TAKHZYRO 150 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

TAKHZYRO150mg solution for injection in pre-filled syringe

lanadelumab

Read all of this leaflet carefully before administering this medicine to a child, because it contains important information.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed to your child or the child in your care, and you should not give it to others, even if they have the same symptoms as your child or the child in your care, as it may harm them.
• If the child experiences side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is TAKHZYRO and what is it used for
2. What you need to know before administering TAKHZYRO
3. How to use TAKHZYRO
4. Possible side effects
5. Storage of TAKHZYRO
6. Contents of the pack and further information
7. Instructions for use

1. What is TAKHZYRO and what is it used for

TAKHZYRO contains the active substance lanadelumab.

What TAKHZYRO is used for

TAKHZYRO 150 mg is a medicine used in patients from 2 years of age with a body weight below 40 kg with hereditary angioedema (HAE) to prevent angioedema attacks.

What is hereditary angioedema (HAE)

HAE is a hereditary disease within a family. When you have this disease, there is not enough of a protein called "C1 inhibitor" in the blood, or the C1 inhibitor does not work properly. This leads to an excess of "plasma kallikrein", which in turn produces higher levels of "bradykinin" in the bloodstream. Too much bradykinin causes HAE symptoms, such as swelling and pain in:

• the hands and feet
• the face, eyelids, lips, or tongue
• the vocal cords (larynx), which can make it difficult to breathe
• the genitals

How TAKHZYRO works

TAKHZYRO is a type of protein that blocks the activity of plasma kallikrein, which helps reduce the amount of bradykinin in the bloodstream and prevents HAE symptoms.

2. What you need to know before starting to use TAKHZYRO

Do not use TAKHZYRO

If your child or the child in your care is allergic to lanadelumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to use TAKHZYRO.
• If your child or the child in your care has a severe allergic reaction to TAKHZYRO with symptoms such as rash, chest tightness, wheezing, or rapid heartbeat, inform your doctor, pharmacist, or nurse immediately.

Keep a record

It is strongly recommended that each time your child or the child in your care receives a dose of TAKHZYRO, you note the name and batch number of the medicine, so that you have a record of the batches used.

Lab tests

Inform your child's doctor that they are receiving TAKHZYRO before subjecting them to lab tests to evaluate their blood clotting, as the presence of TAKHZYRO in the blood may interfere with certain lab tests and give false results.

Children

TAKHZYRO is not recommended for use in children under 2 years of age, as it has not been studied in this age group.

Other medicines and TAKHZYRO

Inform your child's doctor or pharmacist if the child is taking, has recently taken, or might take any other medicines.

It is not known whether TAKHZYRO affects other medicines or is affected by other medicines.

Pregnancy and breastfeeding

Pregnant or breastfeeding patients or those who think they may be pregnant or plan to become pregnant should consult their doctor or pharmacist before using this medicine. The information on the safety of using TAKHZYRO during pregnancy and breastfeeding is limited. As a precautionary measure, it is preferable to avoid the use of lanadelumab during pregnancy and breastfeeding. Your doctor will discuss with you the risks and benefits of receiving this medicine.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible.

TAKHZYRO contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per pre-filled syringe; i.e., it is essentially "sodium-free".

3. How to use TAKHZYRO

TAKHZYRO is available as a pre-filled syringe as a ready-to-use solution. A doctor with experience in treating patients with HAE will initiate and supervise the treatment of your child or the child in your care.

Follow the administration instructions of the medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts or other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

How much TAKHZYRO to use

For children from 2 years to less than 12 years of age, the recommended starting dose is based on body weight:

• In patients with a body weight of 20 to less than 40 kg who have not had any attacks for a prolonged period, the doctor may allow your child or the child in your care to continue receiving the same dose when they reach 12 years of age.

For adults and adolescents from 12 years to less than 18 years of age with a body weight below 40 kg:

• The recommended starting dose is 300 mg of lanadelumab every 2 weeks. If they have not had any attacks for a prolonged period, the doctor may modify the dose to 300 mg of lanadelumab every 4 weeks, especially if their body weight is low.
• A starting dose of 150 mg of lanadelumab every 2 weeks may also be considered. If they have not had any attacks for a prolonged period, the doctor may change the dose to 150 mg of lanadelumab every 4 weeks.

How to inject TAKHZYRO

TAKHZYRO must be injected by a healthcare professional or a caregiver. The caregiver must read and follow the instructions in section 7, "Instructions for use", carefully.

• TAKHZYRO is injected under the skin ("subcutaneous injection").
• The injection can be administered by a healthcare professional or a caregiver.
• A doctor, pharmacist, or nurse should teach you how to prepare and inject TAKHZYRO correctly before you administer it for the first time. Do not perform the injection until you have been taught how to inject the medicine.
• Insert the needle into the fatty tissue of the stomach (abdomen), thigh, or upper arm.
• Inject the medicine into a different place each time.
• Use each pre-filled syringe of TAKHZYRO only once.

If you use more TAKHZYRO than you should

Inform your child's doctor, pharmacist, or nurse if your child has received a dose of TAKHZYRO that is higher than recommended or sooner than prescribed by the doctor.

If you forget to use TAKHZYRO

If you miss a dose of TAKHZYRO, inject the dose as soon as possible. The administration of subsequent doses may require an adjustment according to the desired dosing frequency, ensuring that:

• at least 10 days pass between doses in patients with a dosing regimen every 2 weeks,
• at least 17 days pass between doses in patients with a dosing regimen every 3 weeks,
• at least 24 days pass between doses in patients with a dosing regimen every 4 weeks.

If you are unsure when to inject TAKHZYRO after missing a dose, ask your child's doctor, pharmacist, or nurse.

If you stop treatment with TAKHZYRO

The decision to stop administering TAKHZYRO should be discussed with your child's doctor, as symptoms may return.

If you have any other questions about the use of this medicine, ask your child's doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If your child has a severe allergic reaction to TAKHZYRO with symptoms such as rash, chest tightness, wheezing, or rapid heartbeat, inform your child's doctor, pharmacist, or nurse immediately.

Inform your child's doctor, pharmacist, or nurse if you or your child notice any of the following side effects.

Very common (may affect more than 1 in 10 people):

• Reactions at the injection site: symptoms are pain, redness of the skin, bruising, discomfort, swelling, bleeding, itching, hardening of the skin, tingling, warmth, and rash.

Common (may affect up to 1 in 10 people):

• Allergic reactions, such as itching, discomfort, and tingling in the tongue
• Dizziness, feeling of fainting
• Raised rash
• Muscle pain
• Lab test results showing changes in the liver

Reporting of side effects

If your child or the child in your care experiences any side effects, consult your child's doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TAKHZYRO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown.

TAKHZYRO 150 mg solution for injection in pre-filled syringe.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep the pre-filled syringe in the outer packaging to protect it from light.

The pre-filled syringes can be stored below 25°C for a single period of 14 days, but not beyond the expiry date.

After storage at room temperature, do not refrigerate TAKHZYRO again for storage.

When a pre-filled syringe is removed from the refrigerator from a multiple pack, the remaining pre-filled syringes should be returned to the refrigerator for when they are to be used in the future.

Do not use this medicine if you notice signs of deterioration, such as particles in the pre-filled syringe or a change in the color of the injection solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

TAKHZYRO Composition

• The active ingredient is lanadelumab. Each prefilled syringe contains 150 mg of lanadelumab in a 1 ml solution.
• The other components are disodium phosphate dihydrate, citric acid monohydrate, histidine, sodium chloride, polysorbate 80, and water for injectable preparations; see section 2 "TAKHZYRO contains sodium"

Product Appearance and Container Contents

TAKHZYRO is presented as a clear, colorless to pale yellow injectable solution in a prefilled syringe.

TAKHZYRO is available as:

• a single-unit container containing one 1 ml prefilled syringe in a box
• a single-unit container containing two 1 ml prefilled syringes in a box
• multiple-unit containers containing 3 intermediate cartons, each with two 1 ml prefilled syringes.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50-58 Baggot Street Lower

Dublin 2

D02 HW68

Ireland

Manufacturer

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50-58 Baggot Street Lower

Dublin 2

D02 HW68

Ireland

Shire Pharmaceuticals Ireland Limited

Blocks 2 & 3 Miesian Plaza

50-58 Baggot Street Lower

Dublin 2

Ireland

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.

1. Instructions for Use

Make sure to read, understand, and follow the instructions for use before injecting TAKHZYRO. Contact a healthcare professional if you have questions.

Intended Use

The TAKHZYRO prefilled syringe is a single-dose injection device with a needle, ready for use, intended for subcutaneous administration of the medicinal product by healthcare professionals and caregivers. Self-administration is not recommended in pediatric patients (2 to less than 12 years of age).

Storage of TAKHZYRO

• Store the TAKHZYRO prefilled syringe in the refrigerator at 2 °C to 8 °C. Do notfreeze.
• A prefilled syringe that is removed from refrigeration should be stored at less than 25 °C and used within 14 days. After storage at room temperature, do not refrigerate TAKHZYRO again for storage.
• When a prefilled syringe is removed from refrigeration from a multiple-unit container, the remaining prefilled syringes should be returned to the refrigerator for future use.
• Store TAKHZYRO in the original carton to protect the prefilled syringe from light.
• Discard the TAKHZYRO prefilled syringe if it has not been refrigerated, has been frozen, or has not been stored in its original carton protected from light.
• Do notshake TAKHZYRO.

Keep TAKHZYRO and all medicines out of the reach of children.

Parts of Your TAKHZYRO Prefilled Syringe Before Use (Figure A).

Figure A: TAKHZYRO Prefilled Syringe

Step 1: Preparation of the Injection

1. Take an alcohol swab, a cotton pad or swab, a plaster, and a sharps container (Figure B) and place them on a flat, clean surface in a well-lit area. These items are not included in the TAKHZYRO packaging.

Figure B: Supplies

Figure C: Remove the Prefilled Syringe

Figure D: Hand Washing

Figure E: Expiration Date Location

Step 2: Selection and Preparation of the Injection Site

1. Discard the needle cap in the trash or sharps container.

• To avoid injury from the needle, do notreplace the needle cap.

Step 4: Dispose of the TAKHZYRO Prefilled Syringe