These highlights do not include all the information needed to use XERMELO safely and effectively. See full prescribing information for XERMELO.
XERMELO (telotristat ethyl) tablets, for oral use
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
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. (
1)
DOSAGE AND ADMINISTRATION
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The recommended dosage of Xermelo in adult patients is 250 mg three times daily for patients whose diarrhea is inadequately controlled by a SSA therapy. (2)
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Take Xermelo with food. (2)
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When short-acting octreotide is used in combination with Xermelo, administer short-acting octreotide at least 30 minutes after administering Xermelo. (2, 7.1)
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Discontinue Xermelo if severe constipation develops. (2, 5.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg telotristat ethyl (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Constipation: Xermelo reduces bowel movement frequency; monitor patients for constipation and/or severe persistent or worsening abdominal pain. Discontinue Xermelo if severe constipation or abdominal pain develops. (5.1)
ADVERSE REACTIONS
Most common adverse reactions (≥5%) are nausea, headache, increased GGT, depression, flatulence, decreased appetite, peripheral edema, and pyrexia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Lexicon Pharmaceuticals, Inc. at 1-844-539-7427 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
CYP3A4 Substrates (e.g., midazolam): Efficacy of concomitant drugs may be decreased; monitor for suboptimal efficacy and consider increasing the dose of the concomitant drug. (7.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 3/2017
