NURTEC® ODT Highlights

(rimegepant)

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

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)

DOSAGE AND ADMINISTRATION

•
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)

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

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)

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

•
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)

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.

Revised: 4/2023

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Highlights

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

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)

DOSAGE AND ADMINISTRATION

•
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)

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

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)

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

•
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)

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.

Revised: 4/2023
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