• 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.

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

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.

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 disease is not well controlled by those other medicines alone.

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

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.

• 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.

Talk to your doctor, nurse or pharmacist before you are given 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 are given 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.

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.

Do not suddenly stop taking or change the dose of your preventer medicines for your asthma 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.

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

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

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.

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

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

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.

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

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:
  • swelling of your face, tongue, or mouth
  • breathing problems
  • 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)

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

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

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 Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 and water for injections.

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

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