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Schering-Plough Announces FDA Approval of PEGINTRON(TM) and REBETOL(R) Combination Therapy for Treating Pediatric Hepatitis C
Date:12/12/2008

thema and vomiting. Three percent were treated for clinical hypothyroidism.

Dose modifications were required in 25 percent of patients, most commonly for anemia, neutropenia and weight loss. Therapy was discontinued prematurely in two percent of the patients.

About Hepatitis C

Hepatitis C is a serious and potentially life-threatening disease. It is the most common blood-borne infection in America and the most common form of liver disease, affecting nearly 5 million people in the United States alone. It is the leading cause of cirrhosis and liver cancer, and the number one reason for liver transplants in the United States.

About PEGINTRON

In the United States, PEGINTRON is indicated for use in combination with ribavirin in patients 3 years of age or older, and as monotherapy in patients 18 years of age and older, for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha.

Important Safety Information Regarding U.S. Labeling for PEGINTRON and REBETOL

Alpha interferons, including PEGINTRON, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON therapy.

Use with Ribavirin: Ribavirin may cause birth defects and death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in a worsening of cardiac disease. Ribav
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SOURCE Schering-Plough Corporation
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