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 Lovenox and neuraxial procedures is not known. Monitor patients frequently for signs and symptoms of neurological impairment.
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Postmarketing Experience The following adverse reactions have been identified during postapproval use of Lovenox. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The majority of patients had a postoperative indwelling epidural catheter placed for analgesia or received additional drugs affecting hemostasis such as NSAIDs.
Many of the epidural or spinal hematomas caused neurologic injury, including long-term or permanent paralysis. Local reactions at the injection site e. Cases of hyperkalemia have been reported. Most of these reports occurred in patients who also had conditions that tend toward the development of hyperkalemia e. Very rare cases of hyperlipidemia have also been reported, with one case of hyperlipidemia, with marked hypertriglyceridemia, reported in a diabetic pregnant woman; causality has not been determined.
Cases of headache, hemorrhagic anemia, eosinophilia, alopecia, hepatocellular and cholestatic liver injury have been reported. Osteoporosis has also been reported following long-term therapy. Drug Interactions Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of Lovenox 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. Human data from a retrospective cohort study, which included live births, suggest that enoxaparin does not increase the risk of major developmental abnormalities [see Data ].
Based on animal data, Lovenox 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. 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.
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 Lovenox 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 ]. Pregnant women should be apprised of the potential hazard to the fetus and the mother if Lovenox is administered during pregnancy. It is not known if monitoring of anti-Factor Xa activity and dose adjustment by weight or anti-Factor Xa activity of Lovenox affect the safety and the efficacy of the drug during pregnancy.
The multiple-dose vial of Lovenox contains 15 mg benzyl alcohol per 1 mL as a preservative [see Warnings and Precautions 5. Data Human data There are no adequate and well-controlled studies in pregnant women. A retrospective study reviewed the records of women who used Lovenox during pregnancy.
A total of pregnancies resulted in live births. There were 72 hemorrhagic events 11 serious in 63 women. There were 14 cases of neonatal hemorrhage. Major congenital anomalies in live births occurred at rates 2. There have been postmarketing reports of fetal death when pregnant women received Lovenox. Causality for these cases has not been determined.
Insufficient data, the underlying disease, and the possibility of inadequate anticoagulation complicate the evaluation of these cases. A clinical study using Lovenox in pregnant women with mechanical prosthetic heart valves has been conducted [see Warnings and Precautions 5. There was no evidence of teratogenic effects or fetotoxicity due to enoxaparin. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Lactation Risk Summary It is unknown whether Lovenox is excreted in human milk. In lactating rats, the passage of enoxaparin or its metabolites in the milk is very limited. There is no information available on the effect of enoxaparin or its metabolites on the breastfed child, or on the milk production. Pediatric Use Safety and effectiveness of Lovenox in pediatric patients have not been established.
Lovenox is not approved for use in neonates or infants. Serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and low birth weight infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.
Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.
The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. The incidence of bleeding complications was similar between geriatric and younger patients when 30 mg every 12 hours or 40 mg once a day doses of Lovenox were employed. The incidence of bleeding complications was higher in geriatric patients as compared to younger patients when Lovenox was administered at doses of 1. The risk of Lovenox-associated bleeding increased with age.
Serious adverse events increased with age for patients receiving Lovenox. Other clinical experience including postmarketing surveillance and literature reports has not revealed additional differences in the safety of Lovenox between geriatric and younger patients. Careful attention to dosing intervals and concomitant medications especially antiplatelet medications is advised.
Lovenox should be used with care in geriatric patients who may show delayed elimination of enoxaparin. Patients with Mechanical Prosthetic Heart Valves The use of Lovenox has not been adequately studied for thromboprophylaxis in patients with mechanical prosthetic heart valves and has not been adequately studied for long-term use in this patient population.
Isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received Lovenox for thromboprophylaxis. Some of these cases were pregnant women in whom thrombosis led to maternal and fetal deaths. Insufficient data, the underlying disease and the possibility of inadequate anticoagulation complicate the evaluation of these cases. Pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism [see Warnings and Precautions 5.
Renal Impairment In patients with renal impairment, there is an increase in exposure of enoxaparin sodium. All such patients should be observed carefully for signs and symptoms of bleeding. In patients with renal failure, treatment with Lovenox has been associated with the development of hyperkalemia [see Adverse Reactions 6. Observe low-weight patients frequently for signs and symptoms of bleeding [see Clinical Pharmacology Obese Patients Obese patients are at higher risk for thromboembolism.
Observe these patients carefully for signs and symptoms of thromboembolism. Overdosage Accidental overdosage following administration of Lovenox may lead to hemorrhagic complications. The dose of protamine sulfate should be equal to the dose of Lovenox injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Lovenox, if Lovenox was administered in the previous 8 hours.
An infusion of 0. The second infusion of 0. If at least 12 hours have elapsed since the last Lovenox injection, protamine administration may not be required; however, even with higher doses of protamine, the aPTT may remain more prolonged than following administration of heparin.
Particular care should be taken to avoid overdosage with protamine sulfate. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, it should be given only when resuscitation techniques and treatment of anaphylactic shock are readily available.
For additional information consult the labeling of protamine sulfate injection products. Lovenox Description Lovenox is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa.
Its structure is characterized by a 2-O-sulfoenepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. The drug substance is the sodium salt. The average molecular weight is about daltons.
Lovenox is a proven choice in anticoagulant therapy.
U.S. Food and Drug Administration