Enoxaparin (Lovenox): Uses, Side Effects and Dosage

INSTRUCTIONS FOR USE

ENOXAPARIN SODIUM injection

for subcutaneous use

Single-dose prefilled syringe

This Instructions for Use contains information on how to prepare and inject enoxaparin sodium prefilled syringe.

Read this Instructions for Use before using the enoxaparin sodium prefilled syringe and each time you get a new prescription. There may be new information. Do not inject yourself or someone else until you have been shown how to inject enoxaparin sodium. Your healthcare provider can show you or your caregiver how to prepare and inject a dose of enoxaparin sodium. Call your healthcare provider if you have any questions.

Storing enoxaparin sodium prefilled syringes:

• Store enoxaparin sodium prefilled syringes at 77°F (25°C).
• Store enoxaparin sodium prefilled syringes in the original carton or packaging until ready to use.
• Keep enoxaparin sodium injection and all medicines out of the reach of children.

Parts of enoxaparin sodium prefilled syringe:

Preparing to inject enoxaparin sodium:

Step 1: Gather the following supplies for your injection (see Figure A) :

• 1 enoxaparin sodium prefilled syringe
• 1 alcohol wipe Items not included.
• 1 cotton ball or gauze
• a small adhesive bandage, if needed
• a sharps disposal container (see Step 13)

Figure A

Step 2: Wash your hands well with soap and water.

Step 3: Preparing a dose of enoxaparin sodium injection

Take the prefilled syringe out of the package.

Open the packaging by peeling the lid at the arrow as directed.

Take the prefilled syringe out of the plastic container by holding the middle of the syringe body

(see Figure B).

• Do not remove the prefilled syringe by pulling on the plunger rod or the needle cap as this may damage the syringe.
• Do not pull off the needle cap until you are ready to inject.
• Do not use the enoxaparin sodium prefilled syringe if it has been dropped on a hard surface or damaged.

Figure B

Step 4: Check the enoxaparin sodium prefilled syringe

• When you receive your enoxaparin sodium syringes, always check to see that:

  • you have the correct medicine and dose.
  • the expiration date on the prefilled syringe has not passed (see Figure C).
• Do not use the enoxaparin sodium prefilled syringe if the expiration date has passed.

Figure C

Step 5: Check the medicine

• Look at the medicine inside the enoxaparin sodium prefilled syringe:

  • The liquid should be clear and colorless to pale yellow (see Figure D).
  • Note: You may see air bubble(s), this is normal. Do not try to remove any air bubbles.
• Do not use the enoxaparin sodium prefilled syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles.

Figure D

Step 6: Choose your injection site

• You can inject into either the right or left side of your stomach area (abdomen), at least 2 inches away from your belly button and out towards your side (see Figure E).
• You should alternate between the left or right side of your stomach each time you give yourself an injection.
• Do not inject into skin that has bruises or scars.
• Do not inject through clothes.

Figure E

Step 7: Clean the injection site

Clean the injection site with an alcohol wipe (see Figure F).

Let your skin dry before injecting.

Figure F

Step 8: Remove the needle cap

Hold the prefilled syringe in the middle of the body with the needle pointing away from you. Remove the needle cap by pulling it straight off the syringe (see Figure G).

• Do not twist the needle cap to avoid bending the needle.
• Do not put the needle cap back on.
• Do not touch the needle.

Figure G

Step 9: Injecting a dose that is less than the full amount in the prefilled syringe. If your prescribed dose is the same as the amount in the prefilled syringe, go to Step 10.

If your dose is based on your bodyweight, your healthcare provider may prescribe less than the full amount in the syringe. You will have to get rid of (discard) some of the medicine from the prefilled syringe before you inject enoxaparin sodium.

To measure your prescribed dose, hold the prefilled syringe with the needle pointing down. Carefully watch the numbers on the syringe as you push the plunger down until the amount left in the syringe is the same as your prescribed dose. The tip of the plunger should line up with the number for your prescribed dose (see Figure H).

Figure H

Step 10: Injecting enoxaparin sodium

Hold the prefilled syringe like a pencil in your hand with the needle pointing down. With your other hand, pinch the cleaned stomach (abdomen) area between your forefinger and thumb to make a fold in the skin (see Figure I). Make sure you hold the skin fold during the entire injection.

Figure I

Insert the full length of the needle straight into the skin fold at about a 90° angle (see Figure J).

Figure J

Push the plunger rod down slowly and steadily with your thumb until the enoxaparin sodium prefilled syringe is empty (see Figure K).

Figure K

Step 11: Remove the needle

Remove the needle from the injection site by pulling it straight out while keeping your fingers on the plunger rod (see Figure L).

• Do not put the needle cap back on.
• Do not rub your skin after the injection.

Figure L

Step 12: Activate the safety system

Point the needle away from yourself and other people, and firmly push the plunger rod again to activate the safety system. The protective sleeve will automatically come down and cover the needle. You will hear a "click" when the protective sleeve is released (see Figure M).

• You will feel some resistance. This is normal. Keep pushing until you hear the "click."
• The safety system can only be activated after the syringe has been emptied.
• Only activate the safety system after you have removed the needle from your skin.
• Activation of the safety system may cause a small amount of liquid to leak out of the syringe. Activate the system while facing the syringe away from yourself and other people.

Figure M

Step 13: Dispose of used enoxaparin sodium prefilled syringes and needle caps

Put the used enoxaparin sodium prefilled syringe and needle cap in an FDA-cleared sharps disposal container right away after use (see Figure N). Do not dispose of enoxaparin sodium prefilled syringes or needle caps in your household trash.

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles, syringes, and prefilled syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at http://www.fda.gov/safesharpsdisposal.

Figure N

Manufactured for:

Fresenius Kabi USA, LLC

Lake Zurich, IL 60047

©2021 sanofi-aventis U.S. LLC

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: December 2021