VYEPTI

What it is

VYEPTI is a concentrated injection containing eptinezumab 100 mg/mL, a humanised monoclonal immunoglobulin G1 (IgG1) antibody. It is presented as a concentrated injection for dilution for infusion. Eptinezumab binds to α- and β-forms of human calcitonin gene-related peptide (CGRP) ligand with low picomolar affinity, preventing its activation of the CGRP receptors.

Approved indications

— Preventive treatment of migraine in adults.

Dosing overview

The recommended dosage is 100 mg administered by intravenous infusion every 12 weeks. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 12 weeks. The treatment benefit should be assessed 3–6 months after initiation of the treatment. The need for dose escalation should be assessed within 12 weeks after initiation of the treatment. VYEPTI is for intravenous infusion only after dilution. Infusion takes approximately 30 minutes.

Key safety warnings

Serious hypersensitivity reactions, including anaphylactic reactions, have been reported and may develop within minutes of the infusion. Angioedema, urticaria, facial flushing, and rash have occurred with VYEPTI in clinical studies. If a serious hypersensitivity reaction occurs, administration of VYEPTI should be discontinued immediately and appropriate therapy initiated. Patients with a history of cardiovascular disease were excluded from clinical studies, and limited safety data are available in these patients. Insufficient clinical data is available for patients aged 65 and older, and clinical studies with VYEPTI did not include sufficient numbers of patients in this age group to determine whether they respond differently from younger patients. The safety and efficacy of VYEPTI in patients below the age of 18 years has not yet been established.

Contraindications

VYEPTI is contraindicated in patients with hypersensitivity to eptinezumab or to any of the excipients in VYEPTI.

PBS listing

VYEPTI is listed on the PBS as a solution concentrate for intravenous infusion 100 mg in 1 mL (2 items), with streamlined restriction, at an ex-manufacturer price of A$1317.59.

Regulatory history

VYEPTI eptinezumab 100 mg/mL concentrated injection was first registered on the Australian Register of Therapeutic Goods on 16 June 2021. The TGA approved VYEPTI for the preventive treatment of migraine in adults on 9 June 2021. The PBAC recommended VYEPTI in July 2022 for chronic migraine in patients who have experienced inadequate response, intolerance, or contraindication to at least three prophylactic migraine medications. This medicinal product is subject to additional monitoring in Australia.