- Bleeding is the most common adverse event experienced during therapy. Each patient being considered for therapy should be evaluated and the anticipated benefits weighed against potential risks associated with therapy
- In clinical studies, patients with single organ dysfunction and recent surgery experienced a higher all-cause mortality rate compared to the placebo group
- Physicians should consider continuing heparin for venous thromboembolism prophylaxis, at the time of initiating drotrecogin alfa, unless discontinuation is medically necessary
- Invasive procedures, including arterial and central venous punctures, should be minimized during therapy as they increase the risk of bleeding; avoid puncturing a non-compressible site during drotrecogin alfa infusion
- Discontinue therapy 2 hrs prior to an invasive surgical procedure or procedures with an inherent risk of bleeding; once adequate hemostasis has been achieved, therapy may be restarted 12 hrs after surgery and major invasive procedures or immediately after uncomplicated less invasive procedures
- Drotrecogin alfa may interfere with one-stage coagulation assays associated with activated partial thromboplastin time (APTT), but not those associated with prothrombin time (PT). PT is more preferable to APTT for assessment of degree of coagulopathy in sepsis patients being treated with drotrecogin alfa
Cautions: Use cautiously in
- Chronic severe hepatic disease
- Concurrent therapeutic dosing of heparin to treat an active thrombotic or embolic event
- Platelet count <30,000 x 106/L
- Prothrombin time-INR >3.0
- Recent GI bleeding (within 6 wks)
- Recent administration of thrombolytic therapy (within 3 days)
- Recent administration of oral anticoagulants or glycoprotein IIb/IIIa inhibitors (within 7 days)
- Recent administration of aspirin >650 mg/day or other platelet inhibitors (within 7 days)
- Recent ischemic stroke (within 3 months)
- Intracranial arteriovenous malformation or aneurysm
- Known bleeding diathesis
Pregnancy Category:C
Breastfeeding: Safety unknown. As per manufacturer's data, because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
