Safety Profile & Adverse Reactions | Nurtec® ODT (rimegepant)

Well tolerated for acute and
preventive treatment

Most Common (≥2%) Adverse Events

Percentage of patients
that experienced nausea^1-3

Acute (one 75 mg dose)

2%Nurtec ODT
n=682

0.4%Placebo
n=693

Preventive (75 mg dose every other day)

2.7%Rimegepant
n=370

0.8%Placebo
n=371

Percentage of patients
that experienced
abdominal pain/dyspepsia^1,3

Preventive (75 mg dose every other day)

2.4%Rimegepant
n=370

0.8%Placebo
n=371

Well tolerated in
preventive study
2%(n=7/370)
discontinued
due to AEs³

Nurtec ODT was not associated with any serious
treatment‑related AEs.^2,3

Long‑term safety maintained through 52 weeks¹

1798 patients were exposed to >111,000 doses of rimegepant⁴

Up to 18 doses of Nurtec ODT can be taken per month.¹

A long-term open label safety study with 1800 patients evaluated rimegepant 75 mg dosed as needed for 52 weeks (N=1514) and dosed every other day plus as needed for 12 weeks (N=286).^1,5

Long-term Safety Study Design

Long‑term safety was maintained in
the long‑term open‑label safety study¹

1800 patients were given multiple doses of rimegepant 75 mg,
as needed up to one dose per day, for up to 52 weeks^1,6

Enrollment Groups⁶

History of Moderate
to Severe Migraine

2-8 attacks/month (n=1033)

9-14 attacks/month (n=481)

4-14 attacks/month (n=286)

Rimegepant Treatment⁶

52 weeks as needed up to 1x/daily dosing
(n=1514)

Up to 12 weeks fixed dosing EOD + PRN dosing
(n=286)

EOD: every other day; PRN: as needed⁶

Average of 7.7 doses per 4 weeks/subject for up to 52 weeks (n=1800)⁶

The ODT and tablet formulations of rimegepant are bioequivalent.²

References: 1. Nurtec ODT. Package insert. Biohaven Pharmaceuticals Inc. 2. 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. doi: 10.1016/S0140-6736(19)31606-X. 3. 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. 2020;397(10268): 51-60. doi:10.1016/S0140-6736(20)32544-7. 4. Data on File. RIM113. Biohaven Pharmaceuticals Inc. 5. McGinley JS, L'Italien GJ, Thiry AC, et al. Rimegepant 75 mg results in reductions in monthly migraine days: Secondary analysis of a multicenter, open label, long‑term safety study of rimegepant for the acute treatment of migraine. Virtual Poster presented at: American Academy of Neurology 2020 Annual Meeting; 2020. 6. Croop R, Berman G, Kudrow D, et al. Long-term safety of rimegepant 75 mg for the acute treatment of migraine (study 201). Poster presented at: Virtual Annual Scientific Meeting of the American Headache Society; June 13, 2020.

Terms & Conditions

To the Patient: In order to participate in the Nurtec^® ODT Patient Savings Program ("Program"), you must have a valid prescription for Nurtec^® ODT (rimegepant) orally disintegrating tablets, meet the eligibility requirements set forth herein, adhere to the terms and conditions stated in the Restrictions section below, and present this card to your pharmacist. Eligible patients with commercial insurance may pay as little as $0 out of pocket. Patients with questions about the Program should call 1‑800‑761‑1568.

To the Pharmacist: By redeeming this offer, the Pharmacist certifies: (a) that the Pharmacy has not submitted, and will not submit, a claim for reimbursement under any federal, state, or other government programs for this prescription or where prohibited by law and (b) the Pharmacist will adhere to the terms and conditions stated in the Restrictions section below.

Pharmacist Instructions: For Commercially Insured Patients, please submit this claim to the patient's primary Third-Party Payer first, then submit the balance due to CHANGE HEALTHCARE as a Secondary Payer COB (coordination of benefits) with patient responsibility and a valid Other Coverage Code (e.g. 08). Reimbursement will be received from CHANGE HEALTHCARE. For questions, please call the Concierge line for Nurtec ODT at 1‑800‑731‑4997, Monday – Friday, 8 am – 8 pm ET.

Restrictions: This offer is not valid for Non-Insured/Cash-Paying Patients. This Program is not valid for prescriptions covered by or submitted for reimbursement in part or in full by any state or federally funded programs, including but not limited to Medicare, Medicaid, Medigap, VA, TRICARE (DOD). Patients with managed care restrictions (e.g., prior authorization, step edit) may not be eligible for this offer if such managed care restrictions persist. Continued eligibility may require that the patient has a prior authorization form submitted. This offer may not be used with any other financial assistance program, free trial, discount, prescription savings card or other offer. Valid only for patients 18 years and older in the United States including the Commonwealth of Puerto Rico. This Program is void if copied, transferred, purchased, altered, or traded and where prohibited by law. Limit one offer per individual. Biohaven Pharmaceuticals reserves the right to rescind, revoke or amend this offer without notice anytime. This Program is managed by ConnectiveRx on behalf of Biohaven Pharmaceuticals.

Safety

Most Common (≥2%) Adverse Events

Nurtec ODT was not associated with any serious
treatment‑related AEs.^2,3

Long‑term safety maintained through 52 weeks¹

Important Safety Information

Indication

Safety

Most Common (≥2%) Adverse Events

Nurtec ODT was not associated with any serious treatment‑related AEs.2,3

Long‑term safety maintained through 52 weeks1

Important Safety Information

Indication

Sustained ResponseData-on-File-RIM118,1,2

Sustained ResponseData-on-File-RIM118,1,2

REDUCTION IN MMDs1,*,†

RAPID RESPONSELipton,Data-on-File-RIM103,1,2

RAPID RESPONSELipton,Data-on-File-RIM118,Data-on-File-RIM105,1,2

EXAMPLE Rx

EXAMPLE Rx

Nurtec ODT was not associated with any serious
treatment‑related AEs.^2,3

Long‑term safety maintained through 52 weeks¹

Sustained Response^{Data-on-File-RIM118,1,2}

Sustained Response^{Data-on-File-RIM118,1,2}

REDUCTION IN MMDs^1,*^,†

RAPID RESPONSE^{Lipton,Data-on-File-RIM103,1,2}

RAPID RESPONSE^{Lipton,Data-on-File-RIM118,Data-on-File-RIM105,1,2}