Section 02 · Monograph

Atogepant

Reviewed Nov 2026FDA label

QuliptaGepant · oral

Indications

Small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant")
Competitively blocks CGRP binding to its receptor, inhibiting CGRP-mediated neurogenic vasodilation and trigeminal sensitization implicated in migraine pathophysiology
Orally bioavailable; peak plasma concentration ~1-2 hours; ~95% protein bound; elimination half-life ~11 hours; metabolized primarily via CYP3A4

Episodic migraine: 10 mg, 30 mg, or 60 mg orally once daily
Chronic migraine: 60 mg orally once daily
With strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin): limit to 10 mg once daily for both episodic and chronic migraine
With strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): 60 mg once daily for episodic migraine; not recommended for chronic migraine
With OATP inhibitors (e.g., single-dose rifampin, cyclosporine): limit to 10-30 mg once daily (episodic) or 30 mg once daily (chronic)

Severe renal impairment or ESRD (CrCl <30 mL/min): episodic migraine 10 mg once daily; not recommended for chronic migraine

Severe hepatic impairment: avoid use; mild-to-moderate impairment requires no dose adjustment

Hypersensitivity to atogepant or any component of QULIPTA (reactions have included anaphylaxis and dyspnea)

Strong CYP3A4 inhibitors: significantly increase atogepant exposure (AUC ~5.5-fold) — requires dose reduction to 10 mg daily
Strong CYP3A4 inducers: decrease atogepant exposure (AUC ~60%) — dose increase or avoidance required per indication
OATP1B1 inhibitors: increase atogepant exposure (AUC ~2.85-fold) — requires dose reduction
Moderate/weak CYP3A4 inducers (e.g., topiramate): modest decrease in exposure — dose adjustment recommended
No clinically significant interaction observed with oral contraceptives, triptans, ubrogepant, NSAIDs, or acid-suppressing agents

Nausea (~3-9%, dose-dependent)
Constipation (~2-8%, dose-dependent)
Fatigue/somnolence (~4-5%)
Decreased appetite (up to ~3%)
Weight loss (≥7% body weight decrease in up to 5.3% of patients at 60 mg)
Hypersensitivity reactions including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema (postmarketing, can occur days after dosing)
New-onset or worsening hypertension, typically within 7 days of initiation (postmarketing)
Raynaud's phenomenon (postmarketing)

Blood pressure at baseline and periodically during treatment
Signs/symptoms of hypersensitivity, particularly within the first week of dosing
Signs/symptoms of Raynaud's phenomenon; discontinue if it develops
Clinical efficacy monthly when coadministered with strong CYP3A4 inducers
Liver function in patients with hepatic impairment (avoid use in severe impairment)

Pregnancy: limited human data; animal studies showed decreased fetal body weight and skeletal variations at maternal exposures greater than clinical doses — may cause fetal harm
Pregnancy exposure registry available (1-833-277-0206 or empresspregnancyregistry.com)
Lactation: atogepant present in breast milk in low amounts; estimated relative infant dose ~0.19%; milk-to-plasma ratio ~0.08 — weigh benefits of breastfeeding against maternal need for therapy