2nd Abu Dhabi Brain Conference 2022 Program Book

Nurtec ODT is indicated in adults for the: 1 • acute treatment of migraine with or without aura • preventive treatment of episodic migraine FOR THE ACUTE TREATMENT OF MIGRAINE AND THE PREVENTIVE TREATMENT OF EPISODIC MIGRAINE IN ADULTS 1 REFERENCES: 1. Nurtec ODT 75 mg LPD USPI Revision date May 2021. NURTEC ODT ® Abbreviated Prescribing Information GENERIC NAME: Rimegepant. PRESENTATION: NURTEC ODT 75 mg orally disintegrating tablets are white to o -white, circular, debossed with the symbol, and supplied in cartons containing a blister pack of 8 orally disintegrating tablets. Each ODT contains 75 mg rimegepant INDICATION(s): NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults. NURTEC ODT is indicated for the preventive treatment of episodic migraine in adults. DOSAGE AND ADMINISTRATION: Recommended Dosing for Acute Treatment of Migraine. The recommended dose of NURTEC ODT is 75 mg taken orally, as needed. The maximum dose in a 24-hour period is 75 mg. The safety of using more than 18 doses in a 30-day period has not been established. Recommended Dosing for Preventive Treatment of Episodic Migraine The recommended dosage of NURTEC ODT is 75 mg taken orally every other day. Pregnancy There are no adequate data on the developmental risk associated with the use of NURTEC ODT in pregnant women. In animal studies, oral administration of rimegepant during organogenesis resulted in adverse e ects on development in rats (decreased fetal body weight and increased incidence of fetal variations) at exposures greater than those used clinically and which were associated with maternal toxicity. The evaluation of developmental e ects following oral administration of rimegepant throughout pregnancy and lactation was inadequate. Lactation There are no data on the presence of rimegepant or its metabolites in human milk, the e ects of rimegepant on the breastfed infant, or the e ects of rimegepant on milk production. There are no animal data on the excretion of rimegepant in milk. The developmental and health bene ts of breastfeeding should be considered along with the mother’s clinical need for NURTEC ODT and any potential adverse e ects on the breastfed infant from NURTEC ODT or from the underlyingmaternal condition. Pediatric Use Safety and e ectiveness in pediatric patients have not been established. Geriatric Use In pharmacokinetic studies, no clinically signi cant pharmacokinetic di erences were observed between elderly and younger subjects. Clinical studies of NURTEC ODT did not include su cient numbers of patients aged 65 and over to determine whether they respond di erently from younger patients. Hepatic Impairment No dosage adjustment of NURTEC ODT is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Plasma concentrations of Rimegepant were signi cantly higher in subjects with severe (Child-Pugh C) hepatic impairment. Avoid use of NURTEC ODT in patients with severe hepatic impairment. Renal Impairment No dosage adjustment of NURTEC ODT is required in patients withmild, moderate, or severe renal impairment. NURTEC ODT has not been studied in patients with end-stage renal disease and in patients on dialysis. Avoid use of NURTEC ODT in patients with end-stage renal disease (CLcr < 15 mL/min). CONTRAINDICATIONS: NURTEC ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components. Delayed serious hypersensitivity has occurred. WARNING AND PRECAUTIONS: Hypersensitivity Reactions. Hypersensitivity reactions, including dyspnea and rash, have occurred with NURTEC ODT in clinical studies. Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity has occurred. If a hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy. DRUG 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. Inhibitors of P-gp or BCRP: Avoid concomitant administration. Concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4 results in a signi cant increase in rimegepant exposure. Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4 Concomitant administration of NURTEC ODT with moderate inhibitors of CYP3A4 may result in increased exposure of rimegepant. Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4. Concomitant administration of NURTEC ODT with strong or moderate inducers of CYP3A can result in a signi cant reduction in rimegepant exposure, which may lead to loss of e cacy of NURTEC ODT. Avoid concomitant administration of NURTEC ODT with strong or moderate inducers of CYP3A. Rimegepant is a substrate of P-gp and BCRP e ux transporters. Concomitant administration of NURTEC ODT with inhibitors of P-gp or BCRP may result in a signi cant increase in rimegepant exposure. Avoid NURTEC ODT with inhibitors of P-gp or BCRP. OVERDOSE: There is limited clinical experience with NURTEC ODT overdosage. Treatment of an overdose of NURTEC ODT should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. No speci c antidote for the treatment of rimegepant overdose is available. Rimegepant is unlikely to be signi cantly removed by dialysis because of high serum protein binding. ADVERSE REACTION: Acute treatment of migraine: the adverse reaction reported in ≥ 1% of patients treated with NURTEC ODT is nausea. The most common adverse reaction in Study 1 was nausea (2% in patients who received NURTEC ODT compared to 0.4% of patients who received placebo). Hypersensitivity, including dyspnea and severe rash, occurred in less than 1% of patients treated with NURTEC ODT. Preventive treatment of episodic migraine: adverse reactions reported in ≥ 2% for rimegepant and ≥ 1% higher than placebo are nausea and abdominal pain/dyspepsia. The most common adverse reactions (occurring in at least 2% of rimegepant-treated patients and at a frequency of at least 1% higher than placebo) in Study 2 were nausea (2.7% in patients who received rimegepant compared with 0.8% of patients who received placebo) and abdominal pain/dyspepsia (2.4% in patients who received rimegepant compared with 0.8% of patients who received placebo). PHARMACEUTICAL PRECAUTIONS: Store NURTEC ODT at controlled room temperature, 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F). PHARMACOKINETICS / PHARMACODYNAMICS: Absorption Following oral administration of NURTEC ODT, rimegepant is absorbed with the maximum concentration at 1.5 hours. The absolute oral bioavailability of rimegepant is approximately 64%. E ects of Food Following administration of NURTEC ODT under fed conditions with a high-fat or low-fat meal, Tmax was delayed by approximately 1 to 1.5 hours. A high-fat meal reduced Cmax by 42 to 53% and AUC by 32 to 38%. A low-fat meal reduced Cmax by 36% and AUC by 28%. NURTEC ODT was administered without regard to food in clinical safety and e cacy studies. The impact of the reduction in rimegepant exposure because of administration with food on its e cacy is unknown. Distribution The steady state volume of distribution of rimegepant is 120 L. Plasma protein binding of rimegepant is approximately 96%. Elimination Metabolism Rimegepant is primarily