Safety

Actor Portrayal

Well-tolerated across
clinical trials1

Most Common AE1

2%
Incidence of nausea:
2% Nurtec ODT vs 0.4% placebo

Safety assessment included 682 patients who received a single dose of rimegepant ODT 75 mg and 693 patients who received placebo during the double-blind treatment.1,2


Long-term safety maintained through 52 weeks1

<2.7% (n=48/1798) of patients receiving rimegepant discontinued due to AEs3

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

Can be used to treat up to 15 migraines per month1

A long-term open-label safety study evaluated rimegepant 75 mg in patients (N=1798) exposed to multiple doses, as needed up to one dose per day, for up to 52 weeks.1,5

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. Data on File. RIM121. Biohaven Pharmaceuticals Inc. 4. Data on File. RIM113. Biohaven Pharmaceuticals Inc. 5. Data on File. RIM131. Biohaven Pharmaceuticals Inc.

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Dosing

Important Safety Information

Contraindications: Hypersensitivity to Nurtec ODT or any of its components.

Warnings and Precautions: If a serious hypersensitivity reaction occurs, discontinue Nurtec ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.

Adverse Reactions: The most common adverse reaction was nausea (2% in patients who received Nurtec ODT compared to 0.4% in patients who received placebo). Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with Nurtec ODT.

Drug Interactions: Avoid concomitant administration of Nurtec ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P‑gp or BCRP. Avoid another dose of Nurtec ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.

Use in Specific Populations: Pregnant/breast feeding: It is not known if Nurtec ODT can harm an unborn baby or if it passes into breast milk. Hepatic impairment: Avoid use of Nurtec ODT in persons with severe hepatic impairment. Renal impairment: Avoid use in patients with end-stage renal disease.

Indication

Nurtec ODT is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use
Nurtec ODT is not indicated for the preventive treatment of migraine.

Please click here for full Prescribing Information.