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Drotrecogin Alfa Solution for injection

It is used to treat life-threatening sepsis

Generic Name: drotrecogin alfa  |  Brand Name: Xigris

Brand Names: Xigris

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 10/25/2011] ISSUE: FDA notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of drotrecogin alfa (activated) [Xigris]. In a recently completed clinical trial (PROWESS-SHOCK trial), drotrecogin alfa (activated) failed to show a survival benefit for patients with severe sepsis and septic shock.

BACKGROUND: Drotrecogin alfa (activated) is indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death.

RECOMMENDATION: For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

DROTRECOGIN ALFA (droe tre KOE gin AL fa) is used to treat life-threatening sepsis.
NOTE: Drotecogin alfa has been withdrawn from the market and is no longer available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • bleeding disorders
  • brain or spine surgery or injury
  • history of any bleeding event
  • low platelet count in the blood
  • liver disease
  • stroke
  • take medicines that treat or prevent blood clots
  • an unusual or allergic reaction to drotrecogin alfa, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

  • aspirin and aspirin-like medicines
  • cilostazol
  • clopidogrel
  • dipyridamole
  • medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, heparin
  • pentoxifylline
  • ticlopidine

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • black or tarry stools
  • breathing problems
  • coughing up blood
  • dark urine
  • unusual bleeding or bruising

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: April 09, 2009
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