Nurtec Odt

— THERAPEUTIC CATEGORIES —
  • Migraine and headache
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Nurtec Odt Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Rimegepant 75mg; orally disintegrating tabs (ODT).

    Pharmacological Class

    Calcitonin gene-related peptide (CGRP) receptor antagonist.

    How Supplied

    ODT tabs—8

    How Supplied

    Orally disintegrating tablets

    • 75mg: Round, white to off-white

    Storage

    Store at 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F).

    Manufacturer

    Biohaven Pharmaceuticals Inc.

    Generic Availability

    NO

    Nurtec Odt Indications

    Indications

    Acute treatment of migraine with or without aura. Preventive treatment of episodic migraine.

    Nurtec Odt Dosage and Administration

    Adult

    Allow tablet to dissolve on tongue. Acute: 75mg once as needed (max daily dose). Preventive: 75mg every other day. The safety of using more than 18 doses in a 30-day period has not been established.

    Children

    Not established.

    Nurtec Odt Contraindications

    Not Applicable

    Nurtec Odt Boxed Warnings

    Not Applicable

    Nurtec Odt Warnings/Precautions

    Warnings/Precautions

    Discontinue if hypersensitivity reaction occurs; treat appropriately. Severe hepatic impairment (Child-Pugh C) or ESRD (CrCl <15mL/min): avoid. Dialysis: not studied. Pregnancy. Nursing mothers.

    Pregnancy Considerations

    No adequate data available on the developmental risk associated with Nurtec ODT in pregnant women.There is a pregnancy registry that monitors pregnancy outcomes. Patients and health care providers are encouraged to register:

    Nursing Mother Considerations

    Transfer of rimegepant into breastmilk is low. No data are available on the effects of rimegepant on a breastfed infant or on milk production. Consider benefits to the mother vs potential adverse effects on the breastfed infant.

    In a study of 12 adult lactating women (between 2 weeks and 6 months postpartum), the relative infant dose was observed to be <1% following administration of a single oral dose of rimegepant 75mg to the mother. The average milk to plasma ratio was 0.20.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established. 

    Geriatric Considerations

    No clinically significant pharmacokinetic differences were observed between elderly and younger patients. Clinical studies did not include a sufficient number of patients over the age of 65 years.

    Renal Impairment Considerations

    Nurtec ODT has not been studied in patients with end-stage renal disease (ESRD) and in patients on dialysis; avoid use in patients with ESRD.

    No dosage adjustment is needed for patients with mild, moderate, or severe renal impairment.

    Hepatic Impairment Considerations

    Avoid use of Nurtec ODT in patients with severe (Child-Pugh C) hepatic impairment as plasma concentrations of rimegepant were found to be significantly higher in this patient population.

    No dosage adjustment is needed in patients with mild or moderate hepatic impairment.

    Nurtec Odt Pharmacokinetics

    Absorption

    Max concentration of rimegepant at 1.5 hours following oral administration.

    Distribution

    ~96% protein bound.

    Metabolism

    CYP3A4 (primarily), CYP2C9 (minor).

    Elimination

    Fecal (78%), renal (24%). Half-life: ~11 hours.

    Nurtec Odt Interactions

    Interactions

    Potentiated by strong CYP3A4 inhibitors (eg, itraconazole); avoid concomitant use. May be potentiated by moderate CYP3A4 or potent P-gp inhibitors (eg, amiodarone, cyclosporine, lapatinib, quinidine, ranolazine). Avoid another dose of Nurtec ODT within 48hrs when used with moderate CYP3A4 or potent P-gp inhibitors. May be antagonized by strong or moderate CYP3A inducers (eg, rifampin); avoid concomitant use.

    Nurtec Odt Adverse Reactions

    Adverse Reactions

    Nausea; delayed serious hypersensitivity.

    Nurtec Odt Clinical Trials

    Clinical Trials

    Acute Treatment of Migraine

    Approval was based on efficacy data from a randomized, double-blind, placebo-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT03461757) that compared Nurtec ODT with placebo in 1466 adult patients for the acute treatment of migraine with and without aura. Patients were randomly assigned to receive Nurtec ODT 75mg once (n=732) or placebo (n=734). The primary endpoint was pain freedom and most bothersome symptom (MBS) freedom at 2 hours after dosing in patients who treated a migraine with moderate to severe pain.

    Results demonstrated that a statistically significantly greater proportion of patients treated with Nurtec ODT achieved headache pain freedom (21.2% vs 10.9%; P <.001) and MBS freedom (35.1% vs 26.8%; P =.001) 2 hours after a single dose compared with placebo, respectively. 

    Nurtec ODT was associated with statistically significant improvements in key secondary endpoints when compared with placebo. These included the percentage of patients with pain relief at 2 hours (59.3% vs 43.3%; P <.001), sustained pain freedom at 2-48 hours (13.5% vs 5.4%; P <.001), use of rescue medication within 24 hours (14.2% vs 29.2%; P <.001), and those reporting normal function at 2 hours after dosing (38.1% vs 25.8%; P <.001). The incidence of photophobia and phonophobia was also reduced with Nurtec ODT vs placebo.

    Preventive Treatment of Episodic Migraine

    Approval was based on data from a randomized, double-blind, placebo-controlled phase 2/3 study (ClinicalTrials.gov Identifier: NCT03732638) that assessed the efficacy and safety of Nurtec ODT in adults who had migraines for at least 1 year and 4 to 18 moderate to severe migraine attacks per month over 3 months prior to enrollment. 

    Patients were randomly assigned to receive either Nurtec ODT 75mg orally every other day (n=373) or placebo (n=374). The primary endpoint was the change from baseline in the mean number of monthly migraine days (MMDs) during weeks 9 through 12 of the double-blind treatment phase.

    Findings showed treatment with Nurtec ODT resulted in a statistically significant reduction in MMDs from baseline compared with placebo (-4.3 days vs -3.5 days; P<.010). Additionally, a larger percentage of Nurtec ODT-treated patients achieved at least a 50% reduction from baseline in moderate to severe MMDs during weeks 9 through 12 of the double-blind treatment phase (49.1% vs 41.5%; P=.044).

    Nurtec Odt Note

    Not Applicable

    Nurtec Odt Patient Counseling

    Patient Counseling

    Use dry happens when opening the blister pack. Do not push the orally-disintegrating tablet (ODT) through the foil; peel it back and gently remove. Place the ODT on the tongue or under the tongue. The ODT will disintegrate in saliva; additional liquid is not necessary. Take immediately after removing from the blister pack; do not store the ODT outside the blister pack for future use.

    Hypersensitivity reactions can occur days after administration.Monitor for signs/symptoms.

    Pregnant patients are encouraged to participate in the pregnancy registry:

    Cost Savings Program

    Nurtec® OneSource

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