Pharmacy & Therapeutics - September 2008 - (Page CB6)

Important Safety Information WARNING: SPINAL/EPIDURAL HEMATOMAS When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low-molecular-weight heparins or heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis, such as nonsteroidal anti-inﬂammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture. Monitor patients for signs and symptoms of neurological impairment. If neurologic compromise is noted, urgent treatment is necessary. Consider the potential beneﬁt versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (see Warnings and Precautions [5.1] and Drug Interactions [7]). • LOVENOX® (enoxaparin sodium injection) cannot be used interchangeably with other low-molecular-weight heparins or unfractionated heparin (UFH), as they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage • As with other anticoagulants, use with extreme caution in patients with conditions that increase the risk of hemorrhage. Dosage adjustment is recommended in patients with severe renal impairment. Unless otherwise indicated, agents that may affect hemostasis should be discontinued prior to LOVENOX® therapy. Bleeding can occur at any site during LOVENOX® therapy. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site. (See WARNINGS and PRECAUTIONS) • In the STEMI pivotal trial, the rates of major hemorrhages (deﬁned as requiring 5 or more units of blood for transfusion, or a 15% drop in hematocrit or clinically overt bleeding, including intracranial hemorrhage [ICH]) at 30 days were 2.1% in the LOVENOX® group and 1.4% in the UFH group. The rates of ICH at 30 days were 0.8% in the LOVENOX® group and 0.7% in the UFH group. The 30-day rate of the composite endpoint of death, myocardial infarction (MI) or ICH (a measure of net clinical beneﬁt) was signiﬁcantly lower in the LOVENOX® group (10.1%) as compared to the UFH group (12.2%) • Thrombocytopenia can occur with LOVENOX®. In patients with a history of heparin-induced thrombocytopenia (HIT), LOVENOX® should be used with extreme caution. Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3, LOVENOX® should be discontinued. Cases of HIT have been observed in clinical practice. (See WARNINGS and PRECAUTIONS) • The use of LOVENOX® has not been adequately studied for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves. (See WARNINGS and PRECAUTIONS) • LOVENOX® is contraindicated in patients with hypersensitivity to enoxaparin sodium, heparin, or pork products, and in patients with active major bleeding For more information, contact your local sanoﬁ-aventis Representative or call sanoﬁ-aventis Medical Information Services at 1-800-633-1610. Please see accompanying full prescribing information, including boxed WARNING. Additional Resources Lovenox Healthcare Professionals Website: http://www.lovenox.com/hcp/default.aspx References 1. Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). Circulation. 2004;110:1-49. 2. Antman EM, Morrow DA, McCabe CH, et al. Enoxaparin versus unfractionated heparin as antithrombin therapy in patients receiving ﬁbrinolysis for ST-elevation myocardial infarction: design and rationale for the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction study 25 (ExTRACT-TIMI 25). Am Heart J. 2005;149:217-26. 3. Assessment of the Safety and Efﬁcacy of a New Thrombolytic Regimen (ASSENT)-3 Investigators. Efﬁcacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction. Lancet. 2001;358:605-613. This program was developed in conjunction with and funded by sanoﬁ-aventis U.S. LLC. Dr. Charles Pollack received a fee from sanoﬁ-aventis U.S. LLC for his participation in this project. For additional clinical study summaries, visit www.clinicalimpressions.com Clinical Impressions is a trademark of BioPharm Communications, LLC. Copyright 2007 by BioPharm Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without permission in writing from BioPharm Communications, LLC. © 2007 sanoﬁ-aventis U.S. LLC. Printed in the USA US.ENO.07.08.008 6 http://www.lovenox.com/hcp/default.aspx http://www.clinicalimpressions.com

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Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

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