Enoxaparin Sodium

What it is and how it works

Mechanism of Action Enoxaparin is a low molecular weight heparin which has antithrombotic properties.

Indications

Enoxaparin sodium injection, USP 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 • Inpatient treatment of acute DVT with or without pulmonary embolism • Outpatient treatment of acute DVT without pulmonary embolism • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) • Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) Prophylaxis of Deep Vein Thrombosis 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 • in patients undergoing hip replacement surgery, during and following hospitalization • in patients undergoing knee replacement surgery • in medical patients who are …

Dosage and administration (summary)

See full prescribing information for dosing and administration information. Pretreatment Evaluation Evaluate all patients for a bleeding disorder before starting enoxaparin sodium injection treatment, unless treatment is urgently needed. Adult Dosage Abdominal Surgery The recommended dose of enoxaparin sodium injection 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 .

Contraindications

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 . • Known hypersensitivity to enoxaparin sodium ( e.g. , pruritus, urticaria, anaphylactic/anaphylactoid reactions) . • Known hypersensitivity to heparin or pork products.

Warnings and precautions

• Increased Risk of Hemorrhage: Monitor for signs of bleeding. ( 5.1 , 5.2 , 5.3 ) • Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis. • Thrombocytopenia: Monitor platelet count closely. • Interchangeability with other heparins: Do not exchange with heparin or other LMWHs. • 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.

Pregnancy

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) .

Storage and supply

Enoxaparin sodium injection, USP is available in two concentrations (see Tables 26 and 27 ): Table 26: 100 mg/mL Concentration Dosage Unit/Strength Strength represents the number of milligrams of enoxaparin sodium in Water for Injection.

Source: Enoxaparin Sodium (Enoxaparin Sodium) — US FDA prescribing information, 2024-06-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.