The Food & Drug Administration recently approved hepatitis B immune globulin [human] (HepaGam B, Cangene) for the treatment of acute exposure to blood containing hepatitis B surface antigens (HBsAg), perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons, and household exposure to those with acute hepatitis B virus (HBV) infection. HepaGam B is expected to be distributed by Apotex, and Cangene and Apotex expect to launch the product within the next several months.

Approximately two billion people worldwide have been infected with HBV, and approximately 8,500 new cases of HBV infection are reported every year in the United States.

HepaGam B provides another treatment option for this significant public health issue, said Jack Rosenberg, Pharm.D., Ph.D., director of the International Drug Information Center at the Arnold & Marie Schwartz College of Pharmacy and Health Sciences in Brooklyn, N.Y.

An intramuscular injection of 0.06 mL/kg should be administered as soon as possible after exposure to blood containing HBsAg, and within 24 hours if possible, according to the manufacturer. The company advises those who refuse HBV vaccination or who are known non-responders to vaccine to receive a second dose of HepaGam B one month after the first dose.

Cangene recommends that infants born to known HBsAg-positive mothers receive 0.50 mL of HepaGam B after physiologic stabilization and preferably within 12 hours after birth. The hepatitis B vaccine series should be initiated simultaneously, if not contraindicated, with the first dose of the vaccine given concurrently but at a different site. If a woman admitted for delivery is tested and found to be HBsAg-positive, her infant should receive 0.50 mL of HepaGam B as soon as possible and within one week of birth, the company said.

The manufacturer recommends that those who have had sexual contact with HBsAg-positive persons receive a single dose of 0.06 mL/kg of HepaGam B and begin the hepatitis B vaccine series, if it is not contraindicated, within 14 days of last sexual contact or if sexual contact with the infected partner will continue.

Prophylaxis of an infant less than 12 months old with 0.5 mL of HepaGam B and hepatitis B vaccine is recommended by Cangene if the mother or other primary caregiver has acute HBV infection. The company said that prophylaxis of others in the household is unnecessary unless they had an identifiable blood exposure to the index patient, and that these incidents should be treated like sexual exposures.

The company cautions that the maltose contained in HepaGam B can interfere with blood glucose monitoring systems based on the glucose dehydrogenase pyrroloquinequinone (GDH-PQQ) method, resulting in falsely elevated glucose readings. Cangene advises that only glucose-specific testing systems be used to monitor blood glucose levels in those receiving HepaGam B.

In addition, the company said that because HepaGam B is made from human plasma, the product may contain infectious agents. The manufacturer advises healthcare professionals to report all infections they believe to have been transmitted by HepaGam B to Cangene by calling (877) CANGENE (226-4363).

HepaGam B is supplied as a carton containing a 1-mL single-dose vial and/or a carton containing a 5-mL single-dose vial. The company advises that HepaGam B should be stored at 36-46F (2-8C).

THE AUTHOR is a writer based in New Jersey.