(rimegepant)

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use NURTEC® ODT safely and effectively. See full prescribing information for NURTEC ODT.
NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use
Initial U.S. Approval: 2020

RECENT MAJOR CHANGES

Warnings and Precautions (5.2, 5.3)

3/2025

INDICATIONS AND USAGE

NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the:

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acute treatment of migraine with or without aura in adults (1.1)
•
preventive treatment of episodic migraine in adults (1.2)

DOSAGE AND ADMINISTRATION

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Recommended dosage for acute treatment of migraine: 75 mg taken orally, as needed. (2.1)
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The safety of using more than 18 doses in a 30-day period has not been established. (2.1)
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Recommended dosage for preventive treatment of episodic migraine: 75 mg taken orally every other day. (2.2)
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The maximum dose in a 24-hour period is 75 mg. (2.1)

DOSAGE FORMS AND STRENGTHS

NURTEC ODT orally disintegrating tablets: 75 mg (3)

CONTRAINDICATIONS

Patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or to any of its components. (4)

WARNINGS AND PRECAUTIONS

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Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy. Severe hypersensitivity reactions have included dyspnea and rash, and can occur days after administration. (5.1)
•
Hypertension: New-onset or worsening of pre-existing hypertension may occur. (5.2)
•
Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. (5.3)

ADVERSE REACTIONS

 
Acute treatment of migraine: the adverse reaction reported in ≥ 1% of patients treated with NURTEC ODT is nausea. (6.1)
Preventive treatment of episodic migraine: adverse reactions reported in ≥ 2% for rimegepant and ≥ 1% higher than placebo are nausea and abdominal pain/dyspepsia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

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Strong CYP3A4 Inhibitors: Avoid concomitant administration. (7.1)
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Moderate CYP3A4 Inhibitors: Avoid another dose within 48 hours when administered with a moderate CYP3A4 inhibitor. (7.1)
•
Strong and Moderate CYP3A Inducers: Avoid concomitant administration. (7.2)
•
Potent Inhibitors of P-gp: Avoid another dose of NURTEC ODT within 48 hours when administered with a potent P-gp inhibitor. (7.3)

USE IN SPECIFIC POPULATIONS

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Exposures were significantly higher in subjects with severe hepatic impairment. Avoid use in patients with severe hepatic impairment (Child-Pugh C). (8.6)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2025

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