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NURTEC® ODT (rimegepant)
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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
NURTEC® ODT Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Acute Treatment of Migraine
NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage for Acute Treatment of Migraine
The recommended dose of NURTEC ODT is 75 mg taken orally, as needed.
The...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Orally disintegrating tablets: white to off-white, circular, and debossed with the symbol 
, each containing 75 mg of...
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Contraindications
4 CONTRAINDICATIONS
NURTEC ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components. Delayed serious hypersensitivity has occurred...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Hypersensitivity reactions, including dyspnea and rash, have occurred with NURTEC ODT in clinical studies....
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- •
- Hypersensitivity Reactions [see...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 CYP3A4 Inhibitors
Concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4 results in a significant increase in rimegepant...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There...
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Overdosage
10 OVERDOSAGE
There is limited clinical experience with NURTEC ODT overdosage. Treatment of an overdose of NURTEC ODT should consist of general supportive measures including monitoring of vital signs and observation of the...
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Description
11 DESCRIPTION
NURTEC ODT contains rimegepant sulfate, a calcitonin gene-related peptide receptor antagonist. Rimegepant sulfate is described chemically as (5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-...
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Clinical Pharmacology
...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Rimegepant is a calcitonin gene-related peptide receptor antagonist.
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Acute Treatment of Migraine
The efficacy of NURTEC ODT for the acute treatment of migraine with and without aura in adults was demonstrated...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
NURTEC ODT 75 mg orally disintegrating tablets are white to off-white, circular, debossed with the symbol...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).
Handling of...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.