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Lovenox

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Lovenox

INDICATIONS

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].
  • 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.

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.

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 nonQ-wave myocardial infarction, when concurrently administered with aspirin.

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).

DOSAGE AND ADMINISTRATION

All patients should be evaluated for a bleeding disorder before administration of Lovenox, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring Lovenox activity, routine monitoring of coagulation parameters is not required [see WARNINGS AND PRECAUTIONS].

For subcutaneous use, Lovenox should not be mixed with other injections or infusions. For intravenous use (i.e., for treatment of acute STEMI), Lovenox can be mixed with normal saline solution (0.9%) or 5% dextrose in water.

Lovenox is not intended for intramuscular administration.

Adult Dosage

Abdominal Surgery

In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of Lovenox is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.

Hip or Knee Replacement Surgery

In patients undergoing hip or knee replacement surgery, the recommended dose of Lovenox is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with Lovenox 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.

Medical Patients During Acute Illness

In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of Lovenox is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of Lovenox has been administered in the controlled clinical trial.

Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism

In outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of Lovenox is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of Lovenox is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of Lovenox). Lovenox should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of Lovenox administration has been administered in controlled clinical trials.

Unstable Angina and Non-Q-Wave Myocardial Infarction

In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of Lovenox is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with Lovenox should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of Lovenox has been administered in clinical trials [see WARNINGS AND PRECAUTIONS and Clinical Studies].

Treatment of Acute ST-Segment Elevation Myocardial Infarction

In patients with acute ST-segment elevation myocardial infarction, the recommended dose of Lovenox is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥ 75 years of age. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.

When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), Lovenox should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the Lovenox treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.

For patients managed with percutaneous coronary intervention (PCI): If the last Lovenox SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last Lovenox SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of Lovenox should be administered [see WARNINGS AND PRECAUTIONS].

Renal Impairment

Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.

The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance < 30 mL/min) are described in Table 1 [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Table 1: Dosage Regimens for Patients with Severe Renal Impairment (creatinine clearance < 30mL/minute)

Indication Dosage Regimen
Prophylaxis in abdominal surgery 30 mg administered SC once daily
Prophylaxis in hip or knee replacement surgery 30 mg administered SC once daily
Prophylaxis in medical patients during acute illness 30 mg administered SC once daily
Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily
Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin 1 mg/kg administered SC once daily
Treatment of acute ST-segment elevation myocardial infarction in patients < 75 years of age, when administered in conjunction with aspirin 30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily.
Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥ 75 years of age, when administered in conjunction with aspirin 1 mg/kg administered SC once daily (no initial bolus)

Geriatric Patients with Acute ST-Segment Elevation Myocardial Infarction

For treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥ 75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired.  

Administration

Lovenox is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.

The use of a tuberculin syringe or equivalent is recommended when using Lovenox multiple-dose vials to assure withdrawal of the appropriate volume of drug.

Lovenox must not be administered by intramuscular injection. Lovenox is intended for use under the guidance of a physician.

For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.

Subcutaneous Injection Technique

Patients should be lying down and Lovenox administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.

Lovenox prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.

Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister. Do not remove by pulling on the plunger as this may damage the syringe.

1. Remove the needle shield by pulling it straight off the syringe (see Figure A). If adjusting the dose is required, the dose adjustment must be done prior to injecting the prescribed dose to the patient.

Figure A

Remove the needle shield - Illustration

2. Inject using standard technique, pushing the plunger to the bottom of the syringe (see Figure B).

Figure B

Inject using standard technique - Illustration

3. Remove the syringe from the injection site keeping your finger on the plunger rod (see Figure C).

Figure C

Remove the syringe - Illustration

4. Orient the needle away from you and others, and activate the safety system by firmly pushing the plunger rod. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see Figure D).

Figure D

activate the safety system - Illustration

5. Immediately dispose of the syringe in the nearest sharps container (see Figure E).

Figure E

Dispose of the syringe - Illustration

NOTE:

  • The safety system can only be activated once the syringe has been emptied.
  • Activation of the safety system must be done only after removing the needle from the patient's skin.
  • Do not replace the needle shield after injection.
  • The safety system should not be sterilized.

Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.

Intravenous (Bolus) Injection Technique

For intravenous injection, the multiple-dose vial should be used. Lovenox should be administered through an intravenous line. Lovenox should not be mixed or co-administered with other medications. To avoid the possible mixture of Lovenox with other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of Lovenox to clear the port of drug. Lovenox may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.

HOW SUPPLIED

Dosage Forms And Strengths

Lovenox is available in two concentrations:

100 mg/mL Concentration
  • Prefilled Syringes 30 mg/0.3 mL, 40 mg/0.4 mL
  • Graduated Prefilled Syringes 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL
  • Multiple-Dose Vials 300 mg/3 mL
150 mg/mL Concentration

Graduated Prefilled Syringes 120 mg/0.8 mL, 150 mg/1 mL

Storage And Handling

Lovenox is available in two concentrations [see Tables 26 and 27]:

Table 26 : 100 mg/mL Concentration

Dosage Unit / Strength1 Anti-Xa Activity2 Package Size (per carton) Label Color NDC # 0075-
Prefilled Syringes3
30 mg/0.3 mL 3000 IU 10 syringes Medium Blue 0624-30
40 mg/0.4 mL 4000 IU 10 syringes Yellow 0620-40
Graduated Prefilled Syringes3
60 mg/0.6 mL 6000 IU 10 syringes Orange 0621-60
80 mg/0.8 mL 8000 IU 10 syringes Brown 0622-80
100 mg/1 mL 10,000 IU 10 syringes Black 0623-00
Multiple-Dose Vial4
300 mg/3 mL 30,000 IU 1 vial Red 0626-03
1 Strength represents the number of milligrams of enoxaparin sodium in Water for Injection. Lovenox 30 and 40 mg prefilled syringes, and 60, 80, and 100 mg graduated prefilled syringes each contain 10 mg enoxaparin sodium per 0.1 mL Water for Injection.
2 Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard.
3
Each Lovenox prefilled syringe is for single, one-time use only and is affixed with a 27 gauge x ½ inch needle.
4 Each Lovenox multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative.

Table 27 : 150 mg/mL Concentration

Dosage Unit / Strength1 Anti-Xa Activity2 Package Size (per carton) Syringe Label Color NDC # 0075-
Graduated Prefilled Syringes3
120 mg / 0.8 mL 12,000 IU 10 syringes Purple 2912-01
150 mg / 1 mL 15,000 IU 10 syringes Navy Blue 2915-01
1 Strength represents the number of milligrams of enoxaparin sodium in Water for Injection. Lovenox 120 and 150 mg graduated prefilled syringes contain 15 mg enoxaparin sodium per 0.1 mL Water for Injection.
2 Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard.
3 Each Lovenox graduated prefilled syringe is for single, one-time use only and is affixed with a 27 gauge x ½ inch needle.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Do not store the multiple-dose vials for more than 28 days after the first use.

Keep out of the reach of children.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. A Sanofi Company. Multiple-dose vials are also manufactured by DSM Pharmaceuticals, Inc. Greenville, NC 27835. Revised: May 2013

Last reviewed on RxList: 7/16/2013
This monograph has been modified to include the generic and brand name in many instances.

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