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IMPORTANT SAFETY INFORMATION

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.

INDICATION

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.

Please see full Prescribing Information.

UBRELVY (ubrogepant)
HomePatient ProfilesHow Ubrelvy WorksEfficacySafetyDosingResources & Access


CGRP LEVELS
INCREASE DURING
MIGRAINE ATTACKS1


 * While research into the exact mechanism that causes migraine is ongoing, CGRP
   is known to play a role in migraine pain2
 * CGRP acts at multiple sites along the trigeminovascular pathway, causing
   vasodilation, inflammation, and pain3

CGRP=calcitonin gene-related peptide.


UBRELVY IS THE FIRST ACUTE TREATMENT FOR MIGRAINE THAT DIRECTLY BLOCKS CGRP5-7


CGRP PLAYS A KEY ROLE IN MIGRAINE ATTACKS, BINDING TO CGRP RECEPTORS TO CAUSE
PAIN, INFLAMMATION, AND VASODILATION1,2,8,9

Watch the UBRELVY mechanism of action




UBRELVY WORKS DIFFERENTLY THAN OLDER ACUTE MIGRAINE TREATMENTS—SEE HOW EACH
WORKS AGAINST MIGRAINE2,5,8

MIGRAINE PATHOPHYSIOLOGY CGRP is released, causing meningeal vessel expansion
and pain signaling1,2,9

UBRELVY Targets the CGRP receptor itself, blocking CGRP from attaching5

TRIPTANS 5HT1B/1D agonists that constrict blood vessels and prevent release of
neuropeptides; those already released continue to circulate1-3,9

BARBITURATES This class of drug acts by potentiating GABA-induced increases in
chloride conductance. They enhance GABA binding to GABA A receptors10

NSAIDs The main effect of nonsteroidal anti-inflammatory drugs is the blockade
of cyclooxygenase (COX) receptors11




UBRELVY
PHARMACOKINETIC PROFILE5



Within 11 minutes: time to reach pharmacologically available concentration12* 12
hours: active concentration is maintained6 1.5 hours: time to peak plasma
concentrations (Tmax)5 5-7 hours: elimination half-life5

The clinical significance of these data is not known.

UBRELVY displays dose-proportional pharmacokinetics within the recommended dose
range.5

*Based on the inhibition of human capsaicin-induced dermal vasodilation model, a
pharmacodynamic measure of CGRP blockade, EC90=13 ng/mL.12

See the efficacy results

References

1. Durham PL. CGRP-receptor antagonists—a fresh approach to migraine therapy? N
Engl J Med. 2004;350(11):1073-1075. 2. Edvinsson L, Haanes KA, Warfvinge K,
Krause DN. CGRP as the target of new migraine therapies—successful translation
from bench to clinic. Nat Rev Neurol. 2018;14(6):338-350. 3. Benemei S, Cortese
F, Labastida-Ramírez A, et al; School of Advanced Studies of the European
Headache Federation (EHF-SAS). Triptans and CGRP blockade—impact on the cranial
vasculature. J Headache Pain. 2017;18(1):103. 4. Schuster NM, Rapoport AM. New
strategies for the treatment and prevention of primary headache disorders. Nat
Rev Neurol. 2016;12(11):635-650. 5. UBRELVY [package insert]. Madison, NJ:
Allergan USA, Inc.; 2021. 6. Data on file. Allergan. 7. Voss T, Lipton RB,
Dodick DW, et al. A phase IIb randomized, double-blind, placebo-controlled trial
of ubrogepant for the acute treatment of migraine. Cephalalgia.
2016;36(9):887-898. 8. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the
treatment of migraine. N Engl J Med. 2019;381(23):2230-2241. 9. Goadsby PJ,
Holland PR, Martins-Oliveira M, Hoffmann J, Schankin C, Akerman S.
Pathophysiology of migraine: a disorder of sensory processing. Physiol Rev.
2017;97(2):553-622. 10. Silberstein SD, McCrory DC. Butalbital in the treatment
of headache: history, pharmacology, and efficacy. Headache. 2001;41(10):953-967.
11. Pardutz A, Schoenen J. NSAIDs in the acute treatment of migraine: a review
of clinical and experimental data. Pharmaceuticals (Basel). 2010;3(6):1966-1987.
12. Dodick DW, Goadsby PJ, Lu K, Jakata A, Szegedi A, Trugman JM. Ubrogepant
achieves early pain relief for the acute treatment of migraine. Poster presented
at: 61st Annual Scientific Meeting of the American Headache Society; July 11-14,
2019; Philadelphia, PA. Poster P103.



IMPORTANT SAFETY INFORMATION

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.

INDICATION

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.

Please see full Prescribing Information.

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