Lovenox


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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.

enoxaparin

(e-nox-a-pa-rin) ,

Lovenox

(trade name)

Classification

Therapeutic: anticoagulants
Pharmacologic: antithrombotics
Pregnancy Category: B

Indications

Prevention of venous thromboembolism (VTE) (deep vein thrombosis (DVT) and/or pulmonary embolism (PE)) in surgical or medical patients.Treatment of DVT with or without PE (with warfarin).Prevention of ischemic complications (with aspirin) from unstable angina and non-ST-segment-elevation MI.Treatment of acute ST-segment-elevation MI (with thrombolytics or percutaneous coronary intervention).

Action

Potentiates the inhibitory effect of antithrombin on factor Xa and thrombin.

Therapeutic effects

Prevention of thrombus formation.

Pharmacokinetics

Absorption: ~100% absorbed after subcut administration.
Distribution: Unknown.
Metabolism and Excretion: Metabolized in the liver, primarily renally eliminated Clearance ↓ by 30% in renal impairment (CCr < 30 ml/min).
Half-life: Single dose: 4.5 hr; Repeat dosing: 7 hr.

Time/action profile (anticoagulant effect)

ROUTEONSETPEAKDURATION
Subcutunknown3–5 hr12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity ; Hypersensitivity to benzyl alcohol (multidose vial); Positive in vitro test for antiplatelet antibody in the presence of enoxaparin; Active, major bleeding.
Use Cautiously in: Severe hepatic or renal disease (adjust dose if CCr <30 mL/min); Retinopathy (hypertensive or diabetic); Uncontrolled hypertension; Recent history of ulcer disease; History of congenital or acquired bleeding disorder; Women <45 kg and men <57 kg (↑ exposure to enoxaparin with ↑ risk of bleeding; weight-adjusted dosing recommended); Malignancy; Geriatric: May have ↑ risk of bleeding due to age-related ↓ in renal function; Obstetric / Lactation / Pediatric: Safety not established; should not be used in pregnant patients with prosthetic heart valves without careful monitoring.
Exercise Extreme Caution in: Severe uncontrolled hypertension; Bacterial endocarditis; Bleeding disorders; GI bleeding/ulceration/pathology; Hemorrhagic stroke; Recent CNS or ophthalmologic surgery; History of thrombocytopenia related to heparin; Spinal/epidural anesthesia or spinal puncture (↑ risk of spinal/epidural hematoma that may lead to long-term or permanent paralysis).

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache
  • insomnia

Cardiovascular

  • edema

Gastrointestinal

  • constipation
  • ↑ liver enzymes
  • nausea
  • vomiting

Genitourinary

  • urinary retention

Dermatologic

  • alopecia
  • ecchymoses
  • pruritus
  • rash
  • urticaria

Fluid and Electrolyte

  • hyperkalemia

Hematologic

  • bleeding (most frequent)
  • anemia (most frequent)
  • eosinophilia
  • thrombocytopenia

Local

  • erythema at injection site
  • hematoma
  • irritation
  • pain

Musculoskeletal

  • osteoporosis

Miscellaneous

  • fever

Interactions

Drug-Drug interaction

Risk of bleeding may be ↑ by concurrent use of drugs that affect platelet function and coagulation, including warfarin, aspirin, thrombolytic agents, NSAIDs,dipyridamole, some penicillins, clopidogrel, abciximab, eptifibatide, tirofiban, ticlopidine, and dextran.

Route/Dosage

VTE Prophylaxis
Subcutaneous (Adults) Knee replacement surgery—30 mg q 12 hr starting 12–24 hr after surgery for 7–10 days; Hip replacement—30 mg q 12 hr starting 12–24 hr postop or 40 mg once daily starting 12 hr before surgery (either dose may be continued for 7–14 days; continued prophylaxis with 40 mg once daily may be continued for up to 3 wk); Abdominal surgery—40 mg once daily starting 2 hr before surgery and then continued for 7–12 days or until ambulatory (up to 14 days); Medical patients with acute illness—40 mg once daily for 6–14 days.
Subcutaneous (Infants and Children ≥2 mo —18 yr) 0.5 mg/kg/dose every 12 hr.
Subcutaneous (Infants 1–2 mo) 0.75 mg/kg/dose every 12 hr.
Treatment of DVT/PE
Subcutaneous (Adults) Outpatient—1 mg/kg every 12 hr. Warfarin should be started within 72 hr; enoxaparin may be continued for a minimum of 5 days and until therapeutic anticoagulation with warfarin is achieved (INR >2 for 2 consecutive days); Inpatient—1 mg/kg every 12 hr or 1.5 mg/kg every 24 hr. Warfarin should be started within 72 hr; enoxaparin may be continued for a minimum of 5 days or until therapeutic anticoagulation with warfarin is achieved (INR >2 for two consecutive days).
Subcutaneous (Infants and Children ≥2 mo —18 yr) 1 mg/kg/dose every 12 hr.
Subcutaneous (Infants 1–2 mo) 1.5 mg/kg/dose every 12 hr.
Unstable Angina/Non–ST-Segment-Elevation MI
Subcutaneous (Adults) 1 mg/kg q 12 hr for 2–8 days (with aspirin).
ST-Segment-Elevation MI
Intravenous Subcutaneous (Adults <75 yr) Administer single IV bolus of 30 mg plus 1 mg/kg subcut dose (maximum of 100 mg for first 2 doses only), followed by 1 mg/kg subcut q 12 hr. The usual duration of treatment is 2–8 days. In patients undergoing percutaneous coronary intervention, if last subcut dose was <8 hr before balloon inflation, no additional dosing needed; if last subcut dose was ≥8 hr before balloon inflation, administer single IV bolus of 0.3 mg/kg.
Subcutaneous (Adults ≥75 yr) 0.75 mg/kg every 12 hr (no IV bolus needed) (maximum of 75 mg for first 2 doses only; no initial bolus). The usual duration of treatment is 2–8 days.

Renal Impairment

Subcutaneous (Adults CCr <30 mL/min) VTE prophylaxis for abdominal or knee/hip replacement surgery—30 mg once daily. Treatment of DVT/PE—1 mg/kg once daily. Unstable angina/non-ST-segment-elevation MI—1 mg/kg once daily. Acute ST-segment-elevation MI (patients <75 yr)—Single IV bolus of 30 mg plus 1 mg/kg subcut dose, followed by 1 mg/kg subcut once daily. Acute ST-segment-elevation MI (patients ≥75 yr)—1 mg/kg once daily (no initial bolus).

Availability (generic available)

Solution for injection (prefilled syringes): 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL, 120 mg/0.8 mL, 150 mg/1 mL
Solution for injection (multidose vials): 300 mg/3 mL

Nursing implications

Nursing assessment

  • Assess for signs of bleeding and hemorrhage (bleeding gums; nosebleed; unusual bruising; black, tarry stools; hematuria; fall in hematocrit or BP; guaiac-positive stools); bleeding from surgical site. Notify health care professional if these occur.
    • Assess patient for evidence of additional or increased thrombosis. Symptoms depend on area of involvement.
    • Assess location, duration, intensity, and precipitating factors of anginal pain.
    • Monitor patient for hypersensitivity reactions (chills, fever, urticaria). Report signs to health care professional.
    • Monitor patients with epidural catheters frequently for signs and symptoms of neurologic impairment. Delay placement or removal of catheter for at least 12 hours after administration of lower doses (30 mg once or twice daily or 40 mg once daily) and at least 24 hours after administration of higher doses (0.75 mg/kg twice daily, 1 mg/kg twice daily, or 1.5 mg/kg once daily) of enoxaparin. Monitor for signs and symptoms of neurological impairment (midline back pain, sensory and motor deficits [numbness or weakness in lower limbs], bowel and/or bladder dysfunction) frequently if epidural or spinal anesthesia or lumbar puncture is done during therapy.
  • Subcutaneous: Observe injection sites for hematomas, ecchymosis, or inflammation.
  • Lab Test Considerations: Monitor CBC, platelet count, and stools for occult blood periodically during therapy. If thrombocytopenia occurs, monitor closely. If hematocrit decreases unexpectedly, assess patient for potential bleeding sites.
    • Special monitoring of clotting times (aPTT) is not necessary in most patients. Monitoring of the aPTT may be considered in certain patient populations (such as obese patients or patients with renal insufficiency).
    • Monitoring of Antifactor Xa levels may be necessary to titrate doses in pediatric patients Therapeutic range 0.5–1 unit/mL.
    • May cause ↑ in AST and ALT levels.
    • May cause hyperkalemia.
  • For overdose, protamine sulfate 1 mg for each mg of enoxaparin should be administered by slow IV injection.

Potential Nursing Diagnoses

Ineffective tissue perfusion (Indications)
Risk for injury (Side Effects)

Implementation

  • Do not confuse Lovenox with Levemir.
  • Cannot be used interchangeably (unit for unit) with unfractionated heparin or other low-molecular-weight heparins.
  • Subcutaneous: Administer deep into subcut tissue. Alternate injection sites daily between the left and right anterolateral and left and right posterolateral abdominal wall. Inject entire length of needle at a 45° or 90° angle into a skin fold held between thumb and forefinger; hold skin fold throughout injection. Do not aspirate or massage. Rotate sites frequently. Do not administer IM because of danger of hematoma formation. Solution should be clear, colorless to pale yellow; do not inject solution containing particulate matter.
    • If excessive bruising occurs, ice-cube massage of site before injection may lessen bruising.
    • To avoid the loss of drug, do not expel the air bubble from prefilled syringes before the injection. Use a tuberculin syringe when using multidose vials to ensure correct dose.
    • To minimize risk of bleeding after vascular instrumentation for unstable angina, recommended intervals between doses should be followed closely. Leave vascular access sheath in place for 6–8 hr after enoxaparin dose. Give next enoxaparin dose ≥6–8 hr after sheath removal. Observe site for bleeding or hematoma formation.
  • Intravenous Administration
  • (for treatment of STEMI only)Use multiple-dose vial. Inject via IV line. Flush with 0.9% NaCl or D5W prior to and following administration to avoid mixture with other drugs and clear the port of the drug. May be administered with 0.9% NaCl or D5W.
  • Rate: Inject as a bolus.
  • Y-Site Incompatibility: Do not mix or co-administered with other medications.

Patient/Family Teaching

  • Advise patient to report any symptoms of unusual bleeding or bruising, dizziness, itching, rash, fever, swelling, or difficulty breathing to health care professional immediately.
  • Instruct patient not to take aspirin, naproxen, or ibuprofen without consulting health care professional while on enoxaparin therapy.

Evaluation/Desired Outcomes

  • Prevention of deep vein thrombosis and pulmonary embolism.
  • Resolution of acute deep vein thrombosis.
  • Prevention of ischemic complications (with aspirin) in patients with unstable angina or non-Q-wave MI.
  • Treatment of acute ST-segment elevation myocardial infarction.

Lovenox®

Enoxaparin Cardiology An LMW heparin antithrombolytic for managing unstable angina and non-Q-wave MI, and preventing DVT afterhip or knee replacement, and high-risk abdominal surgery. See Deep vein thrombosis.
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