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

•

acute treatment of migraine with or without aura in adults (1.1)

•

preventive treatment of episodic migraine in adults (1.2)

•

Recommended dosage for acute treatment of migraine: 75 mg taken orally, as needed. (2.1)

•

The safety of using more than 18 doses in a 30-day period has not been established. (2.1)

•

Recommended dosage for preventive treatment of episodic migraine: 75 mg taken orally every other day. (2.2)

•

The maximum dose in a 24-hour period is 75 mg. (2.1)

NURTEC ODT orally disintegrating tablets: 75 mg (3)

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

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)

•

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.

•

Strong CYP3A4 Inhibitors: Avoid concomitant administration. (7.1)

•

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)

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