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
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
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)
WARNINGS AND PRECAUTIONS
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)
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.
USE IN SPECIFIC POPULATIONS
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.
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NURTEC® ODT Highlights (rimegepant)
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