"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(drotrecogin alfa (activated)) Injection, Powder, Lyophilized, For Solution for Intravenous use
Xigris (drotrecogin alfa (activated)) is a recombinant form of human activated protein C. An established human cell line possessing the complementary DNA for the inactive human protein C zymogen secretes the protein into the fermentation medium. Fermentation is carried out in a nutrient medium containing the antibiotic geneticin sulfate. Geneticin sulfate is not detectable in the final product. Human protein C is enzymatically activated by cleavage with thrombin and subsequently purified.
Drotrecogin alfa (activated) is a serine protease with the same amino acid sequence as human plasma-derived activated protein C. Drotrecogin alfa (activated) is a glycoprotein of approximately 55 kilodalton molecular weight, consisting of a heavy chain and a light chain linked by a disulfide bond. Drotrecogin alfa (activated) and human plasma-derived activated protein C have the same sites of glycosylation, although some differences in the glycosylation structures exist.
Xigris (drotrecogin alfa) is supplied as a sterile, lyophilized, white to off-white powder for intravenous infusion. The 5 and 20 mg vials of Xigris contain 5.3 mg and 20.8 mg of drotrecogin alfa (activated), respectively. The 5 and 20 mg vials of Xigris (drotrecogin alfa) also contain 40.3 and 158.1 mg of sodium chloride, 10.9 and 42.9 mg of sodium citrate, and 31.8 and 124.9 mg of sucrose, respectively.
What are the possible side effects of drotrecogin alfa (Xigris)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have any of these serious side effects:
- blood in your urine or stools;
- coughing up blood or vomit that looks like coffee grounds;
- bleeding from any incision or injection in your skin; or
- any bleeding that won't stop.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side...
Last reviewed on RxList: 9/1/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Xigris Information
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