TEZSPIRE 210 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Introduction

Package Leaflet: Information for the Patient

Tezspire 210 mg solution for injection in pre-filled pen

tezepelumab

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tezspire and what is it used for
2. What you need to know before you use Tezspire
3. How to use Tezspire
4. Possible side effects
5. Storage of Tezspire
6. Contents of the pack and other information

1. What is Tezspire and what is it used for

What is Tezspire and how does it work

Tezspire contains the active substance tezepelumab, which is a monoclonal antibody. Antibodies are proteins that recognize and bind to a specific target substance in the body, which in the case of tezepelumab is a protein called thymic stromal lymphopoietin(TSLP). TSLP plays a key role in the inflammation of the airways that causes the signs and symptoms of asthma. By blocking the action of TSLP, this medicine helps to reduce inflammation and symptoms of asthma.

What is Tezspire used for

Tezspire is used to treat severe asthma in adults and adolescents from 12 years of age, in combination with other asthma medicines, when the disease is not controlled with their current asthma medicines.

How can Tezspire help

Tezspire may reduce the frequency of asthma attacks you experience, improve your breathing, and reduce your asthma symptoms.

2. What you need to know before you use Tezspire

Do not use Tezspire

• to tezepelumab or any of the other ingredients of this medicine (listed in section 6). If this applies to you, or if you are not sure, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Tezspire.

• Tezspire is not a rescue medicine.Do not use it to treat a sudden asthma attack.

• If your asthma does not improve, or worsensduring treatment with this medicine, consult a doctor or nurse.

• Be aware of the signs of allergic reactions.Medicines like Tezspire may potentially cause severe allergic reactions in some people. The signs of these reactions can vary, but may include swelling of the face, tongue, or mouth, breathing problems, rapid heartbeat, fainting, dizziness, lightheadedness, hives, and skin rash. If you notice any of these signs, talk to a doctor or nurse immediately.

Consult your doctor about how to recognize the first signs of an allergy and how to manage reactions if they occur.

• Be aware of any signs of a possible serious infectionwhile taking Tezspire, such as:

• fever, flu-like symptoms, night sweats;
• cough that does not go away;
• hot, red, and painful skin, or painful skin rash with blisters.

If you notice any of these signs, tell a doctor or nurse immediately.

If you already have a serious infection, tell your doctorbefore receiving Tezspire.

• Be aware of any symptoms of a heart problem, such as:

• chest pain;
• difficulty breathing;
• a general feeling of being unwell, illness, or lack of well-being;
• feeling of dizziness or fainting.

If you notice any of these symptoms, tell a doctor or nurse immediately.

• If you have a parasitic infectionor if you live (or travel to) an area where parasitic infections are common, consult your doctor.Tezspire may reduce your body's ability to fight certain types of parasitic infections.

Children

Do not give this medicine to children under 12 years of age because the safety and benefits of this medicine in children of this age group are not known.

Other asthma medicines

• Do not stop takingyour other asthma medicines when you start using Tezspire. This is especially important if you are taking steroids (also called corticosteroids). These medicines should 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 been vaccinated recently or are planning to be vaccinated.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

• Do not use Tezspire during pregnancy unless your doctor advises you to. It is not known if Tezspire can affect the unborn baby.
• Tezspire may pass into breast milk. If you are breastfeeding or plan to breastfeed, contact your doctor.

Driving and using machines

It is unlikely that Tezspire will affect your ability to drive and use machines.

Tezspire contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 210 mg dose; this is essentially “sodium-free”.

3. How to use Tezspire

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist, or nurse if you are not sure.

Adults and adolescents from 12 years of age:

• The recommended doseis 210 mg (1 injection) every 4 weeks. Tezspire is given as an injection under the skin (subcutaneously).

Your doctor or nurse will decide if you can inject yourself or if your caregiver can do it for you. If so, 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” of Tezspire pre-filled pen. Do this every time you receive another injection. There may be new information.

Do not share Tezspire pre-filled pen or use a pen more than once.

If you forget to use Tezspire

• If you have forgotten to inject a dose, do so as soon as possible. Then apply the next injection on the next scheduled injection day.
• If you do not realize you have missed a dose until it is time for your 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 not sure when to inject Tezspire, consult your doctor, pharmacist, or nurse.

If you stop treatment with Tezspire

• Do not stop treatment with Tezspire without consulting your doctor, pharmacist, or nurse first. Stopping or interrupting treatment with Tezspire may cause your symptoms and asthma attacks to come back.

If you have any further questions on the use of this medicine, ask 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

See a doctor immediatelyif you think you may be having an allergic reaction. Such reactions can occur within hours or days after the injection.

Frequency not known(cannot be estimated from the available data)

• allergic reactions, including severe allergic reaction (anaphylaxis)

usual symptoms include:

• swelling of the face, tongue, or mouth
• breathing problems, rapid heartbeat
• fainting, dizziness, lightheadedness

Other side effects

Common(may affect up to 1 in 10 people)

• sore throat
• skin rash
• joint pain
• reaction at the injection site (such as redness, swelling, and pain)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tezspire

• 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 carton. The expiry date is the last day of the month stated.

• Store in a refrigerator (between 2°C and 8°C).

• Keep the pre-filled pen in the outer packaging to protect it from light.

• Tezspire can be stored at room temperature (between 20°C and 25°C) in the outer packaging for a maximum of 30 days. Once Tezspire has reached room temperature, do not put it back in the refrigerator. If Tezspire has been stored at room temperature for more than 30 days, it must be disposed of safely.

• 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 of the outer packaging is broken.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Tezspire

• The active ingredient is tezepelumab.
• The other components are acetic acid, L-proline, polysorbate 80, sodium hydroxide, and water for injectable preparations.

Appearance of the Product and Container Contents

Tezspire is a clear or opalescent solution, colorless to light yellow.

Tezspire is available in a container that contains 1 pre-filled pen or in a multiple container that contains 3 pre-filled pens (3 packs of 1).

Only some pack sizes may be marketed.

Marketing Authorization Holder

AstraZeneca AB

SE 151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for Use

Tezspire 210 mg Solution for Injection in Pre-filled Pen

tezepelumab

These ‘Instructions for Use’ contain information on how to inject Tezspire.

Before using Tezspire pre-filled pen, a healthcare professional should teach you or your caregiver how to use it correctly.

Read these ‘Instructions for Use’ before starting to use Tezspire pre-filled pen and each time you receive another injection.There may be new information. This information should not replace consultation with your healthcare professional about your disease and treatment.

If you or your caregiver have any questions, consult your healthcare professional.

Important Information You Should Know Before Injecting Tezspire

Keep Tezspire in a refrigerator between 2°C and 8°C in its outer packaging until you are ready to use it.Tezspire may be kept at room temperature between 20°C and 25°C in the outer packaging for a maximum of 30 days.

Once Tezspire has reached room temperature, do notput it back in the refrigerator.

Discard (throw away) Tezspire that has been stored at room temperature for more than 30 days.

Do notremove the cap until Step 6.

Step 1 – Gather All Materials

• 1 Tezspire pre-filled pen from the refrigerator
• 1 alcohol swab
• 1 cotton ball or gauze
• 1 small bandage (optional)
• 1 sharps container. See Step 10 for instructions on how to safely throw away (dispose of) used Tezspire pre-filled pen.

Step 2 – Prepare to Use Your Tezspire Pre-filled Pen

Do notput Tezspire back in the refrigerator after it has reached room temperature.

Discard (throw away) Tezspire that has been stored at room temperature for more than 30 days.

Do notremove the cap until Step 6.

Step 3 – Remove and Check the Pre-filled Pen

Injecting Tezspire

Step 4 – Choose an Injection Site

Step 5 – Wash Your Hands and Clean the Injection Site

Wash your hands well with soap and water.

Clean the injection site with an alcohol swab in a circular motion. Let it air dry.

Do nottouch the cleaned area before injecting.

Do notfan or blow on the cleaned area.

Step 6 – Remove the Cap

Step 7 – Inject Tezspire

Step 8 – Check the Viewing Window

Step 9 – Check the Injection Site

Disposing of Tezspire

Step 10 – Dispose of the Used Pre-filled Pen Safely

Disposal Guidelines

Discard the filled container according to the instructions of your healthcare professional or pharmacist.

Do notdispose of the used sharps container in the household trash unless your community guidelines permit it.

Do notrecycle your used sharps container.