Tezspire 210 mg solution for injection in Pre-filled syringe – patient leaflet, side effects, dosage

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 recognise 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 causing the inflammation in your airways that leads to the signs and symptoms of asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). By blocking the action of TSLP, this medicine helps to reduce inflammation and symptoms of asthma and CRSwNP.

What Tezspire is used for

Asthma

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

CRSwNP

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

How Tezspire can help

Asthma

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

CRSwNP

Tezspire may reduce the size of your polyps and improves 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 you use Tezspire

Do not use Tezspire

• if you are allergic 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, check with your doctor, pharmacist or nurse.

Warnings and precautions

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

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

  asthma attack.

• If your asthma is not getting any better, or it gets worse during

  treatment with this medicine, talk to a doctor or nurse.

• Look out for signs of allergic reactions. Medicines like Tezspire

  can potentially cause serious allergic reactions in some people. The signs of these reactions may vary, but can include swelling of your face, tongue or mouth, breathing problems, fast heartbeat, fainting, dizziness, feeling lightheaded, hives and rash. If you notice any of these signs, speak to a doctor or nurse immediately. Talk to your doctor about how to recognise early signs of allergy, and how to manage reactions if they occur.

• Look out for any signs of a possible serious infection while you

  are taking Tezspire such as:

  • fever, flu-like symptoms, night sweats;
  • cough which will not go away;
  • warm, red and painful skin, or a painful skin rash with blisters. If you notice any of these signs, speak to a doctor or nurse immediately. If you already have a serious infection, talk to your doctor before taking Tezspire.

• Look out for any symptoms of a heart problem, such as:

  • chest pain;
  • shortness of breath;
  • a general feeling of discomfort, illness, or lack of well-being;
  • feeling lightheaded or faint.

If you notice any of these symptoms, speak 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, talk to your doctor. Tezspire may weaken your body’s ability to fight certain types of parasitic infections.

  Each time you get a new pack of Tezspire

  • Write down the name and the Lot number shown on the outer carton

    and the label of the pre-filled syringe, and keep this information in a safe place. You may be asked for 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 in 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 in this age group.

Other medicines for asthma

• Do not suddenly stop taking your other asthma medicines when you

  start Tezspire. This is especially important if you take 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 use any other

  medicines.

• if you have recently had or are due to have a vaccination.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 it. It

  is not known if Tezspire can harm your unborn baby.

• Tezspire may pass into breast milk. If you are breast-feeding or plan to

  breast-feed, talk to your doctor.

Driving and using machines

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

Tezspire contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 210 mg dose, that is to say essentially ‘sodium-free’.

Tezspire contains L-proline

This medicine contains 48 mg of L-proline per 210 mg dose which is equivalent to 25 mg/mL. L-proline may be harmful for patients with hyperprolinaemia, a rare genetic disorder in which L-proline builds up in the body. Tell your doctor if you or your child have hyperprolinaemia, and do not use this medicine unless your doctor has recommended it.

Tezspire contains polysorbate

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

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. Tezspire is given as an injection under the skin (subcutaneously).

Asthma

Adults and adolescents aged 12 years and over:

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

CRSwNP

Adults aged 18 years and over:

• The recommended dose is 210 mg (1 injection) every 4 weeks. Your doctor or nurse will decide if you can inject yourself or if your caregiver can do that for you. If so, you or your caregiver will receive training on the right way to prepare and inject Tezspire. Before injecting Tezspire yourself, carefully read the ‘Instructions for Use’ for Tezspire pre-filled syringe. Do this each time you get another injection. There may be new information.

Do not share Tezspire pre-filled syringes or use a syringe more than one time.

If you forget to use Tezspire

• If you have forgotten to inject a dose, inject a dose as soon as possible.

  Then have your next injection on your next scheduled injection day.

• If you did not notice that you 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 a forgotten dose.

• If you are not sure when to inject Tezspire, ask your doctor,

  pharmacist or nurse.

If you stop using Tezspire

• Do not stop using Tezspire without speaking first to your doctor,

  pharmacist or nurse. Interrupting or stopping the treatment with Tezspire may cause your symptoms or 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.

Serious allergic reactions

Seek medical attention immediately if you think you may be having an allergic reaction. Such reactions may happen within hours or days after the injection.

Not known (the frequency cannot be estimated from the available data)

• allergic reactions, including serious allergic reaction (anaphylaxis)

  symptoms usually include:

  • swelling of your face, tongue, or mouth
  • breathing problems, fast heartbeat
  • fainting, dizziness, feeling lightheaded

Other side effects

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

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C to 8°C).
• Keep the pre-filled syringe in the outer carton in order to protect from light.
• Tezspire may be kept at room temperature (20°C to 25°C) in the outer carton for a maximum of 30 days. Once Tezspire has reached room temperature, do not put it back in the refrigerator. Tezspire that has been stored at room temperature for more than 30 days should 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 throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tezspire contains

• The active substance is tezepelumab.

• The other ingredients are acetic acid (E 260), L-proline, polysorbate

  80 (E 433), sodium hydroxide, and water for injections.

What Tezspire looks like and contents of the pack

Tezspire is a clear to opalescent, colourless to light yellow solution. Tezspire is available in a pack containing 1 single-use pre-filled syringe. Marketing Authorisation Holder

AstraZeneca UK Limited,

1 Francis Crick Avenue,

CB2 0AA,

UK.

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

This leaflet was last revised in 07/2025

© AstraZeneca 2025

Tezspire is a registered trademark of the AstraZeneca group of companies.

RSP 25 0013

Other sources of information

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Please be ready to give the following information: Product name

Tezspire 210 mg

Reference number 17901/0365 This is a service provided by the Royal National Institute of the Blind.

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