Xigris Side Effects
Generic Name: drotrecogin alfa
Note: This page contains side effects data for the generic drug drotrecogin alfa. It is possible that some of the dosage forms included below may not apply to the brand name Xigris.
For the Consumer
Applies to drotrecogin alfa: parenteral diluted iv solutions, parenteral powder for injection
Side effects include:
Bleeding (e.g., ecchymoses, GI bleeding, intracranial hemorrhage).
For Healthcare Professionals
Applies to drotrecogin alfa: intravenous powder for injection
The most common side effect associated with drotrecogin alfa (the active ingredient contained in Xigris) has been bleeding.[Ref]
Hematologic side effects have most commonly included bleeding (25% vs 18% with placebo). The majority of events were ecchymoses or gastrointestinal tract bleeding. Serious bleeding has been reported in 3.5% of patients (vs 2% with placebo) and included intracranial hemorrhage, life threatening hemorrhage, and any event requiring 3 or more units of packed red blood cells per days for 2 consecutive days.[Ref]
Serious bleeding events have been reported at the following sites: Gastrointestinal, intra-abdominal, intrathoracic, retroperitoneal, intracranial, genitourinary, skin or soft tissues.[Ref]
1. Bernard GR, Vincent JL, Laterre PF, et al. "Efficacy and safety of recombinant human activated protein C for severe sepsis." N Engl J Med 344 (2001): 699-709
2. "Product Information. Xigris (drotrecogin alfa)." Lilly, Eli and Company, Indianapolis, IN.
It is possible that some side effects of Xigris may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
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