Overview
11 DESCRIPTION NURTEC ODT contains rimegepant sulfate, a calcitonin gene-related peptide receptor antagonist. Rimegepant sulfate is described chemically as (5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyridin-9-yl 4-(2-oxo-2,3-dihydro-1H-imidazo[4,5-b]pyridin-1-yl)-1-piperidinecarboxylate hemisulfate sesquihydrate and its structural formula is: Its empirical...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Rimegepant is a calcitonin gene-related peptide receptor antagonist. 12.2 Pharmacodynamics The relationship between pharmacodynamic activity and the mechanism(s) by which rimegepant exerts its clinical effects is unknown. No clinically relevant differences in resting blood pressure were observed when rimegepant was concomitantly administered with sumatriptan (12 mg subcutaneous, given as two 6 mg doses separated by one hour) compared with sumatriptan alone to healthy volunteers. Cardiac Electrophysiology At a single dose 4 times the recommended dose, rimegepant does not prolong the QT interval to any clinically relevant extent. 12.
Indications
- 1 INDICATIONS AND USAGE NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: acute treatment of migraine with or without aura in adults ( 1.1 ) preventive treatment of episodic migraine in adults ( 1.2 ) 1.1 Acute Treatment of Migraine NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults . 1.2 Preventive Treatment of Episodic Migraine NURTEC ODT is indicated for the preventive treatment of episodic migraine in adults.
Common Doses
- 75 mg
Dosage
2 DOSAGE AND ADMINISTRATION Recommended dosage for acute treatment of migraine: 75 mg taken orally, as needed. ( 2.1 ) The safety of using more than 18 doses in a 30-day period has not been established. ( 2.1 ) Recommended dosage for preventive treatment of episodic migraine: 75 mg taken orally every other day. ( 2.2 ) The maximum dose in a 24-hour period is 75 mg. ( 2.1 ) 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.
Contraindications
- 4 CONTRAINDICATIONS NURTEC ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components.Reactions have included anaphylaxis and delayedserious hypersensitivity [see Warnings and Precautions (5.1) ] . Patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or to any of its components. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Hypertension [see Warnings and Precautions (5.2) ] Raynaud’s Phenomenon [see Warnings and Precautions (5.3) ] Acute treatment of migraine: the adverse reaction reported in ≥ 1% of patients treated with NURTEC ODT is nausea. ( 6.
Interactions
- 7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Avoid concomitant administration. ( 7.1 ) Moderate CYP3A4 Inhibitors: Avoid another dose within 48 hours when administered with a moderate CYP3A4 inhibitor. ( 7.1 ) Strong and Moderate CYP3A Inducers: Avoid concomitant administration. ( 7.2 ) Potent Inhibitors of P-gp: Avoid another dose of NURTEC ODT within 48 hours when administered with a potent P-gp inhibitor. ( 7.3 ) 7.1 CYP3A4 Inhibitors Concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4 results in a significant increase in rimegepant exposure.