Benralizumab Injection

Benralizumab injection is used along with other medications to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 6 years and older whose asthma is not controlled with their current asthma medication. Benralizumab injection is also used to treat eosinophilic granulomatosis with polyangiitis (EGPA; a condition that involves asthma, high levels of white blood cells, and blood vessel swelling) in adults. Benralizumab injection is in a class of medications called monoclonal antibodies. It works by reducing a certain type of white blood cell to help decrease swelling and irritation of the airways to allow for easier breathing.

Benralizumab injection comes as a solution (liquid) to inject subcutaneously (just under the skin). To treat asthma, it is usually given once every 4 weeks for the first 3 doses, then given once every 8 weeks. To treat eosinophilic granulomatosis with polyangiitis, it is usually given once every 4 weeks. Your doctor will determine the length of your treatment based on your condition and how well you respond to the medication.

Benralizumab injection comes in a prefilled syringe to be given by a doctor or nurse in the upper arm, thigh or abdomen at a clinic or office. If you are an adult or a child over the age of 11 years, your doctor may allow you or a caregiver to give benralizumab injection at home using an autoinjector (Fasenra Pen). Your doctor or nurse will show you or the person who will be injecting the medication how to use the autoinjector. Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to inject a dose of benralizumab injection using an autoinjector. Make sure you ask your pharmacist or doctor if you have any questions about how to inject this medication.

Always look at benralizumab injection before injecting it. Check that the expiration date on the autoinjector device has not passed. Look through the viewing window on the autoinjector device. The liquid inside should be clear and colorless to slightly yellow, but may contain some small white particles or an air bubble. Do not use the device if the medication is cloudy, discolored, or contains large particles.

You can inject benralizumab injection anywhere on the front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If you have a caregiver to inject the medication, the back of the upper arm may also be used. Choose a different spot each time you inject the medication, at least 1 inch (2.5 centimeters) away from a spot that you have used before. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

Use each autoinjector device only once and inject all the solution in device. Even if there is still some solution left in the device, do not use it again. Dispose of used devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Do not decrease your dose of any other asthma medication or stop taking any other medication that has been prescribed by your doctor unless your doctor tells you to do so. Your doctor may want to decrease the doses of your other medications gradually.

Benralizumab injection is not used to treat a sudden attack of asthma symptoms. Your doctor will prescribe a short-acting inhaler to use during attacks. Talk to your doctor about how to treat symptoms of a sudden asthma attack. If your asthma symptoms get worse or if you have asthma attacks more often, be sure to talk to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving benralizumab injection,

• tell your doctor and pharmacist if you are allergic to benralizumab, any other medications, or any of the ingredients in benralizumab injection. Ask your pharmacist for a list of the ingredients or check the manufacturer's patient information.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have a parasite infection.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving benralizumab injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Call your doctor if you forget to inject a dose of this medication. Your doctor will tell you when to inject the missed dose and when to inject your next scheduled dose.

If you miss an appointment to receive a dose of benralizumab injection, call your doctor to reschedule the appointment.

Benralizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• sore throat

Some side effects can be serious. If you experience any of these symptoms or those in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• wheezing or difficulty breathing
• hives
• rash
• swelling of the face, mouth, and tongue
• fainting or dizziness

Benralizumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about benralizumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Fasenra^®
• Fasenra Pen^®