Interactions may prohibit use or change the second-dose rule.
Strong CYP3A4 inhibitors are contraindicated. With a moderate inhibitor, use 50 mg and avoid another dose within 24 hours. New/worsening hypertension and Raynaud symptoms require evaluation.
Warnings and precautionsIndications
Adult acute migraine treatment differs from prevention.
Labeled indication
Ubrelvy treats acute migraine with or without aura in adults. It is not indicated for preventive migraine treatment. This profile does not supply a pediatric or off-label preventive regimen.
Dosage and administration
The ordinary repeat rule has interaction and organ exceptions.
Ordinary adult dose
Take 50 mg or 100 mg orally as needed, with or without food. If needed, a second dose may be taken at least two hours later; maximum 200 mg in 24 hours. Safety of treating more than eight migraines in thirty days has not been established.
Interaction modifications
| Concurrent exposure | Initial / second dose |
|---|---|
| Strong CYP3A4 inhibitor | Contraindicated |
| Moderate CYP3A4 inhibitor | 50 mg; avoid second dose within 24 hours |
| Weak CYP3A4 inhibitor | 50 mg; if needed 50 mg at least two hours later |
| Strong CYP3A4 inducer | Avoid concomitant use |
| Weak or moderate CYP3A4 inducer | 100 mg; if needed 100 mg at least two hours later |
| BCRP and/or P-gp only inhibitor | 50 mg; if needed 50 mg at least two hours later |
Organ modifications
| Organ status | Selected dose rule |
|---|---|
| Severe hepatic: Child-Pugh C | 50 mg; if needed another 50 mg at least two hours later |
| Severe renal: CLcr 15–29 mL/min | 50 mg; if needed another 50 mg at least two hours later |
| ESRD: CLcr below 15 mL/min | Avoid use |
| Mild/moderate hepatic or renal impairment | No adjustment recommended; interacting medicines may still require modification |
Individual treatment plan
Check all simultaneous restrictions before dosing; the label does not create an algorithm for every combined interaction/organ scenario. Confirm the prescribed strength and repeat eligibility rather than taking extra doses for frequent attacks.
Safety
Allergy, hypertension and Raynaud phenomenon require active attention.
Warnings and precautions
Hypersensitivity can begin within minutes, hours or days; discontinue and treat serious or severe reactions. New or worsening hypertension has been reported, sometimes requiring treatment or hospitalization; monitor blood pressure and consider discontinuation if no alternate cause or inadequate control. Raynaud phenomenon can begin or worsen with severe pain and serious outcomes; discontinue if symptoms develop and obtain evaluation, particularly if symptoms persist. Monitor and counsel patients with prior Raynaud disease.
Contraindications
Concomitant strong CYP3A4 inhibitors and a history of serious hypersensitivity to ubrogepant or an ingredient are contraindicated. ESRD avoidance is a separate population instruction, not listed as a formal section-four contraindication.
Boxed warning status
The selected current Ubrelvy label has no boxed warning. Its serious allergy, hypertension and Raynaud warnings still apply.
Adverse reactions
Trial reactions include nausea, somnolence including sedation/fatigue, and dry mouth. Postmarketing reports include hypersensitivity, hypertension and Raynaud phenomenon; spontaneous reports do not establish a reliable frequency.
Drug interactions
CYP3A4 and efflux-transporter exposures drive dose changes.
CYP3A4 inhibitors and inducers
Strong inhibitors such as ketoconazole, itraconazole or clarithromycin prohibit use. Moderate examples include verapamil, cyclosporine, ciprofloxacin, fluconazole, fluvoxamine and grapefruit juice; apply the 50 mg/no-repeat-within-24-hours rule. Strong inducers such as rifampin, phenytoin, barbiturates or St. John’s wort can reduce efficacy and should be avoided. Weak/moderate inducers and weak inhibitors use the distinct dosing table.
Transporters and compatibility limits
BCRP/P-gp-only inhibitor examples include quinidine, carvedilol, eltrombopag and curcumin; use the stated 50 mg/50 mg modification. Some categories lack dedicated interaction trials and rely on pharmacologic predictions. Absence of a significant PK interaction with selected studied medicines does not prove compatibility with every combination.
Use in specific populations
Severe organ impairment changes dosing; pregnancy evidence remains limited.
Pregnancy and lactation
Human developmental-risk data are inadequate; animal studies found adverse developmental effects at higher exposures with maternal toxicity. Discuss treatment and the pregnancy exposure registry. A twelve-participant single-100-mg lactation study found milk transfer and an estimated relative infant dose about 0.15%; infant effects and milk-production effects remain unknown. Weigh breastfeeding benefits, maternal need and potential infant effects with the clinician.
Children and older adults
Pediatric safety/effectiveness are unestablished. Trials included too few adults 65 or older to determine different response; select doses cautiously, usually at the low end. PK age findings do not override interaction or organ limits.
Renal and hepatic considerations
Mild/moderate impairment needs no adjustment. Severe hepatic Child-Pugh C and renal CLcr 15–29 mL/min use 50 mg with one eligible 50 mg repeat; CLcr below 15 requires avoidance. Severe renal/ESRD patients were not studied; severe renal advice is based on pharmacologic assumptions rather than a dedicated clinical trial.
Clinical pharmacology
CGRP receptor blockade is distinct from a preventive regimen.
Mechanism and electrophysiology
Ubrogepant antagonizes the CGRP receptor. At twice the maximum recommended daily dose, the selected study did not show clinically relevant QT prolongation; this does not remove other cardiovascular warnings.
Disposition
Peak concentration is around 1.5 hours; a high-fat meal delays the peak without changing total exposure. Protein binding is about 87%. Metabolism is mainly CYP3A4, elimination mainly biliary/fecal with a minor renal contribution, and half-life about five to seven hours. It is a BCRP/P-gp substrate.
Monitoring and counseling
Review acute-treatment frequency, blood pressure and peripheral symptoms.
Monitoring and counseling
Track migraine frequency and response; review an overall treatment plan if attacks require frequent acute dosing. Check blood pressure and new painful/cold/color-changing digits. Report all medicines, supplements and grapefruit juice; verify repeat eligibility before dosing. Seek immediate help for severe allergy; discontinue and contact the clinician for Raynaud symptoms. Discuss pregnancy and feeding plans.
Overdose
Seek medical or Poison Control assessment for excess dosing. The label calls for monitoring at least twenty-four hours, or while signs/symptoms persist, because of its five-to-seven-hour half-life. No home antidote or toxic-dose threshold is supplied.
Product identification
Single-tablet packets identify the selected strengths.
Representative product
- Product
- AbbVie Ubrelvy
- Route
- Oral tablet
- Appearance
- White/off-white, capsule-shaped, biconvex; U50 or U100
- Example packages
- 50 mg NDC 0023-6498-10; 100 mg NDC 0023-6501-10 · ten packets each
Dosage forms and strengths
The selected label supplies 50 mg and 100 mg tablets in single-tablet packets; boxes of ten, sixteen or thirty packets are listed. Check actual ingredients for allergy. No liquid, injection, pediatric or compounded preparation is reviewed.
Storage and handling
Store at 20–25°C; excursions 15–30°C are permitted. Follow actual packet/container expiry. No verified crushing, enteral-tube or compounded stability protocol is supplied.
References
Original sources for the clinical and product information.
- DailyMed / AbbVieUbrelvy · Full prescribing information
Current SPL version 28, effective 2025-06-05.