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Drotrecogin alfa Side Effects

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

General

The most common side effect associated with drotrecogin alfa 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.

Not all side effects for drotrecogin alfa may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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