What is the maximum recommended monthly dose of Ubrelvy (ubrogepant) for a patient with anxiety, gastritis, Attention Deficit Hyperactivity Disorder (ADHD), and hypertension, for the acute treatment of migraines?

Maximum Monthly Use of Ubrelvy for Migraine Treatment

The FDA-approved maximum is 8 migraines treated per 30-day period, regardless of comorbidities including anxiety, gastritis, ADHD, or hypertension. 1

FDA-Approved Dosing Limits

• The safety of treating more than 8 migraines in a 30-day period has not been established according to the FDA prescribing information 1
• Each migraine attack can be treated with 50-100 mg initially, with an optional second dose at least 2 hours later if needed 1
• The maximum dose in any 24-hour period is 200 mg (two doses) 1

Critical Frequency Considerations

• This 8-migraine-per-month limit exists to prevent medication-overuse headache (MOH), which occurs when acute medications are used too frequently 2, 3
• The American College of Physicians recommends limiting all acute migraine medications to no more than 2 days per week (approximately 8-10 days per month) to prevent MOH 2, 3
• If a patient requires acute treatment more frequently than twice weekly, preventive therapy should be initiated immediately rather than increasing acute medication frequency 2, 3

Impact of Patient's Comorbidities

• None of the patient's comorbidities (anxiety, gastritis, ADHD, hypertension) require dosage adjustment for ubrogepant 1
• Ubrogepant has no vasoconstrictor activity, making it safe for patients with hypertension, unlike triptans which are contraindicated in uncontrolled hypertension 3
• Dosage modifications are only required for severe hepatic impairment (Child-Pugh Class C), severe renal impairment, or concomitant use of specific CYP3A4 inhibitors/inducers 1

When Maximum Use is Exceeded

• If the patient needs to treat more than 8 migraines per month, this signals inadequate migraine control and necessitates preventive therapy, not increased acute medication use 2, 3
• First-line preventive options include propranolol 80-240 mg/day, amitriptyline 30-150 mg/day, or topiramate, depending on comorbidities 3, 4
• Continuing to use ubrogepant beyond 8 migraines per month risks creating medication-overuse headache, which paradoxically increases headache frequency and can lead to daily headaches 2, 3

Clinical Trial Safety Data

• Long-term safety studies permitted patients to treat up to 8 migraines per month with ubrogepant for up to 1 year 1
• In the TANDEM study evaluating concomitant use with preventive therapy, the mean number of ubrogepant use days was 6.6 over 12 weeks, demonstrating safe use within the 8-migraine limit 5
• No increase in adverse events was identified in relation to the number of ubrogepant use days when kept within recommended limits 5