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About carcinoid syndrome diarrhea (CSD)

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.

CSD is caused primarily by serotonin overproduction from functioning neuroendocrine tumors (NETs)1

Serotonin

Serotonin normally plays a role in mediating secretion and motility of the gastrointestinal tract, but excessive serotonin in the body can lead to significant physiologic consequences.1-4

CSD is one of the most common manifestations of carcinoid syndrome (CS).1

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Symptoms of CSD include1,2:

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Urgency
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Frequency
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Watery stools
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Long-term SSA therapy alone can be ineffective for a majority of patients3,5-9

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In studies that assessed long-term efficacy of long-acting SSA injections, 42%-67% of patients lost response over median time of 3 to 21 months.7-9

 

42% - 67%

of patients lost response

overall median time of 3 to 21 months
 

Understanding why — and possible patient impact

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Mechanisms of resistance can diminish SSA therapy response and serotonin release.5

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Many patients can continue to experience debilitating diarrhea.3,10,11

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Antidiarrheals do not address the underlying pathology of CSD.1

Ask your patients about signs of uncontrolled diarrhea episodes1,12,13

  • Breakthrough diarrhea despite long-acting SSA therapy
  • Increasing dose or frequency of SSA injections
  • Use of short-acting octreotide injections
  • Frequent use of antidiarrheals
  • Limitations attending work and activities outside the home
  • Nocturnal diarrhea
  • Bathroom mapping
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Get more information about XERMELO and resources to support your patients.

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How XERMELO works

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See how XERMELO and SSAs work together.

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Patient access and support

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Ways to help patients with CSD on their treatment journey.

See support options
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Practice resources

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Download helpful forms, checklists, sample letters, and more.

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References:

  1. Naraev B, Halland M, Halperin DM, Purvis AJ, O'Dorisio TM, Halfdanarson TR. Management of diarrhea in patients with carcinoid syndrome. Pancreas. 2019;48(8):961-972.
  2. Clement D, Ramage J, Srirajaskanthan R. Update on pathophysiology, treatment, and complications of carcinoid syndrome. J Oncol. 2020;2020:1-11.
  3. Molina-Cerrillo J, Alonso-Gordoa T, Martínez-Sáez O, Grande E. Inhibition of peripheral synthesis of serotonin as a new target in neuroendocrine tumors. Oncologist. 2016;21(6):701-707.
  4. Camilleri M. Serotonin in the gastrointestinal tract. Curr Opin Endocrinol Diabetes Obes. 2009;16(1):53-59.
  5. Kulke MH, O'Dorisio T, Phan A, et al. Telotristat etiprate, a novel serotonin synthesis inhibitor, in patients with carcinoid syndrome and diarrhea not adequately controlled by octreotide. Endocr Relat Cancer. 2014;21(5):705-714.
  6. SANDOSTATIN® LAR DEPOT (octreotide acetate). Prescribing Information. Novartis Pharmaceuticals Corporation.
  7. Janson ET, Öberg K. Long-term management of the carcinoid syndrome treatment with octreotide alone and in combination with alpha-interferon. Acta Oncologica. 1993;32(2):225-229.
  8. Toumpanakis C, Garland J, Marelli L, et al. Long-term results of patients with malignant carcinoid syndrome receiving octreotide LAR. Aliment Pharmacol Ther. 2009;30(7):733-740.
  9. Khan MS, El-Khouly F, Davies P, Toumpanakis C, Caplin ME. Long-term results of treatment of malignant carcinoid syndrome with prolonged release lanreotide (somatuline autogel). Aliment Pharmacol Ther. 2011;34(2):235-242.
  10. Kvols LK, Oberg KE, O'Dorisio TM, et al. Pasireotide (SOM230) shows efficacy and tolerability in the treatment of patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR: results from a phase II study. Endocr Relat Cancer. 2012;19(5):657-666.
  11. XERMELO® (telotristat ethyl). Prescribing Information. TerSera Therapeutics LLC.
  12. Strosberg JR, Halfdanarson TR, Bellizzi AM, et al. The North American Neuroendocrine Tumor Society consensus guidelines for surveillance and medical management of midgut neuroendocrine tumors. Pancreas. 2017;46(6):707-714.
  13. Anthony L, Ervin C, Lapuerta P, et al. Understanding the patient experience with carcinoid syndrome: exit interviews from a randomized, placebo-controlled study of telotristat ethyl. Clin Ther. 2017;39(11):2158-2168.

Important Safety Information and Indication

  • Contraindications: XERMELO is contraindicated in patients with a history of a hypersensitivity reaction to telotristat. Reactions have included angioedema, rash and pruritis.
  • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Serious complications of constipation have been reported during clinical trials and post marketing with individual reports of intestinal perforation, obstruction, and fecaloma. 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.
  • Contraindications: XERMELO is contraindicated in patients with a history of a hypersensitivity reaction to telotristat. Reactions have included angioedema, rash and pruritis.
  • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Serious complications of constipation have been reported during clinical trials and post marketing with individual reports of intestinal perforation, obstruction, and fecaloma. 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.
  • Adverse Reactions: In a clinical trial of patients with carcinoid syndrome diarrhea and 4-12 bowel movements per day, the most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia. In a second clinical trial of patients with carcinoid syndrome diarrhea and less than 4 bowel movements per day, additional adverse reactions of abdominal pain and constipation were reported in ≥5% of patients.
  • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 and CYP2B6 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.
  • Use in Special Populations: XERMELO is not recommended in patients with moderate and severe hepatic impairment.

Indication

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.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1-844-334-4035 or medicalinformation@tersera.com.

Please see accompanying Full Prescribing Information.

 

Important Safety Information and Indication

  • Contraindications: XERMELO is contraindicated in patients with a history of a hypersensitivity reaction to telotristat. Reactions have included angioedema, rash and pruritis.
  • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Serious complications of constipation have been reported during clinical trials and post marketing with individual reports of intestinal perforation, obstruction, and fecaloma. 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.
  • Contraindications: XERMELO is contraindicated in patients with a history of a hypersensitivity reaction to telotristat. Reactions have included angioedema, rash and pruritis.
  • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Serious complications of constipation have been reported during clinical trials and post marketing with individual reports of intestinal perforation, obstruction, and fecaloma. 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.
  • Adverse Reactions: In a clinical trial of patients with carcinoid syndrome diarrhea and 4-12 bowel movements per day, the most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia. In a second clinical trial of patients with carcinoid syndrome diarrhea and less than 4 bowel movements per day, additional adverse reactions of abdominal pain and constipation were reported in ≥5% of patients.
  • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 and CYP2B6 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.
  • Use in Special Populations: XERMELO is not recommended in patients with moderate and severe hepatic impairment.

Indication

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.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1-844-334-4035 or medicalinformation@tersera.com.

Please see accompanying Full Prescribing Information.

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