Prescribing InformationFor Patients

Introduce XERMELO at any disease stage

Add XERMELO to SSA for inadequately controlled Carcinoid Syndrome Diarrhea for patients with stable or progressive disease during any tumor-directed therapy.1 There are no restrictions in the XERMELO prescribing information on use with concomitant anti-tumor therapies.2

Hormone-Directed Therapies1
  • SSA
  • XERMELO
Tumor-Directed Therapies2-4
  • SSAs
  • LUTATHERA
  • LIVER-DIRECTED THERAPIES
  • CYTOREDUCTIVE SURGERY
  • EVEROLIMUS
  • CYTOTOXIC CHEMOTHERAPY

XERMELO can be added to any tumor control regimen1

Adding XERMELO to your fNET treatment approach helps control serotonin in patients with CSD.

How can XERMELO help the hormonal aspect of CSD?

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend telotristat ethyl + SSA as a treatment option for inadequately controlled CSD.2

NCCN = National Comprehensive Cancer Network

XERMELO is the only oral therapy indicated for CSD that controls overproduction of serotonin at its source inside the tumor cell.1,3

Watch our MOA Video

Give your CSD patients improved control with XERMELO + SSA therapy

Most patients with 1–3 BMs per day report that CSD disrupts their life and may cause them to miss work or social events. Patients with CSD had more absenteeism hours, short-term disability days, and more lost workdays.6,7

Watch for signs of an uncontrolled patient:1,4, 6-9
Diarrhea
Fear of Accidents
Reluctance to Leave Home
Skipping Meals
Wearing Adult Diapers
Nocturnal Diarrhea
Bathroom Mapping
ALSO LOOK FOR 1,3,12,13
  • Breakthrough diarrhea despite long-acting SSA therapy
  • Increased dose or frequency of SSA injections
  • Use of short-acting octreotide injections
  • Patients that need CSD syndrome control in addition to PRRT treatment
  • Frequent use of anti-diarrheals

XERMELO + SSA are proven to work better together

For patients with CSD, XERMELO + SSA therapy provides more comprehensive control of tumor-derived serotonin overproduction1,5

XERMELO was evaluated in two randomized Phase III clinical studies in patients with varying CSD severity

In the pivotal TELESTAR trial, the safety of XERMELO was evaluated over the total 48-week study period14

  • While the TELESTAR trial evaluated both XERMELO 250 mg and XERMELO 500 mg, the FDA-approved dose is 250 mg 3 times daily1
  • Patients were allowed to use rescue medication (short-acting octreotide) and antidiarrheals for symptomatic relief1
  • 98% of patients who completed the double-blind treatment period elected to continue into the open-label extension14

XERMELO + SSA reduced serotonin as measured by urinary 5-HIAA

At Week 12, XERMELO + SSA reduced mean u5-HIAA beyond what was achieved with initial pre-trial SSA treatment.1

24-hour u5-HIAA levels decreased with XERMELO + SSA but increased with SSA alone.14

XERMELO + SSA PROVIDED A SUPERIOR, 2× GREATER REDUCTION14

In average daily BM frequency (primary endpoint) vs SSA alone: -1.4 vs -0.6, respectively (p<0.001) [n=135]14

of patients improved with XERMELO + SSA vs 69% with SSA alone1

See how XERMELO + SSA resulted in lower discontinuation rates vs. SSA alone.

References:

1. XERMELO Prescribing Information. The Woodlands, TX: Lexicon Pharmaceuticals, Inc.; February 2017.2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Neuroendocrine and Adrenal Tumors V.1.2019 © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed March 5, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.3. LUTATHERA® [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; July 2018.4. Pasricha G, Padhi P, Daboul N, Monga DK. Management of well-differentiated gastroenteropancreatic neuroendocrine tumors (GEPNETs): a review. Clin Ther. 2017;39:2146-2157.5. 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;21:701-707.6. Shah A. Carcinoid impact survey findings. Lexicon Pharmaceuticals, Inc. 2016.7. Dasari A, Joish VN, Perez-Olle R, et al. Work productivity burden and indirect costs associated with carcinoid syndrome diarrhea. Expert Rev Pharmacoecon Outcomes Res. 2019:1-5. doi:10.1080/14737167.2019.16606468. 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):2158-2168.9. Singh S, Granberg D, Wolin E, et al. Patient- reported burden of a neuroendocrine tumor (NET) diagnosis: results from the first global survey of patients with NETs. Glob Oncol. 2017;3(1):43-53.10. Gelhorn H, Kulke M, D’Orsio T, et al. Patient-reported symptom experiences in patients with carcinoid syndrome after participation in a study of telostristat etiprate: a qualitative interview approach. Clin Ther. 2016;38(4):759-768.11. Shinn B, Tafe L, Vanichakarn P. A case of carcinoid syndrome due to malignant metastatic carcinoid tumor with carcinoid heart disease involving four cardiac valves. Am J Case Rep. 2018;19:284-288.12. Strosberg J, Halfdanarson T, Bellizi A, et al. The North American neuroendocrine society (NANETS) consensus guidelines for surveillance and medical management of midgut neuroendocrine tumors. Pancreas. 2017;46(6):707-714.13. Sandostatin® LAR Depot Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2016.14. Kulke MH, Hörsch D, Caplin ME, et al. Telotristat ethyl, a tryptophan hydroxylase inhibitor for the treatment of carcinoid syndrome. J Clin Oncol. 2017;35:14-23.15. Pavel M, Gross DJ, Benavent M, et al. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocr Relat Cancer. 2018;25:309-322.

You may report an adverse event related to Lexicon products by calling 1-844-LEX-PHAR (1-844-539-7427) (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

Copyright © 2019 Lexicon Pharmaceuticals, Inc. All rights reserved.
December 2019 PP-XER-US-0053

Important Safety Information and Indication

Important Safety Information

For more information about XERMELO see Full Prescribing 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.
  • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gammaglutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
  • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 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.

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.

For more information about XERMELO see Full Prescribing Information