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FDA Approves Xermelo for Carcinoid Syndrome Diarrhea
FDA news release; 2017 Feb 28
The FDA has approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea.
Indications: Xermelo is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea combined with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
Dosage and administration: The recommended dosage is 250 mg 3 times daily.
Efficacy and safety: Approval is based on results from a 12-week, double-blind, placebo-controlled trial involving 90 individuals with well-differentiated metastatic neuroendocrine tumors and carcinoid syndrome diarrhea. Those who had Xermelo added to SSA treatment experienced a greater reduction in average bowel movement frequency than those on SSA and placebo.
Side effects/risks: Most common adverse reactions are nausea, headache, increased gamma-glutamyl transferase levels, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
FDA approves Xermelo for carcinoid syndrome diarrhea. [news release]. Silver Spring, MD: FDA February 28, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544035.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed March 4, 2017.
Xermelo [package insert]. The Woodlands, TX: Lexicon Pharmaceuticals, Inc. 2017. http://www.xermelo.com/Media/Default/pdfs/Product_Info_telotristat_etiprate.pdf. Accessed March 4, 2017.