What is this medicine?

BENRALIZUMAB (BEN ra LIZ oo mab) is used to help treat severe asthma. It should be used in combination with other asthma treatments.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Fasenra

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • parasitic (helminth) infection
  • an unusual or allergic reaction to benralizumab, hamster proteins, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It may be administered by a healthcare professional in a hospital or clinic setting or at home. If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used injectors, needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor of health care professional if you are unable to keep an appointment. If you give yourself the medicine and you miss a dose, call your doctor or health care professional for advice.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your healthcare professional for regular checks on your progress. NEVER use this medicine for an acute asthma attack. Tell your healthcare professional if your symptoms do not start to get better or if they get worse.

Do not stop taking your other asthma medicines unless instructed to do so by your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls
  • signs and symptoms of infection like fever or chills; cough; sore throat

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

  • headache
  • pain, redness, or irritation at the site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store unopened syringes or injectors in a refrigerator between 2 to 8 degrees C (36 to 46 degrees F). Keep in the original container until ready for use. Protect from light. Do not freeze. Do not shake. Prior to use, remove the syringe or injector from the refrigerator and use after 30 minutes at room temperature. Throw away any unused medicine after the expiration date on the label.

If needed, the unopened syringe or injector may be stored at room temperature up to 25 degrees C (77 degrees F) for a maximum of 14 days. Once removed from the refrigerator and brought to room temperature, the syringe or autoinjector must be used within 14 days or discarded.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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