Enoxaparin Sodium (Page 2 of 11)

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.
  • Do not inject into skin that has bruises or scars. Do not inject through clothes.
  • 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 packaging by peeling at the arrow as directed on the lid. 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

Figure A
(click image for full-size original)

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

Figure B
(click image for full-size original)

Figure B

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

Figure C

Figure C
(click image for full-size original)

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

Figure D
(click image for full-size original)

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

Figure E

Figure E
(click image for full-size original)

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.

2.6 Monitoring for Safety

During therapy monitor complete blood counts including platelets and stool occult blood.

Assess for signs and symptoms of bleeding.

In patients with renal impairment anti-Factor Xa levels may be used to monitor the anticoagulant effects of enoxaparin sodium injection.

If during enoxaparin sodium injection therapy abnormal coagulation parameters or bleeding should occur, anti-Factor Xa levels may be used to monitor the anticoagulant effects of enoxaparin sodium injection [see Clinical Pharmacology (12.3)].

Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) are not adequate for monitoring the anticoagulant effects of enoxaparin sodium injection.

3 DOSAGE FORMS AND STRENGTHS

Enoxaparin Sodium Injection USP is a clear, colorless to pale-yellow solution available in two concentrations.

100 mg/mL Concentration

Single-Dose Prefilled Syringes 30 mg/0.3 mL, 40 mg/0.4 mL

Single-Dose Graduated Prefilled Syringes 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL

150 mg/mL Concentration

Single-Dose Graduated Prefilled Syringes 120 mg/0.8 mL, 150 mg/1 mL

4 CONTRAINDICATIONS

Enoxaparin sodium injection is contraindicated in patients with:

  • Active major bleeding
  • History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies [see Warnings and Precautions (5.4)]
  • Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactic/anaphylactoid reactions) [see Adverse Reactions (6.2)]
  • Known hypersensitivity to heparin or pork products

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