Clexane
enoxaparin sodium
Pharmacologic class: Low-molecular-weight heparin
Therapeutic class: Anticoagulant
Pregnancy risk category B
FDA Box Warning
• During epidural or spinal anesthesia or puncture, patients receiving drug or scheduled to receive it for thromboprophylaxis are at risk for epidural or spinal hematoma, which can lead to long-term or permanent paralysis. Risk increases with use of indwelling epidural catheter for analgesia administration and with concurrent use of drugs affecting hemostasis (such as nonsteroidal anti-inflammatory drugs [NSAIDs], platelet inhibitors, and other anticoagulants). Risk also rises with traumatic or repeated epidural or spinal puncture or history of spinal deformity or spinal surgery. Before neuraxial intervention, physician should weigh drug's potential benefit against risk.
• Monitor patient frequently for signs and symptoms of neurologic impairment. If these occur, provide urgent treatment.
Action
Inhibits thrombus and clot formation by blocking factor Xa and factor IIa. This inhibition accelerates formation of antithrombin III-thrombin complex (a coagulation inhibitor), thereby deactivating thrombin and preventing conversion of fibrinogen to fibrin.
Availability
Solution for injection: 30 mg/0.3 ml, 40 mg/0.4 ml, 60 mg/0.6 ml, 80 mg/0.8 ml, 120 mg/0.8 ml, 100 mg/1 ml, 150 mg/1 ml (all in prefilled syringes); 300 mg/3 ml (in multidose vials)
Indications and dosages
➣ Patients at risk for thromboembolic complications due to severely restricted mobility during acute illness
Adults: 40 mg subcutaneously daily for up to 14 days
➣ Prevention of pulmonary embolism and deep-vein thrombosis (DVT) after abdominal surgery
Adults: 40 mg subcutaneously 2 hours before surgery, repeated 24 hours after initial dose (provided hemostasis has been established) and continued once daily for 7 to 10 days until risk of DVT has diminished
➣ Prevention of pulmonary embolism and DVT after hip or knee replacement surgery
Adults: 30 mg subcutaneously 12 to 24 hours after surgery (provided hemostasis has been established), repeated q 12 hours for 7 to 10 days until risk of DVT has diminished. Alternatively, hip-replacement patient may receive 40 mg subcutaneously 12 hours before surgery and then once daily for 3 weeks, for a total of 4 weeks of therapy.
➣ Prevention of ischemic complications of unstable angina or non-Q-wave myocardial infarction
Adults: 1 mg/kg subcutaneously q 12 hours, given with aspirin 100 to 325 mg P.O. once daily until patient is clinically stable
➣ Hospitalized patients with acute DVT with or without pulmonary embolism (PE) (given with warfarin sodium)
Adults: 1 mg/kg subcutaneously q 12 hours or 1.5 mg/kg subcutaneously once daily for 5 to 7 days until therapeutic effect is established. Warfarin therapy usually begins within 72 hours of enoxaparin injection.
➣ Outpatients with acute DVT without PE (given with warfarin sodium)
Adults: 1 mg/kg subcutaneously q 12 hours for 5 to 7 days until therapeutic effect is established. Warfarin therapy usually begins within 72 hours of enoxaparin injection.
Dosage adjustment
• Patients weighing less than 45 kg (99 lb)
• Creatinine clearance below 30 ml/minute
Off-label uses
• Prevention of clots associated with hemodialysis
• Prevention of thrombosis during pregnancy
Contraindications
• Hypersensitivity to drug, heparin, sulfites, benzyl alcohol, or pork products
• Thrombocytopenia
• Active major bleeding
Precautions
Use cautiously in:
• severe hepatic or renal disease, retinopathy (hypertensive or diabetic), uncontrolled hypertension, hemorrhagic stroke, bacterial endocarditis, GI bleeding or other bleeding disorders
• recent history of ulcer disease, history of congenital or acquired bleeding disorder, history of thrombocytopenia related to heparin use
• recent CNS surgery
• pregnant or breastfeeding patients
• children.
Administration
See Be aware that enoxaparin is a high-alert drug.
• Use tuberculin syringe with multidose vial to ensure accurate dosage.
• Don't expel air bubble from syringe before administering.
• Inject drug deep subcutaneously with patient in supine position. Alternate left and right anterolateral and posterolateral abdominal wall sites.
• Don't rub injection site.
See Don't give by I.M. or I.V. route.
Adverse reactions
CNS: dizziness, headache, insomnia, confusion,cerebrovascular accident
CV: edema, chest pain,atrial fibrillation, heart failure
GI: nausea, vomiting, constipation
GU: urinary retention
Hematologic: anemia,bleeding tendency, thrombocytopenia, hemorrhage
Metabolic: hyperkalemia
Skin: bruising, pruritus, rash, urticaria
Other: fever; pain, irritation, or erythema at injection site
Interactions
Drug-drug. Warfarin, other drugs that affect platelet function (including abciximab, aspirin, clopidogrel, dextran, dipyridamole, eptifibatide, NSAIDs, some penicillins, ticlopidine, tirofiban): increased risk of bleeding
Drug-diagnostic tests. Hepatic enzymes: reversible increases Hemoglobin, platelets: decreased levels
Drug-herbs. Anise, arnica, chamomile, clove, feverfew, garlic, ginger, ginkgo, ginseng: increased risk of bleeding
Patient monitoring
• Monitor CBC and platelet counts. Watch for signs and symptoms of bleeding or bruising.
• Monitor fluid intake and output. Watch for fluid retention and edema.
Patient teaching
• If patient will self-administer drug, teach proper injection technique.
See Instruct patient to promptly report irregular heart beat, unusual bleeding or bruising, rash, or hives.
• Teach patient safety measures to avoid bruising or bleeding.
• Advise patient to weigh himself regularly and to report gains.
• Instruct patient to inform dentists and other health care professionals about enoxaparin use.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.