Pronunciation:

ben-ra-LIZ-ue-mab

Brand Names:

• Fasenra

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiasthma

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Benralizumab injection is used together with other medicines to treat severe asthma in patients whose asthma is not controlled with their current asthma medicines. This medicine helps prevent severe asthma attacks (exacerbations) and can improve your breathing. It is also used in patients whose asthma has an eosinophilic phenotype. This medicine will not relieve an asthma attack that has already started.

Benralizumab helps reduce blood eosinophils, which are a type of white blood cell that may contribute to your asthma.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of benralizumab injection in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of benralizumab injection in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bronchospasm (breathing problem), acute or
• Status asthmaticus (severe asthma attack)—Should not be used in patients with these conditions.

• Parasite or worm infection—Use with caution. It is not known if this medicine may affect patients with this condition. Treat the infection first before using this medicine.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the upper arm, stomach, or thigh once every 4 weeks for the first 3 doses, then once every 8 weeks. It may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.

If you use this medicine at home, 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. This will help prevent skin problems from the injections. Do not inject into scars, moles, or skin areas that are red, bruised, tender, hard, or not intact.

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.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions about:

• How to prepare the injection.
• The proper use of disposable syringes.
• How to give the injection.
• How long the injection can be stored at home.

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 (eg, microwave or hot water). Do not shake.

Check the liquid in the 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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage forms (autoinjector):
  • For severe asthma:
    • Adults and children 12 years of age and older—30 milligrams (mg) injected under the skin once every 4 weeks for the first 3 doses, then once every 8 weeks.
    • Children 6 to 11 years of age—Dose is based on body weight and must be determined by your doctor.
      • Weighing 35 kilograms (kg) or more—30 milligrams (mg) injected under the skin once every 4 weeks for the first 3 doses, then once every 8 weeks.
      • Weighing less than 35 kg—10 mg injected under the skin once every 4 weeks for the first 3 doses, then once every 8 weeks.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store 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 syringes in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hoarseness, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, trouble swallowing, or any swelling of the hands, face, or mouth after using this medicine.

If you or your child are using a steroid medicine for asthma, do not suddenly stop taking it without first checking with your doctor. You may need to slowly decrease the dose before stopping it completely.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Chest tightness

fast heartbeat

fever

hives, itching, or skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

trouble breathing or swallowing

Incidence not known

Cough

dizziness

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

Less common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

body aches or pain

dryness or soreness of the throat

stuffy or runny nose

tender, swollen glands in the neck

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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