For people with previously treated locally advanced or metastatic urothelial carcinoma

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

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.

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