Takhzyro

Patient Information Leaflet: Information for the User

TAKHZYRO 150 mg solution for injection in pre-filled syringe

lanadelumab
Please read this leaflet carefully before administering this medicine to the child, as it contains important information.

• Keep this leaflet. 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 for your child or the child you are caring for. Do not give it to other people, even if their symptoms are the same, as it could be harmful.
• If the child experiences any side effects, including those not listed in this leaflet, contact their doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What TAKHZYRO is and what it is used for
2. What you need to know before using TAKHZYRO
3. How to use TAKHZYRO
4. Possible side 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 and weighing less than 40 kg to prevent attacks of angioedema in patients with hereditary angioedema (HAE).
What is hereditary angioedema (HAE)
HAE is a condition that runs in some families. In this condition, patients' blood does not have enough of a protein called “C1 inhibitor”, or the C1 inhibitor does not work properly. This leads to excessive levels of “plasma kallikrein”, which in turn causes increased levels of “bradykinin” in the blood. Excess bradykinin leads to HAE symptoms such as swelling and pain in:

• hands and feet;
• face, eyelids, lips or tongue;
• larynx, which may make breathing difficult;
• genitals.

How TAKHZYRO works
TAKHZYRO is a type of protein that blocks the activity of plasma kallikrein. This helps reduce the amount of bradykinin in the blood and prevents HAE symptoms.

2. What you should know before using TAKHZYRO

Do not use TAKHZYRO
If your child or the child you are caring for is allergic to lanadelumab or to any of the other
components of this medicine (listed in section 6).
Warnings and precautions

• Talk to the child’s doctor, pharmacist, or nurse before using 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.

Keep a record
It is strongly recommended to record the name and batch number of the medicine each time the
child receives a dose of TAKHZYRO. This helps keep track of the batches used.
Laboratory tests
Inform the child’s doctor if the child is taking TAKHZYRO before undergoing laboratory tests
to assess blood clotting. This is because TAKHZYRO in the blood may interfere with certain laboratory tests, leading to inaccurate results.
Children
TAKHZYRO is not recommended for use in children under 2 years of age. This is because 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 take any other medicines.
It is not known whether TAKHZYRO affects other medicines or is affected by other medicines.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is planning a pregnancy, or is breastfeeding,
consult her doctor or pharmacist before starting to use TAKHZYRO.
There is limited information on the safety of using TAKHZYRO during pregnancy and
breastfeeding. As a precautionary measure, it is preferable to avoid using lanadelumab during
pregnancy and breastfeeding. The doctor will discuss with her the risks and benefits of taking
this medicine.
Driving and using machines
This medicine does not alter or alters negligibly the ability to drive vehicles and use machinery.
TAKHZYRO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, i.e.,
essentially “sodium-free”.

3. How to use TAKHZYRO

TAKHZYRO is supplied in single-use pre-filled syringes as a ready-to-use solution. Treatment
of the child or the child under your care will be initiated and managed under the supervision of a physician
experienced in the treatment of patients with HAE.
Use this medicine exactly as stated in this leaflet or as instructed by the child's doctor, pharmacist, or nurse. If you have any doubts or further questions, consult your doctor, pharmacist, or nurse.
How much TAKHZYRO to use
For children aged 2 to less than 12 years, the recommended dose depends on body weight:

• For patients with a body weight between 20 and less than 40 kg who have not had attacks for a long period, the doctor may allow the child to continue with the same dose upon reaching 12 years of age.

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

• The recommended starting dose is 300 mg of lanadelumab every 2 weeks. If you have had no attacks for a long period, your doctor may change the dose to 300 mg of lanadelumab every 4 weeks, especially if you have a low body weight.
• A starting dose of 150 mg of lanadelumab every 2 weeks may also be considered. If you have had no attacks for a long period, 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 by the person assisting the patient. The person assisting the patient must read carefully and follow the instructions in section 7, “Instructions for use”.

• TAKHZYRO must be injected under the skin (“subcutaneous injection”).
• The injection may be self-administered by a healthcare professional or by the person assisting the patient.
• A doctor, pharmacist, or nurse must show you how to properly prepare and inject TAKHZYRO before you use it for the first time. Do not inject it until you have been adequately trained to inject the medicine.
• Insert the needle into the fatty tissue of the abdomen, thigh, or upper arm.
• Inject the medicine each time in a different area.
• Use each pre-filled syringe of TAKHZYRO only once.

If you use more TAKHZYRO than you should
Inform the doctor if too much TAKHZYRO has been injected into the child or if the dose was administered earlier than prescribed by the doctor.
If you forget to use TAKHZYRO
If you forget a dose of TAKHZYRO, inject the missed dose as soon as possible. It may be necessary to adjust the next recommended dose based on the scheduled dosing frequency to ensure that:

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

If you are unsure about when to inject TAKHZYRO after a missed dose, consult the child’s doctor, pharmacist, or nurse.
If you stop treatment with TAKHZYRO
The decision to stop treatment with TAKHZYRO should be discussed with the child’s doctor. Symptoms may reappear after stopping treatment.
If you have any doubts about using this medicine, consult the child’s doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If the child has a severe allergic reaction to TAKHZYRO with symptoms such as rash,
tightness in the chest, wheezing or rapid heartbeat, inform your doctor, pharmacist or nurse immediately.
Inform your 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, skin hardening, tingling, warmth and rash.

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

• Allergic reactions including itching, discomfort and tingling of the tongue
• Dizziness, feeling faint
• Erythema with raised skin
• Muscle pain
• Blood tests showing changes in liver function

Reporting of side effects
If your child or the child you are caring for experiences any side effect, including those not listed in
this leaflet, consult your doctor, pharmacist or nurse. You can also report side effects directly via the
national reporting system listed in Annex V. Reporting side effects can help provide more information
on the safety of this medicine.

5. How to store 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 carton, indicated respectively after EXP and Scad. The expiry date refers to the last day of that month.
TAKHZYRO 150 mg solution for injection in pre-filled syringe
Store in the refrigerator (2 °C – 8 °C). Do not freeze. Keep the pre-filled syringe in the outer packaging to protect the medicine 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.
Do not return TAKHZYRO to the refrigerator after storage at room temperature.
After removing a pre-filled syringe from a multi-pack stored in the refrigerator, return the remaining pre-filled syringes to the refrigerator until the next required use.
Do not use this medicine if you notice signs of deterioration, such as particles in the pre-filled syringe or changes in the colour of the solution for injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What TAKHZYRO contains

• The active substance is lanadelumab. Each pre-filled syringe contains 150 mg of lanadelumab in 1 mL of solution.
• The excipients are disodium phosphate dihydrate, citric acid monohydrate, histidine, sodium chloride, polysorbate 80, and water for injections – see section 2 “TAKHZYRO contains sodium”.

Description of the appearance of TAKHZYRO and contents of the pack
TAKHZYRO is a clear, colourless to slightly yellow, injectable solution in a pre-filled syringe.
TAKHZYRO is available:

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

Not all pack sizes may 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: +32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]

България Luxembourg/Luxemburg
Takeda Bulgaria EOOD Takeda Belgium NV
Tel.: +359 2 958 27 36 Tél/Tel: +32 2 464 06 11
[email protected] [email protected]

Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: +420 234 722 722 Tel: +36 1 270 7030
[email protected] [email protected]

Danmark Malta
Takeda Pharma A/S Drugsales Ltd
Tlf: +45 46 77 10 10 Tel: +356 21419070
[email protected] [email protected]

Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0)800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]

Eesti Norge
Takeda Pharma OÜ Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]

Ελλάδα Österreich
Takeda Hellas S.A. Takeda Pharma Ges.m.b.H.
Tel: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]

España Polska
Takeda Farmacéutica España, S.A. Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel.: +48223062447
[email protected] [email protected]

France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: +33 1 40 67 33 00 Tel: +351 21 120 1457
[email protected] [email protected]

Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]

Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: +386 (0) 59 082 480
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]

Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: +39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]

Κύπρος Sverige
Proton Medical (Cyprus) Ltd Takeda Pharma AB
Tel: +357 22866000 Tel: 020 795 079
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: +371 67840082 Tel: +44 (0) 3333 000 181
[email protected] [email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.

7. Instructions for Use

Be sure to read, understand, and follow the Instructions for Use before injecting TAKHZYRO. If you have
any questions, consult your healthcare provider.
Intended Use
The TAKHZYRO pre-filled syringe is a ready-to-use, single-use, fixed-dose (150 mg/1 mL) injection device with a needle,
intended for subcutaneous administration by healthcare professionals or by a person assisting the patient.
Self-administration is not recommended in pediatric patients (from 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.
• The pre-filled syringe removed from the refrigerator must be stored at a temperature below 25 °C and used within 14 days. Do not return TAKHZYRO to the refrigerator after storing it at room temperature.
• After removing a pre-filled syringe from a multi-pack stored in the refrigerator, return the remaining pre-filled syringes to the refrigerator until next use, as needed.
• Store TAKHZYRO in its original packaging to protect the pre-filled syringe from light.
• Dispose of the TAKHZYRO pre-filled syringe if it has been left outside the refrigerator, frozen, or not stored in its original packaging protected from light.
• Do not shake TAKHZYRO.

Keep TAKHZYRO and all medicines out of the reach of children.
Components of the TAKHZYRO pre-filled syringe before use (Figure A).

Figure A: TAKHZYRO pre-filled syringe
Step 1: Preparation for Injection
a. Gather an alcohol swab, cotton ball/gauze pad, adhesive bandage, and a sharps disposal container ( Figure B ) and place them on a clean, flat surface in a well-lit area. These supplies are not included in the TAKHZYRO package.

Figure B: Supplies

b. Remove the TAKHZYRO pre-filled syringe box from the refrigerator 15 minutes before administering the injection.

• Do not use if the seal on the box is open or broken.
• The medicine is sensitive to high temperatures. Do not use heat sources such as warm water or a 15 microwave to warm the TAKHZYRO pre-filled syringe. minutes

c. Open the box. Grasp the barrel of the syringe and

remove the TAKHZYRO pre-filled syringe
from its holder ( Figure C ).

• Do not remove the needle cap until ready to perform the injection.
• Do not touch or push the plunger until ready to perform the injection.

Figure C: Remove the pre-filled syringe

d. Wash hands with soap and water. ( Figure D ).
Dry hands completely.

• Do not touch any surface or part of the body after washing hands before the injection.

Figure D: Wash hands
e. Check the expiration date (EXP)

on the barrel of the syringe ( Figure E ).

• Do not use the TAKHZYRO pre-filled syringe if the expiration date has passed. If the TAKHZYRO pre-filled syringe is expired, dispose of it in a sharps disposal container and contact your healthcare provider.

Figure E: Location of expiration date
f. Inspect the TAKHZYRO pre-filled
syringe for any damage. The medicine
inside the syringe barrel should be
colorless to slightly yellow ( Figure F ).

Do not use the TAKHZYRO
pre-filled syringe if it is damaged
or cracked.

• Do not use the TAKHZYRO pre-filled syringe if the medicine is discolored, cloudy, or contains flakes or particles.
• Air bubbles may be visible in the TAKHZYRO pre-filled syringe. This is normal and will not affect the dose. If the syringe cannot be used, contact your healthcare provider.

Step 2: Selection and Preparation of Injection Site
a. TAKHZYRO must be administered by a
healthcare professional or by a person

assisting the patient only at the following
sites ( Figure G ):
o upper arm
o stomach (abdomen)
o thigh

• Do not inject into an area of the child’s skin that is irritated, red, bruised, or infected.
• The selected injection site must be at least 5 cm away from any scars or the child’s navel. Important:

Alternate injection sites to
maintain healthy skin. Each new
injection should be administered at
least 3 cm away from the previous injection site.
Figure G: Injection sites

b. Clean the injection site with an
alcohol wipe and allow it to dry
completely ( Figure H ).

• Do not blow on the cleaned site.
• Do not touch the cleaned site again before administering the injection.

Figure H: Clean the injection site
c. Firmly hold the center of the TAKHZYRO
pre-filled syringe with one hand and
with the other, gently remove the
needle cap straight off ( Figure I ).

Do not touch or press the
plunger until ready to perform
the injection.

• Do not use the TAKHZYRO pre-filled syringe if it has been dropped without the needle cap.
• Do not use the TAKHZYRO pre-filled syringe if the needle appears damaged or bent.
• Do not touch the needle or allow it to Figure I: Remove the needle cap contact other surfaces. Air bubbles may be visible. This is normal; do not attempt to remove them.

d. Dispose of the needle cap in household waste or in a sharps disposal container.

• Do not recap the needle to avoid needlestick injuries.

Step 3: Injecting TAKHZYRO
a. Hold the TAKHZYRO pre-filled syringe
with one hand like a pencil ( Figure J ).
Avoid touching the needle or pressing
the plunger.
Figure J: Hold the pre-filled syringe

b. With the other hand, gently pinch
about 3 cm of skin at the cleaned
injection site.
Keep pinching the skin until the
injection is complete and the needle
is removed ( Figure K ).
Figure K: Pinch about 3 cm of skin
c. With a quick motion,

similar to throwing a dart, insert the
needle at an angle of 45-90 degrees.
Ensure the needle remains in place
( Figure L ).
45º
Important: inject directly into the
fatty tissue beneath the skin
(subcutaneous injection).
90º
Figure L: Insert the needle
d. Slowly push the plunger all the way
down until it stops

( Figure M ).
Important: do not withdraw the needle until all the medicine has been injected and the syringe barrel is empty.
When the injection is complete, the stopper will be visible at the bottom of the syringe barrel ( Figure N ).

Figure M: Push the plunger all the way down
Bottom of syringe barrel
Stopper
Figure N: Stopper visible at the bottom of the syringe barrel
e. Slowly withdraw the needle without changing the syringe angle. Gently release the skin fold.
f. Press a cotton ball or gauze pad on the injection site, if needed, and hold for 10 seconds.

• Do not rub the injection site. Mild bleeding at the injection site may occur. This is normal.
• Cover the injection site with an adhesive bandage, if needed.

Step 4: Dispose of the Used TAKHZYRO Pre-filled Syringe
a. Immediately place the used TAKHZYRO

pre-filled syringe into a sharps disposal container after use ( Figure O ).

• Do not recap the needle to avoid needlestick injuries.
• Do not reuse the TAKHZYRO pre-filled syringe or any other injection materials.
• Do not dispose of the TAKHZYRO pre-filled syringe in household waste.
• Do not touch the needle.
• Important: always keep the sharps disposal container out of the reach of children.

Figure O: Dispose in a sharps disposal container

Package leaflet: Information for the user

TAKHZYRO 300 mg solution for injection in pre-filled syringe

lanadelumab
Please read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What TAKHZYRO is and what it is used for
2. What you need to know before using TAKHZYRO
3. How to use TAKHZYRO
4. Possible side 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 is a medicine used in patients aged 2 years and older to prevent attacks of angioedema in patients with hereditary angioedema (HAE).
What hereditary angioedema (HAE) is
HAE is a condition that runs in some families. With this condition, your blood does not have enough of a protein called “C1 inhibitor”, or the C1 inhibitor does not work properly. This leads to too much “plasma kallikrein”, which in turn causes higher levels of “bradykinin” in the blood. Excess bradykinin leads to HAE symptoms such as swelling and pain in:

• hands and feet;
• face, eyelids, lips or tongue;
• larynx, which can make breathing difficult;
• genitals.

How TAKHZYRO works
TAKHZYRO is a type of protein that blocks the activity of plasma kallikrein. This helps reduce the amount of bradykinin in the blood and prevents HAE symptoms.

2. What you need to know before using TAKHZYRO

Do not use TAKHZYRO
If you are allergic to lanadelumab or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before using TAKHZYRO.
• If you experience 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 to record the name and batch number of the medicine each time a dose of TAKHZYRO is administered. This helps keep track of the batches used.
Laboratory tests
Inform your doctor if you are taking TAKHZYRO before undergoing laboratory tests to assess blood clotting. This is because TAKHZYRO in the blood may interfere with certain laboratory tests, leading to inaccurate results.
Children and adolescents
TAKHZYRO is not recommended for use in children under 2 years of age. This is because it has not been studied in this age group.
Other medicines and TAKHZYRO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is not known that TAKHZYRO has an effect on other medicines or is affected by other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before starting TAKHZYRO. There is limited information on the safety of using TAKHZYRO during pregnancy and breastfeeding.
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 taking this medicine.
Driving and using machines
This medicine does not affect or has a negligible effect on the ability to drive vehicles and operate machinery.
TAKHZYRO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, i.e. essentially “sodium-free”.

3. How to use TAKHZYRO

TAKHZYRO is supplied in single-use, prefilled syringes as a ready-to-use solution.
Treatment will be initiated and managed under the supervision of a physician experienced in the treatment of patients with HAE.
Use this medicine exactly as stated in this leaflet or as instructed by your doctor, pharmacist, or nurse. If you have any doubts or further questions, consult your doctor, pharmacist, or nurse.

How much TAKHZYRO to use

For adults and adolescents aged 12 to less than 18 years:

• The recommended initial dose is 300 mg of lanadelumab every 2 weeks. If you have been attack-free for a prolonged period, your doctor may adjust the dose to 300 mg of lanadelumab every 4 weeks, especially if you have a low body weight.
• In patients with body weight below 40 kg, an initial dose of 150 mg of lanadelumab every 2 weeks may also be considered. If you have been attack-free for a prolonged period, your doctor may adjust the dose to 150 mg of lanadelumab every 4 weeks.

For children aged 2 to less than 12 years, the recommended dose depends on body weight:

• For patients with a body weight between 20 and less than 40 kg who have not experienced attacks for a long period, the doctor might allow the child to continue with the same dose upon reaching 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 carefully and follow the instructions in section 7, “Instructions for use”.

• TAKHZYRO must be injected under the skin (“subcutaneous injection”).
• The injection may be self-administered or administered by a caregiver if patients are at least 12 years old.
• The injection may be administered by a healthcare professional or caregiver if patients are between 2 and less than 12 years old.
• A doctor, pharmacist, or nurse must show you how to properly prepare and inject TAKHZYRO before you use it for the first time. Do not inject it yourself or administer it to others until you have been adequately trained to inject the medicine.
• Insert the needle into the fatty tissue of the abdomen, thigh, or upper arm.
• Inject the medicine each time in a different site.
• Use each pre-filled syringe of TAKHZYRO only once.

If you use more TAKHZYRO than you should
Inform your doctor, pharmacist, or nurse if you have used too much TAKHZYRO.
If you forget to use TAKHZYRO
If you forget a dose of TAKHZYRO, inject the missed dose as soon as possible. An adjustment of the next scheduled dose may be necessary depending on the intended dosing frequency, to ensure that

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

If you are unsure about when to inject TAKHZYRO after a missed dose, consult your doctor, pharmacist, or nurse.
If you stop using TAKHZYRO
It is important that you continue to inject TAKHZYRO as instructed by your doctor, even if you feel better. If you have any doubts about using this medicine, consult 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, tightness in the chest, wheezing or fast heartbeat, inform your doctor, pharmacist or nurse immediately.
Inform 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 include pain, redness of the skin, bruising, discomfort, swelling, bleeding, itching, skin hardening, tingling, warmth and rash.

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

• Allergic reactions including itching, discomfort and tingling of the tongue
• Dizziness, feeling faint
• Erythema with raised skin
• Muscle pain
• Blood tests showing changes in liver function

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store 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 on the carton,
following EXP and Scad respectively. The expiry date refers to the last day of that month.
TAKHZYRO 300 mg solution for injection in pre-filled syringe
Store in the refrigerator (2 °C – 8 °C). Do not freeze. Keep the pre-filled syringe in the
outer packaging to protect the medicine from light.
Pre-filled syringes may be stored at temperatures below 25 °C for a single period of up to 14 days,
but not beyond the expiry date.
Do not return TAKHZYRO to the refrigerator after it has been stored at room temperature.
After removing a pre-filled syringe from a multi-pack stored in the refrigerator,
return the remaining pre-filled syringes to the refrigerator until the next required use.
Do not use this medicine if you notice signs of deterioration such as particles in the pre-filled syringe or
changes in the colour of the solution for injection.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TAKHZYRO contains

• The active substance is lanadelumab. Each pre-filled syringe contains 300 mg of lanadelumab in 2 mL of solution.
• The excipients are disodium phosphate dihydrate, citric acid monohydrate, histidine, sodium chloride, polysorbate 80, and water for injections – see section 2 “TAKHZYRO contains sodium”.

Description of the appearance of TAKHZYRO and contents of the pack
TAKHZYRO is a clear, colourless to slightly yellow, injectable solution in a pre-filled syringe.
TAKHZYRO is available:

• in a single pack containing one 2 mL pre-filled syringe in a box;
• in a single pack containing two 2 mL pre-filled syringes in a box;
• in multiple packs comprising 3 boxes, each box containing two 2 mL pre-filled syringes.

Not all pack sizes may 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: +32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]

България Luxembourg/Luxemburg
Такеда България ЕООД Takeda Belgium NV
Тел.: +359 2 958 27 36 Tél/Tel: +32 2 464 06 11
[email protected] [email protected]

Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: + 420 234 722 722 Tel.: +36 1 270 7030
[email protected] [email protected]

Danmark Malta
Takeda Pharma A/S Drugsales Ltd
Tlf: +45 46 77 10 10 Tel: +356 21419070
[email protected] [email protected]

Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0)800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]

Eesti Norge
Takeda Pharma OÜ Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]

Ελλάδα Österreich
Takeda ΕΛΛΑΣ Α.Ε. Takeda Pharma Ges.m.b.H.
Tηλ: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]

España Polska
Takeda Farmacéutica España, S.A. Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel.: +48223062447
[email protected] [email protected]

France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: + 33 1 40 67 33 00 Tel: + 351 21 120 1457
[email protected] [email protected]

Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]

Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: + 386 (0) 59 082 480
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]

Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: +39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]

Κύπρος Sverige
Proton Medical (Cyprus) Ltd Takeda Pharma AB
Τηλ: +357 22866000 Tel: 020 795 079
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: +371 67840082 Tel: +44 (0) 3333 000 181
[email protected] [email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu. Links to other websites on rare diseases and their treatments are also provided.

7. Instructions for Use

Be sure to read, understand, and follow the Instructions for Use before injecting TAKHZYRO. If you have
any questions, consult your healthcare provider.
Intended Use
The TAKHZYRO pre-filled syringe is a ready-to-use, single-use, fixed-dose (300 mg/2 mL) injection device with a needle, intended for subcutaneous administration by healthcare professionals, caregivers, or via self-administration (for patients aged 12 years and older).
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 the refrigerator must be stored at a temperature below 25 °C and used within 14 days. Do not return TAKHZYRO to the refrigerator after storing at room temperature.
• After removing a pre-filled syringe from a multi-pack stored in the refrigerator, return the remaining pre-filled syringes to the refrigerator until next use, as needed.
• Store TAKHZYRO in its original packaging to protect the pre-filled syringe from light.
• Discard (dispose of) the TAKHZYRO pre-filled syringe if it has been kept outside the refrigerator, frozen, or not stored in the original packaging protected from light.
• Do not shake TAKHZYRO.
• Keep TAKHZYRO and all medicines out of the reach of children.

Components of the TAKHZYRO pre-filled syringe before use (Figure A).

Figure A: TAKHZYRO pre-filled syringe
STEP 1: Preparation for Injection
a. Gather an alcohol swab, cotton ball or gauze pad, adhesive bandage, and a sharps disposal container ( Figure B ), and place them on a clean, flat surface in a well-lit area. These supplies are not included in the TAKHZYRO package.

Figure B: Supplies
b. Remove the TAKHZYRO pre-filled syringe box from the refrigerator.

• Do not use the TAKHZYRO pre-filled syringe if the tamper-evident seal is open or broken.
• Before preparing the injection, allow the pre-filled syringe to reach room temperature for at least 15 minutes.
• The medicine is sensitive to high temperatures. Do not use heat sources such as a microwave or hot water to warm the TAKHZYRO pre-filled syringe.
• Do not remove the needle cap until you are ready to perform the injection.

Wait
15
minutes
c. Open the box. Hold the syringe barrel and remove the TAKHZYRO pre-filled syringe from its holder ( Figure C ).

Figure C: Remove the pre-filled syringe
d. Wash your hands with soap and water ( Figure D ). Dry your hands completely.

• Do not touch any surface or part of the body after washing your hands before the injection.

Figure D: Wash your hands
e. Check the expiration date (EXP) on the syringe barrel ( Figure E ).
Do not use the TAKHZYRO pre-filled syringe if the expiration date has passed. If the TAKHZYRO pre-filled syringe is expired, discard (dispose of) it in a sharps disposal container and contact your healthcare provider.

EXP: MM YYYY
Figure E: Location of expiration date
f. Inspect the TAKHZYRO pre-filled syringe for damage and ensure the medicine is colorless to slightly yellow ( Figure F ).

• Do not use the product if the syringe is damaged, for example, if it has cracks.
• Do not use the TAKHZYRO pre-filled syringe if the medicine is discolored, cloudy, or contains flakes or particles.
• Air bubbles may be visible in the TAKHZYRO pre-filled syringe. This is normal and will not affect the dose. If you are unable to use the syringe, contact your healthcare provider.

Figure F: Inspect the pre-filled syringe
STEP 2: Selection and Preparation of Injection Site
a. The TAKHZYRO pre-filled syringe must be injected only at the following sites ( Figure G ):
o abdomen (stomach)
o thigh
o upper arm (only if the injection is administered by a healthcare professional or caregiver).

• Do not inject into an area where the skin is irritated, red, bruised, or infected.
• The chosen injection site must be at least 5 cm away from scars or the navel.

Figure G: Injection sites
Important:
Rotate injection sites to maintain healthy skin. Each new injection should be administered at least 3 cm away from the previous injection site.
b. Clean the injection site with an alcohol swab and allow it to dry completely ( Figure H ).

• Do not blow on the cleaned site.
• Do not touch this area again before administering the injection.

Figure H: Clean the injection site
c. Firmly hold the middle part of the TAKHZYRO pre-filled syringe with one hand and gently remove the needle cap straight off with the other hand. Discard the needle cap in household waste or in a sharps disposal container ( Figure I ).

• Do not touch or press the plunger until you are ready to administer the injection.
• Do not recap the needle on the TAKHZYRO pre-filled syringe to avoid needle-stick injuries.
• Do not use the TAKHZYRO pre-filled syringe if it has been dropped without the needle cap.
• Do not use the TAKHZYRO pre-filled syringe if the needle appears damaged or bent.
• Do not touch the needle or allow it to contact other surfaces.

Figure I: Remove the needle cap
STEP 3: Injection of TAKHZYRO
a. Hold the TAKHZYRO pre-filled syringe in one hand like a pencil ( Figure J ).
Avoid touching the needle or pressing the plunger.

Figure J: Hold the pre-filled syringe
b. With the other hand, gently pinch about 3 cm of skin at the cleaned injection site.

• Keep pinching the skin until the injection is complete and the needle is removed ( Figure K ).

Figure K: Pinch 3 cm of skin
c. With a quick, short motion, insert the needle completely into the skin at an angle of 45–90 degrees. Make sure to keep the needle in place ( Figure L ).

45°
Important: administer the injection
directly into the fatty tissue
under the skin (subcutaneous injection at 90°).
Figure L: Insert the needle
d. Slowly push the plunger all the way down until it stops ( Figure M ).
e. Slowly remove the needle while maintaining the same angle. Gently release the skin fold.

Important: do not withdraw the needle until all the medicine has been injected and the syringe barrel is empty.
Figure M: Push the plunger all the way down

When the injection is complete,
the plunger stopper will be visible at the bottom of the syringe barrel ( Figure N ).
Bottom of barrel
Stopper
of syringe
Figure N: Stopper at the bottom of the syringe barrel
f. Press a cotton ball or gauze pad on the injection site, if needed, and hold for 10 seconds.

• Do not rub the injection site. Mild bleeding may occur. This is normal.
• Cover the injection site with an adhesive bandage, if needed. g. Discard (dispose of) the used

TAKHZYRO pre-filled syringe.

• Immediately place the used TAKHZYRO pre-filled syringe into a sharps disposal container after use ( Figure O ).
• Do not recap the needle to avoid needle-stick injuries.
• Do not reuse the TAKHZYRO pre-filled syringe or any other injection materials.
• Do not touch the needle. Important: always keep the sharps disposal container out of the reach of children. Figure O: Dispose in a sharps disposal container

Package leaflet: Information for the user

TAKHZYRO 300 mg solution for injection in a pre-filled pen

lanadelumab
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What TAKHZYRO is and what it is used for
2. What you need to know before using TAKHZYRO
3. How to use TAKHZYRO
4. Possible side 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 is a medicine used in patients aged 2 years and older to prevent attacks of angioedema in patients with hereditary angioedema (HAE).
What is hereditary angioedema (HAE)
HAE is a condition that occurs in some families. With this condition, your blood does not have enough of a protein called “C1-inhibitor”, or the C1-inhibitor does not work properly. This leads to too much “plasma kallikrein” in the blood, which in turn causes increased levels of “bradykinin”. Excess bradykinin causes HAE symptoms such as swelling and pain in:

• hands and feet;
• face, eyelids, lips or tongue;
• larynx, which can make breathing difficult;
• genitals.

How TAKHZYRO works
TAKHZYRO is a type of protein that blocks the activity of plasma kallikrein. This helps reduce the amount of bradykinin in the blood and prevents HAE symptoms.

2. What you need to know before using TAKHZYRO

Do not use TAKHZYRO
If you are allergic to lanadelumab or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before using TAKHZYRO.
• If you experience 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 to record the name and batch number of the medicine each time you
administer a dose of TAKHZYRO. This helps keep track of the batches used.

Laboratory tests
Inform your doctor if you are taking TAKHZYRO before undergoing laboratory tests to assess blood
coagulation. This is because TAKHZYRO in the blood may interfere with certain laboratory tests, leading to inaccurate results.

Children and adolescents
TAKHZYRO is not recommended for use in children under 2 years of age. This is because it has not been studied in this age group.

Other medicines and TAKHZYRO
Inform 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, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before starting TAKHZYRO. There is limited information on the safety of using TAKHZYRO during pregnancy and breastfeeding.
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 taking this medicine.

Driving and using machines
This medicine does not affect or has a negligible effect on the ability to drive and use machines.

TAKHZYRO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled pen, i.e. essentially “sodium-free”.

3. How to use TAKHZYRO

TAKHZYRO is supplied in single-use pre-filled pens as a ready-to-use solution.
Treatment will be initiated and managed under the supervision of a physician experienced in the treatment of patients with HAE.
Always use this medicine exactly as stated in this leaflet or as instructed by your doctor, pharmacist, or nurse. If you have any doubts or further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

How much TAKHZYRO to use

For adults and adolescents aged 12 to less than 18 years:

• The recommended initial dose is 300 mg of lanadelumab every 2 weeks. If you have been attack-free for a prolonged period, your doctor may adjust the dose to 300 mg of lanadelumab every 4 weeks, especially if you have a low body weight.
• In patients with body weight below 40 kg, an initial dose of 150 mg of lanadelumab every 2 weeks may also be considered. However, the 150 mg pre-filled syringe must be used, as the 300 mg pre-filled pen cannot be used to administer a 150 mg dose of lanadelumab.

For children aged 2 to less than 12 years:

• The recommended dose depends on body weight and must be administered exclusively via a pre-filled syringe or a vial. The pre-filled pen has not been studied in children aged 2 to less than 12 years and therefore must not be used.

How to inject TAKHZYRO
If you are injecting TAKHZYRO yourself or if it is being injected by your caregiver, you or your caregiver must read carefully and follow the instructions in section 7, “Instructions for use”.

• TAKHZYRO must be injected under the skin (“subcutaneous injection”).
• The injection may be self-administered or administered by a caregiver if patients are at least 12 years old.
• A doctor, pharmacist, or nurse must show you how to properly prepare and inject TAKHZYRO before you use it for the first time. Do not inject it yourself or to others until you have been adequately trained to administer the medicine.
• Administer TAKHZYRO using the pre-filled pen into the fatty tissue of the abdomen, thigh, or upper arm.
• Always inject the medicine into a different site each time.
• Use each pre-filled pen of TAKHZYRO only once.

If you use more TAKHZYRO than you should
Inform your doctor, pharmacist, or nurse if you have used too much TAKHZYRO.

If you forget to use TAKHZYRO
If you miss a dose of TAKHZYRO, inject the missed dose as soon as possible. An adjustment of the next scheduled dose may be necessary depending on the prescribed dosing frequency, to ensure that:

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

If you are unsure about when to inject TAKHZYRO after a missed dose, consult your doctor, pharmacist, or nurse.

If you stop using TAKHZYRO
It is important that you continue to inject TAKHZYRO as instructed by your doctor, even if you feel better. If you have any doubts about using this medicine, consult 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, inform your doctor, pharmacist or nurse immediately.
Inform 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 include pain, redness of the skin, bruising, discomfort, swelling, bleeding, itching, skin hardening, tingling, warmth and rash.

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

• Allergic reactions including itching, discomfort and tingling of the tongue
• Dizziness, feeling faint
• Erythema with skin elevation
• Muscle pain
• Blood tests showing changes in liver function

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 or Exp. The expiry date refers to the last day of that month.
TAKHZYRO 300 mg solution for injection in pre-filled pen
Store in a refrigerator (2 °C–8 °C). Do not freeze. Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Pre-filled pens may be stored at temperatures below 25 °C for a single period of up to 14 days, but not beyond the expiry date.
Do not return TAKHZYRO to the refrigerator after it has been stored at room temperature.
After removing a pre-filled pen from a multi-pack stored in the refrigerator, return the remaining pre-filled pens to the refrigerator for storage until next use, when required.
Do not use this medicine if you notice signs of deterioration such as particles in the pre-filled pen or changes in the colour of the solution for injection.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TAKHZYRO contains

• The active substance is lanadelumab. Each pre-filled pen contains 300 mg of lanadelumab in 2 mL of 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”.

Description of the appearance of TAKHZYRO and contents of the pack
TAKHZYRO is a clear, colourless to slightly yellow, injectable solution in a pre-filled pen.
TAKHZYRO is available:

• in a single pack containing one 2 mL pre-filled pen in a box;
• in a single pack containing two 2 mL pre-filled pens in a box;
• in multiple packs comprising 3 boxes, each box containing two 2 mL pre-filled pens.

Not all pack sizes may 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: +32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]

България Luxembourg/Luxemburg
Takeda Bulgaria EOOD Takeda Belgium NV
Tel.: +359 2 958 27 36 Tél/Tel: +32 2 464 06 11
[email protected] [email protected]

Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: +420 234 722 722 Tel.: +36 1 270 7030
[email protected] [email protected]

Danmark Malta
Takeda Pharma A/S Drugsales Ltd
Tlf.: +45 46 77 10 10 Tel: +356 21419070
[email protected] [email protected]

Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0)800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]

Eesti Norge
Takeda Pharma OÜ Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]

Ελλάδα Österreich
Takeda Hellas A.E. Takeda Pharma Ges.m.b.H.
Tel: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]

España Polska
Takeda Farmacéutica España, S.A. Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel.: +48 223062447
[email protected] [email protected]

France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: +33 1 40 67 33 00 Tel: +351 21 120 1457
[email protected] [email protected]

Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]

Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: +386 (0) 59 082 480
[email protected] [email protected]

Ísland Slovenská republika
Vistor ehf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]

Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: +39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]

Κύπρος Sverige
Proton Medical (Cyprus) Ltd Takeda Pharma AB
Tel: +357 22866000 Tel: 020 795 079
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: +371 67840082 Tel: +44 (0) 3333 000 181
[email protected] [email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.

7. Instructions for Use

Be sure to read, understand, and follow the Instructions for Use before injecting TAKHZYRO. If you have any doubts, consult your healthcare provider.

Intended Use
The TAKHZYRO pre-filled pen is a ready-to-use, single-use, fixed-dose (300 mg/2 mL) injection device with a needle, intended for subcutaneous administration by healthcare professionals, caregivers, or via self-injection (for patients aged 12 years and older).

Storage of the TAKHZYRO Pre-filled Pen

• Store the TAKHZYRO pre-filled pen in the refrigerator at 2 °C to 8 °C. Do not freeze.
• Keep TAKHZYRO in its original packaging to protect the pre-filled pen from light.
• Pre-filled pens removed from the refrigerator must be stored at temperatures below 25 °C and used within 14 days. Do not return TAKHZYRO to the refrigerator after leaving the pen at room temperature.
• After removing a pre-filled pen from a multi-pack, store the remaining pens in the refrigerator in their original box until next use, as needed.
• Dispose of the TAKHZYRO pre-filled pen if it has been kept outside the refrigerator for more than 14 days, if it has been frozen, or if it was not stored in its original packaging protected from light.
• Do not shake TAKHZYRO.
• Keep TAKHZYRO and all medicines out of the reach of children.

The TAKHZYRO pre-filled pen (Figure A) is for single use only.

TAKHZYRO Pre-filled Pen Before and After Use

Figure A

Preparation for Injection

Step 1: Prepare the Pre-filled Pen
Remove the TAKHZYRO pre-filled pen box from the refrigerator 30 minutes before injection.

• Do not use if the seal on the box is open or broken.
• The medicine is sensitive to high temperatures. Do not use heat sources such as a microwave or hot water to warm the TAKHZYRO pre-filled pen.

Wait
30
minutes

Step 2: Gather Supplies
Gather an alcohol swab, cotton ball or gauze pad, adhesive bandage, and a sharps disposal container (Figure B) and place them on a clean, flat surface in a well-lit area. These supplies are not included with the TAKHZYRO pre-filled pen.

Figure B

Step 3: Remove the Pre-filled Pen
Open the box. Hold the body of the pen and remove the TAKHZYRO pre-filled pen from its holder (Figure C).

• Do not remove the protective cap until you are ready to administer the injection.
• Do not touch or press the needle shield until you are ready to administer the injection.

Figure C

Step 4: Wash Hands
Wash your hands thoroughly with soap and water (Figure D). Dry hands completely.

• Do not touch any surface or part of the body after washing your hands before the injection.

Figure D

Step 5: Check Expiration Date
Check the expiration date (EXP) on the body of the pen (Figure E).

• Do not use the TAKHZYRO pre-filled pen if the expiration date has passed. If the TAKHZYRO pre-filled pen has expired, dispose of it in a sharps disposal container and contact your healthcare provider.

Figure E

Step 6: Inspect TAKHZYRO
Inspect the TAKHZYRO pre-filled pen for any damage. Looking through the viewing window (Figure F), ensure the medicine is colorless to slightly yellow.

• Do not use the TAKHZYRO pre-filled pen if it is damaged or cracked.
• Do not use the TAKHZYRO pre-filled pen if the medicine is discolored, cloudy, or contains flakes or particles.
• Air bubbles may be visible in the viewing window of the TAKHZYRO pre-filled pen. This is normal and will not affect the dose. If you cannot use the pen, contact your healthcare provider.

Figure F

Selection and Preparation of Injection Site

Step 7: Select Injection Site
TAKHZYRO must be injected only at the following sites (Figure G for self-injection and
Figure H for injection administered by a caregiver):

• stomach (abdomen)

• thighs

• upper arm (only if the injection is administered by a healthcare professional or caregiver)

• Do not inject into areas where the skin is irritated, red, bruised, or infected.

• The selected injection site must be at least 5 cm away from scars or the navel.

Important:
Rotate injection sites to maintain healthy skin. Each new injection should be administered at least 2.5 cm away from the previous injection site.

Figure G Figure H

Step 8: Clean Injection Site
Clean the injection site with an alcohol swab and allow it to dry completely (Figure I).

• Do not fan or blow on the cleaned area.
• Do not touch the cleaned site again before administering the injection.

Figure I

Step 9: Remove Protective Cap
Firmly hold the middle section of the TAKHZYRO pre-filled pen with one hand and use the other hand to remove the needle protective cap (Figure J).

• The needle is protected by the needle shield.
• A few drops of liquid may be visible leaking from the needle. This is normal and will not affect the dose of TAKHZYRO.
• The TAKHZYRO pre-filled pen is ready for injection once the protective cap has been removed.
• Do not touch or press the needle shield until you are ready to administer the injection.
• Do not reattach the protective cap to the TAKHZYRO pre-filled pen.

Figure J

Step 10: Dispose of Protective Cap
Dispose of the protective cap in the trash or in a sharps disposal container (Figure K).

• Do not reattach the cap to the pen to avoid needlestick injuries.

Figure K

Injection of TAKHZYRO

Step 11: Hold the Pre-filled Pen and Pinch Skin
Hold the TAKHZYRO pre-filled pen in one hand so that the viewing window remains visible during injection (Figure L).
With the other hand, gently pinch about 2.5 cm of skin at the cleaned injection site (Figure M).

• Keep the skin pinched until the injection is complete and the needle is removed.
• Do not press the needle shield against the skin until you are ready to administer the injection.

Figure L Figure M

Step 12: Position Pen at Injection Site
Place the TAKHZYRO pre-filled pen on the skin at a 90-degree angle to the selected injection site (Figure N).

• Do not push down on the pen until you are ready to administer the injection.
• Hold the pen so that the viewing window is visible.

Figure N

Step 13: Inject TAKHZYRO
Press down firmly and continue to hold the pen down. This will insert the needle and start the injection (Figure O).
The injection may take up to 25 seconds.

• When the injection starts, you will hear a "click."
• A second "click" may occur, but this does not indicate the end of the injection.
• Continue to apply steady pressure until the viewing window turns completely magenta.
• Before removing the pen from the skin, ensure the viewing window is completely magenta, indicating that the full dose has been administered (Figure O).
• After the injection is complete, the gray plunger may still be visible in the viewing window. This is normal and will not affect the dose.
• If the viewing window does not turn completely magenta, contact your healthcare provider.

Figure O

Step 14: Remove the Pen
Slowly lift the pen away from the injection site immediately. The needle shield will cover the entire needle (Figure P).

• Release the skin fold.
• Do not rub the injection site. Mild bleeding may occur. This is normal.
• Press a cotton ball or gauze pad on the injection site and cover with an adhesive bandage if needed.

Figure P

Dispose of the TAKHZYRO Pre-filled Pen

Step 15: Dispose in a Sharps Disposal Container
Immediately after use, place the used TAKHZYRO pre-filled pen into a sharps disposal container (Figure Q).

• Do not reattach the cap to the pen to avoid needlestick injuries.
• Do not reuse the TAKHZYRO pre-filled pen or any other injection materials.
• Do not dispose of the TAKHZYRO pre-filled pen in household waste.
• Do not touch the needle.

Important: Always keep the sharps disposal container out of the reach of children.

Figure Q

Package leaflet: information for the user

TAKHZYRO 300 mg solution for injection in vial

lanadelumab
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What TAKHZYRO is and what it is used for
2. What you need to know before using TAKHZYRO
3. How to use TAKHZYRO
4. Possible side 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 is a medicine used in patients aged 2 years and older to prevent attacks of angioedema in patients with hereditary angioedema (HAE).
What is hereditary angioedema (HAE)
HAE is a condition that runs in some families. With this condition, your blood does not have enough of a protein called “C1 inhibitor”, or the C1 inhibitor does not work properly. This leads to too much “plasma kallikrein”, which in turn produces higher levels of “bradykinin” in the blood. Excess bradykinin causes HAE symptoms such as swelling and pain in:

• hands and feet;
• face, eyelids, lips or tongue;
• larynx, which can make breathing difficult;
• genitals.

How TAKHZYRO works
TAKHZYRO is a type of protein that blocks the activity of plasma kallikrein. This helps reduce the amount of bradykinin in the blood and prevents HAE symptoms.

2. What you need to know before using TAKHZYRO

Do not use TAKHZYRO
If you are allergic to lanadelumab or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before using TAKHZYRO.
• If you experience 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 to record the name and batch number of the medicine each time you
administer a dose of TAKHZYRO. This helps keep track of the batches used.
Laboratory tests
Inform your doctor if you are taking TAKHZYRO before undergoing laboratory tests to measure
blood clotting activity. This is because TAKHZYRO in the blood may interfere with certain laboratory tests, leading 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
Inform 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, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before starting to use TAKHZYRO. There is limited information on the safety of using TAKHZYRO during pregnancy and breastfeeding.
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 taking this medicine.
Driving and using machines
This medicine does not alter or alters negligibly the ability to drive and use machines.
TAKHZYRO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially “sodium-free”.

3. How to use TAKHZYRO

TAKHZYRO is supplied in single-use vials as a ready-to-use solution. Treatment will be initiated and managed under the supervision of a physician experienced in the treatment of patients with HAE.
Use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts or further questions, consult your doctor, pharmacist, or nurse.
How much TAKHZYRO to use
For adults and adolescents aged 12 to less than 18 years:

• The recommended initial dose is 300 mg of lanadelumab every 2 weeks. If you have been attack-free for a prolonged period, your doctor may adjust the dose to 300 mg of lanadelumab every 4 weeks, especially if you have a low body weight.
• In patients with body weight below 40 kg, an initial dose of 150 mg of lanadelumab every 2 weeks may also be considered. If you have been attack-free for a prolonged period, your doctor may adjust the dose to 150 mg of lanadelumab every 4 weeks.

For children aged 2 to less than 12 years, the recommended dose depends on body weight:

• For patients with a body weight between 20 and less than 40 kg who have not experienced attacks for a long period, the doctor might allow the child to continue with the same dose upon reaching 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 carefully and follow the instructions in section 7, “Instructions for use”.

• TAKHZYRO must be injected under the skin (“subcutaneous injection”).
• The injection may be self-administered or administered by a caregiver if patients are at least 12 years old.
• The injection may be administered by a healthcare professional or caregiver if patients are between 2 and less than 12 years old.
• A doctor, pharmacist, or nurse must show you how to properly prepare and inject TAKHZYRO before you use it for the first time. Do not inject it yourself or administer it to others until you have been adequately trained to inject the medicine.
• Insert the needle into the fatty tissue of the abdomen, thigh, or upper arm.
• Inject the medicine in a different area each time.
• Use each TAKHZYRO vial only once.

If you use more TAKHZYRO than you should
Inform your doctor, pharmacist, or nurse if you take too much TAKHZYRO.
If you forget to use TAKHZYRO
If you miss a dose of TAKHZYRO, inject the missed dose as soon as possible. An adjustment of the next scheduled dose may be necessary depending on the prescribed dosing frequency, to ensure that

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

If you are unsure about when to inject TAKHZYRO after a missed dose, consult your doctor, pharmacist, or nurse.
If you stop treatment with TAKHZYRO
It is important that you continue injecting TAKHZYRO as instructed by your doctor, even if you feel better.
If you have any questions about the use of this medicine, consult 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, inform 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 include pain, redness of the skin, bruising, discomfort, swelling, bleeding, itching, skin hardening, tingling, warmth and rash.

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

• Allergic reactions including itching, discomfort and tingling of the tongue
• Dizziness, feeling faint
• Erythema with skin lifting
• Muscle pain
• Blood tests showing changes in liver function

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton, indicated respectively after EXP and Scad. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep the vial in the outer packaging to protect the medicine from light.
Vials may be stored at a temperature below 25 °C for a single period of up to 14 days, but not beyond the expiry date. Do not return TAKHZYRO to the refrigerator after storing it at room temperature.
Do not use this medicine if you notice signs of deterioration, such as particles in the vial or changes in the colour of the injectable solution.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TAKHZYRO contains

• The active substance is lanadelumab. Each vial contains 300 mg of lanadelumab in 2 mL of solution.
• The excipients are disodium phosphate dihydrate, monohydrate citric acid, histidine, sodium chloride, polysorbate 80 and water for injections – see section 2 “TAKHZYRO contains sodium”.

Description of the appearance of TAKHZYRO and contents of the pack
TAKHZYRO is a clear, colourless to slightly yellow, injectable solution in a 2 mL glass vial.
TAKHZYRO is available in a single pack containing one 2 mL vial and in multiple packs containing 2 or 6 boxes, each box containing one vial.
Not all pack sizes may be marketed.
Each pack also contains the following items:

• One 3 mL empty syringe
• One vial access needle with an 18 gauge blunt tip
• One sharp administration (injection) needle 27 gauge x 13 mm.

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
Ireland
Shire Pharmaceuticals Ireland Limited
Blocks 2 & 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Ireland
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: +32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]
България Luxembourg/Luxemburg
Takeda Bulgaria EOOD Takeda Belgium NV
Tel.: +359 2 958 27 36 Tél/Tel: +32 2 464 06 11
[email protected] [email protected]
Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: + 420 234 722 722 Tel.: +36 1 270 7030
[email protected] [email protected]
Danmark Malta
Takeda Pharma A/S Drugsales Ltd
Tlf: +45 46 77 10 10 Tel: +356 21419070
[email protected] [email protected]
Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0)800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]
Eesti Norge
Takeda Pharma OÜ Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]
Ελλάδα Österreich
Takeda Hellas A.E. Takeda Pharma Ges.m.b.H.
Tel: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]
España Polska
Takeda Farmacéutica España, S.A. Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel.: +48223062447
[email protected] [email protected]
France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: + 33 1 40 67 33 00 Tel: + 351 21 120 1457
[email protected] [email protected]
Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]
Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: + 386 (0) 59 082 480
[email protected] [email protected]
Ísland Slovenská republika
Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]
Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: +39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]
Κύπρος Sverige
Proton Medical (Cyprus) Ltd Takeda Pharma AB
Tel: +357 22866000 Tel: 020 795 079
[email protected] [email protected]
Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: +371 67840082 Tel: +44 (0) 3333 000 181
[email protected] [email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.

7. Instructions for Use

Be sure to read, understand, and follow each step of the injection instructions for
TAKHZYRO. If you have any doubts, consult your doctor, pharmacist, or nurse.
In addition to the vial, each TAKHZYRO package also contains:

• A 3 mL empty syringe.

• A blunt-tip vial access needle,
  gauge 18.
  Used to withdraw the medicinal solution
  from the vial into the syringe.

A sharp injection needle, gauge 27 x 13 mm.
Used for subcutaneous (under the skin) injection.
Only use syringes, blunt-tip vial access needles, and sharp injection needles provided in this package or prescribed by your doctor.
Use each syringe, blunt-tip vial access needle, and sharp injection needle only once. Place used syringes and needles into a sharps disposal container.
Do not use syringes, blunt-tip vial access needles, or sharp injection needles if they appear damaged.
You will also need:

• Alcohol wipes
• A sharps disposal container for used vials, needles, and syringes

You may obtain the necessary supplies from your doctor, pharmacist, or nurse.
The TAKHZYRO injection can be summarized in 5 steps:
1. Preparation of the TAKHZYRO vial
2. Attaching the blunt-tip vial access needle to the syringe
3. Transferring TAKHZYRO into the syringe and switching to the sharp injection needle
4. Selecting and preparing the injection site
5. Injecting TAKHZYRO
Step 1: Preparation of the TAKHZYRO vial
a) Remove the vial from the refrigerator
15 minutes before use to allow it to
reach room temperature (15 °C –
25 °C) before preparing the injection.
b) Clean your work area and wash your
hands before preparing the dose. Do not touch
any surface or your body, especially your

face, after washing your hands prior
to injection.
c) Take TAKHZYRO and the supplies and
place them on a well-lit work surface.
d) Remove the vial from its packaging.
Do not use the vial if the protective cap covering the stopper is missing.
e) Gently invert the vial 3 to 5 times
to ensure the solution is mixed. Do not shake the
vial, as this may cause foaming.
f) Check the solution in the vial for any particles or changes in color (normally colorless to slightly yellow). Do not use if particles or color changes are visible.
Important: Do not shake.

g) Remove the plastic cap from the
vial. Do not remove the rubber stopper of the vial.

h) Place the vial on a flat surface. Clean the rubber stopper with an alcohol wipe and allow it to dry.
Step 2: Attaching the blunt-tip vial access needle (gauge 18) to the syringe

a) Screw the blunt-tip vial access needle (gauge 18) onto the 3 mL syringe.
Important: Do not remove the needle cap when attaching it to the syringe.
b) Pull back the plunger to fill the syringe with air equal to the volume of solution in the vial.

c) Immediately remove the needle cap from the syringe without touching the needle. Do not pull the plunger.
Step 3: Transferring TAKHZYRO into the syringe and switching to the sharp injection needle

a) Insert the needle into the center of the rubber stopper.
b) Push the plunger down to inject air into the vial and keep the plunger depressed.

c) Slowly turn the vial with the syringe attached upside down. Pull back the plunger
to withdraw the full dose from the vial.
Important: Ensure the needle tip remains in the liquid to avoid drawing air into the syringe while pulling back the plunger.

d) Remove large air bubbles by gently tapping the syringe with your fingers until the bubbles rise to the top. Slowly push the plunger to return air to the vial until the solution reaches the top of the syringe. Repeat these steps until all large air bubbles are removed.

e) Without removing the needle from the vial, unscrew the syringe by holding the upper part of the needle steady and rotating the syringe counterclockwise. Return the syringe to an upright position.

f) Place the blunt-tip vial access needle (gauge 18) and the vial into a sharps disposal container.

g) Screw the sharp injection needle (gauge 27 x 13 mm) onto the syringe.
Important: Do not remove the needle cap when attaching it to the syringe.
Do not use the blunt-tip vial access needle for injecting TAKHZYRO, as this may cause pain and bleeding.
Step 4: Selecting and preparing the injection site

a) Choose an injection site on the stomach (abdomen), thigh, or upper arm.
The injection must be administered subcutaneously.
b) Clean the injection site with an alcohol wipe and allow the skin to dry completely.
Important:

• It is important to rotate injection sites to maintain healthy skin.
• The chosen injection site must be at least 5 cm away from scars or the navel. Do not select an area that is bruised, swollen, or tender.
• The outer area of the arm is not recommended if self-injecting.

Step 5: Injecting TAKHZYRO
c) Remove the needle cap straight off the syringe without touching the needle. Do not pull the plunger. Do not touch the needle tip or allow it to contact any other surface.

Important: Inject TAKHZYRO within 2 hours after preparing the syringe at room temperature. Alternatively, the prepared syringe may be stored in a refrigerator at 2 °C to 8 °C and used within 8 hours.

d) Gently pinch about 3 cm of skin at the cleaned injection site and insert the needle.
Important: Ensure the injection is administered into the subcutaneous space—not too superficial (skin layer) or too deep (muscle).
e) Slowly push the plunger until all the medication has been injected. Release the skin fold and gently remove the needle. Do not recap the needle.

f) Dispose of the sharp injection needle (gauge 27 x 13 mm) and syringe in a sharps disposal container.