XERMELO is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea (CSD) in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

About Carcinoid Syndrome Diarrhea

Carcinoid Syndrome Diarrhea Carcinoid Syndrome Diarrhea
INCLUDES SYMPTOMS OF URGENT,
FREQUENT, AND WATERY STOOLS

Functioning neuroendocrine tumors (NETs) can lead to a constellation of symptoms known as carcinoid syndrome (CS)1-4

CSD is the most common manifestation of CS and is caused primarily by serotonin overproduction from functioning NETs.1

Serotonin

Serotonin normally plays a role in mediating secretion and motility of the gastrointestinal tract, but excessive serotonin in the body can have significant physiologic consequences in multiple systems, including1-4:

  • Flushing of the skin
  • Bronchial constriction
  • Tissue fibrosis and heart valve damage, potentially leading to carcinoid heart disease

Long-term SSA therapy alone can be ineffective in a majority of patients3,5-9

  • Over time, tachyphylaxis and other mechanisms of resistance can lead to a diminished response to SSA therapies, and subsequent release of serotonin5
  • This means that many patients can continue to experience debilitating diarrhea3,10,11

The combination of XERMELO + SSA offers 2 distinct pathways to reduce excess serotonin by addressing the underlying pathology3,10

  • XERMELO inhibits the enzyme tryptophan hydroxylase, which reduces the production of serotonin3,10
  • Together, XERMELO + SSA mediate serotonin overproduction by modifying its production AND release6,10
Have questions?

Request a XERMELO representative

A representative can give you more information about XERMELO and provide resources to support your patients.

Request a rep

Study results

See study results of XERMELO + SSA treatment versus SSA treatment alone.

See study results

Support for your patients

Get support and resources to help your patients on their treatment journey.

Find support

Download practice resources

Download patient brochures, enrollment forms, sample prior authorization letters, checklists, and more.

Get practice resources

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. Møller JE, Connolly HM, Rubin J, Seward JB, Modesto K, Pellikka PA. Factors associated with progression of carcinoid heart disease. N Engl J Med. 2003;348(11):1005-1015.
  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. XERMELO® (telotristat ethyl) Prescribing Information. TerSera Therapeutics LLC.
  11. 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.

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.

Please see Full Prescribing Information.

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.

 

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.

Please see Full Prescribing Information.

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.

Attention

If you click “Continue” below, you will leave the current site and be taken to a site maintained by a third party who is solely responsible for its content. TerSera provides this link as a service to website visitors. TerSera is not responsible for the privacy policy of any third party websites. We encourage you to read the privacy policy of every website you visit.

Continue

NPI LOOKUP

To find your NPI number, please fill out the information below.

Fields marked with an asterisk (*) are required.

Enter your first name.
Enter your last name.
Select your state.

Search results

Select the entry with your name and address information.  

Name NPI number State ZIP Code  

No results found

Refine your search and try again.