Label: information for the user

TAKHZYRO300mg injectable solution in pre-filled syringe

lanadelumab

Read this label carefully before starting to use this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

TAKHZYRO contains the active ingredient lanadelumab.

What is TAKHZYRO used for

TAKHZYRO is a medication used in patients aged 2 years and older with hereditary angioedema (HAE) to prevent angioedema attacks.

What is hereditary angioedema (HAE)

HAE is a hereditary condition within a family. When this condition is present, there is not enough of a protein called the "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.

Do not use TAKHZYRO

If you are allergic to lanadelumab or to any of the other components of this medication (listed in section6).

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to useTAKHZYRO.
• If you have a severe allergic reaction to TAKHZYRO with symptoms such as rash, chest tightness, wheezing, or rapid heartbeat, inform your doctor, pharmacist, or nurseimmediately.

Keeping a record

It is strongly recommended that, each time a dose of TAKHZYRO is administered, you note the name and batch number of the medication, so that you have a record of the batches used.

Laboratory tests

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

Children and adolescents

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 your doctor or pharmacist if you are taking, have 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

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your 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. Your 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; that is, it is 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 its treatment.

Follow exactly the administration instructions for the medication contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt or other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

How much TAKHZYRO to use

For adults and adolescents from 12 years of age 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 during a prolonged period of time, your doctor may modify your dose to 300 mg of lanadelumab every 4 weeks, especially if your body weight is low.
• In patients with a body weight of less than 40 kg, a starting dose of 150 mg of lanadelumab every 2 weeks may also be considered. If you have not had any attacks during a prolonged period of time, your doctor may change your dose to 150 mg of lanadelumab every 4 weeks.

For children from 2 years of age 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 during a prolonged period of time, your doctor may allow your child or the child in your care 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 carefully the instructions that appear in section 7, "Instructions for use".

• TAKHZYRO is injected under the skin ("subcutaneous injection").
• The injection can be administered by you or a caregiver in patients 12 years of age or older.
• The injection can be administered by a healthcare professional or a caregiver in patients 2 years of age to less than 12 years of age.
• A doctor, pharmacist, or nurse must teach you how to prepare and inject TAKHZYRO correctly before you use it for the first time. Do not inject yourself or inject another person until you have been taught how to inject the medication.
• Insert the needle into the abdominal fat (abdomen), thigh, or upper arm tissue.
• 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 your doctor, pharmacist, or nurse if a dose of TAKHZYRO greater than the recommended dose has been administered.

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 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 doctor, pharmacist, or nurse.

If you interrupt treatment with TAKHZYRO

It is essential to continue injecting TAKHZYRO as instructed by your doctor, even if you feel better. If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

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

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

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

• Reactions at the injection site: symptoms include 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 you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 theAppendixV. 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 after CAD. The expiration date is the last day of the month indicated..

TAKHZYRO 300mg 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 300 mg of lanadelumab in a solution of 2 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:

• single unit pack containing a pre-filled syringe of 2 ml in a carton
• single unit pack containing two pre-filled syringes of 2 ml in a carton
• multi-pack containing 3 intermediate cartons, each containing two pre-filled syringes of 2 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.

The summary of product characteristics is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

7.Instructions for use

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

Intended use

The pre-filled syringe of TAKHZYRO is a disposable, pre-filled syringe device with a fixed dose (300 mg/2 ml) intended for subcutaneous administration of the medicinal product by healthcare professionals and caregivers or for self-administration (for patients aged 12 years and above).

Storage of TAKHZYRO

• Store the pre-filled syringe of TAKHZYRO in the refrigerator at 2°C to 8°C.Do notfreeze.
• A pre-filled syringe that has been removed from the refrigerator should be stored at room 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 carton to protect the pre-filled syringe from light.
• Dispose of the pre-filled syringe of TAKHZYRO if it has not been refrigerated, frozen or stored in its original packaging protected from light.
• Do notshake TAKHZYRO.
• Maintain TAKHZYRO and all medicinal products 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: 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 items are not included in the TAKHZYRO pack.

Figure B: Supplies

1. Remove the pre-filled syringe of TAKHZYRO from the refrigerator.
   • Do notuse the pre-filled syringe of TAKHZYRO if the safety cap is open or broken.
   • Waitfor the pre-filled syringe to reach room temperature for at least 15 minutes before preparing the injection.
   • This medicinal product is sensitive to heat.Do notuse heat sources, such as a microwave or hot water, to warm the pre-filled syringe of TAKHZYRO.
   • Do notremove the needle cap until you are ready to start the injection.

1. Open the carton. Hold the barrel of the pre-filled syringe and remove the pre-filled syringe of TAKHZYRO from the tray (Figure C).

1. Wash your hands with water and soap (Figure D).
   • Do nottouch any surface or part of your body after washing your hands before starting the injection.

1. Check the expiry date (CAD) on the barrel of the pre-filled syringe (Figure E).

Do notuse the pre-filled syringe of TAKHZYRO if the expiry date has passed. If the pre-filled syringe of TAKHZYRO is expired, dispose of it in a sharps container and consult your healthcare professional.

Figure E: Location of the expiry date

1. Examine the pre-filled syringe of TAKHZYRO to ensure it is not damaged and that the medicinal product is colourless or pale yellow (Figure F).
   • Do notuse the product if the pre-filled syringe is damaged, for example, if it has cracks.
   • Do notuse the pre-filled syringe of TAKHZYRO if the medicinal product has lost its colour, is turbid or contains particles or residues.
   • You may see air bubbles in your pre-filled syringe of TAKHZYRO. This is normal and will not affect the dose.

If you cannot use the pre-filled syringe, consult your healthcare professional.

Step 2: Selection and preparation of the injection site

1. The pre-filled syringe of TAKHZYRO should only be injected in the following areas (Figure G):

• abdomen (stomach)
• thigh
• • upper arm (only if administered by a healthcare professional or caregiver)
  • Do notinject in an area of the body where the skin is irritated, red, infected or has haematomas.
  • The area you choose for the injection should be at least 5 cm away from any scar or navel.

Important:

• Rotate the injection sites to keep the skin healthy. Each new injection should be administered at a distance of at least 3 cm from the last site used.

1. Clean the injection site with an alcohol wipe and wait for it to dry completely (Figure H).
   • Do notsneeze or fan the area you have cleaned.
   • Do nottouch this area before administering the injection.

1. Carefully remove the needle cap with one hand while holding the pre-filled syringe firmly with the other. Dispose of the needle cap in the trash or a sharps container (Figure I).
   • Do nottouch or press the plunger until you are ready to start the injection.
   • To avoid needlestick injury,do notreplace the needle cap.
   • Do notuse the pre-filled syringe of TAKHZYRO if it has been dropped without the needle cap.
   • Do notuse the pre-filled syringe of TAKHZYRO if the needle appears damaged or bent.
   • Do nottouch the needle or let it come into contact with anything.

Figure I: Remove the needle cap

Step 3: Injection of TAKHZYRO

1. Hold the pre-filled syringe with one hand as if it were a pen (Figure J). Avoid touching the needle or pushing the plunger.

Figure J: Hold the pre-filled syringe

1. Use your other hand to gently pinch the skin, forming a fold of about 3 cm in the injection site you have cleaned.

• Maintain the fold until the injection is complete and the needle is removed (Figure K).

1. Insert the needle into the skin at an angle of 45 to 90 degrees. Ensure that you maintain the needle in place (Figure L).

1. Slowlypush the plungeruntil it stops(Figure M).
2. Withdraw the needle slowly while maintaining the pre-filled syringe at the same angle. Release the skin fold.