Atogepant: Drug information

Atogepant: Drug information

2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Atogepant: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Qulipta

Brand Names: Canada

Qulipta

Pharmacologic Category

Antimigraine Agent; Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

Dosing: Adult
Note: Avoid use in patients with recent cardiovascular or cerebrovascular ischemic events. Limit use to patients with significant disability from frequent
migraines who are unable to tolerate or do not respond to adequate trials of at least 2 other preventive therapies (Ref). An adequate trial for assessment of effect
is considered to be at least 8 weeks at a therapeutic dose (Ref).

Migraine, chronic, prevention (alternative agent): Oral: 60 mg once daily.

Migraine, episodic, prevention (alternative agent):

Note: For the prevention of episodic migraine, limit use to patients with <15 headache days per month (Ref).

Oral: 10 mg, 30 mg, or 60 mg once daily (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions
database for more information.

Dosing: Kidney Impairment: Adult

Migraine, chronic, prevention:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Avoid use.

Migraine, episodic, prevention:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: 10 mg once daily.

Hemodialysis, intermittent (thrice weekly): 10 mg once daily; administer after dialysis on dialysis days.

Dosing: Liver Impairment: Adult

Mild to moderate impairment (Child-Pugh class A, B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): Use is not recommended.

 Dosing: Older Adult
Refer to adult dosing; start at low end of dosing range and use with caution.

Adverse Reactions
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

1% to 10%:

Endocrine & metabolic: Weight loss (4% to 5%)

Gastrointestinal: Constipation (6% to 8%), decreased appetite (1% to 3%), nausea (5% to 9%)

Nervous system: Dizziness (3%), drowsiness (≤5%), fatigue (≤5%)

Frequency not defined: Hepatic: Increased serum transaminases (>3 x ULN)

Postmarketing: Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)

Contraindications
Hypersensitivity (eg, anaphylaxis, dyspnea) to atogepant or any component of the formulation.

Warnings/Precautions
Concerns related to adverse effects:

• Hypersensitivity reactions: Anaphylaxis, dyspnea, facial edema, pruritus, rash, and/or urticaria may occur. Hypersensitivity reactions may occur days
after administration. If a hypersensitivity reaction occurs, discontinue therapy and administer appropriate therapy.

Disease-related concerns:

• Hepatic impairment: Use is not recommended in patients with severe hepatic impairment.

• Renal impairment: Dose reduction or avoidance of use required in severe and end-stage renal impairment.

Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Qulipta: 10 mg, 30 mg, 60 mg

Generic Equivalent Available: US

No

Pricing: US
Tablets (Qulipta Oral)

10 mg (per each): $43.70

30 mg (per each): $43.70

60 mg (per each): $43.70

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one
manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used
for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered
to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied,
and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special,
indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Qulipta: 10 mg, 30 mg, 60 mg

Administration: Adult
Oral: May be administered without regard to meals.

Use: Labeled Indications

Migraine, episodic or chronic, prevention: Preventive treatment of episodic or chronic migraine in adults.

Metabolism/Transport Effects
Substrate of BCRP/ABCG2, CYP3A4 (major), OAT1/3, OATP1B1/1B3 (SLCO1B1/1B3), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor
substrate status based on clinically relevant drug interaction potential

Drug Interactions

(For additional information: Launch drug interactions program)

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]”
are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
by clicking on the “Launch drug interactions program” link above.

Adalimumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

Asciminib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Bimekizumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

Bulevirtide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management:
Coadministration of bulevirtide with OATP1B1/1B3 (also known as SLCO1B1/1B3) substrates should be avoided when possible. If used together, close
clinical monitoring is recommended. Risk D: Consider therapy modification

Ceftobiprole Medocaril: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid
combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of
atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant
with CYP3A4 inducers should be avoided. Risk D: Consider therapy modification

CYP3A4 Inducers (Strong): May decrease the serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of
atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant
with CYP3A4 inducers should be avoided. Risk D: Consider therapy modification
CYP3A4 Inducers (Weak): May decrease the serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of
atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant
with CYP3A4 inducers should be avoided. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Atogepant. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended atogepant
dose is 10 mg once daily with a concurrent strong CYP3A4 inhibitor. If used for treatment of chronic migraine, concurrent use of atogepant with strong
CYP3A4 inhibitors should be avoided. Risk D: Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

Elafibranor: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

Enasidenib: May increase the serum concentration of Atogepant. Enasidenib may decrease the serum concentration of Atogepant. Management: Consider
avoiding this combination if possible, as enasidenib is both an OATP1B1/1B3 inhibitor and weak CYP3A4 inducer, with unknown net effects on atogepant
exposure. Risk D: Consider therapy modification

Encorafenib: May increase the serum concentration of Atogepant. Encorafenib may decrease the serum concentration of Atogepant. Management: Consider
avoiding this combination if possible, as encorafenib is both a strong CYP3A4 inducer and an OATP1B1/1B3 inhibitor, with unknown net effects on
atogepant exposure. Risk D: Consider therapy modification

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this
combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider therapy modification

Grapefruit Juice: May increase the serum concentration of Atogepant. Risk C: Monitor therapy

Interleukin-6 (IL-6) Inhibiting Therapies: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk
C: Monitor therapy

Interleukin-6 (IL-6) Inhibiting Therapies: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C:
Monitor therapy

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Management: Consider
alternatives to this combination when possible. If combined, monitor for decreased effectiveness of these CYP3A4 substrates if combined with ivosidenib.
Risk D: Consider therapy modification

Leniolisib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Mavacamten: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

Nemolizumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors: May increase the serum concentration of Atogepant. Management: For episodic migraine, the recommended
atogepant dose is 10 mg or 30 mg once daily if given with OATP1B1/1B3 inhibitors. For chronic migraine, the recommended atogepant dose is 30 mg once
daily with OATP1B1/1B3 inhibitors. Risk D: Consider therapy modification

Olutasidenib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Management: Avoid use of
olutasidenib with sensitive or narrow therapeutic index CYP3A4 substrates when possible. If concurrent use with olutasidenib is unavoidable, monitor
closely for evidence of decreased concentrations of the CYP3A4 substrates. Risk D: Consider therapy modification

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

Pretomanid: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

RifAMPin: May decrease the serum concentration of Atogepant. Specifically, atogepant concentrations may be reduced with daily dosing of rifampin. RifAMPin
may increase the serum concentration of Atogepant. Specifically, increases in atogepant exposure may occur with single dose of rifampin or at the
initiation of rifampin therapy. Management: Episodic migraine: atogepant dose should be 10 mg or 30 mg once daily with single dose rifampin, or 30 mg
or 60 mg once daily with daily rifampin. Chronic migraine: avoid atogepant with daily rifampin; with single dose rifampin, use atogepant 30 mg daily. Risk
D: Consider therapy modification

Sotagliflozin: May decrease the serum concentration of Atogepant. Sotagliflozin may increase the serum concentration of Atogepant. Management: For treatment
of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with sotagliflozin. When used for
treatment of chronic migraine, use of atogepant with sotagliflozin should be avoided. Risk D: Consider therapy modification

Taurursodiol: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid combination
Tovorafenib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Management: Avoid concurrent
use whenever possible; if the combination cannot be avoided, monitor closely for reduced effectiveness of the CYP3A4 substrate. Risk D: Consider therapy
modification

Trofinetide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Avoid
concurrent use with OATP1B1/1B3 substrates for which small changes in exposure may be associated with serious toxicities. Monitor for evidence of an
altered response to any OATP1B1/1B3 substrate if used together with trofinetide. Risk D: Consider therapy modification

Ustekinumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

Vedolizumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

Voclosporin: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Vorasidenib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid combination

Reproductive Considerations
In general, preventive treatment for migraine in patients trying to become pregnant should be avoided. Options for patients planning a pregnancy should be
considered as part of a shared decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment
should be individualized considering the available safety data and needs of the patient should pregnancy occur. A gradual discontinuation of preventive
medications is generally preferred when the decision is made to stop treatment prior to conception (ACOG 2022; AHS [Ailani 2021a]).

Pregnancy Considerations
Adverse events were observed in animal reproduction studies following oral administration of atogepant in doses greater than the recommended human dose.

Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. Based on animal data, CGRP may help regulate placental blood flow, uterine
relaxation, and maintain BP; CGRP antagonists could potentially increase the risk of gestational hypertension and preeclampsia (Dodick 2019). The risk of
hypertensive disorders, including preeclampsia and eclampsia, are also increased in pregnant patients with migraine (ACOG 2022; Dodick 2019).

In general, preventive treatment for migraine should be avoided during pregnancy. Options for pregnant patients should be considered as part of a shared
decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment should be individualized
considering the available safety data, the potential for adverse maternal and fetal events, and needs of the patient (ACOG 2022; AHS [Ailani 2021a]). Oral CGRP
receptor antagonists are not currently recommended for the prevention of migraine in pregnant patients due to lack of data (ACOG 2022).

Breastfeeding Considerations
It is not known if atogepant is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant,
and the benefits of treatment to the mother. In general, preventive treatment for migraine in lactating patients should be avoided. When needed, therapy
should be individualized considering the available safety data and needs of the patient (AHS [Ailani 2021a]). Oral calcitonin gene-related peptide receptor
antagonists are not currently recommended for the prevention of migraine in lactating patients due to lack of data (ACOG 2022).

Monitoring Parameters
Kidney and liver function (baseline and as clinically indicated).

Mechanism of Action
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 292 L.
Protein binding: ~98% (Boinpally 2021).

Metabolism: Primarily hepatic via CYP3A4.

Half-life elimination: ~11 hours.

Time to peak: ~1 to 2 hours.

Excretion: Feces (~42% as unchanged drug); urine (~5% as unchanged drug).

Brand Names: International

For country code abbreviations (show table)

(QA) Qatar: Aquipta

REFERENCES

1. Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: update on
integrating new migraine treatments into clinical practice. Headache. 2021a;61(7):1021-1039. doi:10.1111/head.14153 [PubMed 34160823]
2. Ailani J, Lipton RB, Goadsby PJ, et al; ADVANCE Study Group. Atogepant for the preventive treatment of migraine. N Engl J Med. 2021b;385(8):695-
706. doi:10.1056/NEJMoa2035908 [PubMed 34407343]
3. American College of Obstetricians and Gynecologists (ACOG). ACOG Committee on Clinical Practice Guidelines–Obstetrics. Headaches in pregnancy and
postpartum: ACOG clinical practice guideline no. 3. Obstet Gynecol. 2022;139(5):944-972. doi:10.1097/AOG.0000000000004766 [PubMed 35576364]
4. Boinpally R, Jakate A, Butler M, Borbridge L, Periclou A. Single-dose pharmacokinetics and safety of atogepant in adults with hepatic impairment:
results from an open-label, phase 1 trial. Clin Pharmacol Drug Dev. 2021;10(7):726-733. doi:10.1002/cpdd.916 [PubMed 33501783]
5. Dodick DW. CGRP ligand and receptor monoclonal antibodies for migraine prevention: evidence review and clinical implications. Cephalalgia.
2019;39(3):445-458. doi:10.1177/0333102418821662 [PubMed 30661365]
6. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition.
Cephalalgia. 2018;38(1):1-211. doi:10.1177/0333102417738202 [PubMed 29368949]
7. Loder EW, Burch RC. Who should try new antibody treatments for migraine? JAMA Neurol. 2018;75(9):1039-1040. doi:10.1001/jamaneurol.2018.1268
[PubMed 29799961]
8. Qulipta (atogepant) [prescribing information]. North Chicago, IL: AbbVie Inc; June 2023.
9. Qulipta (atogepant) [prescribing information]. Dublin, Ireland: AbbVie Inc; April 2023.
10. Qulipta (atogepant) [product information]. Saint-Laurent, Quebec: AbbVie Inc; December 2022.
11. Refer to manufacturer's labeling.
12. Schwedt TJ, Garza I. Preventive treatment of episodic migraine in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc.
[Link] Accessed April 28, 2023.

Topic 133172 Version 65.0

© 2025 UpToDate, Inc. All rights reserved.