AIMOVIG

What it is

AIMOVIG contains the active ingredient erenumab. AIMOVIG is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to the CGRP receptor. It is a solution for injection, for subcutaneous use. Erenumab is a human monoclonal antagonist antibody against the CGRP receptor with no significant pharmacological activity at adrenomedullin, calcitonin, and amylin receptors and lacks agonist activity at the CGRP receptor. CGRP is a neuropeptide that modulates nociceptive signalling and a vasodilator that has been associated with migraine pathophysiology, and CGRP levels have been shown to increase significantly during migraine and return to normal with headache relief.

Approved indications

— Prophylaxis of migraine in adults.

Dosing overview

AIMOVIG should be initiated under the guidance of a neurologist or specialist in the management of migraine. The recommended dose of AIMOVIG is 70 mg injected subcutaneously once every 4 weeks. Some patients may benefit from a dosage of 140 mg injected subcutaneously once every 4 weeks. Treatment response should be evaluated by the prescriber after 8–12 weeks as recommended by the current Australian treatment guideline. The need for treatment continuation should be re-evaluated within regular intervals of 3–6 months as recommended by the current treatment guideline.

Key safety warnings

Hypersensitivity reactions (some of which were serious), including rash, angioedema, and anaphylactoid reactions, have been reported with AIMOVIG in post-marketing experience. These reactions may occur within minutes, although some may occur more than one week after treatment. Constipation with serious complications has been reported following the use of AIMOVIG in the post-marketing setting. There were cases that required hospitalisation, including cases where surgery was necessary. Many of the cases of constipation with serious complications were reported for patients who have a history of constipation or concurrently use medications associated with decreased gastrointestinal motility. Monitor patients treated with AIMOVIG for severe constipation and manage as clinically appropriate. Development of hypertension and worsening of pre-existing hypertension have been reported following the use of AIMOVIG in the post-marketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalisation. Monitor patients treated with AIMOVIG for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of AIMOVIG is warranted if evaluation fails to establish an alternative aetiology.

Contraindications

AIMOVIG is contraindicated in patients with hypersensitivity to erenumab or to any of the excipients.

PBS listing

In November 2024, AIMOVIG was recommended for the Pharmaceutical Benefits Scheme for prophylaxis of chronic migraine in adults with inadequate response, intolerance or contraindication to at least three prophylactic migraine medications on a General Schedule with Authority Required restriction (streamlined).

Regulatory history

AIMOVIG was approved by the TGA on 28 June 2018 for prophylaxis of migraine in adults. ARTG registrations for AIMOVIG 70 mg/mL in prefilled pen and prefilled syringe were first listed on 2 July 2018, and ARTG registrations for AIMOVIG 140 mg/mL in prefilled pen and prefilled syringe were first listed on 29 October 2019. The PBAC initially did not recommend the product in November 2017, considering that the clinical place of erenumab in chronic migraine management was not adequately defined and that clinical evidence was insufficient to establish cost-effectiveness. In November 2024, the PBAC recommended AIMOVIG for listing on the PBS with a streamlined authority required restriction.