Tezspire 210 mg solution for injection in pre-filled pen

Package Leaflet: Information for the User

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 quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end includes information on how to report side effects.

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Tezspire is and what it is used for
2. What you need to know before using Tezspire
3. How to use Tezspire
4. Possible side effects
5. How to store Tezspire
6. 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 and bind to a specific target substance in the body. In the case of tezepelumab, this target is a protein called thymic stromal lymphopoietin (TSLP). TSLP plays a key role in airway inflammation that causes the signs and symptoms of asthma and chronic rhinosinusitis with nasal polyposis (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 to treat severe asthma in adults and adolescents (from 12 years of age) in combination with other asthma medications when the disease is not controlled with their current treatment.

CRSwNP

Tezspire is also used in combination with other medicines to treat CRSwNP in adults.

How Tezspire can help

Asthma

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

CRSwNP

Tezspire may reduce the size of your 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 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 not sure, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Tezspire.

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

• 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 like Tezspire may potentially cause serious allergic reactions in some people. Signs of these reactions may 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, contact a doctor or nurse immediately.

Talk to your doctor about how to recognize early signs of allergy and how to manage reactions if 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 painful blistering rash.

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

• If you already have a serious infection, inform your doctor before receiving Tezspire.

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

• chest pain;

• difficulty breathing;

• a general feeling of discomfort, illness, or uneasiness;

• feeling dizzy or fainting.

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

• If you have a parasitic infection or if you live in (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.

Each time you receive a new package of Tezspire

• Record the name and Lot number shown on the outer packaging and on the label of the prefilled pen, and keep this information in a safe place. You may be asked for this information in the future.

Children

Asthma

Do not administer this medicine to children under 12 years of age for the treatment of asthma, as the safety and benefits of this medicine are unknown in children of this age group.

CSU

Do not administer this medicine to children under 18 years of age for the treatment of CSU, as the safety and benefits of this medicine are unknown in children of this age group.

Other asthma medicines

• Do not stop abruptly your other asthma medicines when starting 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

Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might need to take any other medicine.
• if you have recently been vaccinated or plan to be vaccinated.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

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

Driving and using machines

It is unlikely that Tezspire will affect your ability to drive or 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”.

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 in which L-proline accumulates in the body. If you or your child have hyperprolinemia, do not use this medicine unless your doctor recommends it.

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 have any known allergy.

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 unsure.

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

Asthma

Adults and adolescents aged 12 years and older:

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

RSCcPN

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-inject or whether your caregiver can administer 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” for the Tezspire pre-filled pen. Read them each time you receive another injection, as there may be new information.

Do not share the Tezspire pre-filled pen, and do not 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 administer the next injection on the next scheduled injection day.
• If you do not realize you missed a dose until the time of 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 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 consulting your doctor, pharmacist, or nurse. Interrupting or stopping treatment with Tezspire may cause your symptoms or attacks to return.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Severe allergic reactions

Contact a doctor immediately if you think you may be having an allergic reaction. Such reactions may occur hours or days after the injection.

Frequency not known (cannot be estimated from available data)

• allergic reactions, including severe allergic reaction (anaphylaxis)

typical symptoms include:

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

Other adverse effects

Frequent (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 adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the label and carton. The expiry date refers to the last day of the month indicated.

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

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

• Tezspire may be stored at room temperature (between 20 ºC and 25 ºC) in the outer packaging for up to 30 days. Once Tezspire has reached room temperature, do not return it to the refrigerator. If Tezspire has been stored at room temperature for more than 30 days, it must be safely discarded.

• 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 outer packaging is broken.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Tezspire

• 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.

Appearance of the product and contents of the pack

Tezspire is a solution that is clear to opalescent and colourless to pale yellow.

Tezspire is available in a pack containing 1 pre-filled pen or in a multiple pack containing 3 pre-filled pens (3 packs of 1).

Only certain 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 more information about this medicine, you may contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://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 the Tezspire pre-filled pen, your healthcare professional should train you or your caregiver on how to use it correctly.

Read these ‘Instructions for use’ before starting to use the 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 regarding your illness and treatment.

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

Important information you should know before injecting Tezspire

Store Tezspire in a refrigerator between 2°C and 8°C in its outer packaging until ready to use. Tezspire may be kept 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.

Dispose of any Tezspire that has been stored at room temperature for more than 30 days (see Step 10).

If any of the above occurs, discard the pre-filled pen into a sharps container and use a new Tezspire pre-filled pen.

Each Tezspire pre-filled pen contains 1 dose of Tezspire and is for single use only.

Keep Tezspire pre-filled pen and all medicines out of the sight and reach of children.

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

Your Tezspire pre-filled pen

Do not remove the closure cap until Step 6 of these instructions, when you are ready to inject Tezspire.

Preparing to inject Tezspire

Step 1 – Gather all materials

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

Step 2 – Prepare to use your Tezspire pre-filled pen

Do not put Tezspire back in the refrigerator after it has reached room temperature.

Discard (dispose of) any Tezspire that has been stored at room temperature for more than 30 days.

Do not remove the cap until Step 6.

Step 3 – Remove and check the pre-filled pen

Inject Tezspire

Step 4 – Choose an injection site

Step 5 – Wash your hands and clean the injection site

Wash your hands thoroughly with soap and water.

Clean the injection site with an alcohol wipe using a circular motion. Allow it to air dry.

Do not touch the cleaned area before injecting.

Do not fan 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

Dispose of Tezspire

Step 10 – Dispose of the used pre-filled pen safely

Disposal Guidelines

Dispose of the full container according to the instructions provided by your healthcare professional or pharmacist.

Do not dispose of the used sharps container in household trash unless permitted by your community guidelines.

Do not recycle your used sharps container.