Lovenox

Lovenox

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Prophylaxis of Deep Vein Thrombosis

Lovenox® is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):

  • in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.1)].
  • in patients undergoing hip replacement surgery, during and following hospitalization.
  • in patients undergoing knee replacement surgery.
  • in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.
1.2 Treatment of Acute Deep Vein Thrombosis

Lovenox is indicated for:

  • the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium.
  • the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.
1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction

Lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.

1.4 Treatment of Acute ST-Segment Elevation Myocardial Infarction

Lovenox, when administered concurrently with aspirin, has been shown to 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).

History

There is currently no drug history available for this drug.

Other Information

Lovenox is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5.

Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains an 1,6 anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is:

             <2000 daltons             ≤20%

             2000 to 8000 daltons  ≥68%

             >8000 daltons             ≤18%
 

STRUCTURAL FORMULA

Chemical Structure
*
X = Percent of polysaccharide chain containing 1,6 anhydro derivative on the reducing end.
RX*= 15 to 25%Chemical Structuren= 0 to 20
100 - XHn =1 to 21

Lovenox 100 mg/mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.

Lovenox 150 mg/mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.

The Lovenox prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative [see Dosage and Administration (2) and How Supplied (16)].

Lovenox Manufacturers


  • Physicians Total Care, Inc.
    Lovenox (Enoxaparin Sodium) Injection [Physicians Total Care, Inc.]
  • Cardinal Health
    Lovenox (Enoxaparin Sodium) Injection [Cardinal Health]
  • Sanofi-aventis U.s. Llc
    Lovenox (Enoxaparin Sodium) Injection [Sanofi-aventis U.s. Llc]
  • Sanofi-aventis U.s. Llc
    Lovenox (Enoxaparin Sodium) Injection [Sanofi-aventis U.s. Llc]
  • Sanofi-aventis U.s. Llc
    Lovenox (Enoxaparin Sodium) Injection [Sanofi-aventis U.s. Llc]
  • Cardinal Health
    Lovenox (Enoxaparin Sodium) Injection [Cardinal Health]

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