Description and Brand Names
Drug information provided by: Merative, Micromedex®
US Brand Name
Benralizumab injection is used together with other medicines to treat severe asthma. It is given to patients whose asthma is not controlled with their current asthma medicines. It is also used in patients whose asthma has an eosinophilic phenotype.
Benralizumab helps prevent severe asthma attacks (exacerbations) and may improve your breathing. It also 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.
This product is available in the following dosage forms:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of benralizumab injection in children younger than 12 years of age. Safety and efficacy have not been established.
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 are more sensitive to the effects of this medicine than younger adults.
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.
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.
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:
Asthma attack or
Bronchospasm (breathing problem), acute—Should not be used in patients with these conditions.
Parasite or worm infection—Should be treated first before receiving 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 thighs once every 4 weeks for the first 3 doses, then once every 8 weeks.
Benralizumab injection 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 or your caregiver how to inject the medicine. Be sure that you understand exactly how to use this.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
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 two forms: a prefilled syringe (to be given by the doctor or other healthcare professional) and prefilled autoinjector or Fasenra® Pen™ (to be used by the patient or caregiver).
Allow 30 minutes for the prefilled autoinjector (Fasenra® Pen™) to warm up to room temperature. Do not warm it in any other way.
Use each Fasenra® Pen™ only one time. Do not save an open autoinjector.
Check the liquid in the Fasenra® Pen™. It should be clear and colorless or slightly yellow. Do not use this medicine if it is cloudy or if there are particles in it. Do not use the pen if it looks damaged or broken.
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 (prefilled syringe or prefilled autoinjector):
For severe asthma:
Adults and children 12 years of age and older—30 milligrams (mg) injected under your skin once every 4 weeks for the first 3 doses, then once every 8 weeks.
Children younger than 12 years of age—Use and dose must be determined by your doctor.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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. Do not shake. You may also keep an unopened carton at room temperature for up to 14 days. Throw away any medicine left out of the refrigerator 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.
It is very important that your doctor check your 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 have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
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.
If you use a corticosteroid medicine (inhaled or taken by mouth) to control your asthma, keep using it unless your doctor tells you otherwise.
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:
hives, itching, or skin rash
joint pain, stiffness, or swelling
redness of the skin
swelling of the eyelids, face, lips, hands, or feet
tightness in the chest
troubled breathing or swallowing
Incidence not known
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:
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
tender, swollen glands in the neck
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.