Fasenra 30 mg solucion inyectable en jeringa precargada

Patient Information Leaflet

Fasenra 30mg pre-filled syringe solution for injection

benralizumab

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

Whatis Fasenra

Fasenra contains the active ingredient benralizumab,which is a monoclonal antibody, that is, 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 particularly found in a type of white blood cell called eosinophil.

What is Fasenra used for

Asthma

Fasenra is used to treatsevere eosinophilic asthmain adults. Severe eosinophilic asthma is a type of asthma in which patients have too many eosinophils in the blood or lungs.

Fasenra is used in combination with other medications to treat asthma (high doses of «inhaled corticosteroids» plus other asthma medications) when the disease is not well controlled by those other medications alone.

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Fasenra is used to treat EGPA in adults. EGPA is a disease in which people have too many eosinophils in the blood and tissues and also have some form of vasculitis. This means that there is inflammation of the blood vessels. This disease most often affects the lungs and paranasal 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 medications called «oral corticosteroids», the use of Fasenra may also allow you to decrease your daily dose or discontinue the oral corticosteroid treatment you need to control your asthma.

EGPA

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

Do not use Fasenra:

• If you areallergicto benralizumab or to any of the other components of this medication (listed in section6).Consult your doctor, nurse or pharmacistif you think this affects you.

Warnings and precautions

Consult your doctor, nurse or pharmacist before using Fasenra:

• If you have aparasitic infectionor live in an area where parasitic infections are common or travel to such an area. This medication may reduce your ability to fight certain types of parasitic infections.
• If you have had anallergic reaction to an injection or medication in the past(see section4 to consult the symptoms of an allergic reaction).

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

• If yourasthma remains uncontrolled or worsensduring treatment with this medication.
• If you have any symptoms of anallergic reaction(see section4). Allergic reactions have occurred in patients receiving this medication.

Fasenrais not a rescue medication.Do not use it to treat a sudden asthma attack.

Be aware of signs of severe allergic reactions

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

It is essential that you consult with your doctor about how to recognize early symptoms of severe allergic reactions and how to manage them if they occur.

To improve the traceability of biologic medications, note the name and batch number included on the outer packaging and on the pre-filled syringe label each time you receive a new package of Fasenra and provide this information when reporting any adverse effects.

Other asthma or GEPA medications

Do not suddenly stopor change the dose of your other medications for your disease when starting Fasenra.

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

Inform your doctorif you are using, have used recently or may need to use any other medication before using Fasenra.

Children and adolescents

Do not administer this medication to children under 18 years of age because the safety and benefits of this medication in this population are unknown.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant,consult your doctorbefore using this medication.

Do not use Fasenra if you are pregnant unless your doctor tells you otherwise. The safety of Fasenra for the fetus is unknown.

The components of Fasenra may pass into breast milk.Speak with your doctorif you are breastfeeding or plan to do so.

Driving and operating machinery

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

Fasenra contains polysorbate 20

This medication contains 0.06mg of polysorbate20 (of vegetable origin) in each pre-filled syringe of 30mg. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Use this medicine exactly as your doctor has told you to. If you are unsure, consult your doctor, nurse, or pharmacist.

Asthma

The recommended doseis a 30mg injection. The first 3injections are administered every 4weeks. Subsequently, the injections are 30mg every 8weeks.

GEPA

The recommended doseis a 30mg injection every 4weeks.

Fasenra is administered via a subcutaneous injection. You and your doctor or nurse must decide if you should inject Fasenra yourself. Do not inject Fasenra yourself if you have not received Fasenra previously, or if you have had a previous allergic reaction to Fasenra.

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

Ifyou forget to use Fasenra

If you have forgotten to inject a dose of Fasenra, speak with your doctor, pharmacist, or nurse as soon as possible.

Ifyou interrupt the treatment with Fasenra

Do not interrupt the treatment with Fasenra unless your doctor recommends it. Stopping or suspending treatment with Fasenra may cause your symptoms to return and asthma exacerbations to occur.

If your asthma symptoms worsen while receiving Fasenra injections,speak with your doctor.

If you have any other questions about using this medicine, 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):

•anaphylaxis

The usual symptoms include:

oswelling in the face, tongue, or mouth

obreathing difficulties

olightheadedness, dizziness, or fainting (due to a drop in blood pressure)

Common(may affectup to 1 in 10 people)

• allergic reactions (hives, skin rash)

Other Adverse Effects

Common(may affectup to1 in 10people)

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

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.

Fasenra is for single use only.

Do not use this medication after the expiration date that appears on the label and on the box after ‘EXP/CAD’. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

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

The syringe can be stored at room temperature up to 25°C for a maximum of 14 days. After removing it from the refrigerator, Fasenra must be used within 14 days or discarded, and the disposal date must be written on the box.

Do not shake, freeze, or expose to heat.

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Compositionof Fasenra

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

The other components are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polisorbate20 (E432) and water for injection.

Appearance of the product and contents of the pack

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 Authorization Holder

AstraZeneca AB

SE‑151 85 Södertälje

Sweden

Responsible for manufacturing

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

Last update of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

<---------------------------------------------------------------------------------------------------------------->

Instructions for use

Fasenra 30mg solution for injection in a pre-filled syringe

benralizumab

For subcutaneous injection

Pre-filled syringe for single use

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 administer a new injection.This information does not replace a consultation with your healthcare professional about your disease or treatment.

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

Important information

Keep Fasenra in a refrigerator between 2°C and 8°C in its carton until you are ready to use it.Fasenra can be kept 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.

If any of the above occurs, discard the syringe and use a new one.

Each Fasenra pre-filled syringe contains one 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 activation clips of the needle guard to avoid activating the safety device (needle guard) too soon.

Step 1 – Gather the materials

• 1 Fasenra pre-filled syringe from the refrigerator
• 1 alcohol wipe
• 1 cotton ball or gauze
• 1 sharps container.

(See step 9 – Dispose of the used syringe)