TEZSPIRE 210 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN
Ask a doctor about a prescription for TEZSPIRE 210 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN
How to use 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
- What is Tezspire and what is it used for
- What you need to know before you use Tezspire
- How to use Tezspire
- Possible side effects
- Storage of Tezspire
- 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
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:
België/Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11 | Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 |
| Luxembourg/Luxemburg AstraZeneca S.A./N.V. Tél/Tel: +32 2 370 48 11 |
Ceská republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111 | Magyarország AstraZeneca Kft. Tel.: +36 1 883 6500 |
Danmark AstraZeneca A/S Tlf: +45 43 66 64 62 | Malta Associated Drug Co. Ltd Tel: +356 2277 8000 |
Deutschland AstraZeneca GmbH Tel: +49 40 809034100 | Nederland AstraZeneca BV Tel: +31 85 808 9900 |
Eesti AstraZeneca Tel: +372 6549 600 | Norge AstraZeneca AS Tlf: +47 21 00 64 00 |
Ελλáδα AstraZeneca A.E. Τηλ: +30 210 6871500 | Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 |
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00 | Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00 |
France AstraZeneca Tél: +33 1 41 29 40 00 | Portugal AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00 |
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000 | România AstraZeneca Pharma SRL Tel: +40 21 317 60 41 |
Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100 | Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777 |
Italia AstraZeneca S.p.A. Tel: +39 02 00704500 | Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 |
Κúπρος Αλéκτωρ Φαρµακeυτικ? Λτδ Τηλ: +357 22490305 | Sverige AstraZeneca AB Tel: +46 8 553 26 000 |
Latvija SIA AstraZeneca Latvija Tel: +371 67377100 | United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 836 |
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.
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Pre-filled pen | Alcohol swab | Cotton ball or gauze | Bandage | Sharps container |
Step 2 – Prepare to Use Your Tezspire Pre-filled Pen
Let Tezspire reach room temperature between 20°C and 25°C for about 60 minutes or more (up to a maximum of 30 days) before administering the injection. Keep the pre-filled pen in the outer packaging to protect it from light. Do notheat the pre-filled pen in any other way. For example, do notheat it in a microwave or hot water, under direct sunlight, or near other heat sources. |
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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
Hold the center of the pre-filled pen body to remove the pre-filled pen from its tray. Check if the pre-filled pen is damaged. Do notuse the pre-filled pen if it is damaged. Check the expiration dateof the pre-filled pen. Do notuse the pre-filled pen if the expiration date has passed. Look at the liquid through the viewing window.The liquid should be clear and colorless to light yellow. Do notinject Tezspire if the liquid is cloudy, discolored, or contains large particles. You may see small air bubbles in the liquid. This is normal. You do not need to do anything about it. |
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Expiration date |
Injecting Tezspire
Step 4 – Choose an Injection Site
If you are injecting yourself, the recommended injection siteis the front of the thigh or the lower stomach (abdomen). Do notinject into the arm. A caregiver may inject you in the upper arm, thigh, or abdomen. For each injection, choose a different site, at least 3 cm away from the site of the previous injection. Do notinject:
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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.
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Step 6 – Remove the Cap
Do notremove the cap until you are ready to inject. Hold the pre-filled pen body with one hand and carefully remove the cap with the other hand. Set the cap aside and discard it later. The orange needle guard is now exposed. The needle guard is there to prevent you from touching the needle. Do nottouch the needle or press the orange needle guard with your finger. Do notput the cap back on the pre-filled pen. It could cause the injection to be given too early or damage the needle. |
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Step 7 – Inject Tezspire
Follow your healthcare professional's instructions on how to inject. You can either gently pinch the skin at the injection site or give the injection without pinching the skin. Inject Tezspire following the steps in figures a, b, c, and d. When injecting, you will hear the first click that indicates the injection has started. Hold the pre-filled pen firmly in place for 15 seconds until you hear the second click. Do notchange the position of the pre-filled pen after the injection has started. |
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Position of the pre-filled pen.
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Press down firmly until you no longer see the orange needle guard.
| Hold firmly in place for 15 seconds.
| Once you have completed your injection, lift the pre-filled pen straight up.
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Step 8 – Check the Viewing Window
Check the viewing window to make sure all the medicine has been injected. If the orange plunger does not fill the viewing window completely, you may not have received the full dose. If this happens or you have any other concerns, contact your healthcare professional. |
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Before injection |
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| After injection |
Step 9 – Check the Injection Site
There may be a small amount of blood or liquid where you injected. This is normal. Press gently on the skin with a cotton ball or gauze until the bleeding stops. Do notrub the injection site. If necessary, cover the injection site with a small bandage. |
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Disposing of Tezspire
Step 10 – Dispose of the Used Pre-filled Pen Safely
Each pre-filled pen contains a single dose of Tezspire and cannot be reused. Do notput the cap back on the pre-filled pen. Put the used pre-filled pen and cap in a sharps containerimmediately after use. Put the other used materials in the household trash. Do notthrow the pre-filled pen in the household trash. |
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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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to TEZSPIRE 210 mg SOLUTION FOR INJECTION IN A PRE-FILLED PENDosage form: INJECTABLE, 210 mgActive substance: tezepelumabManufacturer: Astrazeneca AbPrescription requiredDosage form: INJECTABLE PERFUSION, 100 mg injectable 10 mlActive substance: reslizumabManufacturer: Teva B.V.Prescription requiredDosage form: TABLET, 250 µgActive substance: roflumilastManufacturer: Astrazeneca AbPrescription required
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for TEZSPIRE 210 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN – subject to medical assessment and local rules.
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