Pharmacy & Therapeutics - September 2008 - (Page CB7)

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Lovenox safely and effectively. See full prescribing information for Lovenox. Lovenox® (enoxaparin sodium injection) for subcutaneous and intravenous use Initial U.S. Approval: 1993 WARNING: SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. • Enoxaparin use in patients undergoing spinal/epidural anesthesia or spinal puncture increases the risk of spinal or epidural hematoma, which may cause long-term or permanent paralysis (5.5) • Risk is increased by: o Indwelling epidural catheters for analgesia (5.5) o Drugs affecting hemostasis [e.g., nonsteroidal anti-inflammatory drugs, platelet inhibitors, anticoagulants] (5.5, 7) o Traumatic or repeated spinal or epidural puncture (5.5) - - - - - - - - - - - - - - - - - - - - - RECENT MAJOR CHANGES - - - - - - - - - - - - - - - - - - - - Indications and Usage (1.4), 5/2007 Dosage and Administration (2) 5/2007 ST-segment Elevation Myocardial Infarction Warnings and Precautions (5.2) 5/2007 Percutaneous coronary revascularization procedures - - - - - - - - - - - - - - - - - - - - - INDICATIONS AND USAGE - - - - - - - - - - - - - - - - - - - - Lovenox is a low molecular weight heparin [LMWH] indicated for: • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) • Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) • Outpatient treatment of acute DVT without pulmonary embolism. (1.2) • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI] (1.3) • Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI] (1.4) - - - - - - - - - - - - - - - - - - - DOSAGE AND ADMINISTRATION - - - - - - - - - - - - - - - - - - Indication Standard Regimen Severe Renal (2.1, 2.3) Impairment (2.2) DVT prophylaxis in 40 mg SC once daily 30 mg SC once daily abdominal surgery DVT prophylaxis in knee 30 mg SC every 12 hours 30 mg SC once daily replacement surgery DVT prophylaxis in hip 30 mg SC every 12 hours 30 mg SC once daily replacement surgery or 40 mg SC once daily DVT prophylaxis in 40 mg SC once daily 30 mg SC once daily medical patients Inpatient treatment of 1 mg/kg SC every 12 hours 1 mg/kg SC once daily acute DVT with or without or 1.5 mg/kg SC once daily pulmonary embolism (with warfarin) Outpatient treatment of 1 mg/kg SC every 12 hours 1 mg/kg SC once daily acute DVT without (with warfarin) pulmonary embolism Unstable angina and 1 mg/kg SC every 12 hours 1 mg/kg SC once daily non-Q-wave MI (with aspirin) FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SPINAL / EPIDURAL HEMATOMAS 1 INDICATIONS AND USAGE 1.1 Prophylaxis of Deep Vein Thrombosis 1.2 Treatment of Acute Deep Vein Thrombosis 1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction 1.4 Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) 2 DOSAGE AND ADMINISTRATION 2.1 Adult Dosage 2.2 Renal Impairment 2.3 Geriatric patients with acute ST-segment Elevation Myocardial Infarction 2.4 Administration 3 DOSAGE FORMS AND STRENGTHS 3.1 100 mg per mL 3.2 150 mg per mL 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Increased Risk of Hemorrhage 5.2 Percutaneous Coronary Revascularization Procedures 5.3 Use of Lovenox with Concomitant Medical Conditions 5.4 History of Heparin-induced Thrombocytopenia 5.5 Thrombocytopenia 5.6 Interchangeability with Other Heparins 5.7 Pregnant Women with Mechanical Prosthetic Heart Valves 5.8 Benzyl Alcohol 5.9 Laboratory Tests 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Post-Marketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS Acute STEMI in patients 30-mg single IV bolus plus 30-mg single IV bolus 1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, and nausea To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. - - - - - - - - - - - - - - - - - - - - - - - DRUG INTERACTIONS - - - - - - - - - - - - - - - - - - - - - - Discontinue agents which may enhance hemorrhage risk prior to initiation of Lovenox or conduct close clinical and laboratory monitoring (5.9, 7). - - - - - - - - - - - - - - - - - - - USE IN SPECIFIC POPULATIONS - - - - - - - - - - - - - - - - - - • Severe renal impairment: Adjust dose for patients with creatinine clearance <30 mL/min (2.2) • Hepatic Impairment (8.8) • Low-weight patients: Observe for signs of bleeding (8.9) See 17 for PATIENT COUNSELING INFORMATION Revised: October 2007 10 11 12 13 14 16 17 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Patients with Mechanical Prosthetic Heart Valves 8.7 Renal Impairment 8.8 Hepatic Impairment 8.9 Low-Weight Patients OVERDOSAGE DESCRIPTION CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology CLINICAL STUDIES 14.1 Prophylaxis of Deep Vein Thrombosis (DVT) Following Abdominal Surgery in Patients at Risk for Thromboembolic Complications 14.2 Prophylaxis of Deep Vein Thrombosis (DVT)Following Hip or Knee Replacement Surgery 14.3 Prophylaxis of Deep Vein Thrombosis (DVT) in Medical Patients with Severely Restricted Mobility During Acute Illness 14.4 Treatment of Deep Vein Thrombosis (DVT) with or without Pulmonary Embolism (PE) 14.5 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction 14.6 Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) HOW SUPPLIED/STORAGE AND HANDLING PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed http://www.fda.gov/medwatch

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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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