Tezspire 210 mg solucion inyectable en pluma precargada

Prospect: information for the patient

Tezspire 210 mg injectable solution in pre-filled pen

tezepelumab

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

What is Tezspire 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 it is a protein calledthymic stromal lymphopoietin(TSLP). The TSLP plays a key role in the inflammation of the respiratory tract that causes the symptoms of asthma. By blocking the action of TSLP, this medication helps to reduce inflammation and asthma symptoms.

What is Tezspire used for

Tezspire is used to treat severe asthma in adults and adolescents along with other asthma medications (from 12 years old) when the disease is not controlled with current medications.

How Tezspire can help

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

Do not use Tezspire

• if you are allergicto tezepelumab or to any of the other ingredients of this medicine (listed in section 6). If this affects you, or if you are unsure,consult your doctor, pharmacist or nurse.

Warnings and precautions

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

• Tezspireis not a rescue medication.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 signs of allergic reactions.Medicines like Tezspire may potentially cause severe allergic reactions in some people. The signs of these reactions may vary, but may include swelling of the face, tongue or mouth, breathing difficulties, rapid heart rate, dizziness, fainting, confusion, hallucinations 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 sign of a possible serious infectionwhile taking Tezspire, such as:

• fever, flu-like symptoms, night sweats;
• persistent cough;
• hot, red and painful skin, or painful skin rash with blisters.

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

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

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

• chest pain;
• difficulty breathing;
• a general feeling of illness, disease or discomfort;
• dizziness or fainting.

If you notice any of these symptoms,inform 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 administer this medicine to children under 12 years of age because the safety and benefits of this medicine in this age group are unknown.

Other asthma medicines

• Do not stop usingyour other asthma medicines suddenly when starting Tezspire. This is especially important if you take steroids (also known as corticosteroids). These medicines should be tapered off gradually, under the supervision of your doctor and according to your response to Tezspire.

Other medicines and Tezspire

Inform your doctor or pharmacist:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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 unknown if Tezspire may affect the fetus.
• Tezspire may pass into breast milk. If you are breastfeeding or plan to do so, contact your doctor.

Driving and operating machinery

It is unlikely that Tezspire will affect your ability to drive and operate machinery.

Tezspire contains sodium

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

Use this medication exactly as your doctor or pharmacist has instructed. Consult with your doctor, pharmacist, or nurse if you are unsure.

Adults and adolescents 12 years of age and older:

• The recommended doseis 210 mg (1 injection) every 4 weeks. Tezspire is administered as a subcutaneous injection.

Your doctor or nurse will decide if you can administer the injection 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 administer Tezspire.

Before administering Tezspire yourself, carefully read the “Instructions for Use” of the pre-filled Tezspire pen. Do this every time you receive another injection. There may be new information.

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

If you forget to use Tezspire

• If you have forgotten to administer a dose, do it as soon as possible. Then, administer the next injection on the next scheduled injection day.
• If you do not realize you have forgotten a dose until the time of your next dose, simply administer the next dose as scheduled.Do not administer a double dose to compensate for the missed dose.
• If you are unsure when to administer Tezspire, consult your doctor, pharmacist, or nurse.

If you interrupt treatment with Tezspire

• Do not interrupt treatment with Tezspire without first consulting your doctor, pharmacist, or nurse. Interrupting or suspending treatment with Tezspire may cause the return of your symptoms and asthma attacks.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Severe Allergic Reactions

Seek medical attention immediatelyif you think you are having an allergic reaction. Such reactions can occur hours or days after the injection.

Unknown Frequency(cannot be estimated from available data)

• Allergic reactions, including severe allergic reaction (anaphylaxis)

The usual symptoms include:

• Swelling in the face, tongue, or mouth
• Respiratory problems, rapid heart rate
• Loss of consciousness, dizziness, drowsiness

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 Adverse Effects

If you experience any type of adverse effect, consult your doctor,pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.

• Do not use after the expiration date that appears on the label and carton. The expiration date is the last day of the month indicated.

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

• Keep the preloaded 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 return it to 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 medication if it has fallen or been damaged, or if the safety seal on the outer packaging has been broken.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Tezspire

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

Appearance of the product and contents of the container

Tezspire is a transparent or opalescent solution, colorless to pale 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 containers of 1)..

Only some container sizes may be commercially available.

Marketing Authorization Holder

AstraZeneca AB

SE 151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency: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 administer 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.This information should not replace consultation with your healthcare professional about your disease and treatment.

If you or your caregiver have any doubts, 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 carton until you are ready to use it.Tezspire can be kept at room temperature between 20°C and 25°C in its outer carton for a maximum of 30 days.

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

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

Dispose of the pre-filled pen in a sharps container if any of the above occurs. Use a new Tezspire pre-filled pen.

Each Tezspire pre-filled pen contains one dose of Tezspire, which 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 a subcutaneous injection.

Your Tezspire pre-filled pen

Do notremove the cap until Step 6 of these instructions when you are ready to administer Tezspire.

Preparing to inject Tezspire

Step 1 – Gather all the materials

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

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

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

Dispose of the 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 thoroughly with soap and water.

Clean the injection site with an alcohol wipe in a circular motion. Let it 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 window view

Step 9 – Check the injection site

Disposing of Tezspire

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

Waste disposal guidelines

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

Do notthrow the used sharps container in household waste unless your community allows it.

Do notrecycle the used sharps container.