FASENRA 30 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the Patient

Fasenra 30mg solution for injection in pre-filled syringe

benralizumab

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

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

1. What is Fasenra and what is it used for

Whatis Fasenra

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

What is Fasenra used for

Asthma

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

Fasenra is used in addition to other medicines for asthma (high doses of ‘inhaled corticosteroids’ plus other anti-asthma medicines) when the disease is not well controlled with these other medicines alone.

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Fasenra is used to treat EGPA in adults. EGPA is a disease where people have too many eosinophils in their blood and tissues and also have some form of vasculitis. This means there is inflammation of the blood vessels. This disease most commonly affects the lungs and the sinuses, but often affects other organs such as the skin, heart, and kidneys.

How Fasenra works

Eosinophils are white blood cells involved in the inflammation of asthma and EGPA. By binding to eosinophils, Fasenra helps to reduce their frequency and inflammation.

Benefits of using Fasenra

Asthma

Fasenra may reduce the frequency of asthma attacks you are experiencing, helping you to breathe better and reducing your asthma symptoms. If you are using medicines called ‘oral corticosteroids’, using Fasenra may also allow you to reduce the daily dose or stop treatment with oral corticosteroids you need to control your asthma.

EGPA

Fasenra may reduce the 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.

2. What you need to know before you use Fasenra

Do not use Fasenra:

• If you are allergicto benralizumab or any of the other ingredients of this medicine (listed in section 6). Talk to your doctor, nurse or pharmacistif you think this applies to you.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before using Fasenra:

parasitic infectionor live in an area where parasitic infections are common or travel to such an area. This medicine may reduce your ability to fight certain types of parasitic infections.allergic reaction to an injection or medicine in the past(see section 4 for symptoms of an allergic reaction).

Also, talk to your doctor, pharmacist or nurse if you are receiving Fasenra:

asthma remains uncontrolled or worsensduring treatment with this medicine.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.

Be aware of the signs of serious allergic reactions

Fasenra may potentially cause serious allergic reactions. You should be aware of the signs of these reactions (such as hives, skin rash, difficulty breathing, fainting, discomfort, feeling dizzy and/or swelling of the face, tongue or mouth) while you are receiving Fasenra.

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

In order to improve the traceability of biological medicinal products, the name and batch number of the product should be clearly recorded in the patient file each time the product is administered, and this information should be reported when reporting any adverse reactions.

Other medicines for asthma or EGPA

Do not suddenly stopor change the dose of your other medicines for your disease when you start Fasenra.

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

Tell your doctorif you are using, have recently used, or might use any other medicines before using Fasenra.

Children and adolescents

Do not give this medicine to children under 18 years of age because the safety and benefits of this medicine in this population are not known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctorfor advice before using this medicine.

Do not use Fasenra if you are pregnant unless your doctor tells you to. It is not known if Fasenra can affect the fetus.

It is not known if the components of Fasenra can pass into breast milk. Talk to your doctorif you are breastfeeding or plan to breastfeed.

Driving and using machines

Fasenra is unlikely to affect your ability to drive or use machines.

Fasenra contains polysorbate 20

This medicine contains 0.06 mg of polysorbate 20 (of vegetable origin) in each 30 mg pre-filled syringe. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergy.

3. How to use Fasenra

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 doseis one 30 mg injection. The first three injections are given every 4 weeks. After that, the injections are given every 8 weeks.

EGPA

The recommended doseis one 30 mg injection every 4 weeks.

Fasenra is given by injection just under the skin (subcutaneously). You and your doctor or nurse should decide if you should inject Fasenra yourself. You should not inject Fasenra yourself if you have not received Fasenra before, or if you have had a previous allergic reaction with Fasenra.

You or your caregiver should receive training on the correct way to inject Fasenra. Read the ‘Instructions for Use’ for the pre-filled syringe carefully before using Fasenra.

If youmiss a doseof Fasenra

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

If youstop treatment with Fasenra

Do not stop treatment with Fasenra unless your doctor advises you to. Stopping or interrupting treatment with Fasenra may cause your symptoms to come back and asthma exacerbations.

If your asthma symptoms worsen while you are receiving Fasenra injections, talk to 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

See a doctor immediatelyif you think you may be having an allergic reaction. These reactions can occur hours or days after the injection.

Frequency not known(cannot be estimated from the available data):

• anaphylaxis

Common symptoms include:

o swelling of the face, tongue or mouth

o breathing problems

o fainting, dizziness, lightheadedness (due to a drop in blood pressure)

Common(may affect up to 1 in 10 people)

• hypersensitivity reactions (hives, skin rash)

Other side effects

Common(may affect up to 1 in 10 people)

• headache
• pharyngitis (sore throat)
• fever (high temperature)
• injection site reaction (e.g. pain, redness, itching, swelling near the injection site)

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. Storage of Fasenra

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

Fasenra is for single use only.

Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP/CAD’. The expiry date is the last day of the month shown.

Store in the original package to protect from light.

Store in a refrigerator (2°C to 8°C).

The pre-filled syringe can be stored at room temperature (up to 25°C) for a maximum of 14 days. After removal from the refrigerator, Fasenra should 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.

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

Compositionof Fasenra

The active substance is benralizumab. A 1 ml pre-filled syringe of solution contains 30 mg of benralizumab.

The other components are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20 (E 432), and water for injectable preparations.

Appearance and Container Contents of the Product

Fasenra is a solution in a transparent glass syringe. Its color varies between colorless and yellow. It may contain particles.

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

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

You can request more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

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Instructions for Use

Fasenra 30 mg solution for injection in pre-filled syringe

benralizumab

For subcutaneous injection

Single-use pre-filled syringe

Before starting to use Fasenra pre-filled syringe, a healthcare professional should teach you or your caregiver how to use it correctly.

Read these “Instructions for Use” before starting to use Fasenra pre-filled syringe and each time you have to perform a new injection.There may be new information. This information does not replace consultation with your healthcare professional regarding your disease or treatment.

If you or your caregiver has any questions, consult your healthcare professional.

Important Information

Store Fasenra in a refrigerator between 2°C and 8°C in its carton until you are ready to use it.Fasenra may be stored 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.

If any of the above occurs, discard the syringe in a puncture-resistant container for sharp objects and use a new pre-filled syringe.

Each Fasenra pre-filled syringe contains 1 dose of Fasenra, which is for single use only.

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

Your Fasenra pre-filled syringe

Do not removethe needle cap until you have reached Step 6 and are ready to inject Fasenra.

Do not touchthe needle shield activation clips to avoid activating the safety device (needle shield) too early.

Step 1 – Gather materials

• 1 Fasenra pre-filled syringe from the refrigerator
• 1 alcohol swab
• 1 cotton ball or gauze
• 1 puncture-resistant container for sharp objects.

(See Step 9 – Dispose of the pre-filled syringe)