Ubrelvy

Generic name: ubrogepant
Drug class: CGRP inhibitors

Medically reviewed by  A Ras MD.

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.

Description

The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3′S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2′-oxo-1′,2′,5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3′-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula:

Ubrelvy

The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water.

UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.

Mechanism of Action

Ubrogepant is a calcitonin gene-related peptide receptor antagonist.

Who should not take Ubrelvy?

Do not take Ubrelvy if you are taking medicines known 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.

What should I tell my healthcare provider before taking Ubrelvy?

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
  • curcumin

These 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:
    • verapamil
    • cyclosporin ociprofloxacin
    • fluconazole
    • 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.

General information about the safe and effective use of Ubrelvy

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information guide. 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.

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.

What are the ingredients in Ubrelvy?

Active ingredient: ubrogepant

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.

Label

PRINCIPAL DISPLAY PANEL

  • Contains
    30 Tablets
  • NDC 0023-6498-30
  • Rx Only
  • UBRELVY®
    (ubrogepant) tablets
  • 50 mg

Contains 30 Tablets NDC 0023-6498-30 Rx Only UBRELVY® (ubrogepant) tablets 50 mg

 

Imprint U50 - Ubrelvy 50 mg

 

PRINCIPAL DISPLAY PANEL

  • contains
    10 tablets
  • Rx Only   NDC 0023-6501-10
  • UBRELVY®
    (ubrogepant) tablets
  • 100 mg

contains 10 tablets Rx Only NDC 0023-6501-10 UBRELVY® (ubrogepant) tablets 100 mg

 

Imprint U100 - Ubrelvy 100 mg

SRC: NLM .

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