Enoxaparin Sodium INJECTION

Brand Name: Enoxaparin Sodium

Generic Name: ENOXAPARIN SODIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: SUBCUTANEOUS

Dosage Form: INJECTION

Data Current As Of: 2018-10-11

Enoxaparin sodium injection, USP 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.

Enoxaparin sodium injection, USP is indicated for:

• the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium.
• the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.

Enoxaparin sodium injection, USP is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.

Enoxaparin sodium injection, USP, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).

Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of enoxaparin sodium injection therapy. These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDs (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone. If co-administration is essential, conduct close clinical and laboratory monitoring [see Warnings and Precautions (5.9) ].

If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, they should be informed to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness. If any of these symptoms occur the patient should contact his or her physician immediately.

Additionally, the use of aspirin and other NSAIDs may enhance the risk of hemorrhage. Their use should be discontinued prior to enoxaparin therapy whenever possible; if co-administration is essential, the patient’s clinical and laboratory status should be closely monitored [see Drug Interactions (7) ].

Patients should also be informed:

• of the instructions for injecting enoxaparin sodium injection if their therapy is to continue after discharge from the hospital.
• it may take them longer than usual to stop bleeding.
• they may bruise and/or bleed more easily when they are treated with enoxaparin sodium injection.
• they should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [see Warnings and Precautions (5.1, 5.5) ].
• to tell their physicians and dentists they are taking enoxaparin sodium injection and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [see Warnings and Precautions (5.3) ].
• to tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs [see Drug Interactions (7) ].

11-2013

3-4008-264

3-4009-264

Manufactured by

Baxter Pharmaceutical Solutions LLC

for Sandoz Inc., Princeton, NJ 08540