Drug updated on 5/17/2024
Dosage Form | Injection (subcutaneous/intravenous; 100mg/mL [30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL, 300 mg/3 mL]); Injection (subcutaneous/intravenous; 150 mg/mL [120 mg/0.8 mL, 150 mg/1 mL]) |
Drug Class | Low molecular weight heparin |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- Indicated for inpatient treatment of acute DVT with or without pulmonary embolism.
- Indicated for outpatient treatment of acute DVT without pulmonary embolism.
- Indicated for prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction (MI).
- Indicated for treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI).
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Summary
- Enoxaparin sodium (Lovenox) is indicated for prophylaxis of deep vein thrombosis in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness. It is also used for the treatment of acute DVT with or without pulmonary embolism and ischemic complications of unstable angina and non-Q-wave myocardial infarction.
- The information was derived from 10 systematic reviews/meta-analyses that compared Lovenox against a range of anticoagulants such as fondaparinux, aspirin, and various non-vitamin K antagonist oral anticoagulants like apixaban, rivaroxaban, and dabigatran.
- In terms of safety and effectiveness comparison to other drugs for VTE prevention after total hip arthroplasty (THA) and general surgeries, enoxaparin showed variable effectiveness depending on the patient subgroup/surgical context. However, it outperformed placebo in trauma settings without an increased risk of bleeding, indicating its safety and efficacy.
- Population types/subgroup considerations revealed that fixed dosing regimens did not always correlate with adequate anti-Xa levels, suggesting potential inadequacies in prevention for some patient populations, including those undergoing general surgeries. Specific dosing recommendations were suggested for obese patients due to complexities associated with effective dosing among individuals having higher BMIs.
- Safety comparisons, particularly regarding bleeding risks, were consistent across studies, showing a balanced risk profile, except in certain exceptions where variable results were reported when directly compared to specific NOACs. Aspirin was considered a non-inferior option after elective arthroplasty, showing no significant difference in bleeding events, though the quality of evidence varied from low to very low.
- Administration twice daily was hinted at being possibly more effective than once-daily dosage, especially among certain population groups without significantly increasing major hemorrhagic complications, emphasizing the importance of personalized medicine based on individual characteristics, surgical type, and risk factors.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Lovenox (enoxaparin sodium) Prescribing Information. | 2021 | Sanofi-aventis, Bridgewater, NJ |