What are the FDA-approved indications for Nurtec (rimegepant)?

FDA-Approved Indications for Nurtec (Rimegepant)

Nurtec ODT (rimegepant) has two FDA-approved indications: acute treatment of migraine with or without aura in adults, and preventive treatment of episodic migraine in adults. 1

Approved Indications

1. Acute Treatment of Migraine

• Rimegepant 75 mg is approved for the acute treatment of migraine with or without aura in adults 1
• The recommended dosage is 75 mg taken orally as needed 1
• The safety of using more than 18 doses in a 30-day period has not been established 1
• The maximum dose in a 24-hour period is 75 mg 1

2. Preventive Treatment of Episodic Migraine

• Rimegepant 75 mg is approved for the preventive treatment of episodic migraine in adults 1
• The recommended dosage for prevention is 75 mg taken orally every other day 1
• This makes rimegepant the first dual-indication agent approved for both acute treatment and prevention of migraine 2

Clinical Context from Guidelines

Acute Treatment Positioning

• The American College of Physicians (2025) considers rimegepant as a CGRP antagonist-gepant option for treating moderate to severe acute episodic migraine in nonpregnant outpatient adults who do not tolerate or have inadequate response to combination therapy of a triptan with an NSAID or acetaminophen 3
• The VA/DoD guidelines (2024) suggest rimegepant for the short-term treatment of migraine (weak recommendation) 3

Preventive Treatment Positioning

• The VA/DoD guidelines (2024) note there is insufficient evidence to recommend for or against rimegepant for the prevention of episodic migraine 3
• The American College of Physicians (2025) does not prioritize rimegepant as a first-line preventive agent due to cost considerations, suggesting it be used after trials of less expensive options like beta-blockers, valproate, venlafaxine, or amitriptyline 3

Important Safety Considerations

Contraindications

• Patients with a history of hypersensitivity reaction to rimegepant, Nurtec ODT, or any of its components 1

Hepatic Impairment

• Avoid use in patients with severe hepatic impairment (Child-Pugh C) as exposures are significantly higher in these patients 1
• Systemic exposure increases 2.0-fold for total concentrations and 3.9-fold for unbound concentrations in severe hepatic impairment 4

Drug Interactions

• Avoid concomitant administration with strong CYP3A4 inhibitors 1
• Avoid another dose within 48 hours when administered with moderate CYP3A4 inhibitors 1
• Avoid concomitant administration with strong and moderate CYP3A inducers 1
• Avoid another dose within 48 hours when administered with potent P-gp inhibitors 1

Hypersensitivity Reactions

• Severe hypersensitivity reactions have included dyspnea and rash, and can occur days after administration 1
• If a serious hypersensitivity reaction occurs, discontinue Nurtec ODT and initiate appropriate therapy 1

Formulation

• Available as an orally disintegrating tablet (ODT) at 75 mg strength, which offers convenience and potentially faster response time 1, 2