Monograph Details
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Infections & Infestations
> Sepsis
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XIGRIS |
| Manufacturer |
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Lilly, Eli and Company |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Anti-sepsis agent. |
| Generic Name |
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Drotrecogin alfa (activated) 5mg/vial, 20mg/vial; pwd for IV infusion after reconstitution and dilution; preservative free. |
| Indications |
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To reduce mortality in severe sepsis in patients with a high risk of death. |
| Children |
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<18 years: not recommended. |
| Adults |
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≥18 years: 24 micrograms/kg per hour by IV infusion for 96 hours. If therapy is stopped, restart at same dose and rate; do not give bolus or increased dose. |
| Contraindications |
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Active internal bleeding. Within 3 months of hemorrhagic stroke or 2 months of intracranial or intraspinal surgery, or severe head trauma. Trauma with an increased risk of life-threatening bleeding. Epidural catheter. Intracranial neoplasm or mass lesion or evidence of cerebral herniation. |
| Precautions |
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Discontinue if clinically important bleeding occurs; may resume if hemostasis achieved. Severe thrombocytopenia (platelet count <30000 x 106 per liter, even if increased after transfusion). Severe coagulopathy (prothrombin time-INR>3). Within 6 weeks of GI bleed, or 3 months of ischemic stroke. Intracranial arteriovenous malformation or aneurysm. Chronic severe hepatic disease. Known bleeding diathesis. Other conditions with increased risk of, or hard to manage, bleeding. Discontinue 2 hours before surgery; see literature for restarting therapy. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Caution with low dose unfractionated heparin up to 15,000 units/day or low molecular weight heparins, within 3 days of thrombolytics, or within 7 days of oral anticoagulants, GP IIb/IIIa inhibitors (eg, abciximab), aspirin >650mg/day, other platelet inhibitors. Variable effect on APTT assay; use PT instead. |
| Adverse Reactions |
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Bleeding (may be serious), possible antibody formation. |
| How Supplied |
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Single-use vials—1 |
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