The active ingredient of QULIPTA is atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of atogepant is (3' S )- N -[(3 S ,5 S ,6 R )-6-methyl-2-oxo-1-(2,2,2-trifluoroethyl)-5-(2,3,6-trifluorophenyl)piperidin-3-yl]-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[ b ]pyridine-6,3'-pyrrolo[2,3- b ]pyridine]-3-carboxamide, and it has the following structural formula: The molecular formula is C 29 H 2 3 F 6 N 5 O 3 and molecular weight is 603.5. Atogepant is a white...

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QULIPTA is taken orally with or without food. For episodic migraine, the recommended dosage is 10 mg, 30 mg, or 60 mg taken once daily. For chronic migraine, the recommended dosage is 60 mg taken once daily. Severe Renal Impairment or End-Stage Renal Disease: Episodic migraine: 10 mg once daily. Chronic migraine: Avoid use. 2.1 Recommended Dosage QULIPTA is taken orally with or without food. Episodic Migraine The recommended dosage of QULIPTA for episodic migraine is 10 mg, 30 mg, or 60 mg taken once ...

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If a hypersensitivity reaction occurs, discontinue QULIPTA and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis and dyspnea. These reactions can occur days after administration. 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported with use of QULIPTA . Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, disco...

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Recommended dosage modifications: Strong CYP3A4 Inhibitor: ○ Episodic migraine: 10 mg once daily. ○ Chronic migraine: avoid use. Strong, Moderate, or Weak CYP3A4 Inducers: ○ Episodic migraine: 30 mg or 60 mg once daily. ○ Chronic migraine: avoid use. OATP Inhibitors: ○ Episodic migraine: 10 mg or 30 mg once daily. ○ Chronic migraine: 30 mg once daily. 7.1 CYP3A4 Inhibitors Coadministration of QULIPTA with itraconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of atogep...

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There are no adequate data on the developmental risk associated with the use of QULIPTA in pregnant women. In animal studies, oral administration of atogepant during the period of organogenesis (rats and rabbits) or throughout pregnancy and lactation (rats) resulted in adverse developmental effects (decreased fetal and offspring body weight in rats; increased incidence of fetal structural variations in rabbits) at exposures greater than those used clinically . In the U.S. general population, the e...

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