Rimegepant

Rimegepant is a calcitonin gene-related peptide receptor antagonist.

• 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 ) 1.1 Acute Treatment of Migraine NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults . 1.2 Preventive Treatment of Episodic Migraine NURTEC ODT is indicated for the preventive treatment of episodic migraine in adults.ICD-10: G43.909

• NURTEC ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components.Reactions have included anaphylaxis and delayedserious hypersensitivity [see Warnings and Precautions (5.1) ] . Patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or to any of its components.contraindicated

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 ) 2.1 Recommended Dosing for Acute Treatment of Migraine The recommended dose of NURTEC ODT is 75 mg taken orally, as needed. The maximum dose in a 24-hour period is 75 mg. The safety of using more than 18 doses in a 30-day period has not been established. 2.2 Recommended Dosing for Preventive Treatment of Episodic Migraine The recommended dosage of NURTEC ODT is 75 mg taken orally every other day. 2.3 Administration Information Instruct the patient on the following administration instructions: Use dry hands when opening the blister pack. Peel back the foil covering of one blister and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil. As soon as the blister is opened, remove the ODT and place on the tongue; alternatively, the ODT may be placed under the tongue. The ODT will disintegrate in saliva so that it can be swallowed without additional liquid. Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use. 2.4 Concomitant Administration with Strong or Moderate CYP3A4 Inhibitors Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4.

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis, dyspnea, and rash, and can occur days after administration. ( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.3 ) 5.1 Hypersensitivity Reactions Serious hypersensitivityreactions, includinganaphylaxis, dyspnea, and rash, have occurredin patients treatedwith NURTEC ODT. Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity has occurred. If a hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy [see Contraindications (4) and Adverse Reactions (6.1 , 6.2) ]. 5.2 Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including NURTEC ODT, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. NURTEC ODT was discontinued in many of the reported cases.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Hypertension [see Warnings and Precautions (5.2) ] Raynaud’s Phenomenon [see Warnings and Precautions (5.3) ] 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 . 6.1 Clinical 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. Acute Treatment of Migraine The safety of NURTEC ODT for the acute treatment of migraine in adults has been evaluated in a randomized, double-blind, placebo-controlled trial (Study 1) in 682 patients with migraine who received one 75 mg dose of NURTEC ODT [see Clinical Studies (14) ] . Approximately 85% were female, 74% were White, 21% were Black, and 17% were Hispanic or Latino. The mean age at study entry was 40 years (range 18-75 years of age). Long-term safety was assessed in an open-label extension study using a different oral dosage form of rimegepant.

Exposures were significantly higher in subjects with severe hepatic impairment. Avoid use in patients with severe hepatic impairment (Child-Pugh C). ( 8.6 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NURTEC ODT during pregnancy. For more information, healthcare providers or patients are encouraged to contact: 1-877-366-0324, email nurtecpregnancyregistry@ppd.com, or visit nurtecpregnancyregistry.com . Risk Summary There are no adequate data on the developmental risk associated with the use of NURTEC ODT in pregnant women. In animal studies, oral administration of rimegepant during organogenesis resulted in adverse effects on development in rats (decreased fetal body weight and increased incidence of skeletal variations) at exposures greater than those used clinically and which were associated with maternal toxicity (see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated rate of major birth defects (2.2 to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Metabolism

Absorption Following oral administration of NURTEC ODT, rimegepant is absorbed with the maximum concentration at 1.5 hours. The absolute oral bioavailability of rimegepant is approximately 64%.

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 [see Clinical Pharmacology (12.3) ] .

• Feb 27, 2020NDANDA212728Pfizer

1. 1Drug Ineffective4,00933%
2. 2Nausea1,1439.3%
3. 3Migraine8346.8%
4. 4Headache7486.1%
5. 5Therapeutic Product Effect Incomplete6435.2%
6. 6Off Label Use4924.0%
7. 7Dizziness4473.6%
8. 8Fatigue4253.5%
9. 9Vomiting3663.0%
10. 10Feeling Abnormal3192.6%
11. 11Product Dose Omission Issue2792.3%
12. 12Somnolence2792.3%
13. 13Pain2762.3%
14. 14Rash2722.2%
15. 15Pruritus2452.0%

The 10 most recently updated of 59 ClinicalTrials.gov registrations naming Rimegepant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment
  Recruiting · Observational · 100 enrolled · University of Florence
  NCT06409832updated 2026-06-11
• i-NEED: NEw migrainE Drugs Database
  Recruiting · Observational · 2,641 enrolled · IRCCS San Raffaele Roma
  NCT07103694updated 2026-06-11
• A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
  Recruiting · Phase 3 · Interventional · 723 enrolled · Pfizer
  NCT06641466updated 2026-06-10
• A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine
  Recruiting · Phase 4 · Interventional · 400 enrolled · Pfizer
  NCT07609914updated 2026-06-09
• A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
  Recruiting · Phase 3 · Interventional · 200 enrolled · Pfizer
  NCT06616194updated 2026-06-09
• Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
  Recruiting · Phase 3 · Interventional · 640 enrolled · Pfizer
  NCT05156398updated 2026-06-05
• Randomized Study in Children and Adolescents With Migraine: Acute Treatment
  Recruiting · Phase 3 · Interventional · 2,100 enrolled · Pfizer
  NCT04649242updated 2026-06-05
• Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
  Recruiting · Phase 3 · Interventional · 600 enrolled · Pfizer
  NCT04743141updated 2026-06-05
• Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL
  Not yet recruiting · Phase 2 · Interventional · 100 enrolled · Ruijin Hospital
  NCT07613788updated 2026-05-29
• A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area
  Completed · Observational · 120 enrolled · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  NCT06221267updated 2026-05-22

Frequently asked questions

How does Rimegepant work?

Rimegepant is a calcitonin gene-related peptide receptor antagonist.

What is Rimegepant used for?

According to FDA labeling, Rimegepant carries indications including: 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 ) 1.1 Acute Treatment of Migraine NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults . 1.2 Preventive Treatment of Episodic Migraine NURTEC ODT is indicated for the preventive treatment of episodic migraine in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Rimegepant?

Rimegepant is classified as Calcitonin gene-related peptide (CGRP) antagonists, Calcitonin Gene-related Peptide Receptor Antagonist, Calcitonin Gene-related Peptide Receptor Antagonists, Receptor Interactions.

What are the brand names for Rimegepant?

Rimegepant is marketed under brand names including Nurtec.

What are the contraindications for Rimegepant?

Rimegepant labeling lists contraindications including: NURTEC ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components.Reactions have included anaphylaxis and delayedserious hypersensitivity [see Warnings and Precautions (5.1) ] . Patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or to any of its components.. Always consult the full prescribing information and a clinician.