Allergic reactions (e.g., hives, rash) have occurred in patients receiving benralizumab. These reactions often happen within minutes to hours after an injection, but sometimes symptoms can start several days later. Tell your healthcare professional and get immediate emergency medical attention if you have any of the following symptoms of an allergic reaction:

• swelling of your face, eyelids, lips, tongue, or mouth
• difficulty breathing, very wheezy, cough, chest tightness
• fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)
• hives
• rash

Other common side effects that can occur include:

• headache
• sore throat
• fever
• injection site reactions (e.g., pain, redness, itching, swelling near where the injection was given)

Severe eosinophilic asthma is a type of asthma where patients have increased eosinophils in the blood or lungs. Eosinophils are a type of white blood cell that are associated with inflammation of the airways that can cause asthma to get worse or can increase the number of asthma attacks. Benralizumab is a unique monoclonal antibody that binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) thereby reducing the number of eosinophils in the blood and lungs.

Benralizumab may be administered by a healthcare professional or it may be decided that you can do the injections yourself. If doing your own injections, you should receive training on how to prepare and administer the injections. Read the instructions for use carefully.

Safety in patients less than 18 years of age has not been established.

This medication is for regular use to control your health condition.  Do not use to treat sudden, severe breathing problems.

Do not suddenly stop taking your other asthma medications once you have started benralizumab. These medicines (especially corticosteroids) must be stopped gradually, under the direct supervision of your doctor.

Do not stop receiving this medication unless advised by your doctor. Interrupting or stopping the treatment may cause your asthma symptoms to become worse or cause an asthma attack.

Pregnancy and breastfeeding:

• At this time, there is little information about the safety of benralizumab in pregnancy and lactation.  Please discuss with your physician and pharmacist before using.