TEZSPIRE 210 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
How to use TEZSPIRE 210 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the Patient
Tezspire 210 mg solution for injection in pre-filled syringe
tezepelumab
This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this 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 the 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 you start using 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 heart rate, 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 you are 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 you receive 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 suddenly 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 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 tells you to. It is not known if Tezspire can affect the unborn baby.
- Tezspire may pass into breast milk. If you are breast-feeding or plan to breast-feed, 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 you inject Tezspire yourself, read the “Instructions for use” of Tezspire pre-filled syringe carefully. Do this each time you receive another injection. There may be new information.
Do not share Tezspire pre-filled syringes or use a syringe more than once.
If you miss a dose of Tezspire
- If you have forgotten to inject a dose, do it 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 talking to 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 heart rate
- 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 (2°C to 8°C).
- Keep the pre-filled syringe in the outer packaging to protect it from light.
- Tezspire can be stored at room temperature (20°C to 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 discarded safely.
- Do not shake, freeze, or expose to heat.
- Do not use this medicine if it has been dropped or damaged, or if the seal on 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. These measures 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 and Container Contents of the Product
Tezspire is a clear or opalescent solution, colorless to light yellow.
Tezspire is available in a container that contains 1 single-use prefilled syringe or in a multiple container that contains 3 prefilled syringes (3 packs of 1).
Only some package 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 medicine 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 |
Ελλάδα 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 |
Κύπρος Αλκήτωρ Φαρμακευτική 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 Prospectus
Other Sources of Information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Instructions for Use
Tezspire 210 mg Solution for Injection in Prefilled Syringe
tezepelumab
These 'Instructions for Use' contain information on how to inject Tezspire. |
Before using the Tezspire prefilled syringe, a healthcare professional should teach you or your caregiver how to use it correctly. Read these 'Instructions for Use' before starting to use the Tezspire prefilled syringe 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 can 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 (see Step 10). | |
Do notuse your Tezspire prefilled syringe if:
| Do notshake your prefilled syringe. Do notshare or use your prefilled syringe more than 1 time. Do notexpose your Tezspire prefilled syringe to heat. |
If any of the above occurs, discard the syringe in a puncture-resistant container and use a new Tezspire prefilled syringe. Each Tezspire prefilled syringe contains 1 dose of Tezspire that is for single use. Keep Tezspire prefilled syringe and all medicines out of the sight and reach of children. Tezspire is administered only as a subcutaneous injection. |
Your Tezspire Prefilled Syringe | |||||
Do notremove the needle cap until Step 7 of these instructions when you are ready to inject Tezspire. Do nottouch the activation clips of the needle guard. This will prevent the safety device (needle guard) from being activated too early. | |||||
Before Use | After Use | ||||
Activation clips of the needle guard
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Viewing window | Label with expiration date | Needle | ||
Plunger head |
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Plunger | Syringe body | Needle cap | Plunger | Needle guard | |
Finger flange | Needle |
Preparing to Inject Tezspire Step 1: Gather Materials | ||||
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Prefilled syringe | Alcohol swab | Cotton ball or gauze | Bandage | Puncture-resistant container |
Step 2: Prepare to Use Your Tezspire Prefilled Syringe | |
Allow Tezspire to reach room temperature between 20°C and 25°C for approximately 60 minutes or more (up to a maximum of 30 days) before administering the injection. Keep the prefilled syringe in the outer packaging to protect it from light. Do notheat the prefilled syringe 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 needle cap until Step 7. |
Step 3: Remove the Prefilled Syringe | |
Hold the syringe bodyto remove the prefilled syringe from its tray. Do nothold the prefilled syringe by the plunger. | |
| Syringe body |
Step 4: Check the Prefilled Syringe | |
Check if the prefilled syringe is damaged. Do notuse the prefilled syringe if it is damaged. Check the expiration dateon the prefilled syringe. Do notuse the prefilled syringe 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 5: 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 6: 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 7: Remove the Needle Cap | |
Do notremove the needle cap until you are ready to inject. Hold the syringe body with one hand and carefully remove the needle cap with the other hand. Do nothold the plunger or plunger head while removing the needle cap. Set the needle cap aside and discard it later. You may see a drop of liquid at the end of the needle. This is normal. Do nottouch the needle or let it touch any surface. Do notput the needle cap back on the syringe. |
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Step 8: Inject Tezspire | |
Hold the prefilled syringe with one hand as shown. Use your other hand to pinch and gently hold the skin where you want to inject. This will make the skin firmer. Do notpress the plunger head until the needle is inserted into the skin. Do notpull the plunger head at any time. Inject Tezspire following the steps in figures a, b, and c. |
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Insert the needle completely into the pinched skin at a 45-degree angle. Do nottry to change the position of the prefilled syringe after inserting it into the skin. | Use your thumb to push the plunger head. Keep pushing until the end to make sure all the medicine is injected. | Keep your thumb pushing the plunger head while removing the needle from the skin. Slowly release the plunger until the needle guard covers the needle. |
Step 9: Check the Injection Site | |
There may be a small amount of blood or liquid where you injected. This is normal. Gently press 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: Safely Dispose of the Used Prefilled Syringe | |
Each prefilled syringe contains a single dose of Tezspire and cannot be reused. Do notput the needle cap back on the prefilled syringe. Put the used prefilled syringe and needle cap in a puncture-resistant containerimmediately after use. Put the other used materials in the household trash. Do notthrow the prefilled syringe 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 notdiscard the used puncture-resistant container in the household trash unless your community guidelines permit it. Do notrecycle your used puncture-resistant container. |
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a 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 PRE-FILLED SYRINGEDosage 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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