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Xigris Side Effects

Generic Name: drotrecogin alfa

Note: This document contains side effect information about drotrecogin alfa. Some of the dosage forms listed on this page may not apply to the brand name Xigris.

Applies to drotrecogin alfa: intravenous powder for injection

General

The most common side effect associated with drotrecogin alfa (the active ingredient contained in Xigris) has been bleeding.[Ref]

Hematologic

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]

References

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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