Tezspire: detailed information

Package leaflet: Information for the patient

Tezspire 210 mg solution for injection in pre-filled syringe

tezepelumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any 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.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Tezspire is and what it is used for
What you need to know before using Tezspire
How to use Tezspire
Possible side effects
How to store Tezspire
Contents of the pack and other information

1. What Tezspire is and what it is used for

What Tezspire is and how it works
Tezspire contains the active substance tezepelumab, which is a monoclonal antibody. Antibodies are
proteins that recognize a specific target substance in the body and bind to it. In the case of tezepelumab,
this target substance is a protein called thymic stromal lymphopoietin (TSLP). TSLP plays a key role
in causing airway inflammation, which leads to the signs and symptoms of asthma and chronic rhinosinusitis
with nasal polyps (CRSwNP). By blocking the action of TSLP, this medicine helps reduce inflammation and
the symptoms of asthma and CRSwNP.

What Tezspire is used for
Asthma
Tezspire is used, together with other asthma medications, for the treatment of severe asthma in adults
and adolescents (12 years of age and older) whose disease is not controlled with their current asthma
medicines.
CRSwNP
Tezspire is also used together with other medicines for the treatment of CRSwNP in adults.

How Tezspire can help you
Asthma
Tezspire can reduce the number of asthma attacks, improve your breathing, and reduce asthma symptoms.
CRSwNP
Tezspire can reduce the size of nasal polyps and improve symptoms, including nasal congestion and
loss of smell. Tezspire may also reduce the need for oral corticosteroids and for surgery.

2. What you need to know before using Tezspire

Do not use Tezspire

if you are allergic to tezepelumab or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, or if you are unsure, check with your doctor, pharmacist, or nurse.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Tezspire.

Tezspire is not an emergency medicine. Do not use it to treat sudden asthma attacks.
If your asthma does not improve or worsens during treatment with this medicine, consult a doctor or nurse.
Be alert for signs of allergic reactions. Medicines such as Tezspire may potentially cause serious allergic reactions in some people. Signs of such reactions may vary but may include swelling of the face, tongue, or mouth, breathing problems, rapid heartbeat, fainting, dizziness, feeling lightheaded, hives, and skin rash. If you notice any of these signs, speak immediately with a doctor or nurse.

Talk to your doctor about how to recognize early signs of allergic reactions and how to manage them should they occur.

Be alert for any signs of a possible serious infection while taking Tezspire, such as:
- fever, flu-like symptoms, night sweats;
- persistent cough;
- skin that is warm, red, and painful, or a painful skin rash with blisters. If you notice any of these signs, speak immediately with a doctor or nurse.

If you already have a serious infection, talk to your doctor before taking Tezspire.

Be alert for any symptoms of a heart problem, such as:
- chest pain;
- shortness of breath;
- a general feeling of discomfort, illness, or uneasiness;
- feeling dizzy or fainting. If you notice any of these symptoms, speak immediately with a doctor or nurse.
If you have a parasitic infection or if you live (or travel) in an area where parasitic infections are common, talk to your doctor. Tezspire may weaken your body’s ability to fight certain types of parasitic infections.

Each time you receive a new pack of Tezspire

Record the name and batch number shown on the outer packaging and on the label of the pre-filled syringe, and keep this information in a safe place. You may be asked to provide this information in the future.

Children
Asthma
Do not give this medicine to children under 12 years of age for the treatment of asthma, because the safety and benefits of this medicine are not known in children of this age group.
CRSwNP
Do not give this medicine to children under 18 years of age for the treatment of CRSwNP, because the safety and benefits of this medicine are not known in children of this age group.

Other asthma medicines

Do not suddenly stop taking other asthma medicines when starting Tezspire. This is especially important if you are taking steroids (also called corticosteroids). These medicines must be stopped gradually, under the supervision of your doctor and based on your response to Tezspire.

Other medicines and Tezspire
Tell your doctor or pharmacist:

if you are taking, have recently taken, or might take any other medicines.
if you have recently received or need to receive a vaccination.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.

Do not use Tezspire during pregnancy unless your doctor tells you to. It is not known whether Tezspire could harm the unborn baby.
Tezspire may pass into breast milk. If you are breastfeeding or planning to breastfeed, please consult your doctor.

Driving and using machines
It is unlikely that Tezspire will affect your ability to drive or operate machinery.

Tezspire contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 210 mg dose, i.e., essentially ‘sodium-free’.

Tezspire contains L-proline
This medicine contains 48 mg of L-proline per 210 mg dose, equivalent to 25 mg/mL. L-proline may be harmful in patients with hyperprolinaemia, a rare genetic disorder characterized by accumulation of L-proline in the body. If you or your child has hyperprolinaemia, inform your doctor and do not use this medicine unless recommended by your doctor.

Tezspire contains polysorbate
This medicine contains 0.19 mg of polysorbate 80 per 210 mg dose, equivalent to 0.1 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you or your child has any known allergy.

3. How to use Tezspire

Always use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor, pharmacist, or nurse.
Tezspire is administered as an injection under the skin (subcutaneously).
Asthma
Adults and adolescents aged 12 years and older:

The recommended dose is 210 mg (1 injection) every 4 weeks.

CRSwNP
Adults aged 18 years and older:

The recommended dose is 210 mg (1 injection) every 4 weeks.

Your doctor or nurse will decide whether you can self-administer the injection or whether the person assisting you can do it for you. In such cases, you or the person assisting you will receive training on the correct way to prepare and inject Tezspire.
Before injecting Tezspire yourself, carefully read the 'Instructions for Use' of the Tezspire pre-filled syringe. Do this every time you administer another injection, as there may be new
information.
Do not share your pre-filled syringe of Tezspire with others, and do not use it more than once.
If you forget to use Tezspire

If you have forgotten to inject a dose, inject a dose as soon as possible. Then continue with your next injection on the day it is due.
If you do not realize you have missed a dose until it is time to take the next dose, simply inject the next dose as scheduled. Do not inject a double dose to make up for the missed dose.
If you are unsure about when to inject Tezspire, consult your doctor, pharmacist, or nurse.

If you stop treatment with Tezspire

Do not stop treatment with Tezspire without first discussing it with your doctor, pharmacist, or nurse. Stopping or interrupting treatment with Tezspire may cause symptoms or attacks to return.

If you have any questions 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.
Severe allergic reactions
Consult a doctor immediately if you think you are having an allergic reaction. These reactions can
occur within hours or days after the injection.
Not known (frequency cannot be estimated from the available data)

allergic reactions, including severe allergic reaction (anaphylaxis); symptoms usually include:
o swelling of the face, tongue or mouth
o breathing problems, rapid heartbeat
o fainting, dizziness, feeling lightheaded

Other side effects
Common (may affect up to 1 in 10 people)

sore throat
skin rash
joint pain
injection site reactions (such as redness, swelling and pain)

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

5. How to store Tezspire

Keep this medicine out of the sight and reach of children.
Do not use Tezspire after the expiry date stated on the label and on the carton. The expiry date refers to the last day of that month.
Store in the refrigerator (between 2 °C and 8 °C).
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Tezspire may be stored at room temperature (between 20 °C and 25 °C) in the outer packaging for up to 30 days. Once Tezspire has reached room temperature, do not return it to the refrigerator. Any Tezspire stored at room temperature for longer than 30 days must be safely disposed of.
Do not shake, freeze, or expose to heat.
Do not use this medicine if it has been dropped or damaged, or if the safety seal on the carton has been broken.

Do not dispose of any medicine via wastewater. 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 Tezspire contains

The active substance is tezepelumab.
The other components are acetic acid (E 260), L-proline, polysorbate 80 (E 433), sodium hydroxide and water for injections.

Description of the appearance of Tezspire and contents of the pack
Tezspire is a solution ranging from clear to opalescent, colourless to pale yellow.
Tezspire is available in a pack containing 1 pre-filled single-use syringe or in a multiple pack containing 3 pre-filled syringes (3 packs of 1).
Not all pack sizes may be marketed.

Marketing Authorization Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

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

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf.: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

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.

Instructions for use

Tezspire 210 mg solution for injection in pre-filled syringe

tezepelumab
These ‘Instructions for Use’ contain information on how to inject Tezspire.
Before using the pre-filled syringe of Tezspire, your healthcare provider must show you or the person assisting you how to use it correctly.
Read these ‘Instructions for Use’ before starting to use your pre-filled syringe of Tezspire and each time you receive another injection. There may be new information. These instructions should not replace discussions with your healthcare provider about your medical condition and your treatment.
If you or the person assisting you has any questions, consult your healthcare provider.

Important information you should know before injecting Tezspire
Store Tezspire in the refrigerator at between 2 °C and 8 °C in its outer packaging until you are ready to use it. Tezspire may be stored at room temperature between 20 °C and 25 °C in its outer packaging for up to 30 days.
Once Tezspire has reached room temperature, do not return it to the refrigerator.
Discard (dispose of) Tezspire if it has been stored at room temperature for more than 30 days (see Step 10).

Do not use the pre-filled syringe of Tezspire if:

It has been frozen
It has been dropped or damaged
The safety seal on the box has been broken
The expiry date (Exp.) has passed

Do not shake the pre-filled syringe.
Do not share the pre-filled syringe.
Do not use it more than once.
Do not expose the pre-filled syringe of Tezspire to heat.

If any of the above conditions occur, discard the syringe into a sharps disposal container and use a new pre-filled syringe of Tezspire.
Each pre-filled syringe of Tezspire contains 1 dose of Tezspire and must only be used once.
Keep the pre-filled syringe of Tezspire and all medicines out of the sight and reach of children.

Tezspire is administered as an injection under the skin (subcutaneous).

Your pre-filled syringe of Tezspire
Do not remove the needle cap until Step 7 of these instructions, when you are ready to inject Tezspire.
Do not touch the activation clips of the needle safety guard. Doing so may cause the safety device (needle guard) to activate prematurely.

Before use
Technical black and white drawing of a medical device with a cylindrical body, a flat base, and a

After use
Technical drawing of a syringe with plunger, cylindrical body, and protective wings, separated from the protective cap of the

| Component | Description | |---------|-------------| | Activation clips | of the needle safety device | | Observation window | | | Expiry date label | | | Plunger tip | | | Plunger | | | Syringe barrel | | | Needle cap | | | Plunger | | | Needle safety guard | | | Finger flange | | | Needle | |

Preparing to inject Tezspire

Step 1 – Prepare the materials

1 pre-filled syringe of Tezspire from the refrigerator
1 alcohol wipe
1 cotton ball or gauze pad
1 small plaster (optional)
1 sharps disposal container. See Step 10 for instructions on how to safely discard (dispose of) the used pre-filled syringe of Tezspire.

Rectangular adhesive bandage with rounded edges and a central protective pad on a white background with gray dotted texture

Black and white technical diagram of a medical device with a plunger on the left, a central body, and a tip on the right

Stylized black and white drawing of three round, irregular tablets grouped together on a white background

Red biological waste container with transparent lid and wide base for safe disposal of infectious materials

White rectangle with rounded edges and internal shading on a light gray background bordered by a thin black frame

Pre-filled syringe – Alcohol wipe – Cotton ball or gauze – Plaster (optional) – Sharps disposal container

Step 2 – Prepare to use the pre-filled syringe of Tezspire
Allow Tezspire to reach room temperature between 20 °C and 25 °C for about 60 minutes or longer (up to a maximum of 30 days) before administering the injection.

Stylized icon of a stopwatch with thick black border and light blue dial face on a white background

Keep the pre-filled syringe in its outer packaging to protect the medicine from light.
Do not warm the pre-filled syringe by any other method. For example, do not warm it in a microwave, in hot water, in direct sunlight, or near other heat sources.
Once Tezspire has reached room temperature, do not return it to the refrigerator. Discard (dispose of) Tezspire if it has been stored at room temperature for more than 30 days.
Do not remove the needle cap until Step 7.

Step 3 – Remove the pre-filled syringe
Grasp the syringe barrel to remove the pre-filled syringe from its box. Do not grasp the pre-filled syringe by the plunger.
Syringe barrel

A hand holding a pre-filled syringe horizontally placed on a flat white surface for drug preparation

of the
syringe
Step 4 – Check the prefilled syringe
Check the prefilled syringe for any signs of

A hand gripping a pre-filled syringe with an upper plunger and a transparent body showing the

damage. Do not use the prefilled syringe if it is damaged.
Check the expiration date on the prefilled syringe. Do not
use the prefilled syringe if the expiration date has passed.
Inspect the liquid through the viewing window. The liquid should be clear and colorless to slightly yellow.
Do not administer the injection if the liquid is cloudy, has changed color, or contains large particles.
Small air bubbles in the liquid may be visible. This is normal. No action is required. Expiration
date
Inject Tezspire
Step 5 – Choose an injection site
If you are self-injecting, the recommended injection site

Human body diagram viewed from the back with gray highlighted areas on the arms, lower back, and thighs

is the front of the thigh or the lower abdomen. Do not administer the injection in an arm.
A caregiver may administer the injection in the upper arm, thigh, or abdomen.
For each injection, select a different site at least 3 cm away from the previous injection site.
Do not administer the injection:

within the 5 cm area around the navel
where the skin is tender, bruised, scaly, or hard
over scars or damaged skin
through clothing

Step 6 – Wash hands and disinfect the injection site
Wash your hands thoroughly with soap and water.
Disinfect the injection site by wiping it with a circular motion using an alcohol wipe. Allow it to air dry.
Do not touch the disinfected area again before the injection.
Do not blow or fan the disinfected area.

Two open hands rubbing against each other above a stain of

A hand holding a white tissue to clean or dab a smooth, light skin area

Step 7 – Remove the needle cap
Do not remove the needle cap until you are ready to perform the injection.
Hold the syringe body with one hand and carefully remove the needle cap vertically with the other hand.
Do not press on the plunger or plunger rod while removing the needle cap.
Set the needle cap aside and dispose of it later.
A drop of liquid may be visible at the tip of the needle. This is normal.
Do not touch the needle and avoid letting it contact any surface.
Do not re-cap the needle after removal.
Step 8 – Inject Tezspire
Hold the prefilled syringe in one hand, as shown.

A hand holding a syringe with needle pointing downward and gripping the plunger ready for

With the other hand, gently pinch the skin at the injection site. This will make the skin firmer.
Do not press on the plunger rod until the needle is inserted into the skin.
Never pull back on the plunger rod.
Inject Tezspire by following the steps shown in figures a, b, and c.
a b c

Two hands holding a syringe to inject medication into the arm at an angle of approximately 45 degrees to the skin

Two hands holding an injection pen at an angle with a gray arrow indicating the direction of pressure downward

°
At a 45-degree angle, insert the Use your thumb to press the Hold your thumb pressed on the
needle completely into the pinched plunger rod. plunger rod while removing the
skin. Continue pressing to the bottom needle from the skin. Release the
to ensure all the medication is plunger slowly until the needle
injected. safety shield covers the needle.
Do not attempt to reposition the prefilled syringe once the needle is inserted into the skin.
Step 9 – Check the injection site
A small amount of blood or liquid may be present at the

A hand gently pressing a white cotton ball onto the surface of light skin

injection site. This is normal.
Apply gentle pressure to the skin with a cotton ball or gauze until bleeding stops.
Do not rub the injection site. If needed, cover the injection site with a small bandage.
Dispose of Tezspire
Step 10 – Safely dispose of the used prefilled syringe
Each prefilled syringe contains a single dose of Tezspire and

A hand holding a transparent injection pen above a red sharps disposal container for used needles and medical devices

cannot be reused.
Do not recap the needle.
Immediately after use, place the used prefilled syringe and the needle cap into a sharps disposal container. Place other used materials in household waste.
Do not throw the prefilled syringe into household waste.
Disposal guidelines
Dispose of the full sharps container according to instructions from your healthcare provider or pharmacist.
Do not dispose of the used sharps container in household waste.
Do not recycle the used sharps container.

Patient information leaflet

Tezspire 210 mg solution for injection in pre-filled pen

tezepelumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Tezspire is and what it is used for
What you need to know before using Tezspire
How to use Tezspire
Possible side effects
How to store Tezspire
Contents of the pack and other information

1. What Tezspire is and what it is used for

What Tezspire is used for
Asthma
Tezspire is used, together with other asthma medications, for the treatment of severe asthma in adults
and adolescents (12 years of age and older) when the disease is not controlled by the asthma medicines
they are currently taking.

CRSwNP
Tezspire is also used together with other medicines for the treatment of CRSwNP in adults.

How Tezspire can help you
Asthma
Tezspire may reduce the number of asthma attacks, improve your breathing, and reduce asthma symptoms.

CRSwNP
Tezspire may reduce the size of nasal polyps and improve symptoms, including nasal congestion and
loss of smell. Tezspire may also reduce the need for oral corticosteroids and surgery.

2. What you should know before using Tezspire

Do not use Tezspire

if you are allergic to tezepelumab or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, or if you are unsure, check with your doctor, pharmacist, or nurse.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Tezspire.

Tezspire is not an emergency medicine. Do not use it to treat sudden asthma attacks.
If your asthma does not improve or worsens during treatment with this medicine, consult a doctor or nurse.
Be alert for signs of allergic reactions. Medicines such as Tezspire may potentially cause serious allergic reactions in some people. Signs of such reactions may vary but could include swelling of the face, tongue, or mouth, breathing problems, rapid heartbeat, fainting, dizziness, feeling lightheaded, hives, or skin rash. If you notice any of these signs, speak immediately with a doctor or nurse.

Talk to your doctor about how to recognize early signs of allergic reactions and how to manage them should they occur.

Be alert for any signs of a possible serious infection while taking Tezspire, such as:
- fever, flu-like symptoms, night sweats;
- persistent cough;
- skin that is warm, red, and painful, or a painful skin rash with blisters. If you notice any of these signs, speak immediately with a doctor or nurse.

If you already have a serious infection, talk to your doctor before taking Tezspire.

Be alert for any symptoms of a heart problem, such as:
- chest pain;
- shortness of breath;
- a general feeling of discomfort, illness, or unease;
- feeling lightheaded or fainting. If you notice any of these symptoms, speak immediately with a doctor or nurse.
If you have a parasitic infection or if you live (or travel) in an area where parasitic infections are common, talk to your doctor. Tezspire may weaken your body’s ability to fight certain types of parasitic infections.

Each time you receive a new pack of Tezspire

Record the name and batch number shown on the outer packaging and on the label of the pre-filled pen, and keep this information in a safe place. You may be asked to provide this information in the future.

Children
Asthma
Do not give this medicine to children under 12 years of age for the treatment of asthma, as the safety and benefits of this medicine have not been established in children of this age group.
CRSwNP
Do not give this medicine to children under 18 years of age for the treatment of CRSwNP, as the safety and benefits of this medicine have not been established in children of this age group.

Other asthma medicines

Do not stop taking other asthma medicines suddenly when starting Tezspire. This is especially important if you are taking steroids (also called corticosteroids). These medicines must be stopped gradually, under the supervision of your doctor and based on your response to Tezspire.

Other medicines and Tezspire
Inform your doctor or pharmacist:

if you are taking, have recently taken, or might take any other medicine.
if you have recently received or need to receive a vaccination.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.

Do not use Tezspire during pregnancy unless your doctor tells you to. It is not known whether Tezspire may harm the unborn baby.
Tezspire may pass into breast milk. If you are breastfeeding or planning to breastfeed, please consult your doctor.

Driving and using machines
It is unlikely that Tezspire will affect your ability to drive or operate machinery.

Tezspire contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 210 mg dose, i.e., essentially ‘sodium-free’.

Tezspire contains L-proline
This medicine contains 48 mg of L-proline per 210 mg dose, equivalent to 25 mg/mL. L-proline may be harmful in patients with hyperprolinemia, a rare genetic disorder characterized by accumulation of L-proline in the body. If you or your child has hyperprolinemia, inform your doctor and do not use this medicine unless recommended by your doctor.

3. How to use Tezspire

Asthma
Adults and adolescents aged 12 years and older

Recommended dose: 210 mg (1 injection) every 4 weeks.

CRSwNP
Adults aged 18 years and older:

Recommended dose: 210 mg (1 injection) every 4 weeks.

Your doctor or nurse will decide whether you can self-administer the injection or whether a caregiver can administer it for you. In such cases, you or your caregiver will receive training on the correct way to prepare and inject Tezspire.
Before injecting Tezspire yourself, carefully read the ‘Instructions for use’ provided with the Tezspire pre-filled pen. Do this every time you administer another injection, as there may be new information.
Do not share your Tezspire pre-filled pen with others, and do not use it more than once.

If you forget to use Tezspire

If you have forgotten to inject a dose, administer the missed dose as soon as possible. Then continue with the next injection on the scheduled date.
If you do not realize that you have missed a dose until it is time for the next scheduled dose, simply administer the next dose as planned. Do not inject a double dose to make up for the missed dose.
If you are unsure about when to inject Tezspire, contact your doctor, pharmacist, or nurse.

If you stop treatment with Tezspire

Do not stop treatment with Tezspire without first discussing it with your doctor, pharmacist, or nurse. Stopping or interrupting treatment with Tezspire may cause symptoms or attacks to return.

If you have any questions about using this medicine, contact your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions
Consult a doctor immediately if you think you are having an allergic reaction. These reactions may
occur within hours or days after the injection.
Not known (frequency cannot be estimated from the available data)

allergic reactions, including severe allergic reaction (anaphylaxis); symptoms usually include:
o swelling of the face, tongue or mouth
o breathing difficulties, rapid heartbeat
o fainting, dizziness, feeling faint
Other side effects
Common (may affect up to 1 in 10 people)
sore throat
rash
joint pain
injection site reactions (such as redness, swelling and pain)

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 via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tezspire

Keep this medicine out of the sight and reach of children.
Do not use Tezspire after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.
Store in a refrigerator (between 2 °C and 8 °C).
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Tezspire may be stored at room temperature (between 20 °C and 25 °C) in the outer packaging for up to 30 days. Once Tezspire has reached room temperature, do not return it to the refrigerator. Any Tezspire stored at room temperature for more than 30 days must be safely disposed of.
Do not shake, freeze, or expose to heat.
Do not use this medicine if it has been dropped or damaged, or if the security seal on the carton has been broken.

Do not dispose of any medicine via wastewater. 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 Tezspire contains

The active substance is tezepelumab.
The other components are acetic acid (E 260), L-proline, polysorbate 80 (E 433), sodium hydroxide, and water for injections.

Description of the appearance of Tezspire and contents of the pack
Tezspire is a solution ranging from clear to opalescent, colourless to pale yellow.
Tezspire is available in a pack containing 1 single-use pre-filled pen or in a multiple pack containing 3 pre-filled pens (3 packs of 1).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

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