FDA Approves Stand-Alone Package of Rebetol (Ribavirin) for Combination Therapy with Intron A for the Treatment of Chronic Hepatitis C Infection
July 26, 2001
The Food and Drug Administration approved, on July 25, 2001, a stand-alone (unbundled) package for Rebetol capsules (ribavirin), an anti-viral drug for use with Intron A (interferon alfa-2b) for the treatment of patients with chronic hepatitis C infection.
In 1998, FDA approved Rebetron combination therapy, a combination package containing Rebetol capsules and Intron A for injection, based on Schering's application to provide both Rebetol and Intron A in a single package. Schering Corporation manufactures both products.
Use of Rebetol capsules alone is not effective for the treatment of chronic hepatitis C infection, and Rebetol capsules should not be used alone. This approval provides patients and health care providers with flexibility in adopting individualized Rebetol capsule and Intron A-based therapies.
Rebetron combination therapy is not a cure for hepatitis C infection. It is not known how Rebetol capsules and Intron A work together to suppress the hepatitis C virus.
Rebetol capsules can cause serious side effects. Anemia often occurs within one to two weeks after therapy begins. Blood tests to check red blood cell counts should be obtained before treatment and two and four weeks after treatment begins, or more frequently if clinically indicated. Patients should have their red blood cell counts checked as often as their health care provider indicates.
Fatal and non-fatal heart attacks have occurred in patients with anemia caused by Rebetol capsules. Therefore, patients with a history of significant or unstable heart disease should not be treated with Rebetol capsules.
Rebetol may cause birth defects and may lead to death of the exposed fetus. To avoid these birth defects, extreme care must be taken to prevent pregnancy in female patients and female partners of male patients. Female patients must not be pregnant, or become pregnant while being treated with Rebetol capsules and for six months after treatment has stopped. Female sexual partners of male patients being treated with Rebetol capsules must not become pregnant during treatment and for six months after treatment has stopped. Therefore, at least two forms of birth control must be used during this time.
If pregnancy occurs in a patient or partner of a patient during treatment or during the six months after treatment stops, health care providers are encouraged to report such cases to the Rebetron Pregnancy Registry at 1-800-727-7064.
Other common adverse events associated with Rebetol capsules include fatigue, nausea, rash and itching.
Serious side effects due to Intron A include severe depression, psychoses, aggressive behavior, hallucinations, violent behavior (suicidal ideation, suicide attempts, suicides and rare instances of homicidal ideation. These events have occurred in patients without a previous history of psychiatric illnesses. Intron A can cause a serious drop in the cells that help fight infections (white blood cells) and the cells that help bleeding stop (platelets).
A medication guide will accompany each prescription of Rebetol capsules to explain the adverse events associated with Rebetol capsules and Rebetron combination therapy as well as the appropriate use of the products.
Hepatitis C infection is a chronic condition caused by a virus that damages the liver. Although the majority of patients infected with the hepatitis C virus do not develop liver disease, approx. 10-20% may develop cirrhosis (advanced liver scarring), and approximately 1-5% can develop liver cancer after 20-30 years with the infection. Disease may progress faster with HIV coinfection.
The virus that causes hepatitis C infection is spread by contact with an infected person's blood.
Download Rebetol (Ribavirin) Product Information (2001, 46 pages, in PDF format).
This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.