There is no known antidote for Xigris. In case of overdose, immediately stop the infusion and monitor closely for hemorrhagic complications (see Human Pharmacokinetics).

In postmarketing experience there have been a limited number of medication error reports of excessive rate of Xigris infusion for short periods of time (median 2 hours). No unexpected adverse events were observed during the overdose period. However, this information is insufficient to assess whether Xigris overdose is associated with an increased hemorrhage risk beyond that observed with Xigris administered at the recommended dose.

Xigris increases the risk of bleeding. Xigris is contraindicated in patients with the following clinical situations in which bleeding could be associated with a high risk of death or significant morbidity:

· Active internal bleeding

· Recent (within 3 months) hemorrhagic stroke

· Recent (within 2 months) intracranial or intraspinal surgery, or severe head trauma

· Trauma with an increased risk of life-threatening bleeding

· Presence of an epidural catheter

· Intracranial neoplasm or mass lesion or evidence of cerebral herniation

Xigris is contraindicated in patients with known hypersensitivity to drotrecogin alfa (activated) or any component of this product.

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