"A new consumer-friendly form ( is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-"...
- Clinician Information:
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Drotrecogin alfa was withdrawn from the U.S. market in October 2011.
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.
Read the Xigris (drotrecogin alfa) Side Effects Center for a complete guide to possible side effects
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.
Additional Xigris Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.