Benralizumab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 24, 2026🚩 Report this page

Benralizumab

Other Systemic Drugs For Obstructive Airway Diseases

Sold as Fasenra · FASENRA PEN

GB MHRAEU EMACA Health Canada

Drug class: Other Systemic Drugs For Obstructive Airway Diseases
Availability: See label
Routes: Subcutaneous
Markets covered: 3
Products on record: 5

R03DXOther Systemic Drugs For Obstructive Airway Diseases

Overview

Benralizumab is an active pharmaceutical ingredient in the Other Systemic Drugs For Obstructive Airway Diseases group (R03DX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	April 24, 2026
EU European Union	EMA	1	February 27, 2025
CA Canada	Health Canada	2	August 15, 2025

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised April 24, 2026[1]

1). 1).

How to take

GBOfficial regulatory label· revised April 24, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised February 27, 2025[2]

1). 1).

How to take

EUOfficial regulatory label· revised February 27, 2025

CACanada· Health Canada

2 products

2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (2)

Sources & citations

[1]MHRA (UK) · PLGB179010322 · revised April 24, 2026
[2]European Medicines Agency · EMEA/H/C/004433 · revised February 27, 2025
[3]Health Canada (DPD) · 02473232 · revised August 15, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 24, 2026[1]

Summary of the safety profile The safety profile of benralizumab in asthma and EGPA are similar. The most commonly reported adverse reactions during treatment in asthma are headache (8%) and pharyngitis (3%). The most commonly reported adverse reaction in EGPA is headache (17%).
Cases of anaphylactic reaction of varied severity have been reported for benralizumab. Tabulated list of adverse reactions The following adverse reactions have been reported with benralizumab during clinical studies in asthma and EGPA and from post-marketing experience.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1. Tabulated list of adverse reactions MedDRA System organ class Adverse reaction Frequency Infections and infestations Pharyngitisa Common Immune system disorders Hypersensitivity reactionsb Anaphylactic reaction Common Not known Nervous system disorders Headachec Common General disorders and administration site conditions Pyrexia Injection site reactiond Common a Pharyngitis was defined by the following grouped preferred terms: ‘Pharyngitis’, ‘Pharyngitis bacterial’, ‘Viral pharyngitis’, ‘Pharyngitis streptococcal’.
b Hypersensitivity reactions were defined by the following grouped preferred terms: ‘Urticaria’, ‘Papular urticaria’, and ‘Rash’. 4. c a. Very common in EGPA study. d See ‘Description of selected adverse reaction’. g. 9% in patients treated with placebo.
The events were transient in nature. Long-term safety In a 56-week extension trial (Trial 4) in patients with asthma from Trials 1, 2 and 3, 842 patients were treated with Fasenra at the recommended dose and remained in the trial. The overall safety profile was similar to the asthma trials described above.
Additionally, in an open-label safety extension trial (Trial 5) in patients with asthma from previous trials, 226 patients were treated with Fasenra at the recommended dose for up to 43 months. 3 years). The safety profile during this follow-up period was consistent with the known safety profile of Fasenra.
Paediatric population There are limited data in paediatric patients. There were 108 adolescents aged 12 to 17 with asthma enrolled in the phase 3 trials (Trial 1: n=53, Trial 2: n=55). Of these, 46 received placebo, 40 received benralizumab every 4 weeks for 3 doses, followed by every 8 weeks thereafter, and 22 received benralizumab every 4 weeks.
Adolescent patients aged 12 to 17 (n=86) from Trials 1 and 2 continued the treatment with benralizumab in Trial 4 for up to 108 weeks. The frequency, type and severity of adverse reactions in the adolescent population were observed to be similar to those seen in adults.
2). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised April 24, 2026[1]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Asthma exacerbations Fasenra should not be used to treat acute asthma exacerbations.
Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment. Corticosteroids Abrupt discontinuation of corticosteroids after initiation of Fasenra therapy is not recommended.
Reduction in corticosteroid doses, if appropriate, should be gradual and performed under the supervision of a physician. g. 8). e. days). 3). In line with clinical practice, patients should be monitored for an appropriate time after administration of Fasenra.
In the event of a hypersensitivity reaction, Fasenra should be discontinued permanently and appropriate therapy should be initiated. Parasitic (Helminth) infection Eosinophils may be involved in the immunological response to some helminth infections.
Patients with known helminth infections were excluded from participation in clinical trials. It is unknown if benralizumab may influence a patient’s response against helminth infections. Patients with pre-existing helminth infections should be treated before initiating therapy with benralizumab.
If patients become infected, while receiving treatment and do not respond to anti-helminth treatment, therapy with benralizumab should be discontinued until infection resolves. 2).

This is not medical advice. Consult a qualified healthcare professional.