Ubrogepant: Drug information

For additional information see "Ubrogepant: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Ubrelvy

Brand Names: Canada

Ubrelvy

Pharmacologic Category

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

Dosing: Adult

Migraine, moderate to severe, acute treatment

Migraine, moderate to severe, acute treatment (alternative agent):

Note: Consider use if triptans are contraindicated (eg, cardiovascular risk factors), ineffective, or poorly tolerated. Administration early in the course of a migraine attack (eg, at the first sign of pain or prodromal symptoms), may improve response to treatment (Ref).

Oral: 50 to 100 mg as a single dose; if symptoms persist or return, may repeat dose after ≥2 hours. Maximum: 200 mg per 24 hours (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

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

CrCl 15 to 29 mL/minute: 50 mg as a single dose; if symptoms persist or return, may repeat dose after ≥2 hours. Maximum dose: 100 mg per 24 hours.

CrCl <15 mL/minute: Avoid use (has not been studied).

Dosing: Liver Impairment: Adult

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

Severe impairment (Child-Pugh class C): 50 mg as a single dose; if symptoms persist or return, may repeat dose after ≥2 hours. Maximum dose: 100 mg per 24 hours.

Dosing: Older Adult

Refer to adult dosing; initiate at lower end of the dosing range.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reaction reported in adults.

1% to 10%:

Gastrointestinal: Nausea (4%), xerostomia (2%)

Nervous system: Drowsiness (2% to 3%; including fatigue)

Postmarketing:

Cardiovascular: Hypertension, Raynaud disease

Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)

Contraindications

History of serious hypersensitivity (eg, anaphylaxis, dyspnea, facial or throat edema) to ubrogepant or any component of the formulation; concomitant use of strong CYP3A4 inhibitors.

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

Warnings/Precautions

Concerns related to adverse reactions:

• Hypersensitivity reactions: Signs of hypersensitivity reactions, including anaphylaxis, dyspnea, facial or throat edema, pruritus, rash, and urticaria, have occurred minutes, hours, or days after administration; majority of reactions were not serious and occurred within hours after administration. Discontinue therapy in patients with severe hypersensitivity.

• Hypertension: New-onset and worsening of preexisting hypertension, including cases requiring pharmacological treatment or hospitalization, have been reported with calcitonin gene-related peptide (CGRP) receptor antagonists. Onset most frequently occurred within 7 days of administration but may occur at any time. Consider discontinuing treatment in patients in whom an alternative etiology is not established.

• Raynaud phenomenon: New-onset and recurrence/worsening of preexisting Raynaud phenomenon, including cases requiring hospitalization and causing debilitating pain, have been reported with CGRP antagonists. Onset most occurred a median of 1.5 days after administration; most cases resolved after discontinuation of therapy. Consider discontinuing treatment if signs and symptoms of Raynaud phenomenon occur; consider evaluation by a health care provider if symptoms do not resolve upon discontinuation of therapy.

Disease-related concerns:

• Cardiovascular disease: May cause hypertension; use with caution in patients with hypertension or risk factors for hypertension.

• Hepatic impairment: Dose reduction required in severe hepatic impairment.

• Raynaud phenomenon: May cause new or worsening Raynaud phenomenon; use with caution in patients with a history of Raynaud phenomenon.

• Renal impairment: Use is not recommended in patients with end-stage renal impairment; dose reduction required in severe renal impairment.

Other warnings/precautions:

• Appropriate use: Only indicated for treatment of acute migraine; not indicated for prevention of migraine.

Dosage Forms: US

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

Tablet, Oral:

Ubrelvy: 50 mg, 100 mg

Generic Equivalent Available: US

Pricing: US

Tablets (Ubrelvy Oral)

50 mg (per each): $118.08

100 mg (per each): $130.18

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:

Ubrelvy: 50 mg, 100 mg

Administration: Adult

Oral: Administer with or without food.

Use: Labeled Indications

Migraine, moderate to severe, acute treatment: Treatment of migraine with or without aura in adults (AHS [Ailani 2021]; manufacturer's labeling).

Limitations of use: Not indicated for the prevention of migraine.

Metabolism/Transport Effects

Substrate of BCRP, CYP3A4 (Major), OAT1/3, OATP1B1/1B3, P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

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 serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Aldesleukin: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Atazanavir: May increase serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid

BCRP/ABCG2 Inhibitors: May increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a BCRP inhibitor. Risk D: Consider Therapy Modification

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

Bulevirtide: May increase serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Ciprofloxacin (Systemic): May increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and consider avoiding a second dose for 24 hours when used with ciprofloxacin. Risk D: Consider Therapy Modification

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

CycloSPORINE (Systemic): May increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and consider avoiding a second dose for 24 hours when used with cyclosporine. Risk D: Consider Therapy Modification

CYP3A4 Inducers (Moderate): May decrease serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 100 mg and second dose (if needed) of 100 mg when used with a moderate CYP3A4 inducer. Risk D: Consider Therapy Modification

CYP3A4 Inducers (Strong): May decrease serum concentration of Ubrogepant. Risk X: Avoid

CYP3A4 Inducers (Weak): May decrease serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 100 mg and second dose (if needed) of 100 mg when used with a weak CYP3A4 inducer. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Moderate): May increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and avoid a second dose for 24 hours when used with moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Strong): May increase serum concentration of Ubrogepant. Risk X: Avoid

CYP3A4 Inhibitors (Weak): May increase serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (given at least 2 hours later if needed) of ubrogepant should be limited to 50 mg. Risk D: Consider Therapy Modification

Darolutamide: May increase serum concentration of Ubrogepant. Darolutamide may decrease serum concentration of Ubrogepant. Management: Consider an alternative regimen as the most appropriate dose of ubrogepant with darolutamide is unknown. Risk D: Consider Therapy Modification

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

Dinutuximab Beta: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Elacestrant: May increase serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor

Elranatamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Enasidenib: May increase serum concentration of Ubrogepant. Enasidenib may decrease serum concentration of Ubrogepant. Management: Consider avoiding this combination if possible, as enasidenib is both an BCRP inhibitor and weak CYP3A4 inducer, with unknown net effects on ubrogepant exposure. Risk D: Consider Therapy Modification

Epcoritamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Erdafitinib: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Management: If coadministration with these narrow therapeutic index/sensitive P-gp substrates is unavoidable, separate erdafitinib administration by at least 6 hours before or after administration of these P-gp substrates. Risk D: Consider Therapy Modification

FluvoxaMINE: May increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and consider avoiding a second dose for 24 hours when used with fluvoxamine. Risk D: Consider Therapy Modification

Fusidic Acid (Systemic): May increase 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

Futibatinib: May increase serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor

Futibatinib: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Gepotidacin: May increase serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid

Gilteritinib: May increase serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor

Gilteritinib: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Givinostat: May increase serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Glofitamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Grapefruit Juice: May increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and avoid a second dose for 24 hours in patients who consume grapefruit juice. Risk D: Consider Therapy Modification

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

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

Ivosidenib: May decrease 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

Lasmiditan: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid

Leniolisib: May increase serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid

Levacetylleucine: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

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

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

Mosunetuzumab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

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

Olutasidenib: May decrease 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

P-glycoprotein/ABCB1 Inhibitors: May increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a P-gp inhibitor. Risk D: Consider Therapy Modification

Pacritinib: May decrease serum concentration of Ubrogepant. Pacritinib may increase serum concentration of Ubrogepant. Management: Consider avoiding this combination if possible, as pacritinib is both a BCRP inhibitor and a moderate CYP3A4 inducer, with unknown net effects on ubrogepant exposure. Risk D: Consider Therapy Modification

Pirtobrutinib: May increase serum concentration of Ubrogepant. Management: Consider an alternative therapy when possible. If this combination is used, use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg. Risk D: Consider Therapy Modification

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

Pretomanid: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Primaquine: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Ritlecitinib: May increase serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Rucaparib: May increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with rucaparib. Risk D: Consider Therapy Modification

Sotagliflozin: May decrease serum concentration of Ubrogepant. Sotagliflozin may increase serum concentration of Ubrogepant. Management: Consider avoiding this combination if possible. Ubrogepant dose increases are recommended during coadministration with weak CYP3A4 inducers, and dose increases are recommended with P-gp inhibitors. The net effect of sotagliflozin is unknown. Risk D: Consider Therapy Modification

Sparsentan: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid

Spironolactone: May increase serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

St John's Wort: May decrease serum concentration of Ubrogepant. Risk X: Avoid

Talquetamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Tarlatamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

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

Taurursodiol: May increase serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid

Taurursodiol: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid

Teclistamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Tovorafenib: May decrease 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

Treosulfan: May increase serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Trofinetide: May increase serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

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

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

Venetoclax: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Management: Avoid concomitant use of venetoclax and oral p-glycoprotein (P-gp) substrates if possible. If combined use is unavoidable, administer the P-gp substrate at least 6 hours before venetoclax to minimize the potential for an interaction. Risk D: Consider Therapy Modification

Vimseltinib: May increase serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Management: Avoid concomitant use of vimseltinib and BCRP substrates when possible. If combined, monitor for increased effects and toxicities of the BCRP substrate and consider dose adjustments. Risk D: Consider Therapy Modification

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

Xanomeline: May increase serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Xanomeline: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Pregnancy Considerations

Based on data from animal reproduction studies, in utero exposure to ubrogepant may cause fetal harm.

Ubrogepant 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 2019b). The risk of hypertensive disorders, including preeclampsia and eclampsia, are also increased in pregnant patients with migraine (ACOG 2022; Dodick 2019b).

Treatment of migraine during pregnancy should be individualized considering the available safety data, the potential for adverse maternal and fetal events, and needs of the patient (AHS [Ailani 2021]). Oral CGRP receptor antagonists are not currently recommended for the treatment of acute migraine in pregnant patients due to lack of data (ACOG 2022).

Data collection to monitor pregnancy and infant outcomes following exposure to ubrogepant is ongoing. Patients exposed to ubrogepant during pregnancy are encouraged to enroll in the Pregnancy Exposure Registry (1-833-277-0206 or http://empresspregnancyregistry.com).

Breastfeeding Considerations

It is not known if ubrogepant 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. Treatment of migraine in lactating patients should be individualized considering the available safety data and needs of the patient (AHS [Ailani 2021]). Oral calcitonin gene-related peptide receptor antagonists are not currently recommended for the treatment of acute migraine in lactating patients due to lack of data (ACOG 2022).

Monitoring Parameters

New-onset hypertension or worsening of preexisting hypertension; in patients with Raynaud phenomenon, worsening or recurrence of signs/symptoms.

Mechanism of Action

Ubrogepant is a calcitonin gene-related peptide receptor antagonist.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Administration with a high-fat meal delays T_max by 2 hours and reduces C_max by 22%.

Distribution: V_d: 350 L.

Protein binding: Plasma: 87%.

Metabolism: Primarily hepatic via CYP3A4.

Half-life elimination: ~5 to 7 hours.

Time to peak: ~1.5 hours.

Excretion: Feces (42% as unchanged drug); urine (6% as unchanged drug).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Absorption, distribution, metabolism, and excretion information and a conservative assumption suggest severe renal impairment is unlikely to cause more than a 2-fold increase in exposure of ubrogepant; however, ubrogepant has not been studied in patients with CrCl <30 mL/minute.

Hepatic function impairment: Ubrogepant exposure increased by 115% in patients with severe hepatic impairment (Child-Pugh class C).

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(QA) Qatar: Ubrelvy

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. 2021;61(7):1021-1039. doi:10.1111/head.14153 [PubMed 34160823]
American College of Obstetricians and Gynecologists (ACOG) Committee on Clinical Practice Guidelines–Obstetrics. ACOG Clinical Practice Guideline No. 3: Headaches in pregnancy and postpartum. Obstet Gynecol. 2022;139(5):944-972. doi:10.1097/AOG.0000000000004766 [PubMed 35576364]
Dodick DW. CGRP ligand and receptor monoclonal antibodies for migraine prevention: evidence review and clinical implications. Cephalalgia. 2019b;39(3):445-458. doi:10.1177/0333102418821662 [PubMed 30661365]
Dodick DW, Goadsby PJ, Schwedt TJ, et al. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023;402(10419):2307-2316. doi:10.1016/S0140-6736(23)01683-5 [PubMed 37979595]
Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019a;381(23):2230-2241. doi:10.1056/NEJMoa1813049 [PubMed 31800988]
Refer to manufacturer's labeling.
Ubrelvy (ubrogepant) [prescribing information]. North Chicago, IL: AbbVie Inc; March 2025.

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Ubrogepant: Drug information