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Enoxaparin sodium injection 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 ) 1.1 Prophylaxis of Deep Vein Thrombosis Enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): • in patients undergoing abdominal surgery who are at risk for thromboembolic complications [ see Clinical Studies ( 14.1 ) ] • in patients undergoing hip replacement surgery, during and following hospitalization • in patients undergoing knee replacement surgery • in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness 1.2 Treatment of Acute Deep Vein Thrombosis Enoxaparin sodium injection is indicated for: • the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin …

Enoxaparin sodium injection is contraindicated in patients with: • Active major bleeding • History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies [see Warnings and Precautions ( 5.4 )] • Known hypersensitivity to enoxaparin sodium ( e.g., pruritus, urticaria, anaphylactic/anaphylactoid reactions) [ see Adverse Reactions ( 6.2 ) ] • Known hypersensitivity to heparin or pork products • Active major bleeding ( 4 ) • History of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies ( 4 ) • Hypersensitivity to enoxaparin sodium ( 4 ) • Hypersensitivity to heparin or pork products ( 4 )

• Increased Risk of Hemorrhage: Monitor for sign of bleeding ( 5.1 , 5.2 , 5.3 ) • Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis. ( 5.4 ) • Thrombocytopenia: Monitor platelet count closely. ( 5.5 ) • Interchangeability with other heparins: Do not exchange with heparin or other LMWHs ( 5.6 ) • Increased Risk of Thrombosis in Pregnant Women with Mechanical Prosthetic Heart Valves: Women and their fetuses may be at increased risk. Monitor more frequently and adjust dosage as needed. ( 5.7 ) 5.1 Increased Risk of Hemorrhage Cases of epidural or spinal hemorrhage and subsequent hematomas have been reported with the use of enoxaparin sodium injection and epidural or spinal anesthesia/analgesia or spinal puncture procedures, resulting in long-term or permanent paralysis. The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [ see Boxed Warning , Adverse Reactions ( 6.2 ) and Drug Interactions ( 7 ) ]. To reduce the potential risk of bleeding associated with the concurrent use of enoxaparin sodium injection and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of enoxaparin [ see Clinical Pharmacology ( 12.3 ) ]. Placement or removal of an epidural catheter or lumbar …

8.1 Pregnancy Risk Summary Placental transfer of enoxaparin was observed in the animal studies. Human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin does not increase the risk of major developmental abnormalities (see Data ) . Based on animal data, enoxaparin sodium injection is not predicted to increase the risk of major developmental abnormalities (see Data ). Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major …