FASENRA

What it is

Fasenra is a solution for injection containing 30 mg benralizumab per mL, available as a prefilled syringe or prefilled pen. Benralizumab is an antibody that binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity. The absence of fucose sugar units in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors on immune effector cells such as natural killer cells, leading to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity.

Approved indications

— Severe eosinophilic asthma as add-on therapy in patients aged 12 years and over with blood eosinophil count ≥300 cells/μL or ≥150 cells/μL if on oral corticosteroid treatment. — Relapsed or refractory eosinophilic granulomatosis with polyangiitis (EGPA) as add-on treatment in adult patients aged 18 years and over.

Dosing overview

High-dose inhaled corticosteroids and long-acting β-agonists should be optimised prior to commencement of treatment with Fasenra. A decision to continue therapy should be made at least annually based on disease severity and level of disease control.

Key safety warnings

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. Reduction in oral corticosteroid dose should be gradual and performed under physician supervision. Abrupt discontinuation of oral corticosteroids after initiation of Fasenra therapy is not recommended. Hypersensitivity reactions including anaphylaxis, angioedema, urticaria and rash have occurred following administration of Fasenra. These reactions may occur within hours of administration, but in some instances have a delayed onset of days. Eosinophils may be involved in the immunological response to some helminth infections. Patients with pre-existing helminth infections should be treated before initiating therapy with Fasenra. If patients become infected while receiving treatment with Fasenra and do not respond to anti-helminth treatment, discontinue treatment until infection resolves.

Contraindications

Fasenra is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients.

PBS listing

Fasenra 30 mg in 1 mL single dose prefilled pen is listed on the PBS with 6 items, authority required restriction, and an ex-manufacturer price of A$3145.45.

Regulatory history

Fasenra benralizumab 30 mg prefilled syringe was first registered on the ARTG on 3 April 2018. In November 2017, the PBAC did not recommend Fasenra, citing insufficient evidence regarding clinical benefit and cost-effectiveness. In March 2018, the PBAC recommended listing for uncontrolled severe eosinophilic asthma on a cost-minimisation basis with mepolizumab and with Section 100 authority required restrictions. In May 2019, the PBAC recommended changes to PBS restrictions for biologic medicines for severe asthma, including amendments to eosinophil cut-off levels, FEV1 requirements and continuing treatment criteria. The prefilled pen presentation was registered on the ARTG on 10 December 2019. In March 2020, the PBAC recommended listing of the autoinjector presentation on a cost-minimisation basis under the same conditions as the prefilled syringe.