NURTEC

What it is

NURTEC ODT contains rimegepant, with each orally disintegrating tablet containing rimegepant sulfate equivalent to 75 mg rimegepant. It is presented as an orally disintegrating tablet. Rimegepant binds with high affinity to the human calcitonin gene-related peptide (CGRP) receptor and antagonises CGRP receptor function. NURTEC is subject to additional monitoring in Australia, which allows quick identification of new safety information.

Approved indications NURTEC ODT is indicated for:

— Acute treatment of migraine with or without aura in adults. — Prophylactic treatment of episodic migraine in adults who have at least 4 migraine attacks per month.

Dosing overview

For acute treatment of migraine, the recommended dose is 75 mg rimegepant orally disintegrating tablet, as needed. The maximum dose in a 24-hour period is 75 mg. For prophylaxis of migraine, the recommended dose is 75 mg rimegepant every other day. If also requiring rimegepant for acute treatment of migraine, do not exceed a total dose of 75 mg rimegepant in a 24-hour period. NURTEC ODT can be taken with or without meals.

Key safety warnings

Hypersensitivity reactions, including dyspnoea and rash, have occurred in clinical studies and post-marketing settings, with serious hypersensitivity such as anaphylactic reaction reported. Some hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, rimegepant should be discontinued and appropriate therapy initiated. Overuse of many medicinal products for headaches can make them worse. Although there is no evidence that use of rimegepant up to once daily can lead to medication overuse headache, the diagnosis of medication overuse headache should be suspected in patients who have frequent or daily headaches despite or because of regular use of medicinal products for acute headache. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The benefit and safety of using 18 or more doses of rimegepant per month is not established.

Contraindications

NURTEC ODT is contraindicated in patients with hypersensitivity to rimegepant or to any of the excipients.

Regulatory history

NURTEC ODT (rimegepant 75 mg orally disintegrating tablet) was first listed on the ARTG on 27 July 2023. The TGA approved NURTEC ODT on 17 July 2023 for the acute treatment of migraine with or without aura in adults and for the prophylactic treatment of episodic migraine in adults who experience at least four migraine attacks per month. The PBAC recommended against funding for acute migraine attacks in July 2023, and again in March 2024 for acute migraine attacks in adults who had not responded adequately to treatment of at least two triptans.