UBRELVY (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

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

16.2 Storage and Handling

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 ].

17 PATIENT COUNSELING INFORMATION

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

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 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.

Pregnancy

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)].

Lactation

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

v1. 2USPI6498

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:
  • ketoconazole
  • clarithromycin
  • itraconazole
Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take UBRELVY with other medicines.
Before you take UBRELVY tell your healthcare provider about all of your medical conditions, including if you:
  • have liver problems
  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if UBRELVY will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if UBRELVY passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following, as your healthcare provider may need to change the dose of UBRELVY:• verapamil • cyclosporine • ciprofloxacin • fluconazole • fluvoxamine • phenytoin • barbiturates • rifampin • St. John’s Wort • quinidine • carvedilol • eltrombopag • curcuminThese are not all of the medicines that could affect how UBRELVY works. Your healthcare provider can tell you if it is safe to take UBRELVY with other medicines. Keep a list of medicines you take to show to your healthcare provider or pharmacist when you get a new medicine.
How should I take UBRELVY?
  • Take UBRELVY exactly as your healthcare provider tells you to take it.
  • Take UBRELVY with or without food.
  • Most patients can take a second tablet 2 hours after the first tablet, as needed.
  • You should not take a second tablet within 24 hours if you consume grapefruit or grapefruit juice or are taking medications that may include:
o verapamil o cyclosporin o ciprofloxacin o fluconazole o fluvoxamine
  • It is not known if it is safe to take UBRELVY for more than 8 migraine headaches in 30 days.
  • You should write down when you have headaches and when you take UBRELVY so you can talk to your healthcare provider about how UBRELVY is working for you.
  • If you take too much UBRELVY, call your healthcare provider or go to the nearest hospital emergency room right away.
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?
  • Store UBRELVY at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
Keep UBRELVY and all medicines out of the reach of children.
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/patentsAllergan

This Patient Package Insert has been approved by the U.S. Food and Drug Administration Issued: 6/2020

v1.1PPI6498

PRINCIPAL DISPLAY PANEL

NDC 0023-6498-02
tradename
(ubrogepant) tablet
50 mg
Rx onlycontains 1 Tablet

PRINCIPAL DISPLAY PANEL
NDC 0023-6498-02
tradename
(ubrogepant) tablet
50 mg
Rx only
contains 1 Tablet
(click image for full-size original)

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