EMGALITY

What it is

EMGALITY contains galcanezumab 120 mg in 1 mL, supplied as a prefilled pen or prefilled syringe. Galcanezumab is a humanised monoclonal antibody (IgG4) produced in Chinese Hamster Ovary cells by recombinant DNA technology. EMGALITY is administered as a subcutaneous injection.

Approved indications —

EMGALITY is indicated for the prophylaxis of migraine in adults.

Dosing overview

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose. Treatment response should be evaluated by the prescriber after 8–12 weeks as recommended by the current Australian treatment guideline. Patients may self-inject EMGALITY by following the instructions for use, with injection sites including the abdomen, thigh, back of the upper arm and buttocks.

Key safety warnings

Serious hypersensitivity reactions, including cases of anaphylaxis, angioedema and urticaria have been reported. If a serious hypersensitivity reaction occurs, discontinue galcanezumab immediately and initiate appropriate therapy. Serious hypersensitivity reactions could occur days after administration and may be prolonged. No studies have assessed galcanezumab in combination with other agents targeting CGRP or the CGRP receptor, and it is not known whether such combinations are safe. The reported adverse drug reactions include injection site pain (10.1%–11.6%), injection site reactions (9.9%–14.5%), vertigo (0.7%–1.2%), constipation (1.0%–1.5%), pruritus (0.7%–1.2%) and urticaria (0.3%–0.1%). Most of the reactions were mild or moderate in severity.

Contraindications

EMGALITY is contraindicated in patients with known serious hypersensitivity to galcanezumab or to any of the excipients.

PBS listing

The 120 mg prefilled pen is listed on the PBS with 2 items, streamlined restriction, and an ex-manufacturer price of A$463.00.

Regulatory history

The TGA approved EMGALITY for registration on 22 May 2019, with initial entry onto the ARTG on 28 May 2019, for the prophylaxis of migraine in adults. In July 2019, the PBAC recommended EMGALITY for prophylactic treatment of chronic migraine in patients who have experienced inadequate response, intolerance or a contraindication to at least three prior preventive migraine medications, with Authority Required (Streamlined) listing. In March 2022, the PBAC recommended a change to the indication to include treatment-resistant high frequency episodic migraine. In March 2024, the PBAC extended the recommendation for an additional 12 months.