TAKHZYRO (Page 5 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

TAKHZYRO (lanadelumab-flyo) injection is a ready-to-use, clear to slightly opalescent, colorless to slightly yellow solution supplied in the following presentations.

Single-dose prefilled syringe

• Supplied in a carton containing one single-dose prefilled syringe with a bromobutyl rubber stopper, 27-gauge, ½-inch staked needle and rigid needle cap.
• NDC 47783-645-01: 150 mg/mL prefilled syringe
• NDC 47783-646-01: 300 mg/2 mL (150 mg/mL) prefilled syringe

Single-dose vial

• Supplied in a carton containing one single-dose glass vial with chlorobutyl rubber stopper, aluminum crimp seal and polypropylene flip-off cap.
• NDC 47783-644-01: 300 mg/2 mL (150 mg/mL) vial

Storage and Handling

• Store the prefilled syringes and vials refrigerated at 36°F to 46°F (2°C to 8°C).
• Do not freeze. Do not shake.
• Keep the prefilled syringe and vial in the original carton to protect from light.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Hypersensitivity

Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.1)].

Self-Administration:

• Ensure that the patient or caregiver receives clear instructions and training on subcutaneous administration and has demonstrated the ability to perform a subcutaneous injection.
• Instruct patients or caregivers in the technique of proper syringe and needle disposal, and advise them not to reuse these items. Instruct patients or caregivers to dispose needles and syringes in a puncture-resistant container.

For more information, visit 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.

© 2023 Takeda Pharmaceuticals U.S.A., Inc.

All rights reserved.

This Patient Information has been approved by the U.S. Food and Drug Administration.		Revised: 02/2023
PATIENT INFORMATIONTAKHZYRO® (tak-ZYE-roe)(lanadelumab-flyo)injection, for subcutaneous use
Read this Patient Information before you start using TAKHZYRO and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is TAKHZYRO? TAKHZYRO is a prescription medicine used to prevent attacks of Hereditary Angioedema (HAE) in people 2 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 2 years of age.
Before you use TAKHZYRO, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or planning to become pregnant. It is not known if TAKHZYRO can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if TAKHZYRO passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while using TAKHZYRO. Tell your healthcare provider about all the medicines you take , including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.
How should I use TAKHZYRO? See the detailed Instructions for Use that comes with this patient information leaflet about the right way to prepare and inject TAKHZYRO. Use TAKHZYRO exactly as your healthcare provider tells you to use it. TAKHZYRO is given as an injection under your skin (subcutaneous) by you or a caregiver. Your healthcare provider should show you or your caregiver how to prepare and inject your dose of TAKHZYRO before you inject yourself for the first time. Do not try to inject TAKHZYRO unless you have been trained by your healthcare provider. Self-injection is not recommended in children (2 to less than 12 years).
What are the possible side effects of TAKHZYRO?TAKHZYRO may cause serious side effects, including allergic reactions. Allergic reactions may happen with TAKHZYRO. Call your healthcare provider or get emergency help right away if you have any of the following symptoms:
wheezing difficulty breathing chest tightness fast heartbeat	faintness rash hives
The most common side effects of TAKHZYRO are: injection site reactions (pain, redness, and bruising) upper respiratory infections headache rash dizziness diarrhea muscle aches Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TAKHZYRO. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of TAKHZYRO. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TAKHZYRO for a condition for which it is not prescribed. Do not give TAKHZYRO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TAKHZYRO that is written for health professionals.
What are the ingredients in TAKHZYRO?Active ingredient: lanadelumabInactive ingredients: citric acid monohydrate, L-histidine, sodium chloride, sodium phosphate dibasic dihydrate and water for injection.Manufactured by:Takeda Pharmaceuticals U.S.A., Inc.Lexington, MA 02421U.S. License No. 1898TAKHZYRO® is a registered trademark of Dyax Corp., a Takeda company. TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited.©2023 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.For more information, visit www.TAKHZYRO.com or call 1-877-TAKEDA-7 (1-877-825-3327).

INSTRUCTIONS FOR USE

TAKHZYRO^® (tak-ZYE-roe)
(lanadelumab-flyo)
injection, for subcutaneous usesingle-dose 1 mL 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 to children by their healthcare provider or caregiver. Self-injection is not recommended in children (2 to less than 12 years of age). Each TAKHZYRO prefilled syringe contains one 150 mg/1 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.	(click image for full-size original) 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 by a healthcare provider or caregiver into the following sites only (Figure G): stomach area (abdomen) thighs upper arms Do not inject into an area 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 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 remove 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). (click image for full-size original) 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 remove 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.
©2023 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: 02/2023