TAKHZYRO (Page 6 of 8)

INSTRUCTIONS FOR USE

TAKHZYRO^® (tak-ZYE-roe)
(lanadelumab-flyo)
injection, for subcutaneous usesingle-dose prefilled syringe

This Instructions for Use contains information on how to inject TAKHZYRO. Please make sure to read, understand, and follow the Instructions for Use before injecting TAKHZYRO.

A healthcare provider should show you how to prepare and inject TAKHZYRO properly before you use it for the first time. Contact your healthcare provider if you have any questions.

Important information:

TAKHZYRO is a ready to use prefilled syringe (Figure A) for injection under the skin (subcutaneous) to be given by your healthcare provider, caregiver, or by yourself. Each TAKHZYRO prefilled syringe contains one 300 mg/2 mL dose. The TAKHZYRO prefilled syringe is for single use only.

(click image for full-size original) Figure A: TAKHZYRO prefilled syringe

Storing TAKHZYRO:

Store the TAKHZYRO prefilled syringe in the refrigerator at 36°F to 46°F (2°C to 8°C).Do not freeze. Store the TAKHZYRO prefilled syringe in the original carton to protect it from light. Throw away (discard) the TAKHZYRO prefilled syringe if it has been kept out of the refrigerator, frozen, or not kept in the original carton protected from light. Do not shake the TAKHZYRO prefilled syringe.Keep the TAKHZYRO prefilled syringe and all medicines out of the reach of children.

Step 1: Prepare for your injection a. Gather an alcohol swab, cotton ball or gauze pad, adhesive bandage, and sharps disposal container (Figure B) and place the supplies on a clean, flat, surface in a well-lit area. These supplies are not included in the TAKHZYRO carton.
(click image for full-size original) Figure B: Supplies
b. Remove the TAKHZYRO prefilled syringe carton from the refrigerator 15 minutes before injecting. Do not use if the seal on the carton is open or broken. Your medicine is sensitive to warm temperatures. Do not use heat sources such as a microwave or hot water to warm your TAKHZYRO prefilled syringe.
c. Open the carton. Hold the syringe barrel and remove the TAKHZYRO prefilled syringe from the tray (Figure C). Do not remove the needle cap until you are ready to inject. Do not touch or push the plunger rod until you are ready to inject.	Figure C: Remove prefilled syringe
d. Wash your hands with soap and water (Figure D). Dry your hands completely. Do not touch any surface or body part after washing your hands before the injection.	Figure D: Wash hands
e. Check the expiration date (EXP) on the syringe barrel (Figure E). Do not use the TAKHZYRO prefilled syringe if the expiration date has passed. If the TAKHZYRO prefilled syringe is expired throw it away (discard) in a sharps container and contact your healthcare provider.	Figure E: Location of expiration date
f. Inspect the TAKHZYRO prefilled syringe for any damage. The medicine inside the syringe barrel should be colorless to slightly yellow (Figure F). Do not use the TAKHZYRO prefilled syringe if the syringe is damaged or cracked. Do not use the TAKHZYRO prefilled syringe if the medicine is discolored, cloudy, or has flakes or particles in it. You may see air bubbles in the TAKHZYRO prefilled syringe. This is normal and will not affect your dose. If you cannot use the prefilled syringe, contact your healthcare provider.	(click image for full-size original) Figure F: Inspect the prefilled syringe
Step 2: Select and prepare injection site
a. TAKHZYRO should be injected into the following sites only (Figure G): stomach area (abdomen) thighs upper arms (only if a healthcare provider or caregiver is giving you the injection) Do not inject into an area of your body where the skin is irritated, red, bruised, or infected. The area you choose for injection should be at least 2 inches away from any scars or your belly button (navel). Important: Rotate injection sites to keep skin healthy. Each new injection should be given at least 1 inch from the last site you used.	(click image for full-size original) Figure G: Injection sites
b. Clean the injection site with an alcohol swab and allow it to dry completely (Figure H). Do not fan or blow on the clean site. Do not touch the clean site again before giving your injection.	Figure H: Clean injection site
c. Firmly hold the middle of the TAKHZYRO prefilled syringe with one hand, and with the other hand, gently pull the needle cap straight off (Figure I). Do not touch or push the plunger rod until you are ready to inject. Do not use the TAKHZYRO prefilled syringe if it has been dropped without the needle cap on. Do not use the TAKHZYRO prefilled syringe if the needle looks damaged or bent. Do not touch the needle or allow the needle to touch anything. You may see air bubbles, this is normal. Do not try to remove the air bubbles.	(click image for full-size original) Figure I: Remove needle cap
d. Throw away the needle cap in your trash or in your sharps container. Do not recap the needle to avoid a needle-stick injury.

Step 3: Inject TAKHZYRO a. Grip the TAKHZYRO prefilled syringe in one hand like a pencil (Figure J). Avoid touching the needle or pushing on the plunger rod.		Figure J: Grip prefilled syringe
b. With your other hand, gently pinch a 1-inch fold of skin at the cleaned injection site. Keep pinching until the injection is complete and the needle is removed (Figure K).		Figure K: Pinch a 1-inch fold of skin
c. Using a quick dart-like motion, insert the needle at a 45-to-90-degree angle. Make sure to keep the needle in place (Figure L).Important: Inject directly into the fatty layer under the skin (subcutaneous injection).		(click image for full-size original) Figure L: Insert the needle
d. Slowly push the plunger rod all the way down until it stops (Figure M).Important: Do not withdraw the needle until all of the medicine is injected and the syringe barrel is empty.When the injection is complete, you will see the stopper at the bottom of the syringe barrel (Figure N). Figure N: Stopper at the bottom of the syringe barrel		(click image for full-size original) Figure M: Push the plunger rod all the way down
e. Slowly withdraw the needle while maintaining the syringe at the same angle. Gently release the fold of skin.
f. Press a cotton ball or gauze pad over the injection site if needed and hold for 10 seconds. Do not rub the injection site. There may be a small amount of blood where you injected. This is normal. Cover the injection site with an adhesive bandage if needed.

Step 4: Throw away (dispose of) TAKHZYRO prefilled syringe a. Put your used TAKHZYRO prefilled syringe in a sharps disposal container right away after use (Figure O). Do not recap the needle to avoid a needle-stick injury. Do not reuse the TAKHZYRO prefilled syringe or any of your injection supplies. Do not throw away (dispose of) the TAKHZYRO prefilled syringe in your household trash. Do not touch the needle. FDA-cleared sharps containers are generally available through pharmacies, medical supply companies, healthcare providers, and online.

Figure O: Dispose in a sharps container

If you do not have an FDA-cleared sharps 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 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 FDA’s website at: http://www.fda.gov/safesharpsdisposal. Important: Always keep the sharps disposal container out of the reach of children. 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.

Questions?

For product or service-related questions, call 1-877-TAKEDA-7 (1-877-825-3327) or go to www.TAKHZYRO.com.

Manufactured by:
Takeda Pharmaceuticals U.S.A., Inc.
Lexington, MA 02421
U.S. License No. 1898

TAKHZYRO^® is a registered trademark of Dyax Corp., a Takeda company. TAKEDA^® and the TAKEDA Logo^® are registered trademarks of Takeda Pharmaceutical Company Limited.
©2022 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.

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

Approved: 02/2022