Prospect: information for the user

TAKHZYRO150mg injectable solution in pre-filled syringe

lanadelumab

Read this prospect carefully before administering this medication to a child, as it contains important information.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult the child's doctor, pharmacist, or nurse.
• This medication has been prescribed only for the child in your care, and it should not be given to other people, even if they have the same symptoms as the child, as it may harm them.
• If the child experiences adverse effects, consult the child's doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section4.

TAKHZYRO contains the active ingredient lanadelumab.

What is TAKHZYRO used for

TAKHZYRO 150 mg is a medication used in patients aged 2 years and older with a body weight less than 40 kg with hereditary angioedema (HAE) to prevent angioedema attacks.

What is hereditary angioedema (HAE)

HAE is a hereditary disease within a family. When this disease is present, there is not enough of a protein called «C1 inhibitor» in the blood, or the C1 inhibitor does not function correctly. 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 hard 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.

No use TAKHZYRO

If your child or the child in your care is allergic to lanadelumab or any of the other components of this medication (listed in section6).

Warnings and precautions

• Consult a doctor, pharmacist, or nurse caring for the child before starting to useTAKHZYRO.
• If you have a severe allergic reaction to TAKHZYRO with symptoms such as rash, chest tightness, wheezing, or rapid heartbeat, report to the child's doctor, pharmacist, or nurseimmediately.

Keeping a record

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

Laboratory tests

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

Children

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

Other medications and TAKHZYRO

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

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

Pregnancy and breastfeeding

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

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible.

TAKHZYRO contains sodium

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

TAKHZYRO is presented in pre-filled single-use syringes as a ready-to-use solution. A healthcare professional experienced in the care of patients with Hereditary Angioedema (HAE) will initiate and supervise the treatment of your child or the child in their care.

Follow exactly the administration instructions for the medication contained in this leaflet or those indicated by the doctor, pharmacist, or nurse caring for the child. If in doubt or have any questions about the use of this medication, ask the doctor, pharmacist, or nurse caring for the child.

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 crises during a prolonged period of time, the doctor may allow the child to continue receiving the same dose when they reach 12 years of age.

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

• The recommended starting dose is 300 mg of lanadelumab every 2 weeks. If no crises have occurred during a prolonged period of time, the doctor may modify the dose to 300 mg of lanadelumab every 4 weeks, especially if the body weight is low.
• Alternatively, a starting dose of 150 mg of lanadelumab every 2 weeks may be considered. If no crises have occurred during a prolonged period of time, 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 may be administered by a healthcare professional or a caregiver.
• A doctor, pharmacist, or nurse must teach the caregiver how to prepare and inject TAKHZYRO correctly before they administer it for the first time. Do not attempt to inject the medication until you have been taught how to do so.
• Insert the needle into the abdominal fat (abdomen), thigh, or upper arm.
• Inject the medication into a different location each time.
• Use each pre-filled single-use syringe of TAKHZYRO only once.

If you use more TAKHZYRO than you should

Inform the doctor, pharmacist, or nurse caring for the child if the child has received a dose of TAKHZYRO greater than the recommended dose or before the prescribed dose by the doctor.

If you forget to use TAKHZYRO

If a dose of TAKHZYRO is missed, inject the dose as soon as possible. The administration of subsequent doses may require 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 unsure when to inject TAKHZYRO after missing a dose, ask the doctor, pharmacist, or nurse caring for the child.

If you interrupt treatment with TAKHZYRO

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

If you have any other questions about the use of this medication, ask the doctor, pharmacist, or nurse caring for the child.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

If the child has a severe allergic reaction to TAKHZYRO with symptoms such as rash, chest tightness, wheezing, or rapid heartbeat, inform the doctor, pharmacist, or nurse of the childimmediately.

Inform the doctor, pharmacist, or nurse of the child if you or the child notice any of the following adverse effects.

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

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

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

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

Reporting Adverse Effects

If your child or the child under your care experiences any type of adverse effect, consult the doctor, pharmacist, or nurse of the child, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration date is the last day of the month indicated..

TAKHZYRO 150mg injectable solution in pre-filled syringe.

Store in refrigerator (between 2?C and8?C). Do not freeze. Store the pre-filled syringe in the outer packaging to protect it from light.

Pre-filled syringes can be stored below 25°C for a single period of 14days, but not exceeding the expiration date.

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

When removing a pre-filled syringe from a multiple-pack from the refrigerator, the remaining pre-filled syringes should be returned to the refrigerator for future use.

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

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment..

Composition of TAKHZYRO

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

Appearance of the product and contents of the pack

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 a pre-filled syringe of 1 ml in a box
• a single pack containing two pre-filled syringes of 1 ml in a box
• multi-packs containing 3 intermediate packs, each containing two pre-filled syringes of 1 ml

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacture

Marketing authorisation holder

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50-58 Baggot Street Lower

Dublin 2

D02 HW68

Ireland

Responsible person for manufacture

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

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country.

Last update of the summary of product characteristics

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicinal products.

1. Instructions for use

Ensure that you read, understand and follow the instructions for use before administering TAKHZYRO. Contact a healthcare professional if you have any questions.

Indicated use

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

Storage of TAKHZYRO

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

Figura A: TAKHZYRO pre-filled syringe

Step 1: Preparation of the injection

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

Figura B: Supplies

Figura C: Extract the pre-filled syringe

Figura D: Hand washing

Figura E: Location of the expiration date

Step 2: Selection and preparation of the injection site

1. Discard the needle cap in the sharps container.

• To avoid sticking yourself with the needle, do not cover the needle.

Step 4: Discard the pre-filled syringe of TAKHZYRO