Ubrogepant
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Overview
Ubrogepant is a Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist that is FDA approved for the treatment of migraine with or without aura in adults.. Common adverse reactions include Somnolence, Nausea, Dry mouth, Hypersensitivity reactions including rash, urticaria, and facial edema..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
50 mg or 100 mg taken orally, as needed. If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ubrogepant in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ubrogepant in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ubrogepant in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ubrogepant in pediatric patients.
Contraindications
Concomitant use with strong CYP3A4 inhibitors. History of serious hypersensitivity to ubrogepant or any component of the product.
Warnings
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, have occurred. Discontinue ubrogepant if a serious reaction occurs.
Adverse Reactions
Clinical Trials Experience
Nervous System: Somnolence (2-3%)
Gastrointestinal: Nausea (2-4%), Dry mouth (1-2%)
Postmarketing Experience
Hypersensitivity reactions including rash, urticaria, and facial edema.
Drug Interactions
Strong CYP3A4 Inhibitors: Concomitant use is contraindicated.
Moderate CYP3A4 Inhibitors: Dose adjustment may be necessary.
Strong CYP3A4 Inducers: Avoid concomitant use.
BCRP and/or P-gp Inhibitors: Dose adjustment may be necessary.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Ubrogepant in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ubrogepant in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ubrogepant during labor and delivery.
Nursing Mothers
Caution advised; consider the benefits and risks.
Pediatric Use
There is no FDA guidance on the use of Ubrogepant in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Ubrogepant in geriatric settings.
Gender
There is no FDA guidance on the use of Ubrogepant with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ubrogepant with respect to specific racial populations.
Renal Impairment
Dose adjustment recommended for severe impairment; avoid use in end-stage renal disease.
Hepatic Impairment
Dose adjustment recommended for severe impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ubrogepant in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ubrogepant in patients who are immunocompromised.
Administration and Monitoring
Administration
Administer orally, with or without food.
Monitoring
Monitor for signs of hypersensitivity reactions.
IV Compatibility
Not applicable.
Overdosage
There is limited information regarding Ubrogepant overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Ubrogepant Pharmacology in the drug label.
Mechanism of Action
Ubrogepant is a potent, orally administered antagonist of the calcitonin gene-related peptide (CGRP) receptor. By binding to and inhibiting the CGRP receptor, ubrogepant prevents CGRP from exerting its effects, which include vasodilation and transmission of pain signals associated with migraine pathophysiology. This mechanism helps alleviate migraine symptoms without causing vasoconstriction, distinguishing it from some other migraine treatments.
Structure
There is limited information regarding Ubrogepant Structure in the drug label.
Pharmacodynamics
Onset of Action: Pharmacologically active concentrations are achieved within approximately 9 to 11 minutes post-dose.
Peak Plasma Concentration (C_max): Reached at approximately 1.5 hours after oral administration.
Dose-Proportionality: Ubrogepant exhibits dose-proportional pharmacokinetics within the therapeutic dose range.
Cardiac Electrophysiology: At doses up to twice the maximum recommended dose, ubrogepant does not prolong the QT interval to any clinically relevant extent.
Pharmacokinetics
Absorption: Rapidly absorbed with peak plasma levels occurring approximately 1.5 hours post-dose.
Distribution: The apparent volume of distribution is approximately 350 liters, indicating extensive tissue distribution.
Metabolism: Primarily metabolized by cytochrome P450 3A4 (CYP3A4) enzyme.
Excretion: Eliminated mainly through biliary/fecal routes (approximately 83%); renal excretion accounts for about 9.5% of the administered dose.
Half-Life: Approximately 5 to 7 hours.
Nonclinical Toxicology
There is limited information regarding Ubrogepant Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ubrogepant Clinical Studies in the drug label.
How Supplied
Form: Immediate-release tablets.
Strengths: 50 mg and 100 mg.
Packaging: Available in bottles of 8, 10, 30, or 100 tablets.
Storage
Storage Conditions: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
Handling: Protect from moisture.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Usage: Ubrogepant is intended for the acute treatment of migraine attacks and should not be used for preventive treatment.
Dosage: Do not exceed 200 mg in a 24-hour period.
Hypersensitivity Reactions: Seek immediate medical attention if signs of hypersensitivity occur.
Drug Interactions: Inform healthcare providers about all medications being taken, especially strong CYP3A4 inhibitors.
Pregnancy and Lactation: Discuss potential risks with healthcare providers.
Precautions with Alcohol
Alcohol-Ubrogepant interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Ubrelvy®
Manufactured by AbbVie Inc.
Look-Alike Drug Names
There is limited information regarding Ubrogepant Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.