FASENRA® (Benralizumab)

FASENRA®

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Important Safety Information

FASENRA® (benralizumab) is a prescription medication for patients with severe asthma 12 years of age or older, with an eosinophilic phenotype. Patients who have been treated with FASENRA® have reported maintaining better breathing for more than two years.

Do not use FASENRA® if you are allergic to benralizumab or any of the inactive ingredients. These include L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20, and trehalose.

Hypersensitivity reactions — such as anaphylaxis, urticaria, rash, and/or angioedema — could occur within several hours after an infusion treatment. Discontinue treatment with FASENRA® if you experience any of these reactions.

There is insufficient information to determine how FASENRA® may affect an unborn child. Talk with your doctor if you’re pregnant, there’s a possibility you may be pregnant, or if you’re planning on becoming pregnant. There is a pregnancy registry for women undergoing treatment with FASENRA®. To enroll — or for additional information — call 1-877-311-8972 or visit https://mothertobaby.org/ongoing-study/fasenra/.

What is the most important information I should know about FASENRA®?

Do not use FASENRA® to treat acute asthma, acute exacerbations of asthma, or acute bronchospasm. Talk with your doctor about all medications you’re currently taking — whether they’re prescription, over-the-counter, herbal supplements, or vitamins. If you’re taking corticosteroids, a radial reduction may be appropriate. However, only do so if instructed by your physician. Be aware that reducing corticosteroid dosage may lead to withdrawal symptoms.

There is not enough information to determine whether FASENRA® has an effect on a patient’s immunological response against parasitic infections. If you have a history of such infections, obtain treatment prior to receiving FASENRA® infusion therapy. If you contract a parasitic infection while undergoing treatment, FASENRA® infusions will have to be paused until the infection fully heals.

Side Effects of FASENRA®

As with any prescription medication, FASENRA® carries a risk of side effects. The most common ones include:

  • Headaches
  • Pharyngitis
  • Redness, pain or irritation at the site where the IV was inserted
  • Swelling of face, mouth, and/or tongue
  • Hives
  • Dizziness
  • Fainting
  • Rash

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

FASENRA® is indicated as an add-on treatment for patients with severe asthma 12 years of age and older with an eosinophilic phenotype. The recommended dosage is 30 mg once every four weeks for the first three doses. Subsequently, infusions should be administered once every eight weeks.

Please refer to the full prescribing information.