InfoCons Consumer Protection informs you – Fasenra – Package Leaflet

Before anything else

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.

ℹ️ 1. What Fasenra is and what it is used for

What Fasenra is Fasenra contains the active substance benralizumab , which is a monoclonal antibody, a type of protein that recognises and attaches to a specific target substance in the body. The target of benralizumab is a protein called interleukin -5 receptor, which is found particularly on a type of white blood cell called an eosinophil .

What Fasenra is used for

Asthma Fasenra is used to treat severe eosinophilic asthma in adults . Eosinophilic asthma is a type of asthma where patients have too many eosinophils in the blood or lungs.

Fasenra is used together with other medicines to treat asthma ( high doses of ‘corticosteroid inhalers’ plus other asthma medicines) when the condition is not well controlled by those other medicines alone .

Eosinophilic granulomatosis with polyangiitis (EGPA) Fasenra is used to treat EGPA in adults. EGPA is a condition where people have too many eosinophils in the blood and tissues and also have a form of vasculitis. This means there is inflammation of the blood vessels. This condition most commonly affects the lungs and sinuses but often affects othe r organs such as the skin, heart and kidneys .

Hypereosinophilic syndrome (HES) Fasenra is used to treat HES in adults and adolescents 12 years and older weighing at least 35 kg.

Patient s with HES have a high number of eosinophils in the blood. These cells can damage organs in the body, particularly heart, lungs, nerves and skin.

How Fasenra works

Eosinophils are white blood cell s involved in asthma , EGPA and HES inflammation. By attaching to the eosinophils, Fasenra helps to reduce their numbers and inflammation .

48 What are the benefits of using Fasenra Asthma Fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and decrease your asthma symptoms. If you are taking medicines called ‘oral corticosteroids ’, using Fasenra may also allow you to reduce the daily dose or stop the oral corticosteroids you need to control your asthma.

EGPA Fasenra can reduce symptoms and prevent flare -ups of EGPA . This medicine may also allow you to reduce the daily dose of oral corticosteroids you need to control your symptoms.

HES Fasenra helps reduce your symptoms and prevent flares of HES .

⚠️ 2. What you need to know before you use Fasenra

Do not use Fasenra

• If you are allergic to benralizumab or any of the other ingredients of this medicine (listed in section 6). Check with your doctor, nurse or pharmacist if you think this applies to you.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you use Fasenra :

• if you have a parasitic infection or if you live in an area where parasitic infections are common or you are travelling to such a region . This medicine may weaken your ability to fight certain types of parasitic infections .
• if you have had an allergic reaction to an injection or medicine in the past (see section 4 for symptoms of an allergic reaction).

Also, talk to your doctor, nurse or pharmacist when you use Fasenra:

• if your asthma remains uncontrolled or worsens during treatment with this medicine.
• if you have any symptoms of an allergic reaction (see section 4). Allergic reactions have occurred in patients receiving this medicine.

Fasenra is not a rescue medicine . Do not use it to treat a sudden asthma attack.

Look out for signs of serious allergic reactions Fasenra can potentially cause serious allergic reactions. You must look out for signs of these reactions (such as hives, rash, breathing problems, fainting, dizziness, feeling lightheaded and/or swelling of your face, tongue or mouth) while you are taking Fasenra.

It is important that you talk to your doctor about how to recognise early symptoms of serious allergic reactions and how to manage these reactions if they occur .

In order to improve the traceability of biological medicinal products, record the name and the lot number , included on the outer carton and the label of the pre-filled pen, every time you get a new package of Fasenra and provide this information when reporting any side effects.

Other medicines for asthma , EGPA and HES Do not suddenly stop taking or change the dose of your other medicines for your condition once you have started Fasenra .

If your response to the treatment allows it, your doctor may try to reduce the dose of some of these medicines, especially ones called ‘corticosteroids’. This should be done gradually and under the direct supervision of your doctor .

Tell your doctor if you are taking, have recently taken or might take any other medicines before using Fasenra .

Children and adolescents

Do not give this medicine to children with asthma and EGPA below the age of 18 because the safety and benefits of this medicine are not known in this population .

Do not give this medicine to children with HES below the age of 12 or adolescents 12 years of age and older weighing less than 35 kg. The safety and benefits of this medicine are not known in this population.

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 using this medicine.

Do not use Fasenra if you are pregnant unless your doctor tells you otherwise. It is not known whether Fasenra could harm your unborn baby.

It is not known whether the ingredients of Fasenra can pass into breast milk. If you are breast -feeding or plan to breast -feed, talk to your doctor .

Driving and using machines

It is unlikely that Fasenra will affect your ability to drive and use machines.

Fasenra contains Polysorbate 20

This medicine contains 0.06 mg of polysorbate 20 (plant -derived) in each 30 mg pre -filled pen.

Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

💊 3. How to use Fasenra Pen

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

Asthma The recommended dose is an injection of 30 mg. The first 3 injections are every 4 weeks. After this, injections are 30 mg every 8 weeks.

EGPA The recommended dose is an injection of 30 mg every 4 weeks.

HES The recommended dose is an injection of 30 mg every 4 weeks.

Fasenra is given as an injection just under the skin (subcutaneously). You and your doctor or nurse should decide if you should inject F asenra yourself . You should not inject Fasenra yourself if you have not received Fasenra previously and if you had previous allergic reaction with Fasenra.

You or your caregiver should receive training on the right way to inject Fasenra. Read the ‘Instructions for Use’ for the Fasenra Pen carefully before using Fasenra.

If you forget to use Fasenra

If you have forgott en to inject a dose of Fasenra, talk to your doctor, pharmacist or nurse as soon as possible.

Stopping treatment with Fasenra Do not stop treatment with Fasenra unless your doctor advises you to. Interrupting or stopping the treatment with Fasenra may cause your asthma symptoms and attacks to come back.

50 If your asthma symptoms get worse while receiving injections of Fasenra , call your doctor .

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)

• anaphylaxis symptoms usually include: o swelling of your face, tongue, or mouth o breathing problems o fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)

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

• hypersensitivity reactions ( hives , rash)

Other side effects

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

• headache (in patients with EGPA or HES: very common [may affect more than 1 in 10 people ])
• pharyngitis (sore throat)
• fever (high temperature)
• injection site reaction ( for example pain, redness, itching, swelling near where the injection was given)

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 national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Fasenra Pen

Keep this medicine out of the sight and reach of children.

Fasenra Pen is for single -use only.

Do not use this medicine after the expiry date which is stated on the label and the carton after ‘EXP’ .

The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

Store in a refrigerator (2 °C to 8 °C).

The Fasenra Pen may be kept at room temperature up to 25 °C for a maximum of 14 days. After removal from the refrigerator, Fasenra must be used within 14 days or discarded , and the discard date should be written on the carton .

Do not shake, freeze or expose to heat.

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 Fasenra Pen contains

The active substance is benralizumab. One pre -filled pen of 1 mL solution contains 30 mg benralizumab.

The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20 (E 432) and water for injections.

What Fasenra looks like and contents of the pack

Fasenra is a clear solution which is colourless to yellow. It may contain particles .

Fasenra is available in a pack containing 1 pre -filled pen.

Marketing Authorisation Holder

AstraZeneca AB SE-151 85 Södertälje Sweden

Manufacturer

AstraZeneca AB Gärtunavägen SE-152 57 Södertälje Sweden MedImmune UK Ltd 6 Renaissance Way Liverpool, L24 9JW United Kingdom AstraZeneca Nijmegen B.V., Nijmegen Lagelandseweg 78 Nijmegen, 6545CG Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 България АстраЗенека България ЕООД Тел.: +359 24455000 Luxembourg/Luxemburg AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11 Česká 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 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 Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305 Sverige AstraZeneca AB Tel: +46 8 553 26 000 Latvija SIA AstraZeneca Latvija Tel: + 371 67377100

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . <———————————————————————————————————————— > 53 Instructions for Use Fasenra 30 mg solution for injection in pre-filled pen benralizumab For subcutaneous injection Single -use pre-filled pen Before using your Fasenra Pen, your healthcare provider should show you or your caregiver how to use it correctly.

Read this ‘Instructions for Use ’ before you start using your Fasenra Pen and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

If you or your caregiver have any questions, talk to your healthcare provider.

Important information Store Fasenra in a refrigerator between 2 °C to 8 °C in its carton until you are ready to use it.

Fasenra may be kept at room temperature up to 25 °C for a maximum of 14 days. After removal from the refrigerator, Fa senra must be used within 14 days or discarded .

Do not use your Fasenra Pen if

• it has been frozen
• it has been dropped or damaged
• the security seal on the carton has been broken
• the expiry date (EXP) has passed Do not:
• shake your Fasenra Pen
• share or re -use your Fasenra Pen If any of the above happens, throw away the Fasenra Pen in a puncture -resistant sharps container and use a new Fasenra Pen.

Each Fasenra Pen contains 1 dose of Fasenra that is for one -time use only.

Keep Fasenra and all medicines out of the sight and reach of children.

Your Fasenra Pen Do not remove the cap until you have reached Step 6 of these instructions and are ready to inject Fasenra.

Before Use After Use Step 1 – Gather supplies

• 1 Fasenra Pen from the refrigerator
• 1 alcohol wipe
• 1 cotton ball or gauze
• 1 puncture -resistant sharps container.

(See Step 10 – Dispose of the used Fasenra Pen safely ) Needle Guard Label with expiry date Liquid medicine Viewing window Cap Green plunger Fasenra Pen Alcohol wipe Cotton ball or gauze Sharps container Step 2 – Prepare to use your Fasenra Pen Check the expiry date (EXP). Do not use if the expiry date has passed.

Prior to administration, allow the pre -filled pen to reach room temperature 20 °C to 25 °C by leaving the carton out of the refrigerator for about 30 minutes.

Do not warm the Fasenra Pen in any other way. For example, do not warm it in a microwave or hot water, or put it near other heat sources.

Use Fasenra within 14 days of removing from the refrigerator.

Do not remove the cap until you have reached Step 6.

Step 3 – Check the liquid Look at the liquid in the Fasenra Pen through the viewing window. The liquid should be clear and colourless to yellow. It may contain small white particles.

Do not inject Fasenra if the liquid is cloudy, discoloured, or contains large particles.

You may see a small air bubble in the liquid. This is normal. You do not need to do anything about it.

Step 4 – Choose the injection site The recommended injection site is the front of your thigh. You may also use the lower part of your abdomen.

Do not inject:

• into the 5 cm area around your belly -button
• where the skin is tender, bruised, scaly or hard
• into scars or damaged skin
• through clothing A caregiver may inject you in the upper -arm, thigh, or abdomen.

Do not try to inject yourself in the arm.

For each injection, choose a different site that is at least 3 cm away from where you last injected.

Caregiver site only min 55 Step 5 – Clean the injection site Wash your hands well with soap and water.

Clean the injection site with an alcohol wipe in a circular motion. Let it air dry.

Do not touch the cleaned area before injecting.

Do not fan or blow on the cleaned area.

Step 6 – Pull off the cap Hold the Fasenra Pen with 1 hand. Carefully pull the cap straight off with your other hand.

Put the cap aside to throw away later.

The green needle guard is now exposed. It is there to prevent you from touching the needle.

Do not try to touch the needle or push on the needle guard with your finger.

Do not try to put the cap back on the Fasenra Pen. You could cause the injection to happen too soon or damage the needle .

Complete the following steps right away after removing the cap.

Step 7 – Inject Fasenra Follow your healthcare provider’s instructions on how to inject. You can either gently pinch at the injection site or give the injection without pinching the skin.

Inject Fasenra by following the steps in figures a, b, c and d.

Hold the Fasenra Pen in place for the entire injection.

Do not change the position of the Fasenra Pen after the injection has started.

Position the Fasenra Pen at the injection site .

Place the needle guard of the Fasenra Pen flat against your skin (90 -degree angle). Make sure you can see the viewing window. a 90° Press down firmly.

You will hear a click. A ‘click’ tells you the injection has started.

The green plunger will move down in the viewing window during the injection. Hold down firmly for 15 seconds.

You will hear a second ‘click ’.

The second click tells you the injection has finished. The green plunger will fill the viewing window. Lift the Fasenra Pen straight up.

The needle guard will slide down and lock into place over the needle.

Step 8 – Check the viewing window Check the viewing window to make sure all the liquid has been injected.

If the green plunger does not fill the viewing window, you may not have received the full dose. If this happens or if you have any other concerns, call your healthcare provider .

Before Injection After Injection Step 9 – Check the injection site There may be a small amount of blood or liquid where you injected.

This is normal.

Gently hold pressure over your skin with a cotton ball or gauze until the bleeding stops.

Do not rub the injection site.

If needed, cover the injection site with a small bandage. b c sec d 57 Step 10 – Dispose of the used Fasenra Pen safely

• Each Fasenra Pen contains a single dose of Fasenra and cannot be re-used.
• Put your used Fasenra Pen in a puncture -resistant sharps container right away after use.

Do not throw away the Fasenra Pen in your household waste.

Throw away the cap and other used supplies in your household waste.

Disposal guidelines Dispose of the full container as instructed by your healthcare provider or pharmacist.

Do not recycle your used sharps container.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Fasenra (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/17/1252).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.