liver cancer. According to the National Center for Infectious Diseases, an estimated 3.9 million Americans have been infected with the hepatitis C virus (HCV), and of these 2.7 million are chronically infected. Unfortunately, most people who are infected with hepatitis C are unaware of it because it may take years for symptoms to develop.
Side Effects
Side effects associated with Rebetol include (but are not limited to) the following:
- Anemia
- Fatigue
- Nausea
- Rash
- Itching
Individuals with a history of significant or unstable heart disease should not use Rebetol capsules, as fatal and non-fatal heart attacks have occurred in patients with anemia caused by the drug.
Additionally, due to the possibility of severe adverse events, extreme care must be taken to prevent pregnancy in female patients receiving Rebetol and female partners of male patients.
Serious side effects due to Intron A use may include the following:
- Severe depression
- Psychoses
- Aggressive behavior
- Hallucinations
- Decrease in white blood cells
Mechanism of Action
Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog with antiviral activity. Intron A is a recombinant version of naturally occurring alpha interferon. The mechanism of inhibition of hepatitis C virus (HCV) RNA by combination therapy with Rebetol and Intron A has not been established.
Additional Information
For additional information on Rebetol capsules, Rebetron Combination Therapy and other company products, please visit Schering-Plough.
Information on hepatitis C can be obtained at the following web sites:
CDC National Center for Infectious Diseases.
National Institute of Diabetes and Digestive and Kidney Diseases.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
