Hemolytic Disease

FDA approves Rhophylac for prevention of hemolytic disease

Published in Medical Letter on the CDC and FDA, March 21st, 2004

The U.S. Food and Drug Administration (FDA) has approved Rhophylac, the first liquid Rh0(D) immune globulin intravenous (human) - or RhIGIV - that can be administered intramuscularly (IM) or intravenously (IV), for sale in the U.S.

Used in the prevention of hemolytic disease of the fetus and newborn (HDN), Rhophylac provides a choice for physicians and patients who are concerned about the pain associated with IM administration, especially when multiple injections are required.

ZLB Bioplasma manufactures Rhophylac using the distinctive ChromaPlus process, which results in a highly pure therapeutic product that makes it possible to administer the...

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Source: Medical Letter on the CDC and FDA (2004-03-21)

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