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Effective URL: https://www.ubrelvyhcp.com/?uid=001A000000Zmo7IIAR&cid=eml_Ubrelvy_CNS_iRep_hcp_US-UBR-230064&buid=223000&cuid=US-UBR-230064
Submission: On December 01 via manual from US — Scanned from DE
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Skip to Main content * Prescribing Information * Patient Site * * Efficacy * Study Design * Safety * Dosing * How UBRELVY Works * Access * Resources * Request Samples Request a Rep Speaker Programs Request Samples Request a Rep Speaker Programs STRIKE DOWN TO ZERO MIGRAINE PAIN WITH UBRELVY® See the data Pain relief at 2 hours was demonstrated in 62% (UBRELVY 50 mg) vs 49% (placebo) when taken immediately or within 4 hours of onset3,4 Pain freedom at 2 hours (co-primary endpoint) was demonstrated in 21% (UBRELVY 50 mg) vs 13% (placebo).3 Sustained pain freedom from 2 to 24 hours (secondary endpoint) was achieved in 14% (UBRELVY 50 mg) vs 8% (placebo)1 UBRELVY has been prescribed over 2 million times by more than 80,000 HCPs, treating over 500,000 patients3 THE POWER OF ZERO MIGRAINE PAIN3 TAKEN ANYTIME, ANYWHERE1* See the data POWERFUL: Zero pain, sustained1,3 Pain freedom at 2 hours (co-primary endpoint) was demonstrated in 21% (UBRELVY® 50 mg) vs 13% (placebo).1,3 Sustained pain freedom from 2 to 24 hours (secondary endpoint) was achieved in 14% (UBRELVY 50 mg) vs 8% (placebo)1,3,4 RAPID: Quick pain relief1 Pain relief at 2 hours was demonstrated in 62% (UBRELVY 50 mg) vs 49% (placebo) when taken immediately or within 4 hours of onset1,3,5 PRE-HEADACHE: Clinical evidence3 Absence of headache pain of moderate to severe intensity within 24 hours after dosing in the pre-headache phase (primary endpoint)3 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. Get patients started Once you've decided to prescribe UBRELVY, enable access for your patients with our U-CONCIERGE program and learn how eligible patients may pay as little as $0—all pills, all fills.† Help enable access 16-count pack is available for your UBRELVY patients Migraine attacks can be unpredictable.6 Prepare your patients with a 16-count package of UBRELVY 100 mg tablets. View dosing Many patients experience pre-headache symptoms7 See the results of administering UBRELVY during the pre-headache phase of a migraine attack. Explore pre-headache data *In clinical studies, patients took UBRELVY within 4 hours of a migraine attack.5 †Patient out-of-pocket costs may vary. Terms and Conditions apply. This offer is only valid for commercially insured patients. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Request Samples Request a Rep Speaker Programs IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Drug Interactions: UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin). Hypersensitivity Reactions: UBRELVY is contraindicated in patients with a history of serious hypersensitivity to ubrogepant or any ingredient of the product. Cases, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported. Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions were not serious, and some led to discontinuation. If a serious or severe reaction occurs, discontinue UBRELVY and institute appropriate therapy. 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. US-UBR-230117 References: 1. UBRELVY. Package insert. AbbVie Inc; 2023. 2. Retail weekly prescription data from IQVIA as of 01/23. 3. Data on file. AbbVie Inc. 4. Goadsby PJ, Blumenfeld AM, Lipton RB, et al. Time course of efficacy of ubrogepant for the acute treatment of migraine: clinical implications. Cephalalgia. 2021;41(5):546-560. 5. 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. 6. Serrano D, Lipton RB, Scher Al, et al. Fluctuations in episodic and chronic migraine status over the course of 1 year: implications for diagnosis, treatment and clinical trial design. J Headache Pain. 2017;18:101. 7. Lipton RB, Reed ML, Fanning KM, Contreras-De Lama J, Adams AM, Buse DC. Characterizing the pre- and post-headache phases of migraine: interim results from the CaMEO-International Study (US sample). Poster presented at: 64th Annual Scientific Meeting of the American Headache Society; June 9-12, 2022; Denver, CO. * Site Map * Accessibility Statement * Contact Us * Terms of Use * Privacy Notice * Cookies Settings * Your Privacy Choices UBRELVY® and its design are registered trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company. © 2023 AbbVie. All rights reserved. US-UBR-220090 10/20 This site is intended for US healthcare professionals only. US-UBR-230361 IMPORTANT SAFETY INFORMATION Contraindications Drug Interactions: UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin). IMPORTANT SAFETY INFORMATION Contraindications Drug Interactions: UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin). IMPORTANT SAFETY INFORMATION Contraindications Drug Interactions: UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin). IMPORTANT SAFETY INFORMATION Contraindications Drug Interactions: UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Drug Interactions: UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin). Hypersensitivity Reactions: UBRELVY is contraindicated in patients with a history of serious hypersensitivity to ubrogepant or any ingredient of the product. Cases, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported. Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions were not serious, and some led to discontinuation. If a serious or severe reaction occurs, discontinue UBRELVY and institute appropriate therapy. 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. US-UBR-230117 AbbVie may use and disclose online usage data about you collected automatically through online tracking technologies such as cookies, pixels, and web beacons (collectively, “cookies”). We use this data for multiple purposes, including for online targeted advertising (advertisements based on your interests inferred from your activity across other unaffiliated sites and services) and website analytics purposes, as well as to personalize content, save your preferences, provide social media features, and track the site’s performance, as further described in the"Cookies and similar tracking and data collection technologies" section of our Privacy Notice. We retain this data for as long as necessary to fulfill these purposes or as needed to comply with our record retention obligations. We do not sell your data, but we may disclose it to our marketing and advertising partners for purposes of online targeted advertising or for website analytics purposes. To opt out of the use or disclosure of your cookie-based personal data for online targeted advertising or for website analytics purposes, or to otherwise manage your preferences, please click on Cookie Settings below. 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