For: Asthma
Fasenra (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody indicated for the treatment of patients with severe eosinophilic asthma. INTRODUCING FASENRA
Add-on maintenance treatment for patients 12 and older with severe eosinophilic asthma
FASENRA is not used to treat other problems caused by eosinophils and is not used to treat sudden breathing problems.
FASENRA works with your body to target eosinophils (e-o-sin-o-phils), a key cause of severe asthma.
FASENRA has been clinically proven to:
Reduce the occurrence of severe asthma attacks by up to 51%*
Improve lung function, making it easier to breathe
Reduce oral steroid use in people taking them every day by 75%�
Your results may vary.
FASENRA was studied in the largest clinical trial program for targeted therapies in severe eosinophilic asthma. FASENRA added to standard asthma treatments worked better than standard treatments alone. FASENRA is given by a healthcare provider, only once every 8 weeks after the first 2 months.�
What is FASENRA?
What is FASENRA?
FASENRA is a prescription medicine used with other asthma medicines for the maintenance treatment of asthma in people 12 years and older whose asthma is not controlled with their current asthma medicines. FASENRA helps prevent severe asthma attacks (exacerbations) and may improve your breathing. Medicines such as FASENRA reduce blood eosinophils. Eosinophils are a type of white blood cell that may contribute to your asthma.
FASENRA is not used to treat other problems caused by eosinophils and is not used to treat sudden breathing problems.
It is not known if FASENRA is safe and effective in children less than 12 years of age.
Before Starting Treatment
What should I tell my healthcare provider before receiving FASENRA?
Before receiving FASENRA, tell your healthcare provider about all of your medical conditions, including if you:
are taking oral or inhaled corticosteroid medicines. Do not stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back
have a parasitic (helminth) infection
are pregnant or plan to become pregnant. It is not known if FASENRA will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with FASENRA
are breastfeeding or plan to breastfeed. It is not known if FASENRA passes into your breast milk. You and your healthcare provider should decide if you will receive FASENRA and breastfeed. Talk to your healthcare provider about the best way to feed your baby if you receive FASENRA
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements
Do not stop taking your other asthma medicines unless your healthcare provider tells you to.
Do not receive FASENRA if you are allergic to benralizumab or any of the ingredients in FASENRA. See below for a complete list of ingredients in FASENRA.
Receiving FASENRA
How will I receive FASENRA?
A healthcare provider will inject FASENRA under your skin (subcutaneously) every 4 weeks for the first 3 doses, and then every 8 weeks.
Side Effects
What are the possible side effects of FASENRA?
FASENRA may cause serious side effects, including:
allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your FASENRA injection. Allergic reactions can sometimes happen hours or days after you get your injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:
swelling of your face, mouth and tongue
breathing problems
fainting, dizziness, feeling lightheaded (low blood pressure)
rash
hives
The most common side effects of FASENRA include: headache and sore throat.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
General information about the safe and effective use of FASENRA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not receive FASENRA for a condition for which it was not prescribed. Do not give FASENRA to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about FASENRA that is written for healthcare professionals.
What are the ingredients in FASENRA?
Active ingredient: benralizumab Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20, α,α-trehalose dihydrate and Water for Injection, USP
For more information, call 1-800-236-9933.
IMPORTANT SAFETY INFORMATION
Do not receive FASENRA if you are allergic to benralizumab or any of the ingredients in FASENRA.
Do not use to treat sudden breathing problems.
FASENRA may cause serious side effects, including:
allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your FASENRA injection. Allergic reactions can sometimes happen hours or days after you get your injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:
swelling of your face, mouth and tongue
breathing problems
fainting, dizziness, feeling lightheaded (low blood pressure)
rash
hives
Before receiving FASENRA, tell your healthcare provider about all of your medical conditions, including if you:
are taking oral or inhaled corticosteroid medicines. Do not stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back
have a parasitic (helminth) infection
are pregnant or plan to become pregnant. It is not known if FASENRA will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with FASENRA
are breastfeeding or plan to breastfeed. It is not known if FASENRA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive FASENRA
are taking prescription and over-the-counter medicines, vitamins, or herbal supplements
Do not stop taking your other asthma medicines unless instructed to do so by your healthcare provider.
The most common side effects of FASENRA include: headache and sore throat. These are not all the possible side effects of FASENRA.
Approved Use
FASENRA is a prescription medicine used with other asthma medicines for the maintenance treatment of asthma in people 12 years and older whose asthma is not controlled with their current asthma medicines. FASENRA helps prevent severe asthma attacks (exacerbations) and may improve your breathing. Medicines such as FASENRA reduce blood eosinophils. Eosinophils are a type of white blood cell that may contribute to your asthma.
FASENRA is not used to treat other problems caused by eosinophils and is not used to treat sudden breathing problems. Tell your health care provider if your asthma does not get better or if it gets worse after you start treatment with FASENRA
It is not known if FASENRA is safe and effective in children under 12 years of age.
Please see accompanying full Prescribing Information including Patient Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
