Adult Dosing

• Recommended dosage for acute treatment of migraine: 75 mg taken orally, as needed.
• The safety of using more than 18 doses in a 30-day period has not been established.
• Recommended dosage for preventive treatment of episodic migraine: 75 mg taken orally every other day.
• The maximum dose in a 24-hour period is 75 mg.
• Avoid concomitant administration of drug with strong inhibitors of CYP3A4.
• Avoid another dose within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4.
• Avoid concomitant administration of drug with strong or moderate inducers of CYP3A, which may lead to loss of efficacy.
• Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with potent inhibitors of P-gp.

Pediatric Dosing

• Safety and effectiveness have not been established.

[Outline]

• Adult Dosing
• Pediatric Dosing

• Acute treatment of migraine with or without aura in adults.
• Preventive treatment of episodic migraine in adults.

• Patients with a history of hypersensitivity reaction to rimegepant or to any of its components.

Renal Dose Adjustment

• Renal impairment: No dosage adjustment is required in patients with mild, moderate, or severe renal impairment. Has not been studied in patients with end-stage renal disease and in patients on dialysis. Avoid use in patients with end-stage renal disease (CLcr <15 mL/min)

Hepatic Dose Adjustment

• Hepatic impairment: No dosage adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Plasma concentrations were significantly higher in subjects with severe (Child-Pugh C) hepatic impairment. Exposures were significantly higher in subjects with severe hepatic impairment. Avoid use in patients with severe hepatic impairment (Child-Pugh C).

• Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue the drugand initiate appropriate therapy. Severe hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.

Interactions

• Strong CYP3A4 Inhibitors: Avoid concomitant administration.
• Moderate CYP3A4 Inhibitors: Avoid another dose within 48 hours when administered with a moderate CYP3A4 inhibitor.
• Strong and Moderate CYP3A Inducers: Avoid concomitant administration.
• Potent Inhibitors of P-gp: Avoid another dose within 48 hours when administered with a potent P-gp inhibitor.

Pregnancy Category:NR.

Breastfeeding: A relative infant dose of less than 1% of the maternal weight-adjusted dose and the milk-to-plasma ratio of 0.20. Transfer of rimegepant into breastmilk is low.

• Acute treatment of migraine: the adverse reaction reported in 1% of patients treated with drug is nausea.
• Preventive treatment of episodic migraine: adverse reactions reported in 2% for rimegepant and 1% higher than placebo are nausea and abdominal pain/dyspepsia.
• GI: nausea
• MISC: hypersensitivity reactions

• Mechanism of Action: Calcitonin gene-related peptide receptor antagonist.
• Absorption: 64% absorbed following oral administration. Maximum concentration at 1.5 hours. High-fat foods may delay approx. 1 to 1.5 hours and reduce extent of absorption by 42 to53%.
• Distribution: 120 L.
• Protein Binding: 96% bound to plasma protein
• Metabolism/Excretion: Primarily metabolized by CYP3A4 and to a lesser extent by CYP2C9. Primarily excreted as unchanged drug in feces (42%) and urine (51%).
• Half-life: 11 hrs.

US Trade Name(s)

• Nurtec ODT

US Availability

Nurtec ODT

• Orally disintegrating TABS: 75 mg

[Outline]

Neurologic

Antimigraine Agents

CGRP Receptor Antagonists