OBJECTIVE: Evaluate the safety and tolerability of oral rimegepant when used for 
acute treatment concomitantly with a monoclonal antibody (mAb) targeting the 
calcitonin gene-related peptide (CGRP) ligand or receptor (CGRP mAb) for the 
preventive treatment of migraine.
BACKGROUND: The efficacy of CGRP mAbs for the preventive treatment of migraine 
and the small molecule CGRP receptor antagonist rimegepant for acute treatment 
has been demonstrated in randomized controlled clinical trials. Over the past 
few years, the US Food and Drug Administration has approved 4 CGRP mAbs for the 
preventive treatment of migraine and 2 small molecule CGRP receptor antagonists 
for the acute treatment of migraine. A previous case report of 2 patients 
receiving concomitant treatment with rimegepant and erenumab suggested that 
rimegepant may be safely used as acute treatment in patients who are also 
receiving a preventive regimen involving CGRP mAbs. We report here 13 additional 
patients with migraine who simultaneously used rimegepant and either erenumab, 
fremanezumab, or galcanezumab and assess the rate of on-treatment adverse events 
(AEs).
METHODS: This was a substudy nested within a multicenter, open-label, long-term 
safety study in adults with 2-14 monthly migraine attacks of moderate to severe 
pain intensity. A subgroup experiencing 2-8 monthly attacks and taking a stable 
dose of a CGRP mAb also took rimegepant 75 mg as needed up to once daily for 
acute treatment for 12 weeks.
RESULTS: The 13 patients (11 women [85%]; mean age 49.9 years) enrolled in the 
substudy were being treated with CGRP mAbs (erenumab [n = 7], fremanezumab 
[n = 4], or galcanezumab [n = 2]). Mean (SD) time in the rimegepant treatment 
period was 9.6 (4.6) weeks. Mean (SD) 4-week rimegepant exposure was 7.8 (5.5) 
doses; a total of 224 doses were taken. Five (38%) patients reported ≥1 
on-treatment AE. Of these, 2 (15%) patients had mild or moderate 
nasopharyngitis; no other AEs occurred in ≥2 patients. Three patients had AEs of 
mild or moderate severity that were considered potentially treatment-related. No 
patients had serious AEs, AEs leading to discontinuation, or aminotransferase 
levels >3× the upper limit of normal.
CONCLUSION: Rimegepant, when used as an oral acute treatment in patients 
receiving CGRP mAbs as preventive treatment, was well tolerated; no safety 
issues were identified. Studies involving larger patient populations are needed 
to confirm these findings.