NURTEC ODT 7 Warnings And Precautions

rimegepant

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Please see 3 SERIOUS WARNINGS AND PRECAUTIONS.

7.1 Special Populations

7.1.1 Pregnant Women

There are no adequate human data on the developmental risk associated with the use of rimegepant in pregnancy. Animal studies demonstrate that at clinically relevant exposures rimegepant does not result in embryo-fetal death or fetal malformations. There were no developmental effects in rats at doses up to 60 mg/kg/day (exposures 46 times the human AUC at the maximum recommended human dose [MRHD] of 75 mg/day) or in rabbits at up to the highest dose tested of 50 mg/kg/day (exposures 10 times the MRHD of 75 mg/day). Please see 16 NON-CLINICAL TOXICOLOGY. NURTEC ODT should not be used in pregnant women unless the expected benefit to the mother outweighs the potential risk to the fetus. 

7.1.2 Breast-feeding

A lactation study was conducted in 12 healthy adult lactating women (26-37 years of age) who were between 2 weeks and 6 months post-partum and were administered a single oral dose of rimegepant 75 mg. The results have established an average milk-to-plasma ratio of 0.20 and a relative infant dose of less than 1% of the maternal weight-adjusted dose. 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 rimegepant and any potential adverse effects on the breastfed infant from rimegepant or from the underlying maternal condition.

7.1.3 Pediatrics

Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

7.1.4 Geriatrics

Geriatrics (≥ 65 years of age): Clinical trials with rimegepant did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients (131 treated with rimegepant). In pharmacokinetic studies, no clinically significant pharmacokinetic differences were observed between elderly and younger subjects (see 4.2 Recommended Dose and Dosage Adjustment).

7.1.5 Hepatic Impairment

Plasma concentrations of rimegepant were significantly higher in subjects with severe (Child-Pugh C) hepatic impairment (see 4.2 Recommended Dose and Dosage Adjustment, 10.3 Pharmacokinetics). The use of NURTEC ODT in patients with severe hepatic impairment should be avoided.

7.1.6 Renal Impairment

Rimegepant has not been studied in patients with end-stage renal disease (CLcr < 15 mL/min) and in patients on dialysis and should be avoided in these patients (see 4.2 Recommended Dose and Dosage Adjustment, 10.3 Pharmacokinetics).

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7 Warnings And Precautions

Please see 3 SERIOUS WARNINGS AND PRECAUTIONS.

7.1 Special Populations

7.1.1 Pregnant Women

There are no adequate human data on the developmental risk associated with the use of rimegepant in pregnancy. Animal studies demonstrate that at clinically relevant exposures rimegepant does not result in embryo-fetal death or fetal malformations. There were no developmental effects in rats at doses up to 60 mg/kg/day (exposures 46 times the human AUC at the maximum recommended human dose [MRHD] of 75 mg/day) or in rabbits at up to the highest dose tested of 50 mg/kg/day (exposures 10 times the MRHD of 75 mg/day). Please see 16 NON-CLINICAL TOXICOLOGY. NURTEC ODT should not be used in pregnant women unless the expected benefit to the mother outweighs the potential risk to the fetus. 

7.1.2 Breast-feeding

A lactation study was conducted in 12 healthy adult lactating women (26-37 years of age) who were between 2 weeks and 6 months post-partum and were administered a single oral dose of rimegepant 75 mg. The results have established an average milk-to-plasma ratio of 0.20 and a relative infant dose of less than 1% of the maternal weight-adjusted dose. 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 rimegepant and any potential adverse effects on the breastfed infant from rimegepant or from the underlying maternal condition.

7.1.3 Pediatrics

Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

7.1.4 Geriatrics

Geriatrics (≥ 65 years of age): Clinical trials with rimegepant did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients (131 treated with rimegepant). In pharmacokinetic studies, no clinically significant pharmacokinetic differences were observed between elderly and younger subjects (see 4.2 Recommended Dose and Dosage Adjustment).

7.1.5 Hepatic Impairment

Plasma concentrations of rimegepant were significantly higher in subjects with severe (Child-Pugh C) hepatic impairment (see 4.2 Recommended Dose and Dosage Adjustment, 10.3 Pharmacokinetics). The use of NURTEC ODT in patients with severe hepatic impairment should be avoided.

7.1.6 Renal Impairment

Rimegepant has not been studied in patients with end-stage renal disease (CLcr < 15 mL/min) and in patients on dialysis and should be avoided in these patients (see 4.2 Recommended Dose and Dosage Adjustment, 10.3 Pharmacokinetics).

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