Our latest edition of the Guidelines+ Monographs Series will delve into the medication benralizumab, marketed under the brand name Fasenra® by AstraZeneca. Fasenra is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype and for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). It was initially approved in 2017.
In the following sections, we will provide a comprehensive overview of benralizumab and analyze its positioning across various guidelines for its approved indications.
Note* - This Guidelines+ Monographs for benralizumab (Fasenra) is current as of March 2025. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Medication Overview:
- Brand name: Fasenra
- Generic name: benralizumab
- Manufacturer(s): AstraZeneca
- Initial FDA Approval: November 2017
Indications and FDA Approval Details
Indicated Condition | Indicated | Age | Date Approved |
|---|---|---|---|
Severe asthma, and with an eosinophilic phenotype. | as an add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma, and with an eosinophilic phenotype. | 12 years of age and older | November 14, 2017 |
| Severe asthma, and with an eosinophilic phenotype. | as an add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype. | Aged 6 to 11 | April 11, 2024 |
Eosinophilic granulomatosis with polyangiitis (EGPA) | for treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). | Adults | September 18, 2024 |
Limitations of Use
- Not for relief of acute bronchospasm or status asthmaticus.
Dosage and Administration
Administer by subcutaneous injection.
- Asthma - Adult and Adolescent Patients 12 Years of Age and Older:
- Recommended dosage is 30 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter.
- Pediatric Patients 6 Years to 11 Years of Age:
- Weighing Less Than 35 kg: the recommended dosage is 10 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter.
- Weighing 35 kg or More: the recommended dosage is 30 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter.
- EGPA
- Recommended dosage is 30 mg every 4 weeks.
See full prescribing information for administration instructions of FASENRA prefilled syringe and FASENRA PEN.
Dosage Forms and Strengths
- Injection
- 10 mg/0.5 mL solution in a single-dose prefilled syringe.
- 30 mg/mL solution in a single-dose prefilled syringe.
- 30 mg/mL solution in a single-dose autoinjector FASENRA PEN.
Contraindications
- Known hypersensitivity to benralizumab or excipients.
Warnings and Precautions
- Hypersensitivity reactions: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. Discontinue in the event of a hypersensitivity reaction.
- Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Decrease corticosteroids gradually, if appropriate.
- Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until the parasitic infection resolves.
Adverse Reactions
- Most common adverse reactions (incidence greater than or equal to 5%) include headache and pharyngitis.
Now that we’ve covered the basic monograph information for Fasenra, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Benralizumab in the Guidelines
| Guideline | Society | Publication Date | Recommendation | Strength |
|---|---|---|---|---|
| Management of Severe Asthma | American Thoracic Society (ATS) & European Respiratory Society (ERS) | October 01, 2019 | Recommended for managing severe asthma, including the use of newer monoclonal antibody therapies like benralizumab for severe eosinophilic asthma. | Strong Recommendation |
| Medical Management of Chronic Rhinosinusitis with Nasal Polyposis | American College of Allergy, Asthma, and Immunology (ACAAI) & American Academy of Allergy, Asthma & Immunology (AAAAI) | November 08, 2022 | For individuals diagnosed with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP), the guideline panel recommends the use of biologics over no biologics, based on moderate certainty of evidence. | Moderate Recommendation |
| Global Strategy for Asthma Management and Prevention | Global Initiative for Asthma (GINA) | May 07, 2024 | Recommended for severe asthma as an add-on anti-interleukin-5/5R treatment (subcutaneous mepolizumab for patients aged ≥6 years; intravenous reslizumab for ages ≥18 years or subcutaneous benralizumab for ages ≥12 years), for uncontrolled severe eosinophilic asthma on Step 4-5 treatment. | Strong Recommendation (Evidence A) |
| Diagnosis and Management of Eosinophilic Esophagitis | American College of Gastroenterology (ACG) | January 01, 2025 | The authors are unable to make a recommendation for or against cendakimab, benralizumab, lirentelimab, mepolizumab, or reslizumab due to insufficient evidence in either direction to recommend for or against use in EoE. | No Recommendation (Insufficient Evidence) |
This concludes our Guidelines+ Monographs for benralizumab (Fasenra). This list is current as of March 2025, and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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