Takhzyro 150 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TAKHZYRO 150 mg 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, as you may need to read it again.
• If you have any questions, consult the child's doctor, pharmacist or nurse.
• This medicine has been prescribed only for your child or the child under your care, and you should not give it to other people, even if they have the same symptoms as your child or the child under your care, as it may harm them.
• If the child experiences any adverse reactions, consult their doctor, pharmacist or nurse, even if these are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What TAKHZYRO is and what it is 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 attacks of angioedema.

What is hereditary angioedema (HAE)

HAE is an inherited disease within the same family. When a person has this disease, there is either 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 causes higher levels of "bradykinin" in the bloodstream. Too much bradykinin causes symptoms of HAE, 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, helping to reduce the amount of bradykinin in the bloodstream and thereby preventing symptoms of HAE.

2. What you need to know before starting TAKHZYRO

Do not use TAKHZYRO

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

Warnings and precautions

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

Keeping a record

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

Laboratory tests

Inform the child's doctor that the child is receiving TAKHZYRO before the child undergoes blood coagulation tests, as the presence of TAKHZYRO in the blood may interfere with certain laboratory tests and lead to inaccurate results.

Children

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

Other medicines and TAKHZYRO

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

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

Pregnancy and breastfeeding

Patients who are pregnant or breastfeeding, or who think they might be pregnant or plan to become pregnant, should consult their doctor or pharmacist before using this medicine. Information on the safety of using TAKHZYRO during pregnancy and breastfeeding is limited. As a precautionary measure, it is preferable 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

The influence of this medicine on the ability to drive and operate machinery is negligible or none.

TAKHZYRO contains sodium

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

3. How to use TAKHZYRO

TAKHZYRO is supplied in single-use, pre-filled syringes as a ready-to-use solution. Treatment for your child or the child in your care will be initiated and supervised by a physician experienced in the management of patients with HAE.

Follow exactly the instructions for administering this medicine provided in this leaflet or those given by the child's doctor, pharmacist, or nurse. If you have any doubts or further questions about the use of this medicine, consult the child's doctor, pharmacist, or nurse.

How much TAKHZYRO to use

For children aged 2 years to less than 12 years, 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 of time, the doctor may allow your child or the child under your care to continue receiving the same dose upon reaching 12 years of age.

For adults and adolescents 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 you have not had any attacks for a prolonged period of time, your doctor may adjust your dose to 300 mg of lanadelumab every 4 weeks, especially if your body weight is low.
• A starting dose of 150 mg of lanadelumab every 2 weeks may also be considered. If you have not had attacks for a prolonged period of time, your 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 carefully read and follow the instructions provided in section 7, "Instructions for use".

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

If you use more TAKHZYRO than you should

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

If you forget to use TAKHZYRO

If a dose of TAKHZYRO is missed, inject the dose as soon as possible. Administration of subsequent doses may require adjustment according to the desired dosing frequency, ensuring that:

• at least 10 days elapse between doses for patients on a dosing regimen every 2 weeks,
• at least 17 days elapse between doses for patients on a dosing regimen every 3 weeks,
• at least 24 days elapse between doses for patients on a dosing regimen every 4 weeks.

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

If you stop treatment with TAKHZYRO

The decision to discontinue administration of TAKHZYRO should be discussed with the child's doctor, as symptoms may return.

If you have any further questions about the use of this medicine, ask the 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 the child has a severe allergic reaction to TAKHZYRO with symptoms such as rash, chest tightness, wheezing or rapid heartbeat, inform the child's doctor, pharmacist or nurse immediately.

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

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

• Reactions at the injection site: symptoms include 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 of the tongue
• Dizziness, feeling faint
• Raised skin rash
• Muscle pain
• Blood test results showing changes in the liver

Reporting of side effects

If your child or the child in your care experiences any side effect, talk to the child's doctor, pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You may also report them directly through the national reporting system included 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 stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

TAKHZYRO 150 mg solution for injection in a 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.

Pre-filled syringes may be stored below 25 °C for a single period of up to 14 days, but not beyond the expiry date.

After storage at room temperature, do not return TAKHZYRO to the refrigerator for storage.

When a pre-filled syringe is removed from a multi-pack container, the remaining pre-filled syringes should be returned to the refrigerator for future use.

Do not use this medicine if you notice signs of deterioration, such as particles in the pre-filled syringe or a change in colour 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. These measures will help protect the environment.

6. Package contents and other information

Composition of TAKHZYRO

• The active substance is lanadelumab. Each pre-filled 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 injections; see section 2 "TAKHZYRO contains sodium".

Nature of the medicinal product and contents of the container

TAKHZYRO is presented as a clear, colourless to pale yellow injectable solution in a pre-filled syringe.

TAKHZYRO is available as:

• a single pack containing one 1 ml pre-filled syringe in a carton
• a single pack containing two 1 ml pre-filled syringes in a carton
• multiple packs containing 3 intermediate cartons, each containing two 1 ml pre-filled syringes.

Some pack sizes may not be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet

Other sources of information

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

1. Instructions for use

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

Intended use

The TAKHZYRO pre-filled syringe is a single-use, ready-to-use, fixed-dose (150 mg/1 ml) injection device with a needle, intended for subcutaneous administration by healthcare professionals and caregivers. Self-administration is not recommended in paediatric patients (2 to less than 12 years of age).

Storage of TAKHZYRO

• Store the TAKHZYRO pre-filled syringe in the refrigerator at 2°C to 8°C. Do not freeze.
• A pre-filled syringe removed from refrigeration must be stored at less than 25°C and used within 14 days. After storage at room temperature, do not re-refrigerate TAKHZYRO for storage purposes.
• When a pre-filled syringe is removed from a multi-pack container, the remaining pre-filled syringes should be returned to the refrigerator for future use.
• Keep TAKHZYRO in its original carton to protect the pre-filled syringe from light.
• Discard the TAKHZYRO pre-filled syringe if it has not been refrigerated, has been frozen, or has not been stored in its original packaging protected from light.
• Do not shake TAKHZYRO.

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

Parts of your TAKHZYRO pre-filled syringe before use (Figure A).

Figure A: TAKHZYRO pre-filled syringe

Step 1: Preparing the injection

1. Take an alcohol wipe, gauze pad or cotton ball, adhesive bandage, and a sharps disposal container (Figure B) and place them on a clean, flat surface in a well-lit area. These items are not included in the TAKHZYRO package.

Figure B: Supplies

Figure C: Remove the pre-filled syringe

Figure D: Hand washing

Figure E: Location of the expiry date

Step 2: Selection and preparation of the injection site

1. Dispose of the needle cap in the trash or in a sharps container.

• To avoid injury from the needle, do not recap the needle.

Step 4: Dispose of the prefilled syringe of
TAKHZYRO