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ESTABLISHED SAFETY AND TOLERABILITY, WITH LONG-TERM SAFETY DATA^1,2

FEW PATIENTS HAD SIDE EFFECTS IN PIVOTAL TRIALS¹

Name	Placebo (n=984)	UBRELVY® 50 mg (n=954)	UBRELVY 100 mg (n=485)
Nausea	2%	2%	4%
Somnolence	1%	2%	3%
Dry mouth	1%	<1%	2%

Table includes adverse reactions from ACHIEVE I and II.¹
Adverse reactions occurring in at least 2% and at a frequency greater than placebo.¹

No medication overuse headache has been shown with use³

LONG-TERM SAFETY ESTABLISHED

The long-term safety of UBRELVY was further established in 813 patients in a 52-week, open-label trial with 31,968 doses given (UBRELVY 50 mg and 100 mg).² In this study, discontinuation rates due to adverse reactions were <3%.²

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

UBRELVY is contraindicated:

With concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).
In patients with a history of serious hypersensitivity to ubrogepant or any ingredient of the product.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Cases, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported. Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions were not serious, and some led to discontinuation. If a serious or severe reaction occurs, discontinue UBRELVY and institute appropriate therapy.

Hypertension (HTN): Development or worsening of pre-existing HTN has been reported following the use of CGRP antagonists, including UBRELVY. Some patients who developed new-onset HTN had risk factors. There were cases requiring initiation of HTN treatment and, in some cases, hospitalization. HTN may occur at any time but was most frequently reported within 7 days of initiation. The CGRP antagonist was discontinued in many of the cases. Monitor patients for new-onset or worsening of pre-existing HTN and consider whether discontinuation of UBRELVY is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

Raynaud’s phenomenon (RP): Development, recurrence, or worsening of pre-existing RP has been reported following the use of CGRP antagonists, including UBRELVY. In cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. UBRELVY should be discontinued if signs or symptoms of RP develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of RP should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

ADVERSE REACTIONS

The most common adverse reactions were nausea (4% vs 2% placebo) and somnolence (3% vs 1% placebo).

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Should be avoided as concomitant use will result in reduction of ubrogepant exposure.
Dose modifications are recommended when using the following:
- Moderate or weak CYP3A4 inhibitors and inducers
- BCRP and/or P-gp only inhibitors

INDICATION

UBRELVY^® (ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults. UBRELVY is not indicated for the preventive treatment of migraine.

Please see full Prescribing Information.

US-UBR-250101

References: 1. UBRELVY [package insert]. North Chicago, IL: AbbVie Inc.; 2025. 2. Ailani J, Lipton RB, Hutchinson S, et al. Long-term safety evaluation of ubrogepant for the acute treatment of migraine: phase 3, randomized, 52-week extension trial. Headache. 2020;60(1):141-152. 3. Ailani J, Burch RC, Robbins MS. The American Headache Society consensus statement: update on integrating new migraine treatments into clinical practice. Headache. 2021;61(7):1021-1039.

IMPORTANT SAFETY INFORMATION

Contraindications

UBRELVY is contraindicated:

With concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).

IMPORTANT SAFETY INFORMATION

Contraindications

UBRELVY is contraindicated:

With concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).

IMPORTANT SAFETY INFORMATION

Contraindications

UBRELVY is contraindicated:

With concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).

IMPORTANT SAFETY INFORMATION

Contraindications

UBRELVY is contraindicated:

With concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

UBRELVY is contraindicated:

With concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).
In patients with a history of serious hypersensitivity to ubrogepant or any ingredient of the product.

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The most common adverse reactions were nausea (4% vs 2% placebo) and somnolence (3% vs 1% placebo).

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Should be avoided as concomitant use will result in reduction of ubrogepant exposure.
Dose modifications are recommended when using the following:
- Moderate or weak CYP3A4 inhibitors and inducers
- BCRP and/or P-gp only inhibitors

INDICATION

UBRELVY^® (ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults. UBRELVY is not indicated for the preventive treatment of migraine.

Please see full Prescribing Information.

US-UBR-250101

ESTABLISHED SAFETY AND TOLERABILITY, WITH LONG-TERM SAFETY DATA1,2

FEW PATIENTS HAD SIDE EFFECTS IN PIVOTAL TRIALS1

LONG-TERM SAFETY ESTABLISHED

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

INDICATION

Please see full Prescribing Information.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

INDICATION

Please see full Prescribing Information.

ESTABLISHED SAFETY AND TOLERABILITY, WITH LONG-TERM SAFETY DATA^1,2

FEW PATIENTS HAD SIDE EFFECTS IN PIVOTAL TRIALS¹