Get your patient on Nurtec Odt (Rimegepant Sulfate)

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 Acute Treatment of Migraine

  NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults

  .
  )
• •preventive treatment of episodic migraine in adults (
  1.2 Preventive Treatment of Episodic Migraine

  NURTEC ODT is indicated for the preventive treatment of episodic migraine in adults.
  )

• •Recommended dosage for acute treatment of migraine: 75 mg taken orally, as needed. (
  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.
  )
• •The safety of using more than 18 doses in a 30-day period has not been established. (
  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.
  )
• •Recommended dosage for preventive treatment of episodic migraine: 75 mg taken orally every other day. (
  2.2 Recommended Dosing for Preventive Treatment of Episodic Migraine

  The recommended dosage of NURTEC ODT is 75 mg taken orally every other day.
  )
• •The maximum dose in a 24-hour period is 75 mg. (
  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.
  )

Orally disintegrating tablets: white to off-white, circular, and debossed with the symbol , each containing 75 mg of rimegepant.

• •Exposures were significantly higher in subjects with severe hepatic impairment. Avoid use in patients with severe hepatic impairment (Child-Pugh C). (
  8.6 Hepatic Impairment

  No dosage adjustment of NURTEC ODT is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Plasma concentrations of rimegepant were significantly higher in subjects with severe (Child-Pugh C) hepatic impairment. Avoid use of NURTEC ODT in patients with severe hepatic impairment

  [seeClinical Pharmacology (12.3)]

  .
  )
  
  
  
  

NURTEC ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

• •Hypersensitivity Reactions
  [see

  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

  [seeContraindications (4)

  andAdverse Reactions (6.1,6.2)

  ].

  ]
• •Hypertension
  [see

  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.

  ]
• •Raynaud’s Phenomenon
  [see

  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.

  ]

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 formula is C₂₈H₂₈F₂N₆O₃ 0.5 H₂SO₄ 1.5 H₂O, representing a molecular weight of 610.63. Rimegepant free base has a molecular weight of 534.56. Rimegepant sulfate is a white to off-white, crystalline solid that is slightly soluble in water.

NURTEC ODT (orally disintegrating tablets) is for sublingual or oral use and contains 85.7 mg rimegepant sulfate, equivalent to 75 mg rimegepant free base, and the following inactive ingredients: benzyl alcohol, eucalyptol, gelatin, limonene, mannitol, menthol, menthone, menthyl acetate, sucralose, and vanillin.

NURTEC ODT 75 mg orally disintegrating tablets are white to off-white, circular, debossed with the symbol , and supplied in cartons containing a blister pack of 8 orally disintegrating tablets. Each ODT contains 75 mg rimegepant.

NDC: 72618-3000-2

Rimegepant is a calcitonin gene-related peptide receptor antagonist.