Brand name Fasenra

Form solution for injection

Active substance / Dosage

BENRALIZUMAB

Prescription type Restricted prescription – dispensable on hospital or specialist prescription

ATC code

R03DX10

Registration number 045931

Manufacturer ASTRAZENECA AB

Table of Contents

Package leaflet: Information for the patient
Fasenra 30 mg solution for injection in pre-filled syringe
1. What Fasenra is and what it is used for
2. What you need to know before using Fasenra
3. How to use Fasenra
4. Possible side effects
5. How to store Fasenra
6. Package contents and other information
Instructions for use
Fasenra 30 mg solution for injection in pre-filled syringe
Patient Information Leaflet
Fasenra 30 mg solution for injection in a pre-filled pen
1. What Fasenra is and what it is used for
2. What you need to know before using Fasenra
3. How to use Fasenra Pen
4. Possible side effects
5. How to store Fasenra Pen
6. Package contents and other information
Instructions for use
Fasenra 30 mg solution for injection in prefilled pen

Package leaflet: Information for the patient

Fasenra 30 mg solution for injection in pre-filled syringe

benralizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. 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, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Fasenra is and what it is used for
What you need to know before using Fasenra
How to use Fasenra
Possible side effects
How to store Fasenra
Contents of the pack and other information

1. What Fasenra is and what it is used for

What Fasenra is
Fasenra contains the active substance benralizumab, which is a monoclonal antibody, i.e. a type of protein that recognises a specific substance in the body as a target and binds to it.
The target of benralizumab is a protein called interleukin-5 receptor, which is found mainly on a type of white blood cells called eosinophils.

What Fasenra is used for
Asthma
Fasenra is used to treat severe eosinophilic asthma in adults. 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 asthma medicines (high-dose inhaled corticosteroids and other anti-asthma medicines) when the condition is not well controlled by these medicines alone.

Eosinophilic granulomatosis with polyangiitis (EGPA)
Fasenra is used to treat EGPA in adults. EGPA is a condition in which 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 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 reduce their numbers and reduce inflammation.

What benefits can be expected with Fasenra
Asthma
Fasenra may reduce the number of asthma attacks you experience, helping you breathe better and reducing asthma symptoms. If you are taking medicines called 'oral corticosteroids', using Fasenra may also allow you to reduce your daily dose or stop treatment with oral corticosteroids needed to control your asthma.

EGPA
Fasenra may reduce symptoms and prevent relapses 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 using Fasenra

Do not use Fasenra:

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

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

if you have a parasitic infection or live in an area where parasitic infections are common, or if you plan to travel to such areas. This medicine may weaken your ability to fight certain types of parasitic infections.
if you have previously experienced an allergic reaction to an injection or to this medicine (see section 4 for symptoms of an allergic reaction).

Additionally, talk to your doctor, nurse, or pharmacist if you are using Fasenra:

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

Fasenra is not a rescue medicine. Do not use it to treat an acute asthma attack.
Be alert for 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, rash, breathing difficulties, fainting, dizziness,
feeling lightheaded, and/or swelling of the face, tongue, or mouth) while taking Fasenra.
It is important that you discuss with your doctor how to recognize the early symptoms of
serious allergic reactions and how to manage them should they occur.
To improve traceability of biological medicines, each time you receive a new pack
of Fasenra, record the name and batch number shown on the outer packaging and on the
pre-filled syringe label, and provide this information when reporting any adverse reactions.
Other medicines for asthma or EGPA
Do not stop suddenly taking or change the dose of your other medications for your
condition once you have started treatment with Fasenra.
If your response to treatment allows, your doctor may consider reducing the dose of some of these
medicines, especially those called 'corticosteroids'. This must be done gradually and under the
direct supervision of your doctor.
Inform your doctor if you are taking, have recently taken, or might take any other
medicines, before using Fasenra.
Children and adolescents
Do not administer this medicine to individuals under 18 years of age, as the safety and benefits of
this medicine have not been established in this population.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medicine.
Do not use Fasenra during pregnancy unless otherwise directed by your doctor. It is not known whether Fasenra could harm the unborn baby.
It is not known whether the components of Fasenra pass into breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor.
Driving and using machines
It is unlikely that Fasenra will affect your ability to drive or operate machinery.
Fasenra contains Polysorbate 20
This medicine contains 0.06 mg of polysorbate 20 (of plant origin) in each 30 mg pre-filled syringe.
Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Fasenra

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, nurse, or pharmacist.

Asthma
The recommended dose is one 30 mg injection. You will receive the first three injections every 4 weeks.
Afterwards, the 30 mg injections will be given every 8 weeks.

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

Fasenra is administered via an injection under the skin (subcutaneously). You and your doctor or nurse must decide whether you should self-inject Fasenra.
You must not self-inject Fasenra if you have not previously been trained in the treatment with Fasenra, or if you have experienced allergic reactions to Fasenra.

You or the person assisting you must receive training on the correct way to inject Fasenra.
Read carefully the 'Instructions for use' for the pre-filled syringe before using Fasenra.

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

If you stop using Fasenra
Do not stop treatment with Fasenra unless otherwise instructed by your doctor. Stopping or interrupting treatment with Fasenra may cause symptoms and asthma attacks to return.

Contact your doctor if your asthma symptoms worsen during Fasenra injections.

If you have any questions about how to use this medicine, consult 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
Consult your doctor immediately if you think you are having an allergic reaction. These reactions
may occur within a few hours or several days after the injection.
Not known (frequency cannot be estimated from the available data):

anaphylaxis; symptoms generally include: swelling of the face, tongue or mouth, or breathing difficulties, or fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)

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

hypersensitivity reactions (such as urticaria, 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 at the site where the injection was given)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 stated on the label and the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Store in a refrigerator (2°C − 8°C).
The syringe may be kept at room temperature up to 25°C for a maximum of 14 days. Once removed from the refrigerator, Fasenra must be used within 14 days or else disposed of, and the disposal date must be written on the packaging.
Do not shake, freeze, or expose to heat sources.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Fasenra contains
The active substance is benralizumab. One 1 mL pre-filled syringe contains 30 mg of benralizumab.
The other ingredients are histidine, monohydrochloride monohydrate histidine, trehalose dihydrate, polysorbate 20 (E 432) and water for injections.

Description of the appearance of Fasenra and contents of the pack
Fasenra is a solution contained in a clear glass syringe. Its colour may vary from colourless to 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
The Netherlands

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

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

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf.: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija United Kingdom (Northern Ireland)
SIA AstraZeneca Latvija AstraZeneca UK Ltd
Tel: +371 67377100 Tel: +44 1582 836 836

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.
<------------------------------------------------------------------------------------------------------------------------>

Instructions for use

Fasenra 30 mg solution for injection in pre-filled syringe

benralizumab
For subcutaneous injection
Single-use pre-filled syringe
Before using your Fasenra pre-filled syringe, your healthcare provider must show you or the person assisting you how to use it correctly.
Read these ‘Instructions for Use’ before starting to use your Fasenra pre-filled syringe and each time you receive a new supply. There may be new information. These instructions do not replace discussions with your healthcare provider about your medical condition or your treatment.
If you or the person assisting you has any questions, please consult your healthcare provider.

Important information
Store Fasenra in the refrigerator between 2°C and 8°C in its carton until ready for use. Fasenra may be kept at room temperature up to 25°C for a maximum of 14 days. Once removed from the refrigerator, Fasenra must be used within 14 days or discarded.
Do not use the Fasenra pre-filled syringe if: Do not:

it has been frozen • shake the pre-filled syringe
it has been dropped or damaged • share or reuse the syringe
the safety seal on the pre-filled carton is broken
the expiration date (Exp.) has passed

If any of the above conditions apply, dispose of the syringe in a puncture-resistant sharps container and use a new pre-filled syringe.
Each Fasenra pre-filled syringe contains one dose of Fasenra and is for single use only.
Keep Fasenra and all medicines out of the sight and reach of children.

The Fasenra pre-filled syringe
Do not remove the needle cap until you reach Step 6 of these instructions and are ready to inject Fasenra.
Do not touch the activation clip of the needle safety device to avoid premature activation of the safety mechanism (needle protection).

Activation clip of
needle safety device Body of syringe Expiry date label Needle cap

Technical drawing of a syringe with plunger, cylindrical barrel, winged protective shield, and a separate needle covered by a protective cap

Plunger stopper
Plunger Finger flange Observation window Needle

Step 1 – Gather the supplies

1 Fasenra pre-filled syringe from the refrigerator
1 alcohol wipe
1 cotton ball or gauze pad
1 puncture-resistant sharps container. (See Step 9 – Disposal of used pre-filled syringe)

Red container for biological waste with white lid and black biohazard symbol centered

Technical drawing of a single-use syringe with plunger on the left, transparent cylindrical barrel, and a tip with connector on the right

Two square white pouches with gray borders and slightly indented, glossy central surfaces, overlapping each other

Stylized drawing of two irregular, rounded white tablets placed side by side

Pre-filled syringe Alcohol wipe Cotton ball or gauze Sharps container

Step 2 – Prepare to use your pre-filled syringe

Stylized icon of a circular stopwatch with black border, interior vertically divided between white and light blue, with an upper button

Check the expiration date (Exp.). Do not use if the expiration date has passed.
Before administration, allow the pre-filled syringe to reach room temperature (20–25°C) by leaving it outside the refrigerator for approximately 30 minutes.
Do not heat the pre-filled syringe in any other way. For example, do not warm it in a microwave, with hot water, or near other heat sources. Use Fasenra within 14 days of removal from the refrigerator.

Step 3 – Check the solution
Hold the body of the syringe ( do not touch the plunger) to remove the pre-filled syringe.

A hand holding vertically a transparent syringe with metallic plunger and cylindrical barrel against a white background

Look through the observation window. The solution should be clear and colorless to yellow. It may contain small white particles.
Do not inject Fasenra if the solution is cloudy, discolored, or contains large particles.
Small air bubbles in the solution may be visible. This is normal. No action is required.

Step 4 – Choose the injection site
The recommended injection site is the front of the thigh.
The lower abdomen may also be used.
Do not inject:

within 5 cm of the navel
where the skin is tender, bruised, scaly, or hard
into scars or damaged skin
through clothing

A person assisting you may inject into the upper arm, thigh, or abdomen.
Do not attempt to self-inject into the arm.
For each injection, select a different site at least 3 cm away from the previous injection site.

Step 5 – Clean the injection site
Wash hands thoroughly with soap and water.

A hand holding a white tissue and gently placing it onto a light skin surface

Clean the injection site using an alcohol wipe with a circular motion. Allow the area to air dry.
Do not touch the cleaned area before injecting.
Do not blow or fan the cleaned area.

Step 6 – Remove the needle cap
Hold the body of the syringe with one hand and firmly pull off the needle cap with the other hand.

Two hands connecting a needle to a syringe barrel with a gray arrow indicating leftward insertion movement

Do not touch the plunger or plunger stopper while removing the needle cap.
Set aside the needle cap for disposal later.
A small drop of liquid at the tip of the needle may be visible. This is normal.
Do not use the syringe if it was dropped without the needle cap in place or if the needle is damaged or soiled.
Do not touch the needle or allow it to contact any surface.
Proceed immediately to the next steps.

Step 7 – Inject Fasenra
Hold the pre-filled syringe in one hand as shown.

A hand holding a syringe with needle pointing downward and a finger pressing the plunger to inject liquid from the transparent cylinder

With the other hand, gently pinch and hold the skin at the injection site. This creates a more stable surface.
Do not press on the plunger until the needle is fully inserted into the skin.
Do not pull back on the plunger at any time.
Inject Fasenra by following the steps shown in figures a, b, and c.

Medical illustration showing two hands holding a syringe for administration

Two hands holding a medical injection pen with a gray arrow indicating downward pressure movement

a b c
Quickly and firmly insert the Use your thumb to push down Release pressure slowly from
needle at a 45-degree angle into the plunger stopper. Continue the plunger while removing
the pinched skin. pushing until it fully depresses. the needle from the skin.
This ensures delivery of the full Ensure the safety device covers
dose of medication. the needle.

Step 8 – Check the injection site
There may be a small amount of blood or fluid at the injection site.

A hand holding a white cotton ball and gently pressing it against a light skin surface

This is normal.
Gently apply pressure to the site with a cotton ball or gauze until bleeding stops.
Do not rub the injection site.
If needed, cover the injection site with a small bandage.

Step 9 – Dispose of the used pre-filled syringe

Each pre-filled syringe contains a single dose of Fasenra and must not be reused.
Immediately after use, place the used pre-filled syringe into a puncture-resistant sharps container.

Do not dispose of the pre-filled syringe in household waste.
Do not recap the pre-filled syringe.
Dispose of the needle cap and other used supplies in household waste.

Disposal guidelines
Dispose of the full sharps container according to instructions from your healthcare provider or pharmacist.
Do not recycle used sharps containers.

Patient Information Leaflet

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

benralizumab
Please read this entire leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Fasenra is and what it is used for
What you need to know before using Fasenra
How to use Fasenra Pen
Possible side effects
How to store Fasenra Pen
Contents of the pack and other information

1. What Fasenra is and what it is used for

What Fasenra is
Fasenra contains the active substance benralizumab, which is a monoclonal antibody, i.e. a type of protein that recognises a specific substance in the body as its target and binds to it. The target of benralizumab is a protein called the interleukin-5 receptor, which is found mainly on a type of white blood cells called eosinophils.
What Fasenra is used for
Asthma
Fasenra is used to treat severe eosinophilic asthma in adults. 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 medicines for the treatment of asthma (‘high-dose inhaled corticosteroids’ and other anti-asthma medicines) when the condition is not well controlled by these medicines alone.
Eosinophilic granulomatosis with polyangiitis (EGPA)
Fasenra is used to treat EGPA in adults. EGPA is a condition in which 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 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 reduce their numbers and the associated inflammation.
What benefits have been seen with Fasenra
Asthma
Fasenra may reduce the number of asthma attacks you are experiencing, helping you to breathe better and reducing asthma symptoms. If you are taking medicines called ‘oral corticosteroids’, treatment with Fasenra may also allow you to reduce your daily dose or stop treatment with oral corticosteroids needed to control your asthma.
EGPA
Fasenra may reduce symptoms and prevent relapses 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 using Fasenra

Do not use Fasenra:

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

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

if you have a parasitic infection, live in an area where parasitic infections are common, or plan to travel to regions where such infections are a risk. This medicine may reduce your ability to fight certain types of parasitic infections.
if you have previously experienced an allergic reaction to an injection or to this medicine (see section 4 for symptoms of an allergic reaction).

Additionally, speak with your doctor, nurse, or pharmacist if you are using Fasenra:

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

Fasenra is not a rescue medicine. Do not use it to treat sudden asthma attacks.
Be alert for 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, rash, breathing difficulties, fainting, dizziness,
feeling lightheaded, and/or swelling of the face, tongue, or mouth) while taking Fasenra.
It is important that you discuss with your doctor how to recognize the early symptoms of serious
allergic reactions and how to manage them if they occur.
To improve traceability of biological medicines, each time you receive a new Fasenra package,
record the name and batch number shown on the outer carton and on the prefilled pen label, and provide this information when reporting any adverse events.

Other medicines for asthma or EGPA
Do not stop suddenly taking or change the dose of any other medicines for your condition once you have started treatment with Fasenra.
If your response to treatment allows, your doctor may consider gradually reducing the dose of some of these medicines, especially those known as 'corticosteroids'. This must be done gradually and under direct medical supervision.
Inform your doctor if you are taking, have recently taken, or might take any other medicines, before using Fasenra.

Children and adolescents
Do not administer this medicine to individuals under 18 years of age, as the safety and benefit of this medicine have not been established in this population.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medicine.
Do not use Fasenra during pregnancy unless otherwise directed by your doctor. It is not known whether Fasenra could harm the unborn baby.
It is not known whether the components of Fasenra pass into breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor.

Driving and using machines
It is unlikely that Fasenra will affect your ability to drive or operate machinery.

Fasenra contains Polysorbate 20
This medicine contains 0.06 mg of polysorbate 20 (of plant origin) in each 30 mg prefilled pen. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Fasenra Pen

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, nurse, or pharmacist.

Asthma
The recommended dose is one 30 mg injection. You will receive the first three injections every 4 weeks.
Afterwards, the 30 mg injections will be given every 8 weeks.

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

Fasenra is administered via an injection under the skin (subcutaneously). You and your doctor or nurse must decide whether you should self-inject Fasenra. You must not self-inject Fasenra if you have not previously been trained in using Fasenra, or if you have experienced allergic reactions to Fasenra.

You or the person assisting you must receive training on the correct way to inject Fasenra.
Read the 'Instructions for use' for Fasenra Pen carefully before using Fasenra.

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

Stopping treatment with Fasenra
Do not stop treatment with Fasenra unless otherwise instructed by your doctor. Stopping or interrupting treatment with Fasenra may cause asthma symptoms and attacks to return.

Contact your doctor if your asthma symptoms worsen during treatment with Fasenra.

If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Severe allergic reactions
Consult your doctor immediately if you think you are experiencing an allergic reaction. These reactions
may occur within a few hours or several days after the injection.
Not known (frequency cannot be estimated from the available data):

anaphylaxis, symptoms of which generally include: swelling of the face, tongue or mouth, or breathing difficulties, or fainting, dizziness, feeling faint (due to a drop in blood pressure)

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

hypersensitivity reactions (urticaria, skin rash)

Other side effects
Common (may affect up to 1 in 10 people):

headache
pharyngitis (sore throat)
fever (high temperature)
reaction at the injection site (for example pain, redness, itching, swelling at or near the site where the injection was given)

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system referred to in Annex 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 on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Store in a refrigerator (2°C - 8°C).
Fasenra Pen may be kept at room temperature up to 25°C for a maximum of 14 days. Once removed from the refrigerator, Fasenra must be used within 14 days or disposed of, and the disposal date must be written on the packaging.
Do not shake, freeze, or expose to heat sources.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fasenra Pen contains
The active substance is benralizumab. One 1 mL pre-filled pen contains 30 mg of benralizumab.
The other components are histidine, monohydrochloride monohydrate of histidine, trehalose dihydrate, polysorbate 20 (E 432) and water for injections.

Description of the appearance of Fasenra and package contents
Fasenra is a solution ranging from 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
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder: