Uses

Benralizumab is used along with other medications to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school.

This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed.

How To Use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using benralizumab and each time you receive this medication. If you have any questions, ask your doctor or pharmacist.

This medication is used by injection under the skin into the upper arm, thigh, or abdomen. It is given as directed by your doctor, usually once every 4 weeks for the first 3 doses and then once every 8 weeks.

If you are using the autoinjector, take it out of the refrigerator before use. Let it warm up to room temperature for at least 30 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into areas of skin that are tender, bruised, scaly, or hard.

Learn how to store and discard medical supplies safely.

Serious allergic reactions can happen during or even several days after your treatment. Careful monitoring by your doctor may decrease your risk. If you have a serious reaction, your treatment may be stopped. Get medical help right away if you have swelling of face/tongue/throat, trouble breathing, rash, or hives.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.

If you are regularly using a corticosteroid medication, you should not stop using it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop using the corticosteroid medication, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your corticosteroid medication after you begin using benralizumab. Tell your doctor or pharmacist right away if you have withdrawal.

Tell your doctor if you do not get better or if you get worse.

Side Effects

See also How to Use section.

Headache may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using benralizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• infection caused by worms (helminths)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Keep all medical and lab appointments.

Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.

Learn to use a peak flow meter, use it daily, and promptly report worsening breathing problems (such as readings in the yellow/red range, increased use of quick-relief inhalers).

Because the flu virus can worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store the autoinjector in the original package in the refrigerator. Protect from light. Do not freeze. If needed, the unopened carton can be stored at room temperature for up to 14 days. Once the autoinjector is removed from the refrigerator, use/discard within 14 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).