Important Updates to the Patient Information for UBRELVY® (ubrogepant) tablets1
On February 17, 2023, the UBRELVY (ubrogepant) Prescribing Information and Patient Information were updated to include new information about serious allergic reactions.
The following describes the recent changes to the UBRELVY Patient Information:
The following serious allergic reactions information was added:
Who should not use UBRELVY?
Do not take UBRELVY if you are:
- allergic to ubrogepant or any of the ingredients in UBRELVY. See the end of the Medication Guide for a complete list of ingredients in UBRELVY.
What are the possible side effects of UBRELVY?
UBRELVY may cause serious side effects, including:
- Allergic reactions. Allergic reactions can happen after you take UBRELVY. Most reactions happened within hours and were not serious. Some reactions may occur days after taking UBRELVY. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, which may be part of an allergic reaction:
- Swelling of the face, mouth, tongue, or throat
- Trouble breathing
This is not a complete list of all the changes made to the Prescribing Information and Patient Information for UBRELVY. Please refer to the full Prescribing Information and Patient Information for additional safety information.
What is UBRELVY® (ubrogepant)?
UBRELVY is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY is not used to prevent migraine headaches.
IMPORTANT SAFETY INFORMATION
Do not take UBRELVY if you are taking medicines known as strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin, or itraconazole, or if you are allergic to UBRELVY or any of its ingredients.
Before taking UBRELVY, tell your healthcare provider about all your medical conditions, including if you:
- Have liver problems
- Have kidney problems
- Are pregnant or plan to become pregnant
- Are breastfeeding or plan to breastfeed
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider can tell you if it is safe to take UBRELVY with other medicines.
UBRELVY may cause serious side effects, including allergic reactions. Most reactions happened within hours after taking UBRELVY and were not serious. Some reactions may occur days after taking UBRELVY. Call your healthcare provider or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing.
The most common side effects of UBRELVY are nausea (4%) and sleepiness (3%). These are not all of the possible side effects of UBRELVY.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn more.
Please see accompanying Patient Information or visit
www.rxabbvie.com/pdf/ubrelvy_pil.pdf
Reference: 1. UBRELVY [package insert]. Madison, NJ: Allergan USA, Inc.
© 2023 AbbVie. All rights reserved. US-UBR-230012 February 2023
