Benralizumab

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.

• 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).ICD-10: J45.909

• FASENRA is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see Warnings and Precautions (5.1) ] . Known hypersensitivity to benralizumab or excipients.contraindicated

Administer by subcutaneous injection. ( 2.4 ) Asthma Adult and Pediatric 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 and HES • Recommended dosage is 30 mg every 4 weeks. ( 2.2 , 2.3 ) See full prescribing information for administration instructions of FASENRA prefilled syringe and FASENRA PEN. ( 2.4 , 2.5 , 2.6 ) 2.1 Recommended Dosage for Asthma Adult and Pediatric 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 thereafter. Pediatric Patients 6 to 11 Years of Age The recommended dosage of FASENRA for pediatric patients 6 to 11 years of age is based on body weight as provided in Table 1 . Table 1. Recommended Dosage of FASENRA in Pediatric Patients 6 to 11 Years of Age with Asthma Body weight Recommended Dosage Less than 35 kg 10 mg (one injection) administered subcutaneously every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. 35 kg or more 30 mg (one injection) administered subcutaneously every 4 weeks for the first 3 doses, and then every 8 weeks thereafter.

• 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. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until the parasitic infection resolves. (5.4) 5.1 Hypersensitivity Reactions Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred following administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, FASENRA should be discontinued [see Contraindications (4) ] . 5.2 Acute Asthma Symptoms or Deteriorating Disease FASENRA should not be used to treat acute asthma symptoms or acute exacerbations. Do not use FASENRA to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA. 5.3 Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with FASENRA.

The following adverse reactions are described in greater detail in other sections: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence greater than or equal to 5%): • Asthma: headache and pharyngitis. ( 6.1 ) • EGPA: headache. ( 6.1 ) • HES: headache, hypersensitivity reactions, and influenza-like illness. ( 6.1 ) 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 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. Adult and Pediatric 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)].

8.1 Pregnancy Risk Summary The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In a prenatal and postnatal development study conducted in cynomolgus monkeys, there was no evidence of fetal harm with IV administration of benralizumab throughout pregnancy at doses that produced exposures up to approximately 310 times the exposure at the maximum recommended human dose (MRHD) of 30 mg subcutaneously (see Data) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.

Metabolism

The pharmacokinetic properties of benralizumab below are based on the population pharmacokinetic analyses from the asthma trials. Findings in EGPA and HES were generally consistent with those in asthma, although a lower clearance is predicted for patients with EGPA and HES relative to patients with asthma (see Elimination) .

There is no specific treatment for an overdosage with benralizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

• Nov 14, 2017BLABLA761070Astrazeneca Ab

1. 1Asthma2,88015%
2. 2Dyspnoea1,89410%
3. 3Death1,5578.3%
4. 4Drug Ineffective1,4617.8%
5. 5Cough9975.3%
6. 6Pneumonia9405.0%
7. 7Product Dose Omission Issue9094.8%
8. 8Headache9024.8%
9. 9Wheezing7153.8%
10. 10Fatigue6143.3%
11. 11Malaise5893.1%
12. 12Inappropriate Schedule Of Product Administration5693.0%
13. 13Arthralgia5342.8%
14. 14Pyrexia5282.8%
15. 15Rash5002.7%

The 10 most recently updated of 118 ClinicalTrials.gov registrations naming Benralizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
  Recruiting · Observational · 335 enrolled · AstraZeneca
  NCT07214753updated 2026-06-12
• Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
  Active not recruiting · Phase 4 · Interventional · 75 enrolled · AstraZeneca
  NCT03953300updated 2026-06-02
• Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies
  Completed · Phase 2 · Interventional · 51 enrolled · Memorial Sloan Kettering Cancer Center
  NCT04552288updated 2026-06-01
• A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
  Recruiting · Phase 3 · Interventional · 200 enrolled · AstraZeneca
  NCT05692180updated 2026-06-01
• A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
  Recruiting · Phase 3 · Interventional · 14 enrolled · AstraZeneca
  NCT06512883updated 2026-05-29
• Fasenra Pediatric Japan Post-Marketing Study(PMS)
  Recruiting · Observational · 40 enrolled · AstraZeneca
  NCT06427876updated 2026-05-27
• Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS With Biologics
  Not yet recruiting · Observational · 500 enrolled · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  NCT07602881updated 2026-05-22
• Taiwan Severe Asthma Biologic Registry
  Recruiting · Observational · 500 enrolled · Taichung Veterans General Hospital
  NCT06456450updated 2026-05-19
• This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab
  Recruiting · Observational · 1,000 enrolled · AstraZeneca
  NCT06862206updated 2026-05-19
• A Non-interventional, Prospective Study With Benralizumab
  Recruiting · Observational · 300 enrolled · AstraZeneca
  NCT06422078updated 2026-05-19

Frequently asked questions

How does Benralizumab work?

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.

What is Benralizumab used for?

According to FDA labeling, Benralizumab carries indications including: 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).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Benralizumab?

Benralizumab is classified as Other systemic drugs for obstructive airway diseases, Interleukin-5 Receptor alpha-directed Cytolytic Antibody, Interleukin 5 Receptor alpha-directed Antibody Interactions.

What are the brand names for Benralizumab?

Benralizumab is marketed under brand names including Fasenra.

What are the contraindications for Benralizumab?

Benralizumab labeling lists contraindications including: FASENRA is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see Warnings and Precautions (5.1) ] . Known hypersensitivity to benralizumab or excipients.. Always consult the full prescribing information and a clinician.