Nurtec ODT
- Generic Name: rimegepantorally disintegrating tablets, for sublingual or oral use
- Brand Name: Nurtec ODT
- Drug Class: CGRP Receptor Antagonists
Nurtec ODT(RimegepantOrally Disintegrating Tablets, for Sublingual or Oral Use) side effects drug center
Nurtec ODT Side Effects Center
What Is Nurtec ODT?
Nurtec ODT (rimegepant) is a calcitonin gene-related peptide receptor antagonist used for acute treatment of migraine with or without aura in adults.
What Are Side Effects of Nurtec ODT?
Side effects of Nurtec ODT include:
- nausea and
- hypersensitivity (including shortness of breath and severe rash)
Dosage for Nurtec ODT
The recommended dose of Nurtec ODT is 75 mg taken orally, as needed.
Nurtec ODT In Children
Safety and effectiveness of Nurtec ODT in pediatric patients have not been established.
What Drugs, Substances, or Supplements Interact with Nurtec ODT?
Nurtec ODT may interact with other medicines such as:
- strong CYP3A4 inhibitors,
- moderate CYP3A4 inhibitors,
- strong and moderate CYP3A inducers, and
- inhibitors of P-gp or BCRP.
Tell your doctor all medications and supplements you use.
Nurtec ODT During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Nurtec ODT; it is unknown how it would affect a fetus. It is unknown if Nurtec ODT passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Nurtec ODT (rimegepant) Orally Disintegrating Tablets, for Sublingual or Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Nurtec ODT Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives, rash; difficult breathing; swelling of your face, lips, tongue, or throat.
An allergic reaction can be severe, and may occur days after you have taken rimegepant.
Common side effects may include nausea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Nurtec ODT (RimegepantOrally Disintegrating Tablets, for Sublingual or Oral Use)
Nurtec ODT Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
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]. 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. That study evaluated 1,798 patients, dosing intermittently for up to one year, including 1,131 patients who were exposed to rimegepant 75 mg for at least 6 months, and 863 who were exposed for at least one year, all of whom treated an average of at least two migraine attacks per month.
The most common adverse reaction in Study 1 was nausea (2% in patients who received NURTEC ODT compared to 0.4% of patients who received placebo).
Hypersensitivity, including dyspnea and severe rash, occurred in less than 1% of patients treated with NURTEC ODT [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
Preventive Treatment Of Episodic Migraine
The safety of NURTEC ODT for the preventive treatment of episodic migraine in adults has been established in a randomized, double-blind, placebo-controlled trial with an open-label extension (Study 2) using a different oral dosage form of rimegepant [see Clinical Studies]. In the 12-week, double-blind treatment period, 370 patients with migraine received one 75 mg dose of rimegepant every other day. Approximately 81% were female, 80% were White, 17% were Black, and 28% were Hispanic or Latino. The mean age at study entry was 41 years (range 18-74 years of age). Long-term safety was assessed in an open-label extension study that included 603 patients who were treated for up to one year. Overall, 527 patients were exposed to rimegepant 75 mg for at least 6 months, and 311 were exposed for at least one year.
The most common adverse reactions (occurring in at least 2% of rimegepant-treated patients and at a frequency of at least 1% higher than placebo) in Study 2 were nausea (2.7% in patients who received rimegepant compared with 0.8% of patients who received placebo) and abdominal pain/dyspepsia (2.4% in patients who received rimegepant compared with 0.8% of patients who received placebo).
DRUG INTERACTIONS
CYP3A4 Inhibitors
Concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4 results in a significant increase in rimegepant exposure. Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4 [see CLINICAL PHARMACOLOGY].
Concomitant administration of NURTEC ODT with moderate inhibitors of CYP3A4 may result in increased exposure of rimegepant. Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4 [see CLINICAL PHARMACOLOGY].
CYP3A Inducers
Concomitant administration of NURTEC ODT with strong or moderate inducers of CYP3A can result in a significant reduction in rimegepant exposure, which may lead to loss of efficacy of NURTEC ODT. Avoid concomitant administration of NURTEC ODT with strong or moderate inducers of CYP3A [see CLINICAL PHARMACOLOGY].
Transporters
Rimegepant is a substrate of P-gp and BCRP efflux transporters. Concomitant administration of NURTEC ODT with inhibitors of P-gp or BCRP may result in a significant increase in rimegepant exposure [see CLINICAL PHARMACOLOGY]. Avoid NURTEC ODT with inhibitors of P-gp or BCRP.
Read the entire FDA prescribing information for Nurtec ODT (RimegepantOrally Disintegrating Tablets, for Sublingual or Oral Use)
&Copy; Nurtec ODT Patient Information is supplied by Cerner Multum, Inc. and Nurtec ODT Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.