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TerSera NurseSupport Doctor Discussion Guide

How XERMELO can help

How XERMELO was studied

In the TELESTAR study, XERMELO + somatostatin analog (SSA) was compared with SSA injections alone in 90 people (45 per test group) with carcinoid syndrome diarrhea (CSD). Participants were having between 4 to 12 bowel movements (BMs) per day and were already on a steady SSA dose for at least 3 months. All participants were followed for 12 weeks and recorded diarrhea frequency in a daily diary.

XERMELO pills + SSA injections provide long-term relief for CSD

TELESTAR, the clinical study that led to the FDA approval of XERMELO, showed meaningful reductions in CSD symptoms. XERMELO was studied in multiple long-term safety studies. The average treatment was 92 weeks.

Down arrow that reads: 2X

XERMELO + SSA reduced average daily BM frequency 2X more than SSA injections alone (-1.4 vs -0.6, respectively).

How to get XERMELO

Give XERMELO 12 weeks to work

In the TELESTAR study, almost 9 out of 10 people with CSD (89%) taking XERMELO pills plus SSA injections had a reduction in diarrhea frequency at 12 weeks. In the same study, only 69% of patients on SSA injections alone reduced their BM frequency.

Nearly 9 out of 10 people taking XERMELO had a reduction in diarrhea frequency; 8.9 out of 10 male/female public restroom figure symbols are highlighted
Calendar page that reads: 12 WEEKS

Most patients see improvement in 12 weeks and some patients may start to see results within 3 weeks.

XERMELO reduced serotonin levels

CSD occurs when there is too much serotonin in the gut. When serotonin breaks down in your body, it becomes 5-hydroxyindoleacetic acid (5-HIAA). People with CSD often have high levels of 5-HIAA. About 25% of patients who enrolled in the TELESTAR study had normal 5‑HIAA levels, and the remaining 75% had elevated levels.

At the end of the TELESTAR study, patients' 5-HIAA levels were measured. In the group treated with XERMELO + SSA injections, 5-HIAA levels were reduced by 40.1 mg. In patients treated with SSA alone, 5‑HIAA levels showed an increase of 11.5 mg.

Your doctor may measure your 5-HIAA to see how much serotonin is in your body.

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XERMELO was shown to be effective in patients regardless of their baseline 5-HIAA levels.

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How to talk to your doctor about XERMELO

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How XERMELO works

XERMELO targets a key
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Important Safety Information

  • Do not take XERMELO if you have a history of hypersensitivity to telotristat or any of the ingredients in XERMELO.
  • XERMELO may cause constipation which can be serious. You should stop taking XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops. Talk to your doctor if you have these symptoms.
  • Do not take XERMELO if you have a history of hypersensitivity to telotristat or any of the ingredients in XERMELO.
  • XERMELO may cause constipation which can be serious. You should stop taking XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops. Talk to your doctor if you have these symptoms.
  • The most common side effects of XERMELO include nausea, headache, increase in liver enzymes, depression, flatulence, decreased appetite, swelling of your hands and feet, fever, abdominal pain, and constipation.
  • Talk to your doctor about all medications you are taking as some may interact with XERMELO.
  • XERMELO is not recommended if you have moderate or severe liver impairment.

Indication

XERMELO is a prescription pill, used along with somatostatin analog (SSA) therapy, for carcinoid syndrome diarrhea in adults who are not adequately controlled by SSA therapy.

You are encouraged to report negative side effects of prescription drugs to the FDA. 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 Full Prescribing Information.

 

Important Safety Information

  • Do not take XERMELO if you have a history of hypersensitivity to telotristat or any of the ingredients in XERMELO.
  • XERMELO may cause constipation which can be serious. You should stop taking XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops. Talk to your doctor if you have these symptoms.
  • Do not take XERMELO if you have a history of hypersensitivity to telotristat or any of the ingredients in XERMELO.
  • XERMELO may cause constipation which can be serious. You should stop taking XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops. Talk to your doctor if you have these symptoms.
  • The most common side effects of XERMELO include nausea, headache, increase in liver enzymes, depression, flatulence, decreased appetite, swelling of your hands and feet, fever, abdominal pain, and constipation.
  • Talk to your doctor about all medications you are taking as some may interact with XERMELO.
  • XERMELO is not recommended if you have moderate or severe liver impairment.

Indication

XERMELO is a prescription pill, used along with somatostatin analog (SSA) therapy, for carcinoid syndrome diarrhea in adults who are not adequately controlled by SSA therapy.

You are encouraged to report negative side effects of prescription drugs to the FDA. 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 Full Prescribing Information.

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