Interleukin-5 Receptor alpha-directed Cytolytic AntibodyPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Fasenra
BENRALIZUMAB
1 INDICATIONS AND USAGE FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for: • add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. (1.1) • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). (1.2) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. (1.1) 1.1 Asthma FASENRA is indicated for ...
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:FASENRA
Quick Reference
Medicine ClassInterleukin-5 Receptor alpha-directed Cytolytic Antibody
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- BENRALIZUMAB
- Medicine class
- Interleukin-5 Receptor alpha-directed Cytolytic Antibody
- Brand names
- FASENRA
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life was approximately 3
- FDA approved
- Yes
What Is Fasenra?
1 INDICATIONS AND USAGE FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for: • add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. (1.1) • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). (1.2) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. (1.1) 1.1 Asthma FASENRA is indicated for ...
Fasenra (BENRALIZUMAB) belongs to the Interleukin-5 Receptor alpha-directed Cytolytic Antibody class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Fasenra. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Fasenra with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Fasenra is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for: • add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype.
(1.1) • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
(1.2) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus.
(1.1) 1.1 Asthma FASENRA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype [see Use in Specific Populations (8.4) , Clinical Studies (14.1) ] .
Limitations of Use: • FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus.
1.2 Eosinophilic Granulomatosis with Polyangiitis FASENRA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection. ( 2.3 ) 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. ( 2.1 ) 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. ( 2.1 ) • 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. ( 2.1 ) EGPA Recommended dosage is 30 mg every 4 weeks. (2.2) See full prescribing information for administration instructions of FASENRA prefilled syringe and FASENRA PEN. ( 2.4 , 2.5) 2.1 Recommended Dosage for Asthma Adult and Adolescent Patients 12 Years of Age and Older The recommended dosage of FASENRA is 30 mg (one injection) administered subcutaneously every 4 weeks for the first 3 doses, and then every 8 weeks t
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- Most common adverse reactions (incidence greater than or equal to 5%) include headache and pharyngitis.
- (6.1, 6.2) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Trials Experience Adult and Adolescent Patients 12 Years of Age and Older with Asthma Across three clinical trials (SIROCCO, CALIMA, and ZONDA) for asthma, 1,808 patients received at least 1 dose of FASENRA [see Clinical Studies (14.1) ] .
- The data described below reflect exposure to FASENRA in 1,663 patients, including 1,556 exposed for at least 24 weeks and 1,387 exposed for at least 48 weeks.
- The safety exposure for FASENRA is derived from two Phase 3 placebo-controlled trials (SIROCCO and CALIMA) from 48 weeks duration [FASENRA every 4 weeks (n=841), FASENRA every 4 weeks for 3 doses, then every 8 weeks (n=822), and placebo (n=847)].
- While a dosing regimen of FASENRA every 4 weeks was included in clinical trials, FASENRA administered every 4 weeks for 3 doses, then every 8 weeks thereafter is the recommended dose [ see Dosage and Administration (2.1) ] .
Serious
- 5 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.
- (5.1) • Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA.
- Decrease corticosteroids gradually, if appropriate.
- (5.3) • Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with FASENRA.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 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. (5.1) • Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Decrease corti
How Fasenra Works
12.1 Mechanism of Action Benralizumab is a humanized afucosylated, monoclonal antibody (IgG1, kappa) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with a dissociation constant of 11 pM. The IL-5 receptor is expressed on the surface of eosinophils and basophils. In an in vitro setting, the absence of fucose in the Fc domain of benralizumab facilitates binding (45.5 nM) to FcɣRIII receptors on immune effector cells, such as natural killer (NK) cells, leading to apoptosis of eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC). Inflammation is an important component in the pathogenesis of asthma and EGPA. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., hist
Pharmacokinetics
Absorption
Absorption Following subcutaneous administration to patients with asthma, the absorption half-life was approximately 3
Half-Life
half-life was approximately 3
Metabolism
Metabolism Benralizumab is a humanized IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Fasenrawhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
Related on MedCentralHub
- Class hub
Interleukin-5 Receptor alpha-directed Cytolytic Antibody alternatives
Compare all Interleukin-5 Receptor alpha-directed Cytolytic Antibody medications — uses, side effects, and cost differences
- Detail
Fasenra dosage guide
Adult, pediatric, renal, and hepatic dosing for Fasenra
- Detail
Fasenra side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Fasenra
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.