Benralizumab (ben-ra-LIZ-ue-mab)

Treats severe asthma.

Brand Name(s):

Fasenra PFS, Fasenra Pen

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the upper arm, stomach, or thigh.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes in 2 forms: a prefilled syringe and Fasenra® Pen™ autoinjector. The prefilled syringe is given by a nurse or other trained health professional.
• Allow the Fasenra® Pen™ autoinjector to warm to room temperature for 30 minutes. Do not warm it by using a heat source or in any other way (including microwave or hot water). Do not shake.
• Check the liquid in the Fasenra® Pen™ autoinjector. It should be clear and colorless to slightly yellow. Do not use it if it is cloudy, discolored, or has large particles in it. Do not use the autoinjector if it has been frozen, damaged, or dropped.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are bruised, hardened, red, or tender.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect this medicine from direct light. You may keep it at room temperature for up to 14 days. Throw away if it has been stored at room temperature for more than 14 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a parasite or worm infection.
• This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an asthma attack. Tell your doctor right away if your symptoms do not improve or if they get worse.
• If you are using a steroid medicine for your asthma, do not suddenly stop taking it without first checking with your doctor. You may need to slowly decrease your dose before stopping it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Worsening of breathing problems

If you notice these less serious side effects, talk with your doctor:

• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Sore throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088