Brand Name
Nurtec ODT
Generic Name
Rimegepant
View Brand Information FDA approval date: March 05, 2020
Classification: Calcitonin Gene-related Peptide Receptor Antagonist
Form: Tablet
What is Nurtec ODT (Rimegepant)?
NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: acute treatment of migraine with or without aura in adults.
Approved To Treat
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age
Summary: The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE
Summary: The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks. Rimegepant is a tablet that dissolves when you put it on or under your tongue. The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an...
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE
Summary: The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.
Related Latest Advances
Brand Information
NURTEC ODT (rimegepant sulfate)
1DOSAGE FORMS AND STRENGTHS
Orally disintegrating tablets: white to off-white, circular, and debossed with the symbol
2CONTRAINDICATIONS
NURTEC ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypersensitivity Reactions
- Hypertension
- Raynaud’s Phenomenon
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of NURTEC ODT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Hypersensitivity (e.g., anaphylaxis) [see
Vascular Disorders: Hypertension [see , Raynaud’s phenomenon [see
4OVERDOSAGE
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 clinical status of the patient. No specific antidote for the treatment of rimegepant overdose is available. Rimegepant is unlikely to be significantly removed by dialysis because of high serum protein binding
5DESCRIPTION
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-cyclohepta[b]pyridin-9-yl 4-(2-oxo-2,3-dihydro-1H-imidazo[4,5-b]pyridin-1-yl)-1-piperidinecarboxylate hemisulfate sesquihydrate and its structural formula is:
Its empirical formula is C
NURTEC ODT (orally disintegrating tablets) is for sublingual or oral use and contains 85.7 mg rimegepant sulfate, equivalent to 75 mg rimegepant free base, and the following inactive ingredients: benzyl alcohol, eucalyptol, gelatin, limonene, mannitol, menthol, menthone, menthyl acetate, sucralose, and vanillin.
6PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).
7PRINCIPAL DISPLAY PANEL - 75 mg Tablet Blister Pack Carton
NDC 72618-3000-2
NURTEC
75 mg PER ORALLY DISINTEGRATING TABLET (ODT)
This package contains 8 ODTs.
8PRINCIPAL DISPLAY PANEL - 75 mg NURTEC ODT Blister Pack
PEEL HERE
9PRINCIPAL DISPLAY PANEL - 75 mg Tablet Blister Pack Carton SAMPLE
NDC 72618-3001-2
PROFESSIONAL SAMPLE -
Rx only
NURTEC
75 mg PER ORALLY DISINTEGRATING TABLET
This carton contains 4 blister packs containing 2 orally disintegrating tablets (ODT) each for patient sampling.
10PRINCIPAL DISPLAY PANEL - 75 mg Tablet Blister Pack Dosepak SAMPLE
NDC 72618-3001-1
PROFESSIONAL SAMPLE -
NURTEC
75 mg PER ORALLY DISINTEGRATING TABLET (ODT)
This package contains 2 ODTs.
Rx only
11PRINCIPAL DISPLAY PANEL - 75 mg NURTEC ODT Blister Pack SAMPLE
PEEL HERE
