NURTEC® ODT Dosage and Administration

(rimegepant)

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 Recommended Dosing for Preventive Treatment of Episodic Migraine

The recommended dosage of NURTEC ODT is 75 mg taken orally every other day.

2.3 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.

2.4 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)].

2.5 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)].

2.6 Concomitant Administration with Potent Inhibitors of P-gp

Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with potent inhibitors of P-gp [see Drug Interactions (7.3), Clinical Pharmacology (12.3)].

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 Recommended Dosing for Preventive Treatment of Episodic Migraine

The recommended dosage of NURTEC ODT is 75 mg taken orally every other day.

2.3 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.

2.4 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)].

2.5 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)].

2.6 Concomitant Administration with Potent Inhibitors of P-gp

Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with potent inhibitors of P-gp [see Drug Interactions (7.3), Clinical Pharmacology (12.3)].
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