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The first and only oral treatment for
carcinoid syndrome diarrhea1,2
XERMELO is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
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Dear valued partner,
We are excited to introduce XERMELO, the first and only tryptophan hydroxylase inhibitor, a new treatment for patients with carcinoid syndrome diarrhea.1,2
XERMELO is now available by prescription in a 250‑mg oral tablet.
Through inhibition of tryptophan hydroxylase, XERMELO decreases the production of serotonin and the frequency of carcinoid syndrome diarrhea.1,2
XERMELO, administered at 250 mg 3 times daily with food, was evaluated in a 12-week, multicenter, Phase III, randomized, placebo-controlled trial of XERMELO + SSA (n=45) vs SSA alone (n=45).1
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At 6 and 12 weeks, 24-hour u5-HIAA levels decreased with XERMELO + SSA but not with SSA alone1
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89% of patients receiving XERMELO + SSA experienced improvement in bowel-movement frequency vs 69% of patients receiving SSA alone1
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XERMELO + SSA provided significant and superior reductions in daily bowel movements averaged over 12 weeks (–1.4 with XERMELO 250 mg + SSA vs –0.6 with SSA alone; P<0.001) (primary endpoint)1
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XERMELO + SSA provided early and sustained reductions in bowel-movement frequency, observed as early as 1 to 3 weeks and maintained throughout the 12‑week study1
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The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia1
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SSA=somatostatin analog; u5-HIAA=urinary 5-hydroxyindoleacetic acid.
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Read the press release detailing the FDA approval of XERMELO.
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Today marks an important leap forward in adding a new treatment option for patients suffering from carcinoid syndrome diarrhea. On behalf of Lexicon, we thank you for the critical role you serve as a key member of the patient care team helping to improve the lives of patients managing the effects of this disease.
Lexicon is committed to simplifying access to XERMELO and to improving a patient's chance for a successful clinical outcome. To that end, we've developed LexCares, a comprehensive program providing information and tools to help patients access the medication they need. Visit LexCares to complete the Enrollment Form now.
We look forward to meeting with you and your staff to discuss how XERMELO may be an appropriate option for your patients with carcinoid syndrome. If you have any questions, please call 1-844-XERMELO, contact a territory business manager via 1-866-203-9159, or visit www.XERMELO.com.
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| Important Safety Information |
Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
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| Important Safety Information (continued) |
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Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
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Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure.
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For more information about XERMELO, please see full Prescribing Information.
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Sincerely,
Pablo Lapuerta
Executive Vice President and Chief Medical Officer
on behalf of Lexicon Pharmaceuticals, Inc.
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References: 1. XERMELO Prescribing Information. The Woodlands, TX: Lexicon Pharmaceuticals, Inc.; February 2017. 2. Molina-Cerrillo J, Alonso-Gordoa T, Martínez-Sáez O, Grande E. Oncologist. 2016;21:701-707.
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This email is intended for US healthcare professionals only.
Lexicon Pharmaceuticals, Inc.
8800 Technology Forest Place
The Woodlands, TX 77381-1160
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Copyright © 2017 Lexicon Pharmaceuticals, Inc.
All rights reserved. PP-LX1606-US-0071 02/17
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