NUCALA

What it is

NUCALA contains mepolizumab, a humanised monoclonal antibody directed against human interleukin-5 (IL-5). It is available as a powder for injection containing 100 mg per vial, or as a solution for injection in pre-filled pens or pre-filled syringes, each delivering 100 mg mepolizumab in 1 mL.

Approved indications

— Severe eosinophilic asthma in patients aged 12 years and over as add-on treatment. — Uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils on stable inhaler triple therapy (or equivalent regimen) in adult patients as add-on maintenance treatment. — Severe chronic rhinosinusitis with nasal polyps (CRSwNP) with an inadequate response to intranasal corticosteroids in adult patients aged 18 years and above as add-on treatment. — Relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients aged 18 years and over as add-on treatment.

Dosing overview

Key safety warnings

NUCALA should not be used to treat acute asthma or COPD exacerbations. Abrupt discontinuation of corticosteroids after initiation of NUCALA therapy is not recommended; reductions in corticosteroid doses should be gradual and performed under physician supervision. Acute and delayed systemic reactions, including hypersensitivity reactions such as anaphylaxis, urticaria, angioedema, rash, bronchospasm, and hypotension, have occurred following NUCALA administration, with reactions generally occurring within hours but sometimes with delayed onset in days. Eosinophils may be involved in the immunological response to some helminth infections; patients with pre-existing helminth infections should be treated for their infection prior to NUCALA therapy. In controlled clinical trials, 2 serious cases of herpes zoster occurred in patients treated with NUCALA versus none in the placebo group.

Contraindications

Hypersensitivity to mepolizumab or to any of the excipients.

PBS listing

NUCALA 100 mg solution for injection in pre-filled pen is listed on the PBS as 8 items with authority required restriction at an ex-manufacturer price of A$1556.10.

Regulatory history

NUCALA mepolizumab 100 mg powder for injection was first registered on the ARTG on 2 February 2016. In July 2016, the PBAC recommended listing for severe eosinophilic asthma under Section 100 (Highly Specialised Drugs Program) on a cost-minimisation basis with omalizumab. In November 2017, the PBAC recommended expansion of eligibility criteria to include patients aged 12 years and older and extended the validity period for eosinophil blood tests from 6 weeks to 12 months. Solution for injection formulations in pre-filled pens and pre-filled syringes were registered on 2 December 2019. In March 2020, the PBAC recommended listing of the new formulations on a cost-minimisation basis under the same conditions as the powder for injection. An AusPAR was issued on 24 January 2019 for the EGPA indication. In November 2022, the PBAC recommended listing for chronic rhinosinusitis with nasal polyps.