Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

UBRELVY (NDA-211765)

(UBROGEPANT)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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06/05/2025 (SUPPL-12)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

Data from a lactation study in twelve healthy adult females indicate that ubrogepant is excreted in breast milk in low amounts. The estimated relative infant dose is approximately 0.15% of the maternal weight-adjusted dose, and the milk-to-plasma ratio is 0.23 (see Data). There are no data on the effects of ubrogepant on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for UBRELVY and any potential adverse effects on the breastfed infant from UBRELVY or from the underlying maternal condition.

Data

A study was conducted in twelve healthy adult lactating females who were between 24 and 34 years of age and between 1 month and 6 months postpartum. Each subject was administered a single oral dose of ubrogepant 100 mg. Maternal plasma and breast milk were collected for 24 hours after dosing. Using a 150 mL/kg/day estimated infant milk intake, the mean estimated relative infant dose was approximately 0.15% of the maternal weight-adjusted dose. The mean milk-to-plasma ratio was 0.23. All subjects had detectable levels of ubrogepant in breast milk during the study; by 16 to 24 hours after dosing, 17% of females in the study had detectable levels of ubrogepant in breast milk. The mean cumulative amount of ubrogepant excreted in breast milk over 24 hours was less than 0.02 mg of a 100 mg dose.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

Before you take UBRELVY tell your healthcare provider about all of your medical conditions, including if you:

. . .

are pregnant or plan to become pregnant. It is not known if UBRELVY will harm your unborn baby.

Pregnancy Registry: There is a pregnancy registry for women who take UBRELVY. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-833-277-0206 to enroll in this registry. You can also visit http://empresspregnancyregistry.com.

Are breastfeeding or plan to breastfeed. Very small amounts of UBRELVY pass into breast milk. Talk with your healthcare provider if you plan to breastfeed.

. . .

03/21/2025 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly added subsections:

5.2 Hypertension

Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including UBRELVY, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases.

Monitor patients treated with UBRELVY for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of UBRELVY is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

5.3 Raynaud’s Phenomenon

Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including UBRELVY. In reported 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 reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.

UBRELVY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

6 Adverse Reactions

Additions and/or revisions underlined:

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

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Hypertension [see Warnings and Precautions (5.2)]
Raynaud’s Phenomenon [see Warnings and Precautions (5.3)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

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)]

Vascular Disorders: Hypertension [see Warnings and Precautions (5.2)], Raynaud’s phenomenon [see Warnings and Precautions (5.3)]

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Hypertension

Inform patients that hypertension can develop or pre-existing hypertension can worsen with UBRELVY, and that they should contact their healthcare providers if they experience elevation in their blood pressure [see Warnings and Precautions (5.2)].

Raynaud’s Phenomenon

Inform patients that Raynaud’s phenomenon can develop or worsen with UBRELVY. Advise patients to discontinue UBRELVY and contact their healthcare provider if they experience signs or symptoms of Raynaud’s phenomenon [see Warnings and Precautions (5.3)].

. . .

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

Before you take UBRELVY tell your healthcare provider about all of your medical conditions, including if you:

have high blood pressure
have circulation problems in your fingers and toes

. . .

What are the possible side effects of UBRELVY?

UBRELVY may cause serious side effects, including:

. . .

High blood pressure: High blood pressure or worsening of high blood pressure can happen after you take UBRELVY. Contact your healthcare provider if you have an increase in blood pressure
Raynaud’s phenomenon: A type of circulation problem can worsen or happen after you take UBRELVY. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.

. . .

02/17/2023 (SUPPL-7)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

UBRELVY is contraindicated:

With concomitant use of strong CYP3A4 inhibitors [see Drug Interactions (7.1)]
In patients with a history of serious hypersensitivity to ubrogepant or any component of UBRELVY. Reactions have included anaphylaxis, dyspnea, and facial or throat edema [see Warnings and Precautions (5.1)]

5 Warnings and Precautions

(Newly added section)

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported with use of UBRELVY. Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions occurred within hours after dosing and were not serious, and some reactions led to discontinuation. If a serious or severe hypersensitivity reaction occurs, discontinue UBRELVY and institute appropriate therapy [see Contraindications (4) and Adverse Reactions (6.2)].

6 Adverse Reactions

(Additions and/or revisions underlined)

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

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]

6.2 Postmarketing Experience

(Newly added subsection)

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)]

8 Use in Specific Populations

8.1 Pregnancy

(Additions and/or revisions underlined)

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while taking UBRELVY. Patients should be encouraged to enroll by calling 1-833-277-0206 or visiting http://empresspregnancyregistry.com.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

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)].