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LOVENOX® (enoxaparin sodium injection) has a consistent, highly controlled manufacturing process
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LOVENOX® has a consistent, highly controlled manufacturing process

Proven in clinical trials and widely used in medical practice1-18

WARNING: SPINAL/EPIDURAL HEMATOMA

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • Use of indwelling epidural catheters
  • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
  • A history of traumatic or repeated epidural or spinal punctures
  • A history of spinal deformity or spinal surgery

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

LOVENOX® is produced by a unique, proprietary manufacturing process that creates a biological product with specific biochemical features

Complex biological product created through unique manufacturing process

To help ensure the quality and safety of LOVENOX®, sanofi-aventis uses a consistent and highly controlled manufacturing process

  • Our high standards of manufacturing, drug testing, quality controls, and audits are used to help ensure:
    • —Traceability and quality of crude heparin from controlled sources
    • —Verification of multiple pharmacologic and chemical characteristics (molecular weight, anti-Xa or anti-IIa activities)
  • LOVENOX® is consistently tested to ensure the high quality and integrity of its manufacturing practices, which help ensure that the product is stable and reliable

LOVENOX® is well established with over 17 years of experience19

  • Evidence-based medicine supports the use of LOVENOX® based on Phase III clinical trial data and real-world experience1-18
  • LOVENOX® has been studied in more than 72,000 patients20
    • —Efficacy and safety demonstrated in the management of patients across the spectrum of acute coronary syndrome, deep vein thrombosis (DVT) prophylaxis in acutely ill medical patients, DVT prophylaxis in certain surgical patients, and DVT treatment of both inpatients and outpatients1-18
    • —Benefit/risk profile confirmed in registry and outcome trials in thousands of patients21-24
    • —Recommended in key guidelines worldwide and cited for extent of clinical evidence10-12,14
  • Reinforced by over 17 years of experience in clinical settings in the United States19
    • —The most widely studied and prescribed LMWH25,26
    • —Demonstrated efficacy and safety in a wide range of patients1-18

LOVENOX® — produced by a sanofi-aventis proprietary process — has established clinical safety and efficacy data through Phase III clinical trials to support the proven and predictable product profile.



Important Safety Information for LOVENOX®

WARNING: SPINAL/EPIDURAL HEMATOMA

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • Use of indwelling epidural catheters
  • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
  • A history of traumatic or repeated epidural or spinal punctures
  • A history of spinal deformity or spinal surgery

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

CONTRAINDICATIONS
  • LOVENOX® (enoxaparin sodium injection) is contraindicated in patients with active major bleeding; thrombocytopenia with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium; known hypersensitivity to enoxaparin sodium, heparin, pork products, or benzyl alcohol (multi-dose formulation only)

WARNINGS AND PRECAUTIONS
  • LOVENOX® should be used with extreme caution in conditions with increased risk of hemorrhage. Major hemorrhages including retroperitoneal and intracranial bleeding have been reported. Some of these cases have been fatal. Bleeding can occur at any site during LOVENOX® therapy. An unexplained fall in hematocrit (HCT) or blood pressure should lead to a search for a bleeding site

  • For percutaneous coronary revascularization procedures, obtain hemostasis at the puncture site before sheath removal and observe the site for signs of bleeding or hematoma formation

  • In the STEMI population, the rates of major hemorrhages (defined as requiring 5 or more units of blood for transfusion, or 15% drop in HCT or clinically overt bleeding, including intracranial hemorrhage [ICH]) at 30 days were 2.1% in the LOVENOX® group and 1.4% in the unfractionated heparin (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, or ICH (a measure of net clinical benefit) was significantly lower in the LOVENOX® group (10.1%) compared to the UFH group (12.2%)

  • LOVENOX® should be used with caution in patients with bleeding diathesis, uncontrolled arterial hypertension or a history of recent gastrointestinal ulceration, diabetic retinopathy, renal dysfunction, or hemorrhage

  • 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

  • LOVENOX® cannot be used interchangeably with other branded LMWH or UFH, as they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosages

  • Pregnant women with mechanical prosthetic heart valves and their fetuses may be at increased risk for thromboembolism. Frequent monitoring of anti-Factor Xa levels and adjusting of dosage may be needed

  • LOVENOX® multiple-dose vials contain benzyl alcohol and should be used with caution in pregnant women and only if clearly needed due to the risk of fatal "gasping syndrome" in premature neonates

  • Periodic complete blood counts, including platelet count, and stool occult blood tests are recommended during the course of treatment with LOVENOX®

ADVERSE REACTIONS
  • Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, and nausea

For more information, contact your local sanofi-aventis U.S. Representative or call sanofi-aventis U.S. Medical Information Services at 1-800-633-1610.

Please see full Prescribing Information, including boxed WARNING.

Prescription LOVENOX® is available in pharmacies.

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References
1. Antman EM, Morrow DA, McCabe CM, et al; ExTRACT-TIMI 25 Investigators. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction. N Engl J Med. 2006;354(14):1477-1488.
2. Antman EM, Morrow DA, McCabe CH, et al; ExTRACT-TIMI 25 Investigators. 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(2):217-226.
3. Cohen M, Demers C, Gerfinkel EP, et al; Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events Study Group. A comparison of low-molecular weight heparin with unfractionated heparin for unstable coronary artery disease. N Engl J Med. 1997;337(7):447-452.
4. Samama MM, Cohen AT, Darmon J-Y, et al. A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients. Prophylaxis in Medical Patients with Enoxaparin Study Group. N Eng J Med. 1999;341(11):793-800.
5. Levine M, Gent M, Hirsh J, et al. A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis. N Engl J Med. 1996;334(11):677-681.
6. Colwell CW Jr, Collis DK, Paulson R, et al. Comparison of enoxaparin and warfarin for the prevention of venous thromboembolic disease after total hip arthroplasty: evaluation during hospitalization and three months after discharge. J Bone Joint Surg Am. 1999;81(7):932-940.
7. Bergqvist D, Benoni G, Björgell O, et al. Low-molecular-weight heparin (enoxaparin) as prophylaxis against venous thromboembolism after total hip replacement. N Engl J Med. 1996;335(10):696-700.
8. Fitzgerald RH Jr, Spiro TE, Trowbridge AA, et al; Enoxaparin Clinical Trial Group. Prevention of venous thromboembolic disease following primary total knee arthroplasty. A randomized multicenter, open-label, parallel-group comparison of enoxaparin and warfarin. J Bone Joint Surg Am. 2001;83-A(6):900-906.
9. Bergqvist D, Eldor A, Thorlacius-Ussing O, et al; ENOXACAN Study Group. Efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep vein thrombosis in elective cancer surgery: a double-blind randomized multicentre trial with venographic assessment. Br J Surg. 1997;84(8):1099-1103.
10. Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non—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 2002 Guidelines for the Management of Patients With Unstable Angina/Non—ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, American College of Physicians, Society of Academic Emergency Medicine, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2007;50(7):652-726.
11. Antman EM, Hand M, Armstrong PW, et al; 2007 Writing Group to Review New Evidence and Update the ACC/AHA 2004 Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction, Writing on Behalf of the 2004 Writing Committee. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2008;117(2):296-329.
12. Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008;133(6 suppl):381S-453S.
13. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008;133(6 suppl):454S-545S.
14. Stahl TJ, Gregorcyk SG, Hyman NH, Buie WD; Standards Practice Task Force of The American Society of Colon and Rectal Surgeons. Practice parameters for the prevention of venous thrombosis. Dis Colon Rectum. 2006;49(10):1477-1483.
15. Lyman GH, Khorana AA, Falanga A, et al. American Society of Clinical Oncology guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer. J Clin Oncol. 2007;25(34):5490-5505.
16. Johanson NA, Lachiewicz PF, Lieberman JR, et al; AAOS Physician Volunteer Work Group. American Academy of Orthopaedic Surgeons clinical guideline on prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty: summary of recommendations. http://www.aaos.org/Research/guidelines/PE_guideline.pdf. Accessed April 1, 2008.
17. ACOG Committee on Practice Bulletins—Gynecology, American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 84: prevention of deep vein thrombosis and pulmonary embolism. Obstet Gynecol. 2007;110(2, pt 1):429-440.
18. American Society of Regional Anesthesia and Pain Medicine. Consensus statements: regional anesthesia in the anticoagulated patient: defining the risks. http://www.asra.com/publications/consensus-statements-2.html. Accessed September 26, 2006.
19. LOVENOX® (enoxaparin sodium injection) Prescribing Information. sanofi-aventis, Bridgewater, NJ.
20. Data on file, sanofi-aventis, Bridgewater, NJ.
21. Klein W, Kraxner W, Hödl R, et al; GRACE Investigators. Patterns of use of heparins in ACS. Correlates and hospital outcomes: the Global Registry of Acute Coronary Events (GRACE). Thromb Haemost. 2003;90(3):519-527.
22. Goldhaber SZ, Tapson VF; DVT FREE Steering Committee. A prospective registry of 5,451 patients with ultrasound-confirmed deep vein thrombosis. Am J Cardiol. 2004;93(2):259-262.
23. Fitchett DH, Langer A, Armstrong PW, Tan M, Mendelsohn A, Goodman SG; INTERACT Trial Long-Term Follow-Up Investigators. Randomized evaluation of the efficacy of enoxaparin versus unfractionated heparin in high-risk patients with non—ST-segment elevation acute coronary syndromes receiving the glycoprotein IIb/IIIa inhibitor eptifibatide. Long-term results of the Integrilin and Enoxaparin Randomized Assessment of Acute Coronary Syndrome Treatment (INTERACT) trial. Am Heart J. 2006;151(2):373-379.
24. Goodman SG, Cohen M, Bigonzi F, et al; Efficacy and Safety of Subcutaneous Enoxaparin in Non—Q Wave Coronary Events (ESSENCE) Study Group. Randomized trial of low molecular weight heparin (enoxaparin) versus unfractionated heparin for unstable coronary artery disease: one-year results of the ESSENCE study. J Am Coll Cardiol. 2000;36(3):693-698.
25. IMS National Sales Perspectives, February 2009.
26. PubMed.gov: a service of the US National Library of Medicine and the National Institutes of Health. Search clinical trials for: ardeparin, certoparin, dalteparin, enoxaparin, nadroparin, reviparin, and tinzaparin. PubMed.gov website. http://www.ncbi.nlm.nih.gov/pubmed. Accessed April 22, 2009.

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Last Update: July 2010
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