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AboutCurrent Migraine Treatment LimitationsMechanism of ActionEfficacyStudy DesignsAcute TreatmentPreventive TreatmentSafetyDosingResourcesPatient Resources

Currently not reimbursed by the HSE.

Established safety profile
across multiple studies1–4

The safety and adverse event profiles of treatment with VYDURA were assessed in studies of both acute and preventive treatment of migraine.2,3

VYDURA demonstrated a tolerability profile similar to placebo.2
  • More than 3800 unique subjects received VYDURA* in the Phase 2 and Phase 3 studies5
  • The most common adverse reaction was nausea for acute treatment (1.2%) and for migraine prophylaxis (1.4%). Most of the reactions were mild or moderate in severity1
  • Hypersensitivity reactions, including dyspnoea and rash, have occurred in fewer than 1% of patients treated with VYDURA in clinical studies1
  • No serious adverse events were reported in the acute study (303) while less than 1% of subjects reported serious adverse events in the prevention study (305)2,3
  • 2% of patients experienced an adverse event that led to discontinuation of VYDURA* in the prevention study (305)3 
  • VYDURA is not contraindicated for patients who have cardiovascular risk factors1
Safety was maintained in Study 201, an open-label safety study, for up to one year4,6 The results were consistent with the safety findings of Acute Study 303 and Preventive Study 305
  • The majority of adverse events were mild4
  • Serious adverse events were reported in 47 (2.6%) subjects but none were considered to be related to VYDURA6*
  • No clinically relevant laboratory abnormalities were observed6
Study 201 assessed the longer-term safety of VYDURA* treatment for up to 1 year4

D/C, discontinuation; ODT, orally disintegrating tablet; PRN, as required; QOD, every other day.
*Patients received a rimegepant 75 mg tablet that was bioequivalent to VYDURA.4,5
Subjects treated with VYDURA* (i.e. safety population).4
Scheduled QOD+PRN, every other day dosing plus as needed on non-scheduled dosing days for up to 12 weeks.4

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

References:VYDURA (rimegepant) Summary of Product Characteristics.Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019;394(10200):737-745.Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51-60.Croop R, Berman G, Kudrow D, et al. Long-term safety of rimegepant 75 mg for the acute treatment of migraine (study 201). Abstract presented at 62nd Annual Scientific Meeting American Headache Society. June 4-7, 2020. Headache. 2020;60(suppl 1):111-112.European Medicines Agency. Vydura (rimegepant) Assessment Report. 2022. 1-135.Croop R, Berman G, Kudrow D, et al. Long-term safety of rimegepant 75 mg for the acute treatment of migraine (study 201) (4829). Neurology. 2020;94(suppl 15).Johnston K, Harris L, Powell L, et al. Monthly migraine days, tablet utilization, and quality of life associated with rimegepant—post hoc results from an open label safety study (BHV3000-201). J Headache Pain. 2022;23(1):10.
Discover dosing information Simple DosingLoading

Legal Category: S1B
Further information is available upon request

PP-NNT-IRL-0018. June 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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