enoxaparin sodium
Lovenox

Pharmacologic classification: low-molecular-weight heparin
Therapeutic classification: anticoagulant
Pregnancy risk category B


Available forms
Available by prescription only
Ampules: 30 mg/0.3 ml
Syringes (graduated prefilled): 60 mg/0.6 ml, 80 ml, 100 mg/1 ml
Syringes (prefilled): 30 mg/0.3 ml, 40 mg/0.4 ml

Indications and dosages
 Prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism, following hip or knee replacement surgery. Adults: 30 mg S.C. q 12 hours for 7 to 10 days. Give first dose 12 to 24 hours postoperatively provided hemostasis has been established.
 Prevention of DVT, which may lead to pulmonary embolism, following abdominal surgery. Adults: 40 mg S.C. once daily for 7 to 10 days. Give first dose 2 hours before surgery.
 Prevention of ischemic complications of unstable angina and non-Q-wave MI, when administered with aspirin. Adults: 1 mg/kg S.C. q 12 hours for 2 to 8 days in conjunction with oral aspirin therapy (100 to 325 mg once daily). To minimize risk of bleeding after vascular instrumentation during the treatment of unstable angina, adhere precisely to the intervals recommended between enoxaparin doses.
 Inpatient treatment of acute DVT with and without pulmonary embolism when administered with warfarin sodium. Adults: 1 mg/kg S.C. every 12 hours; or, 1.5 mg/kg S.C. once daily (at the same time every day) for 5 to 7 days until therapeutic oral anticoagulant effect (INR 2 to 3) has been achieved. Warfarin sodium therapy usually starts within 72 hours of enoxaparin injection.
 Outpatient treatment of acute DVT without pulmonary embolism when administered with warfarin sodium. Adults: 1 mg/kg S.C. every 12 hours for 5 to 7 days until therapeutic oral anticoagulant effect (INR 2 to 3) has been achieved. Warfarin sodium therapy usually starts within 72 hours of enoxaparin injection.
 Patients during acute illness who are at risk for embolism because of decreased mobility. Adults: 40 mg once daily S.C. for 6 to 11 days. Up to 14 days has been well tolerated.

Pharmacodynamics
Anticoagulant action: Enoxaparin is a low-molecular-weight heparin that accelerates formation of antithrombin III-thrombin complex and deactivates thrombin, preventing conversion of fibrinogen to fibrin. It has a higher anti-factor Xa to anti-factor IIa activity than unfractionated heparin.

Pharmacokinetics
Absorption: Bioavailability is 92%.
Distribution: Volume of distribution of anti-factor Xa activity is about 6 L.
Metabolism: Information not available.
Excretion: Elimination half-life based on anti-factor Xa activity is about 4 1/2 hours after S.C. administration.

Route Onset Peak Duration
S.C. Unknown 3-5 hr 24 hr


Contraindications and precautions
Contraindicated in patients hypersensitive to drug, heparin, or pork products; in patients with active, major bleeding or thrombocytopenia; and in those who demonstrate antiplatelet antibodies in the presence of drug. Use is not recommended for thromboprophylaxis in patients with prosthetic heart valves.
 Use with extreme caution in patients with history of heparin-induced thrombocytopenia. Use cautiously in patients with conditions that put them at increased risk for hemorrhage, such as bacterial endocarditis; congenital or acquired bleeding disorders; ulcer disease; angiodysplastic GI disease; hemorrhagic stroke; or recent spinal, eye, or brain surgery; or in those treated concomitantly with NSAIDs, platelet inhibitors, or other anticoagulants that affect hemostasis.
 Use with extreme caution in patients with postoperative indwelling epidural catheters. Epidural or spinal hematomas, resulting in long-term or permanent paralysis, have been reported.
 Also use cautiously in patients with a bleeding diathesis, uncontrolled hypertension, recent GI ulceration, diabetic retinopathy, and hemorrhage.
 Use carefully in elderly patients and patients with renal insufficiency.

Interactions
Drug-drug. Anticoagulants, antiplatelet drugs, NSAIDs: Increases risk of bleeding. May also lead to spinal or epidural hematomas in patients with spinal punctures or epidural or spinal anesthesia. Monitor patient carefully.
Plicamycin, valproic acid: May cause hypoprothrombinemia and inhibit platelet aggregation. Monitor patient closely.

Adverse reactions
CNS: confusion, neurologic injury (when used with spinal or epidural puncture), pain, fever.
CV: edema, peripheral edema, hematoma, CV toxicity (chest pain, dizziness, irregular heartbeat).
GI: nausea.
Hematologic: hypochromic anemia, thrombocytopenia, hemorrhage, bleeding complications.
Skin: rash, urticaria, erythema (at injection site), ecchymoses.
Other: angioedema.

Effects on lab test results
• May increase ALT and AST levels.
• May decrease hemoglobin and platelet count.

Overdose and treatment
Accidental overdose may lead to hemorrhagic complications, which may be largely neutralized by the slow I.V. injection of protamine sulfate (1%) solution. The dose of protamine sulfate should be equal to the dose of enoxaparin injection (1 mg of protamine neutralizes 1 mg of enoxaparin).

Special considerations
• Enoxaparin isn’t intended for I.M. administration.
 ALERT Drug can’t be used interchangeably (unit for unit) with unfractionated heparin or other low-molecular-weight heparins.
• Don’t mix drug with other injections or infusions.
• Screen all patients before prophylactic use of enoxaparin to rule out a bleeding disorder.
• Don’t expel air bubble from syringe before injecting drug because drug may be lost.
Pregnant patients
• Use during pregnancy may cause congenital anomalies to the fetus.
Breast-feeding patients
• It isn’t known whether drug appears in breast milk. Use cautiously in breast-feeding women.
Pediatric patients
• Safety and efficacy of enoxaparin in children haven’t been established.

Patient education
• Explain risk of adverse reactions.
• Instruct patient to watch for signs of bleeding and hemorrhage. Urge him to avoid activities that might increase risk of cuts, bruises, or bleeding.
• Caution patient against use of aspirin or other salicylates.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use