rimegepant 75 MG Disintegrating Oral Tablet

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.

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 ) • NURTEC ODT can be taken with or without food. ( 2.1 , 2.2 ) 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. NURTEC ODT can be taken with or without food [see Clinical Pharmacology (12.3) ] . 2.2 Recommended Dosing for Preventive Treatment of Episodic Migraine The recommended dosage of NURTEC ODT is 75 mg taken orally every other day , with or without food . 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) ] .

WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis, dyspnea, and rash, and can occur days after administration. ( 5.1 ) • Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) • Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.3 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, dyspnea , and rash, have occurred in patients treated with NURTEC ODT . Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity has occurred. If a hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy [see Contraindications (4) and Adverse Reactions (6.1 , 6.2) ] . 5.2 Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including NURTEC ODT, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. NURTEC ODT was discontinued in many of the reported cases. Monitor patients treated with NURTEC ODT for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of NURTEC ODT is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. 5.3 Raynaud’s Phenomenon Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including NURTEC ODT. In reported cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. NURTEC ODT should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

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 delayed serious 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 )

Mechanism of Action Rimegepant is a calcitonin gene-related peptide receptor antagonist.