What is the recommended dosage and treatment plan for Ubrelvy (ubrogepant) for acute migraine attacks in adults?

From the Guidelines

Ubrelvy (ubrogepant) is typically prescribed at a dose of 50 mg or 100 mg taken orally as a single dose for acute migraine treatment in adults. If needed, a second dose may be taken at least 2 hours after the initial dose, but patients should not exceed 200 mg in a 24-hour period. The medication can be taken with or without food, though high-fat meals may delay the onset of action. Patients with severe renal or hepatic impairment should use the lower 50 mg dose. Those taking strong CYP3A4 inhibitors (like ketoconazole or clarithromycin) should limit their dose to 50 mg once daily, while Ubrelvy should be avoided entirely with strong CYP3A4 inducers (like rifampin or phenytoin) 1. Ubrelvy works by blocking calcitonin gene-related peptide (CGRP) receptors, which are involved in pain transmission during migraines. It's essential to treat migraines early when symptoms are mild to moderate for best results. Patients should discuss with their healthcare provider if they experience inadequate relief, as dose adjustments may be necessary based on individual response and tolerability.

Some key considerations for the use of Ubrelvy include:

• Counseling patients to begin treatment of migraine headache as soon as possible after its onset, using combination therapy (such as a triptan with an NSAID or acetaminophen) to improve efficacy 1.
• Being aware that patients who do not tolerate or have inadequate response to a recommended migraine treatment may respond to another within the same drug class 1.
• Considering the use of CGRP antagonists-gepants (rimegepant, ubrogepant, or zavegepant) or ergot alkaloid (dihydroergotamine) for moderate to severe acute episodic migraine headache in nonpregnant outpatient adults who do not tolerate or have inadequate response to combination therapy of a triptan and an NSAID or acetaminophen 1.
• Avoiding the use of opioids or butalbital for the treatment of acute episodic migraine 1.
• Highlighting the importance of lifestyle modifications with patients, including staying well hydrated, maintaining regular meals, securing sufficient and consistent sleep, engaging in regular physical activity, managing stress with relaxation techniques or mindfulness practices, and pursuing weight loss for those who are overweight or obese 1.

From the FDA Drug Label

The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food. 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. The recommended dosage and treatment plan for Ubrelvy (ubrogepant) for acute migraine attacks in adults is:

• Initial dose: 50 mg or 100 mg taken orally with or without food
• Second dose: may be taken at least 2 hours after the initial dose if needed
• Maximum dose in 24 hours: 200 mg
• Maximum number of migraines treated in 30 days: 8 (safety of treating more than 8 migraines in a 30-day period has not been established) 2 Key considerations:
• Dosing modifications are necessary for concomitant use of specific drugs and for patients with hepatic or renal impairment
• The safety of treating more than 8 migraines in a 30-day period has not been established 2

From the Research

Dosage and Treatment Plan for Ubrelvy (Ubrogepant)

• The recommended dosage of Ubrelvy (ubrogepant) for acute migraine attacks in adults is 50-100 mg, with a maximum dose of 200 mg within 48 hours 3.
• Ubrogepant can be administered as a single dose, and in some cases, a full relief of pain was achieved with a single dose of the drug 3.
• The efficacy and safety of ubrogepant were demonstrated in two pivotal phase III clinical trials (ACHIEVE I and ACHIEVE II) 3, 4, 5.

Efficacy of Ubrogepant

• Ubrogepant has been shown to be effective in alleviating migraine-associated symptoms such as nausea, photophobia, and sound sensitivity 3, 4, 5.
• The drug has been found to be effective in achieving pain freedom and absence of the most bothersome migraine-associated symptom at 2 hours after the dose 4, 5.
• Ubrogepant has been found to be safe and well-tolerated for the acute treatment of migraine, with a low incidence of treatment-related adverse events and serious adverse events 6.

Safety and Tolerability

• The most common adverse events reported with ubrogepant were nausea, somnolence, and dry mouth 4, 5.
• Ubrogepant has been found to be free from hepatotoxicity at therapeutic doses 3.
• Long-term intermittent use of ubrogepant has been found to be safe and well-tolerated, with a low incidence of treatment-related adverse events and serious adverse events 6.

Prior Exposure and Response to Triptans

• The efficacy of ubrogepant has been found to be consistent across participants with different historical experiences with triptans, including triptan responders, triptan-insufficient responders, and triptan-naïve participants 7.
• Ubrogepant has been found to be effective and well-tolerated for the acute treatment of migraine in participants with different levels of prior exposure and response to triptans 7.