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.

Some side effects of Xigris may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to drotrecogin alfa: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking drotrecogin alfa (the active ingredient contained in Xigris) 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.

For Healthcare Professionals

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.

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.

Serious bleeding events have been reported at the following sites: Gastrointestinal, intra-abdominal, intrathoracic, retroperitoneal, intracranial, genitourinary, skin or soft tissues.

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