Enoxaparin

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 Prophy …

• See full prescribing information for dosing and administration information
• Pretreatment Evaluation Evaluate all patients for a bleeding disorder before starting enoxaparin sodium treatment, unless treatment is urgently needed
• Adult Dosage Abdominal Surgery The recommended dose of enoxaparin sodium is 40 mg by subcutaneous injection once a day (with the initial dose given 2 hours prior to surgery) in patients undergoing abdominal surgery who are at risk for thromboembolic complications
• The usual duration of administration is 7 to 10 days [see Clinical Studies ]
• Hip or Knee Replacement Surgery The recommended dose of enoxaparin sodium is 30 mg every 12 hours administered by subcutaneous injection in patients undergoing hip or knee replacement surgery
• Administer the initial dose 12 to 24 hours after surgery, provided that hemostasis has been established
• The usual duration of administration is 7 to 10 days [see Clinical Studies ]
• A dose of enoxaparin sodium of 40 mg once a day subcutaneously may be considered for hip replacement surgery for up to 3 weeks
• Administer the initial dose 12 (±3) hours prior to surgery
• Medical Patients during Acute Illness The recommended dose of enoxaparin sodium is 40 mg once a day administered by subcutaneous injection for medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness
• The usual duration of administration is 6 to 11 days [see Clinical Studies ]. …

Enoxaparin sodium injection is a clear, colorless to pale-yellow solution available in two concentrations. 100 mg/mL Concentration – Single-Dose Prefilled Syringes 30 mg/0.3 mL, 40 mg/0.4 mL – Single-Dose Graduated Prefilled Syringes 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL 150 mg/mL Concentration – Single-Dose Graduated Prefilled Syringes 120 mg/0.8 mL, 150 mg/1 mL 100 mg/mL concentration ( 3 ): S …

• Safety and effectiveness of enoxaparin sodium
• In pediatric patients have not been established
• Enoxaparin sodium is not approved for use in neonates or infants

Prevention of Deep Vein Thrombosis in Hip, Knee and Abdominal Surgery; Treatment of Deep Vein Thrombosis, Prevention of Ischemic Complications of Unstable Angina and Non − Q-wave Myocardial Infarction Over 2800 patients, 65 years and older, have received enoxaparin sodium in clinical trials. The efficacy of enoxaparin sodium in the geriatric (≥65 years) was similar to that seen in younger patients (

• Advise the patient to read the FDA-approved patient labeling (Instructions for Use)
• If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, advise them to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness
• Instruct the patient to seek immediate medical attention if any of these symptoms occur
• Inform patients: of the instructions for injecting enoxaparin sodium if they continue enoxaparin sodium therapy after discharge from the hospital. …

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 …

Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of enoxaparin sodium therapy. These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDs (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone. If coadministration is essential, conduct close clinical and laboratory monitoring [see Warnings and Precautions (5.1) ] . Discontinue agents which may enhance hemorrhage risk prior to initiation of enoxaparin sodium or conduct close clinical and laboratory monitoring ( 2.6 , 7 )

Increased risk of hemorrhage: Monitor for signs 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. …

The following serious adverse reactions are also discussed in other sections of the labeling: • Spinal/epidural hematomas [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Increased Risk of Hemorrhage [see Warnings and Precautions ( 5.1 )] • Thrombocytopenia [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, nausea, ecchymosis, fever, edema, peripheral edema, dyspnea, confusion, and injection site pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

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 sodium does not increase the risk of major developmental abnormalities [see Data]. Based on animal data, enoxaparin is not predicted to increase the risk of major developmental abnormalities [see Data]. …

Accidental overdosage following administration of enoxaparin sodium may lead to hemorrhagic complications. Injected enoxaparin sodium may be largely neutralized by the slow intravenous injection of protamine sulfate (1% solution). The dose of protamine sulfate should be equal to the dose of enoxaparin sodium injected: 1 mg protamine sulfate should be administered to neutralize 1 mg enoxaparin sodium, if enoxaparin sodium was administered in the previous 8 hours. …

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