Adjusting Lovenox Dosage for Severe Renal Impairment
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Adjusting Lovenox Dosage for Severe Renal Impairment
Aventis Pharmaceuticals has revised the labeling for the anticoagulant drug Lovenox (enoxaparin sodium injection) stressing the need to adjust the dose in patients with severe renal impairment-that is, those with a creatinine clearance of less than 30 mL per minute. These patients don't clear and eliminate the drug normally, and so they may require a lower dose to prevent bleeding. The label notes that low-weight patients and those with mild or moderate renal impairment don't require a specific dosage adjustment, but that low-weight patients on the drug should be carefully monitored for bleeding. The label also contains a "black box warning," cautioning that patients on anticoagulant drugs who receive epidural or spinal anesthesia, or who receive a spinal puncture, are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. The black box warns that these patients should be frequently monitored for signs of neurological impairment, and if neurologic compromise is noted, urgent treatment is needed. It also recommends that physicians consider benefits versus risks before deciding on neuraxial intervention in patients who are receiving or will receive anticoagulant drugs. Additional Information: FDA MedWatch Safety Alert - Lovenox (enoxaparin sodium injection). http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#lovenox
YouTube | May 7, 2008
