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Enoxaparin

Brand Name: Lovenox

Generic Name: Enoxaparin

Drug Class: Anticoagulants, Cardiovascular; Anticoagulants, Hematologic

What Is Enoxaparin and How Does It Work?

Enoxaparin is prescription medication used for as prophylaxis treatment of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing abdominal surgery, hip replacement surgery (during and following hospitalization), knee replacement surgery and in medical patient who are at risk for thromboembolic complications due to severe restricted mobility during acute illness.

  • Enoxaparin is available under the following different brand names: Lovenox.

What Are Dosage of Enoxaparin?

Dosage of Enoxaparin:

Multidose vial

  • 100 mg/ml (3 ml/vial)

Prefilled syringe

  • 30 mg/0.3 ml
  • 40 mg/0.4 ml
  • 60 mg/0.6 ml
  • 80 mg/0.8 ml
  • 100 mg/ml
  • 120 mg/0.8 ml
  • 150 mg/ml

Adults

Abdominal surgery

  • 40 mg subcutaneously each day; initiate 2 hours preoperatively

Knee or hip replacement surgery

  • 30 mg subcutaneously every 12 hours; initiate therapy 12-24 hours postoperatively and continued for 10 days or up to 35 days postoperatively or until the risk of deep vein thrombosis has been significantly reduced or the patient is on anticoagulant therapy
  • For hip replacement surgery, may consider administering 40 mg subcutaneously each day, initiated 9-15 hours preoperatively, and continued for 10 days or up to 35 days postoperatively or until the risk of deep vein thrombosis has been significantly reduced or the patient is on anticoagulant therapy

Medical patients with restricted mobility

  • 40 mg subcutaneously each day; continue until the risk of deep vein thrombosis has been significantly (6-11 days) reduced or the patient is on anticoagulant therapy

Dosing considerations

  • Abdominal surgery: Duration of administration is 7-10 days; up to 12 days has been administered in clinical trials or until the risk of deep vein thrombosis has diminished
  • Knee or hip replacement surgery: Duration of administration is 7-10 days; up to 14 days has been administered in clinical trials or until the risk of deep vein thrombosis has diminished Medical patients with restricted mobility: Duration of administration is 6-11 days; up to 14 days has been administered in clinical trials

Pediatric (off-label)

  • Infants under 2 months: 0.75 mg/kg subcutaneously every 12 hours
  • Infants 2 months or older: 0.5 mg/kg subcutaneously every 12 hours

Deep Vein Thrombosis (Treatment)

Adults

Inpatient treatment

  • Acute deep vein thrombosis with or without PE, when administered in conjunction with warfarin sodium
  • 1 mg/kg subcutaneously every 12 hours, or 1.5 mg/kg subcutaneously each day (administer at the same time each day)

Outpatient treatment

  • Acute deep vein thrombosis without PE, when administered in conjunction with warfarin sodium
  • 1 mg/kg subcutaneously every 12 hours

Dosing considerations

  • In inpatient and outpatient treatments, initiate warfarin therapy within 72 hours of starting enoxaparin
  • Continue enoxaparin for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (INR 2.0-3.0)
  • The average duration of administration is 7 days; up to 17 days has been administered in clinical trials

Pediatric

  • Infants under 2 months: 1.5 mg/kg subcutaneously every 12 hours
  • Infants 2 months or older: 1 mg/kg subcutaneously every 12 hours
  • Dose Titration for Pediatric Dosing Based on Anti-Factor Xa Concentrations
  • Under 0.35 units/mL: Increase dose by 25%; administer next dose at the scheduled time; repeat anti-factor Xa level 4 hours after next dose
  • 0.35-0.46 units/mL: Increase dose by 10%; administer next dose at the scheduled time; repeat anti-factor Xa level 4 hours after next dose
  • 0.5 - 1 unit/mL: Dose adjustment not necessary; administer next dose at the scheduled time; repeat anti-factor Xa level every other day
  • 1.1-1.5 units/mL: Decrease dose by 20%; administer next dose at the scheduled time; repeat anti-factor Xa level 4 hours after next dose
  • 1.6-2 units/mL: Decrease dose by 30%; delay next dose 3 hours; repeat anti-factor Xa level 4 hours after next dose
  • Greater than 2 units/mL: Decrease dose by 40%; delay next dose until anti-factor Xa under 0.5 units/mL; repeat anti-factor Xa level before next dose and every 12 hours until anti-factor Xa under 0.5 units/mL

Dosing considerations

  • Unstable Angina and Non-Q-Wave Myocardial Infarction
    • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin 1 mg/kg subcutaneously every 12 hours
    • The regimen includes aspirin (100-325 mg/day orally)

Administration

  • Administer for at least 2 days and then continue until clinical stabilization
  • The usual duration of treatment is 2-8 days; up to 12.5 days has been administered in clinical trials

Acute Segment Elevation Myocardial Infarction (STEMI)

  • Reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI)
  • All patients should receive aspirin as soon as they are identified as having STEMI and should be maintained with 75-325 mg orally each day unless contraindicated
    • Younger than 75 years old
      • Loading dose: 30 mg intravenous bolus once plus 1 mg/kg subcutaneously once; not to exceed 100 mg cumulative loading dose
      • Maintenance: 1 mg/kg subcutaneously every 12 hours
    • Older than 75 years old
      • No intravenous bolus
      • 0.75 mg/kg subcutaneous 12 hour
      • Not to exceed 75 mg/dose for first 2 doses only, followed by 0.75 mg/kg for remaining doses
    • With percutaneous coronary intervention (PCI)
      • If last enoxaparin was given less than 8 hours before balloon inflation, no additional dosing is needed
      • If last enoxaparin was given 8-12 hours before balloon inflation, an intravenous bolus of 0.3 mg/kg should be administered
      • If percutaneous coronary intervention (PCI) occurs more than 12 hours after the last subcutaneous dose; use established anticoagulation therapy (full-dose unfractionated heparin or low-molecular-weight heparin [LMWH])
      • A patient that has not received prior anticoagulant therapy: 0.5-0.75 mg/kg bolus dose
  • Dosing considerations
    • Administered concurrently with aspirin
    • In conjunction with thrombolytic: Administer enoxaparin between 15 minutes before and 30 minutes after initiating fibrinolytic therapy; optimal treatment duration of enoxaparin is 8 days or until hospital discharge (whichever comes first)
    • Dosing Modifications
    • Renal impairment
      • Severe (Creatinine Clearance under 30 mL/min): Dosage reductions required
      • Prophylaxis in abdominal surgery: 30 mg subcutaneously each day
      • Prophylaxis in hip or knee replacement surgery: 30 mg subcutaneously each day
      • Prophylaxis in medical patients with restricted mobility: 30 mg subcutaneously each day
      • Deep vein thrombosis treatment (inpatient or outpatient) coadministered with warfarin: 1 mg/kg subcutaneously each day
      • Non-Q-wave myocardial infarction: 1 mg/kg subcutaneously each day
      • Treatment of acute segment elevation myocardial infarction (STEMI) (under 75 years): 30 mg intravenously single bolus plus 1 mg/kg subcutaneously, THEN 1 mg/kg subcutaneously each day
      • Treatment of acute segment elevation myocardial infarction (STEMI) (over 75 years): No initial bolus; maintenance of 1 mg/kg subcutaneously each day
    • Administration
      • Low body weight (below 45 kg for women or below 57 kg for men): Increased exposure has been observed with prophylactic (non-weight adjusted) dosage; carefully monitor for signs/symptoms of bleeding
      • Administer deep subcutaneously alternating right and left anterior and posterior abdominal walls into a skin fold held between thumb and forefinger
      • Use of tuberculin syringe (or equivalent) is recommended to assure appropriate measurement of dose
      • For intravenous administration, may administer in intravenous line with 0.9% NaCl or D5W
    • Geriatric
      • Increased risk of bleeding with doses of 1.5 mg/kg/day or 1 mg/kg every 12 hours
        • Dosing considerations
      • Risk of serious adverse reactions increases in the elderly
      • Bodyweight below 45 kg may require dose adjustment

What Are Side Effects Associated with Using Enoxaparin?

Side effects of enoxaparin include:

Postmarketing side effects of enoxaparin reported include:

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What Other Drugs Interact with Enoxaparin?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

What Are Warnings and Precautions for Enoxaparin?

Warnings

Epidural or spinal hematomas may occur in patient's anticoagulated with low-molecular-weight heparin (LMWH) or heparinoids who receive neuraxial (epidural/spinal) anesthesia or spinal puncture

These hematomas may result in long-term or permanent paralysis

Patients should be frequently monitored for signs and symptoms of neurologic impairment (tingling, numbness, muscular weakness)

If neurologic compromise is noted, urgent treatment is necessary

Physicians should consider the benefits versus risk before neuraxial intervention in patient's anticoagulated or to be anticoagulated for thromboprophylaxis

Factors increasing the risk of epidural or spinal hematomas:

  • Indwelling epidural catheters.
  • Concomitant use of other drugs that affect hemostasis (nonsteroidal anti-inflammatory drugs [NSAIDs], platelet inhibitors, other anticoagulants).
  • History of traumatic or repeated epidural or spinal punctures.
  • History of spinal deformity or spinal surgery.
  • Appropriate timing of enoxaparin dosing to catheter placement or removal.
  • Optimal timing between the administration of enoxaparin and neuraxial procedures is not known.
  • Placement or removal of a spinal catheter should be delayed for at least 12 hours after administration of prophylactic doses (doses used for deep vein thrombosis prevention).
  • Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses (enoxaparin 1 mg/kg twice daily or 1.5 mg/kg per day).
  • A post-procedure dose of enoxaparin should usually be given no sooner than 4 hours after catheter removal.
  • In all cases, a benefit-risk assessment should consider both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.

This medication contains enoxaparin. Do not take Lovenox if you are allergic to enoxaparin or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

  • Active major bleeding, thrombocytopenia with antiplatelet antibody in presence of enoxaparin or heparin
  • Hypersensitivity to enoxaparin, heparin, pork products, or other ingredients

Effects of Drug Abuse

  • No information available

Short-Term Effects

  • Bleeding may occur
  • See "What Are Side Effects Associated with Using Enoxaparin?"

Long-Term Effects

  • Osteoporosis following long-term therapy
  • See "What Are Side Effects Associated with Using Enoxaparin?"

Cautions

  • Epidural or spinal hemorrhage and subsequent hematomas were reported with the use of enoxaparin and epidural or spinal anesthesia/analgesia or spinal puncture procedures, resulting in long-term or permanent paralysis
  • Bleeding may occur; monitor patients with risk factors including congenital or acquired bleeding disorders, bacterial endocarditis, severe uncontrolled hypertension, hemorrhagic stroke, used shortly after brain, spinal, or ophthalmic surgery in patients treated concomitantly with platelet inhibitors or history of heparin-induced thrombocytopenia, severe liver disease, diabetic retinopathy, patients undergoing invasive procedures, active ulcerative or angiodysplasia diseases, recent gastrointestinal (GI) bleeding or ulceration
  • To minimize the risk of bleeding following percutaneous coronary intervention (PCI), achieve hemostasis, at the puncture site after PCI; sheath can be removed immediately if closure device used; if manual compression is used remove sheath 6 hours after last intravenous/subcutaneous dose of enoxaparin; additional doses not recommended until 6-8 hour after sheath removal; observe for signs of bleeding/hematoma formation
  • The multidose formulation contains benzyl alcohol preservative, linked to fatal "gasping syndrome" in premature neonates
  • Monitor for hyperkalemia (possibly from aldosterone suppression); mainly a concern among patients with risk factors including kidney (renal) dysfunction, concomitant use of potassium-sparing diuretics or potassium supplements
  • Enoxaparin-induced thrombocytopenia and thrombosis reported; use extreme caution or avoid in patients with history heparin-induced thrombocytopenia (HIT), especially if administered within 100 days of HIT episode; monitor platelet count closely; discontinue therapy and consider alternate treatment if platelets are under 100,000/mm³ and/or thrombosis develops
  • Not for long-term thrombocytopenia in patients with prosthetic heart valves
  • Not for intramuscular administration
  • Use caution in patients with kidney (renal) impairment
  • Safety and efficacy not established in obese patients (over 30 kg/m²)
  • The risk of bleeding may increase in women below 45 kg and men below 57 kg
  • Not for use interchangeably (unit for the unit) with heparin or any low-molecular-weight heparins (LMWHs)

Pregnancy and Lactation

  • Enoxaparin use during pregnancy may be acceptable. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk
  • Excretion of enoxaparin in breast milk is unknown; it is not recommended for use while breastfeeding