QULIPTA

Calcitonin Gene-Related Peptide (CGRP) Antagonists

Oral Administration

Administer with or without food.

Severe

anaphylactoid reactions / Rapid / Incidence not known

Moderate

constipation / Delayed / 6.0-8.0
elevated hepatic enzymes / Delayed / 0.9-0.9
dyspnea / Early / Incidence not known

Mild

nausea / Early / 5.0-9.0
weight loss / Delayed / 3.2-5.3
fatigue / Early / 4.0-5.0
drowsiness / Early / 4.0-5.0
anorexia / Delayed / 1.0-3.0
rash / Early / Incidence not known
pruritus / Rapid / Incidence not known
urticaria / Rapid / Incidence not known

QULIPTA

Rx

Oral calcitonin gene-related peptide (CGRP) receptor antagonist
Used for the preventive treatment of episodic or chronic migraine in adults
Coadministration of certain other drugs may need to be avoided or dosage adjustments may be necessary

For migraine prophylaxis. For episodic migraine prophylaxis. Oral dosage Adults

10, 30, or 60 mg PO once daily. Coadministration of certain other drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

For chronic migraine prophylaxis. Oral dosage Adults

60 mg PO once daily. Coadministration of certain other drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Hepatic Impairment

Avoid use in patients with severe hepatic impairment. No dosage adjustment is needed for mild or moderate hepatic impairment.

Renal Impairment

Limit the atogepant dose to 10 mg PO once daily in persons with episodic migraine and severe renal impairment or end-stage renal disease (CrCl less than 30 mL/minute). Avoid atogepant use in persons with chronic migraine and severe renal impairment or end-stage renal disease (CrCl less than 30 mL/minute). No dosage adjustment is needed for mild or moderate renal impairment (CrCl 30 mL/minute or more).
 
Intermittent hemodialysis
Limit the atogepant dose to 10 mg PO once daily in persons with episodic migraine and severe renal impairment or end-stage renal disease (CrCl less than 30 mL/minute). Avoid atogepant use in persons with chronic migraine and severe renal impairment or end-stage renal disease (CrCl less than 30 mL/minute). Administer atogepant after dialysis.

Adagrasib: (Major) Avoid use of atogepant and adagrasib when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with adagrasib. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and adagrasib is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Amobarbital: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Amoxicillin; Clarithromycin; Omeprazole: (Major) Avoid use of atogepant and clarithromycin when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with clarithromycin. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; clarithromycin is a strong CYP3A inhibitor and an OATP1B1/3 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Apalutamide: (Major) Avoid use of atogepant and apalutamide when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with apalutamide. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and apalutamide is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Armodafinil: (Major) Avoid use of atogepant and armodafinil when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with armodafinil. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and armodafinil is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Asciminib: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with asciminib. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and asciminib is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Aspirin, ASA; Butalbital; Caffeine: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Atazanavir: (Major) Avoid use of atogepant and atazanavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with atazanavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; atazanavir is a strong CYP3A inhibitor and an OATP1B1 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Atazanavir; Cobicistat: (Major) Avoid use of atogepant and atazanavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with atazanavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; atazanavir is a strong CYP3A inhibitor and an OATP1B1 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. (Major) Avoid use of atogepant and cobicistat when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with cobicistat. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; cobicistat is a strong CYP3A inhibitor and an OATP1B1/3 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Barbiturates: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Belzutifan: (Major) Avoid use of atogepant and belzutifan when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with belzutifan. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and belzutifan is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Bexarotene: (Major) Avoid use of atogepant and bexarotene when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with bexarotene. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and bexarotene is a moderate CYP3A inducer.
Bosentan: (Major) Avoid use of atogepant and bosentan when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with bosentan. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and bosentan is a moderate CYP3A inducer.
Brigatinib: (Major) Avoid use of atogepant and brigatinib when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with brigatinib. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and brigatinib is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Butalbital; Acetaminophen: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Butalbital; Acetaminophen; Caffeine: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Butalbital; Acetaminophen; Caffeine; Codeine: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Butalbital; Aspirin; Caffeine; Codeine: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Carbamazepine: (Major) Avoid use of atogepant and carbamazepine when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with carbamazepine. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and carbamazepine is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Cenobamate: (Major) Avoid use of atogepant and cenobamate when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with cenobamate. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and cenobamate is a moderate CYP3A inducer.
Ceritinib: (Major) Avoid use of atogepant and ceritinib when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with ceritinib. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and ceritinib is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Chloramphenicol: (Major) Avoid use of atogepant and chloramphenicol when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with chloramphenicol. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and chloramphenicol is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Clarithromycin: (Major) Avoid use of atogepant and clarithromycin when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with clarithromycin. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; clarithromycin is a strong CYP3A inhibitor and an OATP1B1/3 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Clobazam: (Major) Avoid use of atogepant and clobazam when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with clobazam. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and clobazam is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Cobicistat: (Major) Avoid use of atogepant and cobicistat when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with cobicistat. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; cobicistat is a strong CYP3A inhibitor and an OATP1B1/3 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Cyclosporine: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with cyclosporine. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and cyclosporine is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Dabrafenib: (Major) Avoid use of atogepant and dabrafenib when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with dabrafenib. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and dabrafenib is a moderate CYP3A inducer.
Daclatasvir: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with daclatasvir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and daclatasvir is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Darolutamide: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with darolutamide. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and darolutamide is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Darunavir: (Major) Avoid use of atogepant and darunavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with darunavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and darunavir is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Darunavir; Cobicistat: (Major) Avoid use of atogepant and cobicistat when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with cobicistat. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; cobicistat is a strong CYP3A inhibitor and an OATP1B1/3 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration. (Major) Avoid use of atogepant and darunavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with darunavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and darunavir is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: (Major) Avoid use of atogepant and cobicistat when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with cobicistat. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; cobicistat is a strong CYP3A inhibitor and an OATP1B1/3 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration. (Major) Avoid use of atogepant and darunavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with darunavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and darunavir is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Deferasirox: (Major) Avoid use of atogepant and deferasirox when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with deferasirox. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and deferasirox is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Delavirdine: (Major) Avoid use of atogepant and delavirdine when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with delavirdine. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and delavirdine is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Dexamethasone: (Major) Avoid use of atogepant and dexamethasone when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with dexamethasone. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and dexamethasone is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Efavirenz: (Major) Avoid use of atogepant and efavirenz when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with efavirenz. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and efavirenz is a moderate CYP3A inducer.
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate: (Major) Avoid use of atogepant and efavirenz when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with efavirenz. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and efavirenz is a moderate CYP3A inducer.
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Major) Avoid use of atogepant and efavirenz when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with efavirenz. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and efavirenz is a moderate CYP3A inducer.
Elagolix: (Major) Avoid use of atogepant and elagolix when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with elagolix. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and elagolix is a moderate CYP3A inducer.
Elagolix; Estradiol; Norethindrone acetate: (Major) Avoid use of atogepant and elagolix when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with elagolix. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and elagolix is a moderate CYP3A inducer.
Elexacaftor; tezacaftor; ivacaftor: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with elexacaftor. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and elexacaftor is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Eltrombopag: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with eltrombopag. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and eltrombopag is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Eluxadoline: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with eluxadoline. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and eluxadoline is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide: (Major) Avoid use of atogepant and cobicistat when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with cobicistat. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; cobicistat is a strong CYP3A inhibitor and an OATP1B1/3 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate: (Major) Avoid use of atogepant and cobicistat when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with cobicistat. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; cobicistat is a strong CYP3A inhibitor and an OATP1B1/3 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Enasidenib: (Major) Avoid concurrent use of atogepant and enasidenib due to unpredictable effects on atogepant. Concurrent use may alter atogepant exposure and decrease its efficacy and/or increase the risk of adverse effects. Atogepant is a CYP3A and OATP1B1/3 substrate and enasidenib is a OATP inhibitor and weak CYP3A inducer. The net effect on atogepant exposure is unknown. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Encorafenib: (Major) Avoid use of atogepant and encorafenib due to the risk for altered atogepant exposure. Concurrent use may decrease atogepant exposure and reduce efficacy or increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3 and encorafenib is a strong CYP3A inducer and OATP inhibitor. The net effect on atogepant exposure is unknown. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Enzalutamide: (Major) Avoid use of atogepant and enzalutamide when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with enzalutamide. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and enzalutamide is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Erythromycin: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with erythromycin. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and erythromycin is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Eslicarbazepine: (Major) Avoid use of atogepant and eslicarbazepine when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with eslicarbazepine. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and eslicarbazepine is a moderate CYP3A inducer.
Etravirine: (Major) Avoid use of atogepant and etravirine when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with etravirine. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and etravirine is a moderate CYP3A inducer.
Fosphenytoin: (Major) Avoid use of atogepant and phenytoin/fosphenytoin when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with phenytoin/fosphenytoin. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and phenytoin/fosphenytoin is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Fostemsavir: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with fostemsavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and fostemsavir is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Gemfibrozil: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with gemfibrozil. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and gemfibrozil is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Glecaprevir; Pibrentasvir: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with glecaprevir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and glecaprevir is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration. (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with pibrentasvir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and pibrentasvir is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Glycerol Phenylbutyrate: (Major) Avoid use of atogepant and glycerol phenylbutyrate when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with glycerol phenylbutyrate. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and glycerol phenylbutyrate is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Grapefruit juice: (Major) Advise patients to avoid grapefruit and grapefruit juice during atogepant treatment due to the risk of increased atogepant exposure and adverse reactions. Atogepant is a CYP3A substrate and grapefruit juice is a strong CYP3A inhibitor.
Idelalisib: (Major) Avoid use of atogepant and idelalisib when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with idelalisib. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and idelalisib is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Indinavir: (Major) Avoid use of atogepant and indinavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with indinavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and indinavir is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Isoniazid, INH; Pyrazinamide, PZA; Rifampin: (Major) Avoid use of atogepant and rifampin when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with rifampin. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and rifampin is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Isoniazid, INH; Rifampin: (Major) Avoid use of atogepant and rifampin when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with rifampin. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and rifampin is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Itraconazole: (Major) Avoid use of atogepant and itraconazole when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with itraconazole. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and itraconazole is a strong CYP3A inhibitor. Coadministration resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Ivosidenib: (Major) Avoid use of atogepant and ivosidenib when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with ivosidenib. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and ivosidenib is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Ketoconazole: (Major) Avoid use of atogepant and ketoconazole when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with ketoconazole. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and ketoconazole is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Lansoprazole; Amoxicillin; Clarithromycin: (Major) Avoid use of atogepant and clarithromycin when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with clarithromycin. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; clarithromycin is a strong CYP3A inhibitor and an OATP1B1/3 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Leflunomide: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with leflunomide. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and leflunomide is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Leniolisib: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with leniolisib. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and leniolisib is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Letermovir: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with letermovir. Avoid use of atogepant and combination letermovir plus cyclosporine when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with combination letermovir plus cyclosporine. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; letermovir is an OATP1B1/3 inhibitor and combination letermovir plus cyclosporine is a strong CYP3A inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Levoketoconazole: (Major) Avoid use of atogepant and ketoconazole when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with ketoconazole. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and ketoconazole is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Lonafarnib: (Major) Avoid use of atogepant and lonafarnib when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with lonafarnib. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and lonafarnib is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Lopinavir; Ritonavir: (Major) Avoid use of atogepant and ritonavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with ritonavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and ritonavir is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with lopinavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and lopinavir is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Lorlatinib: (Major) Avoid use of atogepant and lorlatinib when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with lorlatinib. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and lorlatinib is a moderate CYP3A inducer.
Lumacaftor; Ivacaftor: (Major) Avoid use of atogepant and lumacaftor; ivacaftor when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with lumacaftor; ivacaftor. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and lumacaftor; ivacaftor is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Lumacaftor; Ivacaftor: (Major) Avoid use of atogepant and lumacaftor; ivacaftor when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with lumacaftor; ivacaftor. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and lumacaftor; ivacaftor is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Mavacamten: (Major) Avoid use of atogepant and mavacamten when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with mavacamten. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and mavacamten is a moderate CYP3A inducer.
Meropenem: (Major) Avoid use of atogepant and meropenem when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with meropenem. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and meropenem is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Meropenem; Vaborbactam: (Major) Avoid use of atogepant and meropenem when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with meropenem. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and meropenem is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Methohexital: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Midostaurin: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with midostaurin. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and midostaurin is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Mifepristone: (Major) Avoid use of atogepant and mifepristone when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with mifepristone. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and mifepristone is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Mitapivat: (Major) Avoid use of atogepant and mitapivat when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with mitapivat. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and mitapivat is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Mitotane: (Major) Avoid use of atogepant and mitotane when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with mitotane. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and mitotane is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Mobocertinib: (Major) Avoid use of atogepant and mobocertinib when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with mobocertinib. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and mobocertinib is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Modafinil: (Major) Avoid use of atogepant and modafinil when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with modafinil. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and modafinil is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Nafcillin: (Major) Avoid use of atogepant and nafcillin when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with nafcillin. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and nafcillin is a moderate CYP3A inducer.
Nefazodone: (Major) Avoid use of atogepant and nefazodone when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with nefazodone. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and nefazodone is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Nelfinavir: (Major) Avoid use of atogepant and nelfinavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with nelfinavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and nelfinavir is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Nevirapine: (Major) Avoid use of atogepant and nevirapine when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with nevirapine. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and nevirapine is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Nirmatrelvir; Ritonavir: (Major) Avoid use of atogepant and ritonavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with ritonavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and ritonavir is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Odevixibat: (Major) Avoid use of atogepant and odevixibat when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with odevixibat. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and odevixibat is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Olutasidenib: (Major) Avoid use of atogepant and olutasidenib when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with olutasidenib. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and olutasidenib is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Omaveloxolone: (Major) Avoid use of atogepant and omaveloxolone when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with omaveloxolone. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and omaveloxolone is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Omeprazole; Amoxicillin; Rifabutin: (Major) Avoid use of atogepant and rifabutin when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with rifabutin. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and rifabutin is a moderate CYP3A inducer.
Oritavancin: (Major) Avoid use of atogepant and oritavancin when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with oritavancin. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and oritavancin is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Oxcarbazepine: (Major) Avoid use of atogepant and oxcarbazepine when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with oxcarbazepine. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and oxcarbazepine is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Pentobarbital: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Pexidartinib: (Major) Avoid use of atogepant and pexidartinib when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with pexidartinib. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and pexidartinib is a moderate CYP3A inducer.
Phenobarbital: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Phenobarbital; Hyoscyamine; Atropine; Scopolamine: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Phentermine; Topiramate: (Major) Avoid use of atogepant and topiramate when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with topiramate. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and topiramate is a weak CYP3A inducer. Coadministration resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Phenytoin: (Major) Avoid use of atogepant and phenytoin/fosphenytoin when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with phenytoin/fosphenytoin. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and phenytoin/fosphenytoin is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Pitolisant: (Major) Avoid use of atogepant and pitolisant when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with pitolisant. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and pitolisant is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Posaconazole: (Major) Avoid use of atogepant and posaconazole when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with posaconazole. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and posaconazole is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Pretomanid: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with pretomanid. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and pretomanid is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Primidone: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Repotrectinib: (Major) Avoid use of atogepant and repotrectinib when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with repotrectinib. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and repotrectinib is a moderate CYP3A inducer.
Ribociclib: (Major) Avoid use of atogepant and ribociclib when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with ribociclib. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and ribociclib is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Ribociclib; Letrozole: (Major) Avoid use of atogepant and ribociclib when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with ribociclib. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and ribociclib is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Rifabutin: (Major) Avoid use of atogepant and rifabutin when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with rifabutin. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and rifabutin is a moderate CYP3A inducer.
Rifampin: (Major) Avoid use of atogepant and rifampin when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with rifampin. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and rifampin is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Rifapentine: (Major) Avoid use of atogepant and rifapentine when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with rifapentine. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and rifapentine is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Ritonavir: (Major) Avoid use of atogepant and ritonavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with ritonavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and ritonavir is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Saquinavir: (Major) Avoid use of atogepant and saquinavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with saquinavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and saquinavir is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Secobarbital: (Major) Avoid use of atogepant and barbiturates when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with barbiturates. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and barbiturates are strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concent

ration.
Sodium Phenylbutyrate; Taurursodiol: (Major) Avoid use of atogepant and taurursodiol when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with taurursodiol. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and taurursodiol is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Sofosbuvir; Velpatasvir: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with velpatasvir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and velpatasvir is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Sofosbuvir; Velpatasvir; Voxilaprevir: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with velpatasvir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and velpatasvir is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration. (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with voxilaprevir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and voxilaprevir is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Sotorasib: (Major) Avoid use of atogepant and sotorasib when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with sotorasib. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and sotorasib is a moderate CYP3A inducer.
St. John's Wort, Hypericum perforatum: (Major) Avoid use of atogepant and St. John's wort when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with St. John's wort. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and St. John's wort is a strong CYP3A inducer. Coadministration with a strong CYP3A inducer resulted in a 60% reduction in atogepant overall exposure and a 30% reduction in atogepant peak concentration.
Stiripentol: (Major) Avoid use of atogepant and stiripentol when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with stiripentol. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and stiripentol is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Tazemetostat: (Major) Avoid use of atogepant and tazemostat when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with tazemostat. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and tazemostat is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Tecovirimat: (Major) Avoid use of atogepant and tecovirimat when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with tecovirimat. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and tecovirimat is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Telotristat Ethyl: (Major) Avoid use of atogepant and telotristat when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with telotristat. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and telotristat is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Teriflunomide: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with teriflunomide. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and teriflunomide is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Tipranavir: (Major) Avoid use of atogepant and tipranavir when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with tipranavir. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and tipranavir is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Topiramate: (Major) Avoid use of atogepant and topiramate when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with topiramate. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and topiramate is a weak CYP3A inducer. Coadministration resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.
Trofinetide: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with trofinetide. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and trofinetide is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Tucatinib: (Major) Avoid use of atogepant and tucatinib when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with tucatinib. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and tucatinib is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Voclosporin: (Major) Limit the dose of atogepant to 10 or 30 mg PO once daily for episodic migraine or 30 mg PO once daily for chronic migraine if coadministered with voclosporin. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of OATP1B1 and OATP1B3 and voclosporin is an OATP inhibitor. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Vonoprazan; Amoxicillin; Clarithromycin: (Major) Avoid use of atogepant and clarithromycin when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with clarithromycin. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and OATP1B1/3; clarithromycin is a strong CYP3A inhibitor and an OATP1B1/3 inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration. Coadministration with an OATP1B1/3 inhibitor resulted in a 2.85-fold increase in atogepant overall exposure and a 2.23-fold increase in atogepant peak concentration.
Voriconazole: (Major) Avoid use of atogepant and voriconazole when atogepant is used for chronic migraine. Limit the dose of atogepant to 10 mg PO once daily for episodic migraine if coadministered with voriconazole. Concurrent use may increase atogepant exposure and the risk of adverse effects. Atogepant is a substrate of CYP3A and voriconazole is a strong CYP3A inhibitor. Coadministration with a strong CYP3A inhibitor resulted in a 5.5-fold increase in atogepant overall exposure and a 2.15-fold increase in atogepant peak concentration.
Zanubrutinib: (Major) Avoid use of atogepant and zanubrutinib when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with zanubrutinib. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and zanubrutinib is a weak CYP3A inducer. Coadministration with a weak CYP3A inducer resulted in a 25% reduction in atogepant overall exposure and a 24% reduction in atogepant peak concentration.

QULIPTA Oral Tab: 10mg, 30mg, 60mg

Adults

60 mg/day PO.

Geriatric

60 mg/day PO.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP is distributed throughout the nervous system, and it is concentrated at anatomical sites, such as the trigeminovascular system, which are involved in migraine pathophysiology. Centrally, CGRP is involved in nociceptive transmission through second and third-order neurons and pain modulation in the brainstem. Peripherally, CGRP mediates vasodilation through smooth muscle receptors. CGRP concentrations are elevated during acute migraine attacks and may be chronically elevated in chronic migraineurs.

Atogepant is administered orally. Plasma protein binding of atogepant is not concentration dependent in the range of 0.1 to 10 micromolar, and the unbound fraction of atogepant is approximately 4.7% in plasma. The mean apparent volume of distribution (Vz/F) of atogepant is approximately 292 L. Atogepant is eliminated mainly through metabolism, primarily by CYP3A4. The parent compound and a glucuronide conjugate metabolite (M23) are the most prevalent circulating components in human plasma. The mean apparent oral clearance (CL/F) of atogepant is approximately 19 L/hour. After a single 50 mg oral dose, approximately 42% and 5% of the dose were recovered as unchanged atogepant in feces and urine, respectively. The elimination half-life of atogepant is approximately 11 hours.
 
Affected cytochrome P450 isoenzymes and drug transporters: CYP3A4, OATP1B1, OATP1B3
Atogepant is a substrate of CYP3A4, BCRP, OATP1B1, OATP1B3, OAT1, and P-gp and a weak inhibitor of OATP1B1, OATP1B3, OCT1, and MATE1. Atogepant dosage adjustments are recommended for strong CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, and OATP inhibitors. Coadministration of atogepant with BCRP and/or P-gp inhibitors is not expected to increase the exposure of atogepant. No clinical drug interactions are expected for atogepant as a perpetrator with drug transporters.

Oral Route

After once daily dosing, atogepant displays dose-proportional pharmacokinetics up to 170 mg, with no accumulation. Peak plasma concentrations occur at approximately 1 to 2 hours after oral administration. Although not significant, administration of atogepant with a high-fat meal reduced AUC and Cmax by approximately 18% and 22%, respectively; median Tmax was not affected.

Pregnancy

There are no adequate data on the developmental risk associated with atogepant use during human pregnancy. Women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. In animal studies, oral administration of atogepant during the period of organogenesis or throughout pregnancy 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.

There are no data on the presence of atogepant in human milk, the effects on the breast-fed infant, or the effects on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for atogepant and any potential adverse effects on the breast-fed infant from atogepant or the underlying maternal condition. In lactating rats, oral dosing with atogepant resulted in milk concentrations of atogepant approximately 2-fold higher than maternal plasma concentrations.