UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side in unit-dose packets (each packet contains 1 tablet):
- Box of 6 Packets, NDC: 0023-6498-06
- Box of 8 Packets, NDC: 0023-6498-08
- Box of 10 Packets, NDC: 0023-6498-10
- Box of 12 Packets, NDC: 0023-6498-12
- Box of 16 Packets, NDC: 0023-6498-16
- Box of 30 Packets, NDC: 0023-6498-30
UBRELVY 100 mg is supplied as white to off-white capsule-shaped, biconvex tablets debossed with “U100” on one side in unit-dose packets (each packet contains 1 tablet):
- Box of 6 Packets, NDC: 0023-6501-06
- Box of 8 Packets, NDC: 0023-6501-08
- Box of 10 Packets, NDC: 0023-6501-10
- Box of 12 Packets, NDC: 0023-6501-12
- Box of 16 Packets, NDC: 0023-6501-16
- Box of 30 Packets, NDC: 0023-6501-30
Store between 20°C and 25°C (68°F and 77°F): excursions permitted between 15°C and 30°C (59°F and 86°F) [ see USP Controlled Room Temperature ].
Advise the patient to read the FDA-approved patient labeling (Patient Information).
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 Contraindication s ( 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.
Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations ( 8.1)].
Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations ( 8.2)] .
Distributed by: Allergan USA, Inc.
Madison, NJ 07940
© 2020 Allergan. All rights reserved.
UBRELVY™ is a trademark of Allergan Pharmaceuticals International Limited.
Allergan® and its design are trademarks of Allergan, Inc.
Patented. See www.allergan.com/patents
|Patient Information UBRELVY ™ (you-brel-vee) (ubrogepant)tablets, for oral use|
|What is UBRELVY? 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.It is not known if UBRELVY is safe and effective in children.|
|Do not take UBRELVY if you are taking medicines kno wn as a strong CYP3A4 Inhibitor , such as: |
|Before you take UBRELVY tell your healthcare provider about all of your medical conditions, including if you: |
|How should I take UBRELVY? |
|What are the possible side effects of UBRELVY? The most common side effects of UBRELVY are nausea and sleepiness. These are not all of the possible side effects of UBRELVY. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|How should I store UBRELVY? |
|General information about the safe and effective use of UBRELVY. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use UBRELVY for a condition for which it was not prescribed. Do not give UBRELVY to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about UBRELVY that is written for health professionals.|
|What are the ingredients in UBRELVY? Active ingredient: ubrogepantInactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.Distributed by: Allergan USA, Inc.Madison, NJ 07940© 2020 Allergan. All rights reserved.UBRELVY™ is a trademark of Allergan Pharmaceuticals International Limited.Allergan® and its design are trademarks of Allergan, Inc.Patented. See www.allergan.com/patents|
This Patient Package Insert has been approved by the U.S. Food and Drug Administration Issued: 6/2020
PRINCIPAL DISPLAY PANEL
Rx onlycontains 1 Tablet
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