INSTRUCTIONS FOR USE
INCRELEX® (EENK-RUH-LEX)
(mecasermin) injection
for subcutaneous use

Read this Instructions for Use before you start using INCRELEX and each time you get a refill. There may be new information. This information does not take the place of talking to your child's doctor about your child's medical condition or treatment.

Do not share your child's needles and syringes with another person. Your child may give another person an infection or your child could get an infection from them.

Important:

Inject INCRELEX exactly as your child's doctor or nurse has shown you.
Follow your doctor's instructions for the type of syringe and needle to use to prepare and inject your child's dose of INCRELEX.
Always use a new, unopened needle and syringe for each injection.
Only use single-use, disposable needles and syringes. Never reuse disposable needles and syringes.
Throw away used needles and syringes in a puncture-resistant, disposable sharps container as soon as you finish giving the injection. See step 5 "How should I throw away (dispose of) used needles and syringes?" at the end of these instructions.

Supplies needed to give the injection:

1 vial of INCRELEX
1 alcohol swab
1 gauze or cotton ball
alcohol (to clean the skin at the injection site)
1 sharps container for throwing away (disposing of) used needles and syringes. See step 5 "How should I throw away (dispose of) used needles and syringes?" at the end of these instructions.

Preparing the Dose:

Wash your hands before getting INCRELEX ready for your child's injection.
Check the liquid to make sure it is clear and colorless. Do not use if it is cloudy or if you see particles.
Check the expiration date printed on the label of the vial. Do not use INCRELEX if the expiration date has passed.
If you are using a new vial, remove the protective cap. Do not remove the rubber top (see Figure 1).
Figure 1: Remove the protective cap
Wipe the rubber top on the vial with an alcohol swab (see Figure 2).
Figure 2: Wipe rubber top with alcohol swab
Before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the INCRELEX dose. Put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see Figure 3).
Figure 3: Inject air into vial
Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly (see Figure 4).
Figure 4: Prepare to withdraw liquid
Make sure the tip of the needle is in the liquid (see Figure 5). Pull the plunger to withdraw the correct dose into the syringe (see Figure 6).
Figure 5: Tip in liquid Figure 6: Withdraw correct dose
Before you take the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the vial and syringe with needle straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw liquid back in until you have the correct dose (see Figure 7).
Figure 7: Remove air bubbles and refill syringe
Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject (see Figure 8).
Figure 8: Ready to inject

Injecting the Dose:

Inject INCRELEX exactly as your child's doctor or nurse has shown you.

Do not give the INCRELEX injection if your child is unable to eat within 20 minutes before or after the injection.

1.: Choose an injection site – upper arm, upper leg (thigh), buttocks, or stomach area (abdomen) (see below). The injection site should be changed (rotated) for each injection.


Upper arm	Thigh	Buttock	Abdomen

2.

Use alcohol to clean the skin where you are going to inject your child. The injection site should be dry before you inject.
Do not fan or blow on the cleaned skin.
Do not touch the injection site again before giving the injection.

3.

Lightly pinch the skin. Insert the needle into the pinched skin as instructed by your child's doctor or nurse (see Figure A). Release the pinched skin.


	Figure A: Lightly pinch the skin and inject as instructed

4.

Slowly push the plunger of the syringe all the way in to make sure you have injected all of the liquid. Pull the needle straight out and gently press on the injection site with gauze or a cotton ball for a few seconds. Do not rub the injection site (see Figure B).


	Figure B: Press (do not rub) with gauze or cotton ball

5.

How should I throw away (dispose of) used needles and syringes?

Put used needles and syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
Do not try to touch the needle.
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 to throw away needles and 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.
For the safety and health of you and others, needles and used syringes must never be re-used.
The used alcohol swabs, cotton balls, and gauze may be placed in your household trash.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Always keep the sharps disposal container out of the reach of children.

How should I store INCRELEX?

Before Opening: Store new, unopened vials of INCRELEX in the refrigerator between 36°F to 46°F (2°C to 8°C).
After Opening: Store opened vials of INCRELEX in the refrigerator between 36°F to 46°F (2°C to 8°C) for 30 days after you start using the vial. Throw away any unused INCRELEX after 30 days.
Do not freeze INCRELEX. If a vial freezes, throw it away.
Keep INCRELEX out of direct light.
Do not use INCRELEX after the expiration date printed on the label.

Keep INCRELEX and all medicines out of reach of children.

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

For additional information, call 855-463-5127.

Manufactured by: Ipsen Biopharmaceuticals, Inc.
Cambridge, MA 02142 USA

U.S. License No. 2194

www.ipsenus.com

Revised: October 2023