Tezspire 210 mg solution for injection in pre-filled pen

• 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.

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

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. By blocking the action of TSLP, this medicine helps to reduce inflammation and asthma symptoms.

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.

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

• 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.

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.

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

• 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.

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.

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.

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

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

• The recommended dose is 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 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 pen. Do this each time you get another injection. There may be new information.

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

• 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.

• Do not stop using Tezspire without speaking first to your doctor, pharmacist or nurse. Interrupting or stopping the treatment with Tezspire may cause your asthma symptoms and attacks to come back.

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

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

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

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.

• The active substance is tezepelumab.
• The other ingredients are acetic acid, L-proline, polysorbate 80, sodium hydroxide, and water for injections.

Tezspire is a clear to opalescent, colourless to light yellow solution.

Tezspire is available in a pack containing 1 single-use pre-filled pen.