Xigris

DRUG DESCRIPTION

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...

Read All Potential Side Effects and See Pictures of Xigris


Xigris Patient Information Including Side Effects

Brand Names: Xigris

Generic Name: drotrecogin alfa (Pronunciation: droe tre KOE gin AL fa)

  • What is drotrecogin alfa (Xigris)?
  • What are the possible side effects of drotrecogin alfa (Xigris)?
  • What is the most important information I should know about drotrecogin alfa (Xigris)?
  • What should I discuss with my health care provider before receiving drotrecogin alfa (Xigris)?
  • How is drotrecogin alfa given (Xigris)?
  • What happens if I miss a dose (Xigris)?
  • What happens if I overdose (Xigris)?
  • What should I avoid while receiving drotrecogin alfa (Xigris)?
  • What other drugs will affect drotrecogin alfa (Xigris)?
  • Where can I get more information?

What is drotrecogin alfa (Xigris)?

Drotrecogin alfa is a form of human protein (Protein C).

Drotrecogin alfa is used to treat sepsis in patients who have a high risk of death due to multi-system organ failure.

Drotrecogin alfa may also be used for purposes not listed in this medication guide.

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 effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about drotrecogin alfa (Xigris)?

You should not receive this medication if you have active internal bleeding, brain cancer, tumor, or bleeding in the brain. You should also not receive drotrecogin alfa if you have had brain or spine surgery or a head injury in the past 2 months, or if you have had a stroke within the past 3 months.

Before receiving drotrecogin alfa, tell your doctor if you have severe liver disease, a bleeding or blood clotting disorder, if you have recently had stomach or intestinal bleeding, or have recently taken aspirin, a blood-thinner, or medications to treat or prevent blood clots.

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