FRIDAY, April 6, 2007 (HealthDay News) -- HepaGam B, a first-of-its-kind immune globulin product, has been approved by the U.S. Food and Drug Administration to prevent hepatitis B reinfection among people who have received liver transplants, the agency said Friday.
Immune-compromised liver transplant recipients who have already been exposed to hepatitis B are at increased risk of re-infection from the virus, which attacks the liver and can cause liver failure or liver cancer. HepaGam B, produced from human plasma, stimulates an immune response to the virus, the FDA said.
The product reduced the infection recurrence rate to about 13 percent from 86 percent among liver transplant recipients who participated in clinical trials, the agency said. Common adverse reactions included headache and high blood pressure.
HepaGam B was first FDA-approved in January 2006 to prevent hepatitis B infection acquired by sexual or contact exposure, and in unborn infants whose mothers had been exposed to the virus. The product is manufactured by Cangene Corp. of Winnipeg, Canada.
More information
This FDA page has more about the approval.
