Atogepant 

Atogepant – Introduction

• Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the preventive treatment of episodic or chronic migraine in adults. In 2 randomized, double-blind, placebo-controlled trials for the preventative treatment of episodic migraine, atogepant significantly reduced monthly migraine days in comparison to placebo across 12 weeks.
• Monthly migraine days were reduced by 3.6 to 4.2 days for subjects given atogepant compared to 2.5 to 2.8 days for placebo from a baseline of approximately 8 days/month.
• A 50% or more reduction in monthly migraine days was achieved by 56%, 59%, and 61% of subjects treated with atogepant 10, 30, and 60 mg, respectively, compared to 29% of subjects given placebo. In a randomized, double-blind, placebo-controlled trial for the preventative treatment of chronic migraine, atogepant significantly reduced monthly migraine days in comparison to placebo across 12 weeks.
• Monthly migraine days were reduced by a mean of 6.9 days for subjects given atogepant compared to a mean of 5.1 days for placebo from a baseline of approximately 19 days/month.
• A 50% or more reduction in monthly migraine days was achieved by 41% of subjects treated with atogepant 60 mg compared to 26% of subjects given placebo.
• The most common adverse reactions associated with atogepant are fatigue, nausea, and constipation. Coadministration of certain other drugs may need to be avoided or dosage adjustments may be necessary.⁶⁷⁰¹¹

Indications & Dosage

•  Migraine prophylaxis

Guideline indications for initiating migraine prevention with calcitonin gene-related peptide (CGRP) receptor antagonists: ⁷⁰⁶⁴⁵

• Consider as a first-line preventative therapy for episodic migraine with or without aura (4 to 14 monthly migraine days) based upon ICHD-3 with at least moderate disability, defined by Migraine Disability Assessment Score (MIDAS) of 11 or more or 6-item Headache Impact Test Score (HIT-6) more than 50.
• Consider as a first-line preventative therapy for chronic migraine with or without aura (15 or more monthly headache days) based upon ICHD-3.

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.⁶⁷⁰¹¹ Guidelines classify atogepant as having established efficacy for episodic migraine prophylaxis.⁷⁰⁶⁴⁵

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.⁶⁷⁰¹¹ Guidelines classify atogepant as having established efficacy for chronic migraine prophylaxis.⁷⁰⁶⁴⁵

Maximum Dosage Limits:

•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.

Patients with Hepatic Impairment Dosing

Avoid use in patients with severe hepatic impairment. No dosage adjustment is needed for mild or moderate hepatic impairment.⁶⁷⁰¹¹

Patients with Renal Impairment Dosing

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).⁶⁷⁰¹¹

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.⁶⁷⁰¹¹

Contraindications & Precautions

 indicates a Black Box warning

Contraindications

Precautions

•  breast-feeding
•  Child-Pugh class C
•  hepatic failure
•  hypertension
•  pregnancy
•  Raynaud phenomenon
•  renal failure
•  renal impairment

Interactions

Interactions

•  Adagrasib
•  Amobarbital
•  Amoxicillin; Clarithromycin; Omeprazole
•  Apalutamide
•  Armodafinil
•  Asciminib
•  Aspirin, ASA; Butalbital; Caffeine
•  Atazanavir
•  Atazanavir; Cobicistat
•  Barbiturates
•  Belumosudil
•  Belzutifan
•  Bexarotene
•  Bosentan
•  Brigatinib
•  Butalbital; Acetaminophen
•  Butalbital; Acetaminophen; Caffeine
•  Butalbital; Acetaminophen; Caffeine; Codeine
•  Butalbital; Aspirin; Caffeine; Codeine
•  Carbamazepine
•  Ceftobiprole
•  Cenobamate
•  Ceritinib
•  Chloramphenicol
•  Clarithromycin
•  Clobazam
•  Cobicistat
•  Cyclosporine
•  Dabrafenib
•  Darolutamide
•  Darunavir
•  Darunavir; Cobicistat
•  Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
•  Deferasirox
•  Dexamethasone
•  Efavirenz
•  Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate
•  Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
•  Elafibranor
•  Elagolix
•  Elagolix; Estradiol; Norethindrone acetate
•  Elexacaftor; tezacaftor; ivacaftor
•  Eltrombopag
•  Eluxadoline
•  Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
•  Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
•  Enasidenib
•  Encorafenib
•  Enzalutamide
•  Erythromycin
•  Eslicarbazepine
•  Etravirine
•  Fexinidazole
•  Fosphenytoin
•  Fostemsavir
•  Gemfibrozil
•  Glecaprevir; Pibrentasvir
•  Glycerol Phenylbutyrate
•  grapefruit juice
•  Idelalisib
•  Itraconazole
•  Ivosidenib
•  Ketoconazole
•  Lansoprazole; Amoxicillin; Clarithromycin
•  Leflunomide
•  Leniolisib
•  Letermovir
•  Levoketoconazole
•  Lonafarnib
•  Lopinavir; Ritonavir
•  Lorlatinib
•  Lumacaftor; Ivacaftor
•  Lumacaftor; Ivacaftor
•  Mavacamten
•  Meropenem
•  Meropenem; Vaborbactam
•  Methohexital
•  Midostaurin
•  Mifepristone
•  Mitapivat
•  Mitotane
•  Mobocertinib
•  Modafinil
•  Nafcillin
•  Nefazodone
•  Nelfinavir
•  Nevirapine
•  Nirmatrelvir; Ritonavir
•  Odevixibat
•  Olutasidenib
•  Omaveloxolone
•  Omeprazole; Amoxicillin; Rifabutin
•  Oritavancin
•  Oxcarbazepine
•  Pacritinib
•  Pentobarbital
•  Pexidartinib
•  Phenobarbital
•  Phenobarbital; Hyoscyamine; Atropine; Scopolamine
•  Phentermine; Topiramate
•  Phenytoin
•  Pitolisant
•  Posaconazole
•  Pretomanid
•  Primidone
•  Repotrectinib
•  Ribociclib
•  Ribociclib; Letrozole
•  Rifabutin
•  Rifampin
•  Rifapentine
•  Ritonavir
•  Saquinavir
•  Secobarbital
•  Sodium Phenylbutyrate; Taurursodiol
•  Sofosbuvir; Velpatasvir
•  Sofosbuvir; Velpatasvir; Voxilaprevir
•  Sotorasib
•  St. John’s Wort, Hypericum perforatum
•  Stiripentol
•  Suzetrigine
•  Tazemetostat
•  Tecovirimat
•  Telotristat Ethyl
•  Teriflunomide
•  Tipranavir
•  Topiramate
•  Tovorafenib
•  Trofinetide
•  Tucatinib
•  Voclosporin
•  Vonoprazan; Amoxicillin; Clarithromycin
•  Vorasidenib
•  Voriconazole
•  Zanubrutinib

Adverse Reactions

•  anaphylactoid reactions
•  anorexia
•  constipation
•  drowsiness
•  dyspnea
•  elevated hepatic enzymes
•  fatigue
•  hypertension
•  nausea
•  pruritus
•  rash
•  Raynaud phenomenon
•  urticaria
•  weight loss

Administration

• Oral Administration
  • Administer with or without food.⁶⁷⁰¹¹

Mechanism of Action

• Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.⁶⁷⁰¹¹ 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.⁶³¹⁶⁹

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