Pharmacy & Therapeutics- August 2008 - (Page 475) CASE REPORT: Low-Dose Drotrecogin Alfa in Sepsis continued from page 472 c. Respiratory rate of ≥20 breaths/min or PaCO2 of ≤32 mm Hg or the use of mechanical ventilation for an acute respiratory process –or– d. White cell count ≥12,000/mm3 or ≤4,000/mm3 or a differential count showing >10% immature neutrophils Step 2. Contraindications (please circle): Drotrecogin alfa increases the risk of bleeding. Drotrecogin alfa is contraindicated in patients with the following clinical situations in which bleeding could be associated with a high risk of death or significant morbidity: 1. Active internal bleeding 2. Recent (within 3 months) hemorrhagic stroke 3. Recent (within 2 months) intracranial or intraspinal surgery, or severe head trauma 4. Trauma with an increased risk of life-threatening bleeding 5. Presence of an epidural catheter 6. Intracranial neoplasm or mass lesion or evidence of cerebral herniation 7. Known hypersensitivity to drotrecogin alfa or any component of the product Step 3. Warnings (please circle): No data are available in the following clinical situations; therefore, drotrecogin alfa should be used only if the benefits greatly outweigh the risks at the discretion of the critical care attending physician. 1. Patients who are not expected to survive for 28 days due to a pre-existing, non-sepsis related medical condition 2. Age 135 kg 3. HIV-positive patients whose most recent CD4+ count was ≤50/mm3 4. Chronic renal failure requiring hemodialysis or peritoneal dialysis 5. Patients who had undergone bone marrow, lung, liver, pancreas, or small-bowel transplantation 6. Pregnancy or breast-feeding 7. Concurrent therapeutic unfractionated heparin (≥15 units/kg per hour) or therapeutic low-molecular-weight heparin 8. Platelet count 3.0 10. Recent (within 6 weeks) gastrointestinal bleeding 11. Recent administration (within 3 days) of thrombolytic therapy 12. Recent administration (within 7 days) of oral anticoagulants or glycoprotein IIb/IIIa inhibitors 13. Recent administration (within 7 days) of aspirin > 650 mg/day or other platelet inhibitors 14. Recent (within 3 months) ischemic stroke 15. Intracranial arteriovenous malformation or aneurysm 16. Known bleeding diathesis 17. Chronic severe hepatic disease 18. Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location. 19. Known hypercoagulable conditions: • resistance to activated protein C • hereditary deficiency of protein C, protein S, or antithrombin III • presence of anticardiolipin antibody, antiphospholipid antibody, lupus anticoagulant, or homocysteinemia; or recently documented (within 3 months) • highly suspected deep-vein thrombosis or pulmonary embolism 20. Known or suspected portosystemic hypertension, chronic jaundice, cirrhosis, or chronic ascites 21. Acute pancreatitis with no established source of infection 22. Moribund state in which death was perceived to be imminent 23. Patient not located in an ICU (unless ICU admission pending) 24. Patient’s family, physician, or both not in favor of aggressive treatment or presence of advance directive to withhold life-sustaining treatment Step 4. Call any of the following physicians for final approval of drotrecogin alfa use (the person approving drug use will notify the pharmacy that drug may be released) • Pulmonary/Critical Care Fellow • Pulmonary/Critical Care Attending Step 5. Complete drotrecogin alfa dosing orders 1. Pharmacy orders: a. Patient weight = kg (use actual body weight (ABW) unless patient is obese; suggested dosing weight for obese patients: IBW + 0.4 (ABW – IBW) b. Start drotrecogin alfa @ 24 mcg/kg per hour continuous infusion for total duration of 96 hours Vol. 33 No. 8 • August 2008 • P&T® 475
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