Ubrelvy 160x600

UBRELVY^® (ubrogepant) is
indicated for the acute
treatment of migraine with
or without aura in adults.
UBRELVY is not indicated
for the preventive
treatment of migraine.

Contraindication:
Concomitant use of
strong CYP3A4 inhibitors
(eg, ketoconazole,
itraconazole,
clarithromycin).

Adverse Reactions: The
most common adverse
reactions were nausea
(4% vs 2% placebo) and
somnolence (3% vs 1%
placebo).

Drug Interactions:

• Strong CYP3A4
Inducers: Should be
avoided as concomitant
use will result in
reduction of ubrogepant
exposure.

• Dose modifications are
recommended when
using the following:

–Moderate or weak
CYP3A4 inhibitors
and inducers
–BCRP and/or P-gp
only inhibitors

Dosage and
Administration:

• The recommended dose
is 50 mg or 100 mg
taken orally, as needed.

• If needed, a second
dose may be
administered at least 2
hours after the initial
dose.

• The maximum dose in a
24-hour period is 200
mg. The safety of
treating more than 8
migraines in a 30-day
period has not been
established.

• Severe hepatic or severe
renal impairment:
Recommended dose is
50 mg; if needed, a
second 50 mg dose may
be taken at least 2
hours after the initial
dose.

• Avoid use in patients
with end-stage renal
disease.

Two randomized, double-blind, placebo-controlled, multicenter trials, ACHIEVE I (50 mg or 100 mg) and ACHIEVE II (50 mg), evaluated the efficacy and safety of UBRELVY for the acute treatment of a single migraine attack of moderate or severe intensity in adults with a history of migraine with or without aura, who had 2 to 8 migraine attacks of moderate to severe pain in each of the previous 3 months. Data were pooled for the 50 mg analysis. Patients in trials were 89% female, 82% White, 15% Black, 17% Hispanic or Latino, and the mean age at study entry was 41 years (range 18-75 years).

Patients were randomized to receive an IP, either UBRELVY 50 mg (n=886) or UBRELVY 100 mg (n=448), or placebo (n=912). Patients had 1 to 60 days to treat a moderate to severe migraine with the IP. A second dose of IP or rescue medication (triptan, NSAID, acetaminophen, ergot, or opioid) could be taken from 2 to 48 hours after the initial dose of IP.

Co-primary endpoint
included MBS freedom
at 2 hours postdose. MBS
was defined as
photophobia,
phonophobia, or nausea.
In patients taking UBRELVY 50 mg, 39%
(342/883) were absent of
MBS at 2 hours vs 28%
(251/910) taking placebo.
In patients taking
UBRELVY 100 mg, 38%
(169/448) were absent of
MBS at 2 hours vs 28%
(126/454) taking placebo.

IP=investigational
product; MBS=most
bothersome symptom; NSAID=nonsteroidal anti-inflammatory drug.

References: 1. UBRELVY.
Package insert. Allergan
USA, Inc.; 2021. 2. Retail
monthly prescription data
from IQVIA on a 6-month
rolling basis as of 04/22.
3. Data on file. Allergan.
4. Lipton RB, Dodick DW,
Ailani J, et al. Effect of
ubrogepant vs placebo on
pain and the most
bothersome associated
symptom in the acute
treatment of migraine: the
ACHIEVE II randomized
clinical trial. JAMA.
2019;322(19):1887-1898.
5. Dodick DW, Lipton RB,
Ailani J, et al. Ubrogepant
for the treatment of
migraine. N Engl J Med.
2019;381(23):2230-2241.

UBRELVY^® and its design
are registered trademarks of
Allergan Pharmaceuticals
International Limited, an
AbbVie company.