THE RISKS AND 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. These are not all the possible side effects of FASENRA.

The safety information above does not replace discussions with your healthcare provider about your medical condition or treatment. Please read Patient Information and Prescribing Information for 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. 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.

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 full Prescribing Information including Patient Information for FASENRA.

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