TAKHZYRO 300 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

TAKHZYRO300mg solution for injection in vial

lanadelumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is TAKHZYRO and what is it used for

TAKHZYRO contains the active substance lanadelumab.

What is TAKHZYRO used for

TAKHZYRO is a medicine used in patients from 2 years of age with hereditary angioedema (HAE) to prevent angioedema attacks.

What is hereditary angioedema (HAE)

HAE is a hereditary disease within the same 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 to reduce the amount of bradykinin present in the bloodstream and prevents HAE symptoms.

2. What you need to know before you use TAKHZYRO

Do not use TAKHZYRO

If you are allergic to lanadelumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before starting to use TAKHZYRO.
• If you have a severe allergic reaction to TAKHZYRO with symptoms such as rash, chest tightness, wheezing, or rapid heartbeat, tell your doctor, pharmacist, or nurse immediately.

Keep a record

It is strongly recommended that each time you are given 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

Tell your doctor if you are using TAKHZYRO before undergoing lab tests to evaluate your blood clotting, as the presence of TAKHZYRO in the blood may interfere with certain lab tests and lead to inaccurate results.

Children and adolescents

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

Tell your doctor or pharmacist if you are taking, have 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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using TAKHZYRO. Information on the safety of using TAKHZYRO during pregnancy and breastfeeding is limited. As a precaution, it is recommended to avoid using lanadelumab during pregnancy and breastfeeding. Your doctor will discuss with you the risks and benefits of receiving this medicine.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

TAKHZYRO contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which is essentially "sodium-free".

3. How to use TAKHZYRO

TAKHZYRO comes in single-use vials as a ready-to-use solution. A doctor with experience in treating patients with HAE will start and supervise your treatment.

Follow the instructions for administration of the medicine contained 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 adults and adolescents from 12 years to less than 18 years of age:

• The recommended starting dose is 300 mg of lanadelumab every 2 weeks. If you have not had any attacks for a long period, your doctor may change your dose to 300 mg of lanadelumab every 4 weeks, especially if your body weight is low.
• In patients with a body weight below 40 kg, a starting dose of 150 mg of lanadelumab every 2 weeks may also be considered. If you have not had any attacks for a long period, your doctor may change your dose to 150 mg of lanadelumab every 4 weeks.

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 long period, the doctor may allow your child to continue receiving the same dose when they reach 12 years of age.

How to inject TAKHZYRO

If you self-inject TAKHZYRO or if it is injected by your caregiver, you or your 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 given by you or a caregiver in patients from 12 years of age.
• The injection can be given by a healthcare professional or by a caregiver in patients from 2 years to less than 12 years of age.
• A doctor, pharmacist, or nurse should teach you how to prepare and inject TAKHZYRO correctly before you use it for the first time. Do not inject yourself or inject someone else 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 vial of TAKHZYRO only once.

If you use more TAKHZYRO than you should

Tell your doctor, pharmacist, or nurse if you have been given a dose of TAKHZYRO that is higher than recommended.

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, making sure to:

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

If you are not sure when to inject TAKHZYRO after missing a dose, ask your doctor, pharmacist, or nurse.

If you stop treatment with TAKHZYRO

It is important that you keep injecting TAKHZYRO as your doctor has told you, even if you feel better.

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

4. Possible side effects

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

If you have a severe allergic reaction to TAKHZYRO with symptoms such as rash, chest tightness, wheezing, or rapid heartbeat, tell your doctor, pharmacist, or nurse immediately.

Tell your doctor, pharmacist, or nurse if you 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 you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 stated.

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

The vials can be stored below 25°C for a single period of 14 days but without exceeding the expiry date.

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

Do not use this medicine if you notice signs of deterioration, such as particles in the vial 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 vial contains 300 mg of lanadelumab in 2 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 glass vial.

TAKHZYRO is available as a single-unit package that contains a 2 ml vial and as multiple packages that contain 2 or 6 intermediate boxes, each with 1 vial.

Not all pack sizes may be marketed.

Each package also contains the following components:

• A 3 ml empty syringe
• A 18-gauge vial access needle with a blunt tip
• A 27 G x 13 mm injection needle with a sharp tip

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 the 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 step-by-step instructions for injecting TAKHZYRO. Contact your doctor, pharmacist, or nurse if you have questions.

In addition to the vial, each TAKHZYRO package also contains:

Use only the syringes, vial access needles with blunt tips, and injection needles with sharp tips that come in this package or that your doctor has prescribed.

Use the syringes, vial access needles with blunt tips, and injection needles with sharp tips only once. Place all used syringes and needles in a puncture-proof container.

Do not use a syringe, vial access needle with a blunt tip, or injection needle with a sharp tip that appears to be damaged.

You will also need:

• Alcohol swabs
• A puncture-proof container for used vials, needles, and syringes

You can obtain these items from your doctor, pharmacist, or nurse.

The injection of TAKHZYRO can be summarized in 5 steps:

1. Preparation of the TAKHZYRO vial
2. Attaching the vial access needle with a blunt tip to the syringe
3. Transferring TAKHZYRO to the syringe and changing to the injection needle with a sharp tip
4. Selection and preparation of the injection site
5. Injection of TAKHZYRO

Step 1: Preparation of the TAKHZYRO vial

Step 2: Attaching the vial access needle with a blunt tip to the syringe

Step 3: Transferring TAKHZYRO to the syringe and changing to the injection needle with a sharp tip

Step 4: Selection and Preparation of the Injection Site

Step 5: Injection of TAKHZYRO