Rebetol (ribavirin)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
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
