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 ?
An additional 1,000 patients will be randomized into a satellite study, ASSENT 3 Plus, investigating pre-hospital administration of either TNKase with enoxaparin sodium or TNKase with heparin sodium.
3 Investigation on Sales Value of Enoxaparin Sodium in China, 2009-2013
This multicentre, double-blind, double dummy, centrally randomised trial evaluated the efficacy and safety of edoxaban compared with enoxaparin sodium in patients undergoing THR in Japan.
These products include rhBMP-2, a novel bone inducing recombinant human protein used in bone surgery; abarelix, a novel GnRH antagonist peptide used as a prostate cancer therapy; and a generic version of enoxaparin sodium, an anticoagulant used in several cardiovascular indications.
Table 27: US Enoxaparin Sodium Market by Sector (2011):
Results from pivotal Phase III studies showed that once-daily oral administration of edoxaban reduced the incidence of VTE in patients undergoing total knee replacement or total hip replacement, and the non-inferiority to injectable enoxaparin sodium was confirmed.
NYSE: WPI), today confirmed that the United States Court of Appeals for the Federal Circuit has granted Watson and Amphastar Pharmaceuticals, Inc's request for a stay of the preliminary injunction preventing the companies from marketing or selling Amphastar's Enoxaparin Sodium Injection, a generic equivalent to Sanofi-aventis' LOVENOX[R].
Enoxaparin sodium is known by the brand name Lovenox(R) or Clexane(R) or Klexane(R) and its labelling may vary country to country.
from marketing or selling Amphastar's Enoxaparin Sodium Injection product, a generic equivalent to Sanofi-aventis' LOVENOX.
to develop and commercialize a transdermal patch for delivering enoxaparin sodium (currently marketed as Lovenox[R]) utilizing the PassPort[R] Transdermal Delivery System.
The suit alleges that Amphastar's Enoxaparin Sodium Injection product, which Watson has the exclusive right to distribute in the U.