rimegepant 75 MG Disintegrating Oral Tablet [Nurtec]
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Is NURTEC ODT safe to use during 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 effects on development in rats (decreased fetal body weight and increased incidence of skeletal variations) at exposures greater than those used clinically and which were associated with maternal toxicity. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated rate of major birth defects (2.2 to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Women exposed to NURTEC ODT during pregnancy can participate in a pregnancy exposure registry that monitors pregnancy outcomes. Healthcare providers or patients can contact 1-877-366-0324, email email@example.com, or visit nurtecpregnancyregistry.com for more information.
Can I take NURTEC ODT while breastfeeding?A lactation study conducted on 12 healthy adult lactating women who were between 2 weeks and 6 months postpartum and were administered a single oral dose of rimegepant 75 mg established a relative infant dose of less than 1% of the maternal weight-adjusted dose and a milk-to-plasma ratio of 0.20. These data support that transfer of rimegepant into breastmilk is low. However, there are no data on the effects of rimegepant on a breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for NURTEC ODT and any potential adverse effects on the breastfed infant from NURTEC ODT or from the underlying maternal condition.
Is NURTEC ODT safe for use in children?Safety and effectiveness in pediatric patients have not been established for NURTEC ODT.
Is NURTEC ODT safe for use in elderly patients?In pharmacokinetic studies, no clinically significant pharmacokinetic differences were observed between elderly and younger subjects. However, clinical studies of NURTEC ODT did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Do patients with renal impairment need a dosage adjustment of NURTEC ODT?No, dosage adjustment is not required in patients with mild, moderate, or severe renal impairment. However, NURTEC ODT has not been studied in patients with end-stage renal disease and in patients on dialysis. It is advised to avoid the use of NURTEC ODT in patients with end-stage renal disease (CLcr < 15 mL/min).
What is the recommended dose of NURTEC ODT for patients with severe renal impairment?The recommended dosage of NURTEC ODT for patients with severe renal impairment (CLcr 15-29 mL/min) is the same as for patients with normal renal function, which is a single dose of 75 mg. However, NURTEC ODT has not been studied in patients with end-stage renal disease and in patients on dialysis. It is advised to avoid the use of NURTEC ODT in patients with end-stage renal disease (CLcr < 15 mL/min).
Can patients on dialysis use NURTEC ODT?NURTEC ODT has not been studied in patients on dialysis. It is advised to avoid the use of NURTEC ODT in patients with end-stage renal disease (CLcr < 15 mL/min).
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