Enoxaparin Sodium (Page 2 of 12)

2.3 Dose Reduction for Patients with Severe Renal Impairment

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 (8.7) and Clinical Pharmacology (12.3)].

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

Indication	Dosage Regimen
Prophylaxis in abdominal surgery	30 mg administered subcutaneously once daily
Prophylaxis in hip or knee replacement surgery	30 mg administered subcutaneously once daily
Prophylaxis in medical patients during acute illness	30 mg administered subcutaneously 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 subcutaneously once daily
Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium	1 mg/kg administered subcutaneously once daily
Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction, when concurrently administered with aspirin	1 mg/kg administered subcutaneously 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 intravenous bolus plus a 1 mg/kg subcutaneous dose followed by 1 mg/kg administered subcutaneously 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 subcutaneously once daily (no initial bolus)

Although no dose adjustment is recommended in patients with creatinine clearance 30 to 50 mL/min and creatinine clearance 50 to 80 mL/min, observe these patients frequently for signs and symptoms of bleeding.

2.4 Recommended Dosage for 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 intravenous bolus. Initiate dosing with 0.75 mg/kg subcutaneously 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 (8.5) and Clinical Pharmacology (12.3)].

No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].

2.5 Administration

Do not administer enoxaparin sodium by intramuscular injection.

Administer enoxaparin sodium injection by intravenous or subcutaneous injection only.

Enoxaparin sodium injection 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.

Use a tuberculin syringe or equivalent when using enoxaparin sodium injection multiple-dose vials to assure withdrawal of the appropriate volume of drug.

Patients may self-inject by the subcutaneous route of administration only after their physicians determine that it is appropriate and with medical follow-up, as necessary. Provide proper training in subcutaneous injection technique before allowing self-injection (with or without the assistance of an injection device).

Subcutaneous Injection Technique

• Position patients in a supine position for enoxaparin sodium injection administration by deep subcutaneous injection.
• Do not expel the air bubble from the prefilled syringes before the injection, to avoid the loss of drug.
• Alternate injection sites between the left and right anterolateral and left and right posterolateral abdominal wall.
• Introduce the whole length of the needle into a skin fold held between the thumb and forefinger; hold the skin fold throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.

Enoxaparin sodium injection 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 less than the full syringe volume is needed to administer the prescribed dose, eject syringe contents until the prescribed dose is left in the syringe.
   Figure A
   

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

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   Figure B

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

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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
   

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

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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

Use the multiple-dose vial for intravenous injections. Administer enoxaparin sodium injection through an intravenous line. Do not mix or coadminister enoxaparin sodium injection with other medications. Flush the intravenous access device with a sufficient volume of saline or dextrose solution prior to and following the intravenous bolus administration of enoxaparin sodium injection, to prevent mixing of drugs. Enoxaparin sodium injection is compatible with normal saline solution (0.9%) or 5% dextrose in water.