Rimegepant: uses, dosing, side effects & brands

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. ( 6.1 ) Preventive treatment of episodic migraine: adverse reactions reported in ≥ 2% for rimegepant and ≥ 1% higher than placebo are nausea and abdominal pain/dyspepsia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Acute Treatment of Migraine The safety of NURTEC ODT for the acute treatment of migraine in adults has been evaluated in a randomized, double-blind, placebo-controlled trial (Study 1) in 682 patients with migraine who received one 75 mg dose of NURTEC ODT [see Clinical Studies (14) ] . Approximately 85% were female, 74% were White, 21% were Black, and 17% were Hispanic or…

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 )

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. Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4 [see Clinical Pharmacology (12.3) ] . Concomitant administration of NURTEC ODT with moderate inhibitors of CYP3A4 may result in increased exposure of rimegepant. Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4 [see Clinical Pharmacology (12.3) ] . 7.2 CYP3A Inducers Concomitant administration of NURTEC ODT 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 NURTEC ODT with strong or moderate inducers of CYP3A [see Clinical Pharmacology (12.3) ] . 7.3 P-gp Inhibitors Concomitant administration of NURTEC ODT with potent inhibitors of P-gp (e.g., amiodarone, cyclosporine, lapatinib, quinidine, ranolazine) may result in increased exposure of rimegepant. Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with potent inhibitors of P-gp [see Clinical Pharmacology (12.3) ] .