30 mg injection, in pre-filled pen
bevacizumab
1. What Fasenra is and what it is used for
What Fasenra is
Fasenra is a drug that contains the active substance bevacizumab, which is a monoclonal antibody, ie a type of protein that recognizes and attaches to a specific target substance in the body. The target of benralizumab is a protein called the interleukin ‑5‑ receptor, which is specifically found on a type of white blood cell called the eosinophil.
What Fasenra is used for
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 their blood or lungs.
Fasenra is used with other medicines to treat asthma (high doses of ‘inhaled corticosteroids’ plus other asthma medicines) when the disease cannot be kept under control with the other medicines alone.
How Fasenra works
Eosinophils are white blood cells that are involved in asthma inflammation. By attaching to the eosinophils, Fasenra helps reduce their number.
What are the benefits of using Fasenra?
Phase cleansing can reduce your asthma attacks, help you breathe better, and reduce your asthma symptoms. If you are taking medicines called oral corticosteroids, using Fasenra may also allow you to reduce your daily dose or stop taking the oral corticosteroids you need to control your asthma.
2. What you need to know before using Fasenra
Do not use Fasenra
- if you are allergic to benralizumab or any of the other ingredients of this medicine (listed in section 6). If you have any further questions, ask your doctor, nurse, or pharmacist.
Warnings and cautions
Talk to your doctor, nurse, or pharmacist before using Fasenra:
- if you have a parasitic infection or if you live in an area where parasitic infections are common or travel to such an area. This medicine may weaken your ability to fight certain types of parasite infections.
- if you have previously had an allergic reaction to an injection or medicine(the symptoms of an allergic reaction are described in section 4).
Also talk to your doctor, nurse, or pharmacist when using Fasenra:
- if you still do not get control of your asthma or it gets worse while you are being treated with this medicine.
- if you get any symptoms of an allergic reaction (see section 4). There have been allergic reactions in patients who have received this medicine.
Be aware of signs of severe allergic reactions
Fasenra can potentially cause severe allergic reactions. You must be aware of signs of these reactions (such as hives, rash, difficulty breathing, fainting, dizziness, fainting, and/or swelling of the face, tongue, or mouth) while taking Fasenra.
You must talk to your doctor about recognizing early symptoms of severe allergic reactions and how to deal with these reactions if they occur.
Other medicines for asthma
Do not suddenly stop taking your asthma preventative medicines once you have started taking Fasenra.
If your response to treatment allows it, your doctor may try to reduce the dose of one of these drugs, especially those called corticosteroids. This must be done gradually, under the direct supervision of a physician.
Other medicines and Fasenra
Tell your doctor if you are taking, have recently taken, or might take any other medicines, before using Fasenra.
Children and young people
The safety and usefulness of this medicine are not known in children under 18 years of age.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
If you are pregnant, do not use Fasenra unless your doctor tells you to. It is not known if Fasenra can harm your unborn baby.
It is not known whether the ingredients in Fasenra can pass into breast milk. If you are breast-feeding or planning to breast-feed, talk to a doctor.
Driving and using machines
It is unlikely that Fasenra will affect your ability to drive and use machines.
3. How to use Fasenra
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, nurse, or pharmacist.
Phase row is given as an injection just under the skin ( subcutaneously ). You and your doctor or nurse should decide if you can inject Fasenra yourself. You should not inject Fasenra yourself if you have not previously been treated with Fasenra and if you have previously had an allergic reaction to Fasenra.
You or your carer must correctly receive training to prepare and inject Fasenra. Read the instructions for use for the pre-filled syringe carefully before using Fasenra.
The recommended dose is an injection of 30 mg. The first 3 injections are given every four weeks. Thereafter, 30 mg is injected every eight weeks.
If you forget a dose of Fasenra
If you forget to inject a dose of Fasenra, talk to your doctor, pharmacist, or nurse as soon as possible.
Interruption of treatment with Fasenra
You should not stop taking Fasenra unless your doctor tells you to. If you interrupt or stop treatment with Fasenra altogether, your asthma symptoms and seizures may return.
If your asthma symptoms worsen while you are being injected with Fasenra, contact your doctor.
If you have any further questions on the use of this product, 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
Seek medical attention immediately if you think you may have had an allergic reaction. Such reactions may occur within a few hours or days after injection.
Has been reported (occurs in an unknown number of users):
- allergic reaction
the symptoms are usually:
- swelling of the face, tongue, or mouth
- breathing difficulties
- fainting, dizziness, fainting (due to drop in blood pressure)
Common (may affect up to 1 in 10 people )
- hives
- rash
Other side effects ar
Common (may affect up to 1 in 10 people )
- headache
- pharyngitis (sore throat)
- fever
- injection site reaction (eg pain, redness, itching, swelling near the injection site )
5. How to store Fasenra
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 after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light.
Store in a refrigerator (2 o C ‑ 8 o C).
The pen can be stored at room temperature (at a maximum of 25 ° C) for a maximum of 14 days. After Fasenra has been removed from the refrigerator, it must be used within 14 days or discarded.
Do not shake, freeze or expose to heat.
Phase row is for single use only. 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 to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is benralizumab. One pre-filled pen with 1 ml solution contains 30 mg benralizumab.
The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate, and water for injections.
What the medicine looks like and the contents of the pack
Phase pure is a solution that is colorless to yellow. The drug may contain particles.
Fasenra is marketed in a package with 1 pre-filled pen.
Manufacturer
MedImmune UK Ltd
6 Renaissance Way
Liverpool, L24 9JW
UK
MedImmune Pharma BV, Nijmegen
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 | LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550 |
| BulgariaAstrology Bulgaria BODYTel: +359 24455000 | Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11 |
| Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111 | HungaryAstraZeneca Kft.Tel .: +36 1 883 6500 |
| DenmarkAstraZeneca A / STel: +45 43 66 64 62 | MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000 |
| GermanyAstraZeneca GmbHTel: +49 41 03 7080 | The NetherlandsAstraZeneca BVTel: +31 79 363 2222 |
| EestiAstraZenecaTel: +372 6549 600 | NorwayAstraZeneca ASTel: +47 21 00 64 00 |
| GreeceAstraZeneca AE:Ηλ: +30 210 6871500 | AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0 |
| SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00 | PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 245 73 00 |
| FranceAstraZenecaTel: +33 1 41 29 40 00 | PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00 |
| CroatiaAstraZeneca dooTel: +385 1 4628 000 | RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41 |
| IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100 | SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicAstraZeneca AB, ozTel: +421 2 5737 7777 |
| ItalyAstraZeneca SpATel: +39 02 9801 1 | Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010 |
| LatviaSIA AstraZeneca LatvijaTel: +371 67377100 | United KingdomAstraZeneca UK LtdTel: +44 1582 836 836 |