Nurtec ODT

/ Pfizer

Recommended Dosing for Acute Treatment of Migraine
The recommended dose of 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 is 75 mg taken orally every other day.

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

Hypersensitivity to the active substance or to any of the excipients.
Delayed serious hypersensitivity has occurred.

Hypersensitivity Reactions:
Hypersensitivity reactions, including dyspnea and rash, have occurred with the drug in clinical studies. Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity has occurred. If a hypersensitivity reaction occurs, discontinue  and initiate appropriate therapy.

nausea, abdominal pain/dyspepsia. Hypersensitivity, including dyspnea and severe rash, occurred in less than 1% of patients.
See prescribing information for more details.

CYP3A4 Inhibitors:
Concomitant administration with strong inhibitors of CYP3A4 results in a significant increase in rimegepant exposure. Avoid concomitant administration of this medicinal product with strong inhibitors of CYP3A4.
Concomitant administration with moderate inhibitors of CYP3A4 may result in increased exposure of rimegepant. Avoid another dose of this medicinal product within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4 .
CYP3A Inducers:
Concomitant administration with strong or moderate inducers of CYP3A can result in a significant reduction in rimegepant exposure, which may lead to loss of efficacy of NURTEC ODT.
Avoid concomitant administration of this medicinal product with strong or moderate inducers of CYP3A.
Transporters
Rimegepant is a substrate of P-gp and BCRP efflux transporters. Concomitant administration with inhibitors of P-gp or BCRP may result in a significant increased in rimegepant exposure. Avoid use with inhibitors of P-gp or BCRP.
See prescribing information for more details.

Pregnancy:
There are no adequate data on the developmental risk associated with the use of the drug 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.
Lactation:
A lactation study was conducted, and the results have established a relative infant dose of less than 1% of the maternal weight-adjusted dose and the milk-to-plasma ratio of 0.20. These data support that transfer of rimegepant into breastmilk is low. 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 the medication and any potential adverse effects on the breastfed infant from this medicinal product or from the underlying maternal condition.
A study was conducted in twelve healthy adult lactating women who were between 2 weeks and 6 months postpartum and were administered a single oral dose of rimegepant 75 mg. The relative infant dose was <1%. The average milk to plasma ratio was 0.20.
please see prescribing information for more details.

There is limited clinical experience with overdosage. Treatment of an overdose  should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. No specific antidote for the treatment of rimegepant overdose is available. Rimegepant is unlikely to be significantly removed by dialysis because of high serum protein binding.

Store below 25ºC.
Instruct the patient on the following administration instructions:
 -Use dry hands when opening the blister pack.
-Peel back the foil covering of one blister and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil.
-As soon as the blister is opened, remove the ODT and place on the tongue; alternatively, the ODT may be placed under the tongue.
-The ODT will disintegrate in saliva so that it can be swallowed without additional liquid.
-Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use.