NURTEC ODT Orally disintegrating tablet Ref.[10188] Active ingredients: Rimegepant

The recommended dose of NURTEC ODT is 75 mg taken orally.

The maximum dose in a 24-hour period is 75 mg. The safety of treating more than 15 migraines in a 30-day period has not been established.

2.2 Administration Information

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.

2.3 Concomitant Administration with Strong or Moderate CYP3A4 Inhibitors

Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4. Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4 [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

2.4 Concomitant Administration with Strong or Moderate CYP3A Inducers

Avoid concomitant administration of NURTEC ODT with strong or moderate inducers of CYP3A, which may lead to loss of efficacy of NURTEC ODT [see Drug Interactions (7.2), Clinical Pharmacology (12.3)].

2.5 Concomitant Administration with Inhibitors of P-gp or BCRP

Avoid concomitant administration of NURTEC ODT with inhibitors of P-gp or BCRP [see Drug Interactions (7.3), Clinical Pharmacology (12.3)].

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 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 [see Clinical Pharmacology (12.3)].

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) [see USP controlled room temperature].