RECENT MAJOR CHANGES SECTION

RECENT MAJOR CHANGES

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INDICATIONS & USAGE SECTION

Highlight: UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. (1)

Limitations of Use

UBRELVY is not indicated for the preventive treatment of migraine. (1)

1****INDICATIONS AND USAGE

UBRELVY is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use

UBRELVY is not indicated for the preventive treatment of migraine.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: Tablets: 50 mg and 100 mg (3)

3****DOSAGE FORMS AND STRENGTHS

UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side.

UBRELVY 100 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U100” on one side.

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ADVERSE REACTIONS SECTION

Highlight: The most common adverse reactions (at least 2% and greater than placebo) were nausea and somnolence. (6.1)

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To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6** ADVERSE REACTIONS**

The following clinically significant adverse reactions are described elsewhere in labeling:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1)]

6.1** ClinicalTrialsExperience**

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of UBRELVY was evaluated in 3,624 subjects who received at least one dose of UBRELVY. In two randomized, double-blind, placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 1,439 patients received UBRELVY 50 mg or 100 mg [see Clinical Studies (14)]. Of the UBRELVY-treated patients in these 2 studies, approximately 89% were female, 82% were White, 15% were Black, and 17% were of Hispanic or Latino ethnicity. The mean age at study entry was 41 years (range of 18-75 years).

Long-term safety was assessed in 813 patients, dosing intermittently for up to 1 year in an open-label extension study. Patients were permitted to treat up to 8 migraines per month with UBRELVY. Of these 813 patients, 421 patients were exposed to 50 mg or 100 mg for at least 6 months, and 364 patients were exposed to these doses for at least one year, all of whom treated at least two migraine attacks per month, on average. In that study, 2.5% of patients were withdrawn from UBRELVY because of an adverse reaction. The most common adverse reaction resulting in discontinuation in the long-term safety study was nausea.

Adverse reactions in Studies 1 and 2 are shown in Table 2.

Table 2: Adverse Reactions Occurring in At Least 2% and at a Frequency Greater than Placebo in Studies 1 and 2

*Somnolence includes the adverse reaction-related terms sedation and fatigue.

6**.****2******Postmarketing Experience

The following adverse reactions have been identified during post-approval use of UBRELVY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Hypersensitivity (e.g., anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus) [see Contraindications (4) and Warnings and Precautions (5.1)]

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OVERDOSAGE SECTION

10** OVERDOSAGE**

The elimination half-life of ubrogepant is approximately 5 to 7 hours; therefore, monitoring of patients after overdose with UBRELVY should continue for at least 24 hours, or while symptoms or signs persist.

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INFORMATION FOR PATIENTS SECTION

17****PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions

Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur with UBRELVY. Advise patients to discontinue UBRELVY and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.1)].

Drug Interactions

Inform patients that UBRELVY may interact with certain other drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription medications, over-the-counter medications, or herbal products [see Contraindications (4) and Drug Interactions (7.1, 7.2, 7.3)]. Advise patients to inform their healthcare provider of grapefruit juice intake because a dosage modification is recommended with co-administration.

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant. Encourage pregnant patients to enroll in the registry that monitors pregnancy outcomes in women exposed to UBRELVY during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2)].

Manufactured for:

AbbVie Inc.
North Chicago, IL 60064

© 2023 AbbVie. All rights reserved.
UBRELVY and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company.

20079163 June 2023

SPL PATIENT PACKAGE INSERT SECTION

This Patient Package Insert has been approved by the U.S. Food and Drug Administration Issued: 6/2023

20079163

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