enoxaparin sodium


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enoxaparin sodium

Clexane (UK), Lovenox

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

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.

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.

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.

References in periodicals archive ?
She had been treated with subcutaneous enoxaparin sodium (80 mg/day) and oral warfarin sodium (5 mg/day) for her immobilization-related deep-vein thrombosis (DVT) prophylaxis.
Warfarin and enoxaparin sodium are currently the most widely used anticoagulants for the treatment of DVT in SA public hospitals.
Group 8: L-asparaginase and enoxaparin sodium and diclofenac sodium
On 19 September 2011, Amphastar received US Food and Drug Administration (FDA) approval for Enoxaparin Sodium Injection in the 30 mg/mL, 40 mg/mL, 60 mg/mL, 80 mg/mL,100 mg/mL, 120 mg/mL, 150 mg/mL and 300 mg/mL strengths.
She remained on low molecular weight heparin (Enoxaparin Sodium) throughout the pregnancy for thrombo-prophylaxis and was compliant with her iron and vitamin supplements.
M2 EQUITYBITES-September 20, 2011-Watson Pharmaceuticals Inc announces FDA approval for Enoxaparin Sodium Injection(C)2011 M2 COMMUNICATIONS http://www.m2.com
"Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to ensure that the drug would be as safe and effective as the brand-name product," noted Dr Keith Webber, deputy director of the FDA's Office of Pharmaceutical Science, in an agency news release.
As a result of the Court of Appeals' ruling, the United States Lovenox (enoxaparin sodium) patent is deemed to be unenforceable.
The Food and Drug Administration denied the biotechnology company's approval for its blood-clotting drug enoxaparin sodium, being developed with partner Novartis AG.
Martin administers large doses of enoxaparin sodium (Lovenox) and takes other measures to prevent deep venous thromboses and pulmonary emboli in his patients.
A study organised by the San Valentino Screening Project has revealed that long-haul airline travellers with a history of heart disease could prevent deep vein thrombosis (DVT) and pulmonary embolism through a single dose of the widely prescribed antithrombotic agent enoxaparin sodium.
It is co-sponsored by Boehringer Ingelheim, Genentech's international marketing partner for Activase(R) (Alteplase, recombinant) and TNKase(TM) (Tenecteplase), and with Aventis Pharmaceuticals, makers of Lovenox(R) (enoxaparin sodium) Injection, the world's leading low-molecular-weight heparin.