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Xigris (Drotrecogin Alfa (Activated)) - Drug Interactions, Contraindications, Overdosage, etc



Coadministration of Drugs that Affect Hemostasis

Since there is an increased risk of bleeding with Xigris, caution should be employed when Xigris is used with other drugs that affect hemostasis [see Warnings and Precautions and Clinical Pharmacology].

Coadministration of Prophylactic Heparin

Heparin for venous thromboembolism (VTE) prophylaxis may be coadministered with Xigris [see Warnings and Precautions and Clinical Studies]. No dosage adjustment of Xigris is recommended when coadministered with prophylactic heparin [see Clinical Pharmacology].

Interference with Coagulation Assays

Xigris has minimal effect on the prothrombin time (PT). Prolongation of the activated partial thromboplastin time (APTT) in patients with severe sepsis receiving Xigris may be due to the underlying coagulopathy, the pharmacodynamic effect of Xigris, and/or the pharmacodynamic effect of other concurrent medications. The effect of Xigris on the APTT assay is dependent on the reagent and instrument used to perform the assay and the time that elapses between sample acquisition and assay performance. Drotrecogin alfa (activated) present in a plasma sample will be gradually neutralized by endogenous inhibitors. Due to these biological and analytical variables, the APTT should not be used to assess the pharmacodynamic effect of Xigris. The interpretation of sequential determination of the PT and/or APTT should take these variables into consideration.

Because Xigris may affect the APTT assay, drotrecogin alfa (activated) present in plasma samples may interfere with one-stage coagulation assays based on the APTT (such as factor VIII, IX, and XI assays). This interference may result in a measured factor concentration that is lower than the actual concentration. Drotrecogin alfa (activated) present in plasma samples does not interfere with one-stage factor assays based on the PT (such as factor II, V, VII, and X assays).


There is no known antidote for Xigris. In case of overdose, immediately stop the infusion and monitor closely for hemorrhagic complications [see Clinical Pharmacology].

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 the following clinical situations where bleeding could lead to significant morbidity or death:

  • 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


Knaus WA, et al. APACHE II: a severity of disease classification system. Crit Care Med. 1985;13:818-829.

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