May enhance risk of hemorrhage. Discontinue prior to Lovenox initiation if possible, or conduct close clinical and laboratory monitoring if coadministration is essential.
Source: NLP:enoxaparin sodium
Brand names: Enoxaparin Sodium
Route: Subcutaneous
FDA Black Box Warning
WARNING: SPINAL/ EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, and other anticoagulants • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery • Optimal timing between the administration of enoxaparin sodium injection and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [ see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7 ) ]. WARNING: SPINAL/EPIDURAL HEMATOMAS See full prescribing information for complete boxed warning. Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, and other anticoagulants • A history
Contraindications
4 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 [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 )
Pregnancy & Breastfeeding
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 birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic disease and certain high-risk pregnancy conditions. While not adequately studied, pregnant women with mechanical prosthetic heart valves may be at even higher risk for thrombosis [ see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.6 ) ]. Pregnant women with thromboembolic disease, including those with mechanical prosthetic heart valves and those with inherited or acquired thrombophilias, have an increased risk of other maternal complications and fetal loss regardless of the type of anticoagulant used. All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. Pregnant women receiving enoxaparin sodium injection should be carefully monitored for evidence of bleeding or excessive anticoagulation. Consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches [ see Boxed Warning ]. Hemorrhage can occur at any site and may lead to death of mother and/or fetus. Pregnant women should be apprised of the potential hazard to the fetus and the mothe
5 interactions on record
May enhance risk of hemorrhage. Discontinue prior to Lovenox initiation if possible, or conduct close clinical and laboratory monitoring if coadministration is essential.
Source: NLP:enoxaparin sodium
Platelet inhibitor that may enhance risk of hemorrhage. Discontinue prior to Lovenox initiation if possible, or conduct close clinical and laboratory monitoring if coadministration is essential.
Source: NLP:enoxaparin sodium
NSAID that may enhance risk of hemorrhage. Discontinue prior to Lovenox initiation if possible, or conduct close clinical and laboratory monitoring if coadministration is essential.
Source: NLP:enoxaparin sodium
May enhance risk of hemorrhage. Discontinue prior to Lovenox initiation if possible, or conduct close clinical and laboratory monitoring if coadministration is essential.
Source: NLP:enoxaparin sodium
May enhance risk of hemorrhage. Discontinue prior to Lovenox initiation if possible, or conduct close clinical and laboratory monitoring if coadministration is essential.
Source: NLP:enoxaparin sodium