Fasenra

1). 4), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary. Self-administration should only be considered in patients already experienced with Fasenra treatment.

3 Posology Fasenra is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on disease severity, level of disease control and blood eosinophil counts. Asthma The recommended dose of benralizumab is 30 mg by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter.

EGPA The recommended dose of benralizumab is 30 mg by subcutaneous injection every 4 weeks. Patients who develop life-threatening manifestations of EGPA should be evaluated for the need for continued therapy, as Fasenra has not been studied in this population.

Missed Dose If an injection is missed on the planned date, dosing should resume as soon as possible on the indicated regimen; a double dose must not be administered. 2). 2). Paediatric population The safety and efficacy of Fasenra in children and adolescents aged 6 to 17 years with asthma has not been established.

2, but no recommendation on a posology can be made. The safety and efficacy of Fasenra in children less than 6 years with asthma have not been established. No data are available. The safety and efficacy of Fasenra in children and adolescents less than 18 years with EGPA have not been established.

Method of administration This medicinal product is administered as a subcutaneous injection. It should be injected into the thigh or abdomen. If the healthcare professional or caregiver administers the injection, the upper arm can also be used.

It should not be injected into areas where the skin is tender, bruised, erythematous, or hardened. Comprehensive instructions for administration using the pre-filled syringe/pre-filled pen are provided in the ‘Instructions for Use’.

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 6 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. 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.

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).

1. 4