Xermelo

Last updated on RxList: 11/5/2020
Xermelo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Xermelo?

Xermelo (telotristat ethyl) tablets are 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.

What Are Side Effects of Xermelo?

Common side effects of Xermelo include:

  • nausea,
  • headache,
  • increased GGT,
  • depression,
  • gas,
  • decreased appetite,
  • swelling of the extremities, and
  • fever.

Dosage for Xermelo

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.

What Drugs, Substances, or Supplements Interact with Xermelo?

Xermelo may interact with midazolam, and octreotide. Tell your doctor all medications and supplements you use.

Xermelo During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Xermelo; it is unknown how it will affect a fetus. It is unknown if Xermelo passes into breast milk or if it would affect a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Xermelo (telotristat ethyl) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Xermelo Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using telotristat ethyl and call your doctor at once if you have:

  • severe constipation; or
  • severe or worsening stomach pain.

Common side effects may include:

  • nausea, loss of appetite, gas;
  • headache, depressed mood;
  • swelling in your hands or feet;
  • fever; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xermelo (Telotristat Ethyl Tablets)

Xermelo Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Xermelo was studied in a double-blind, placebo-controlled clinical trial of 90 patients with metastatic neuroendocrine tumors and carcinoid syndrome diarrhea. Patients reported between 4 to 12 bowel movements daily despite the use of SSA therapy at a stable dose for at least 3 months [see Clinical Studies]. Placebo or Xermelo 250 mg was administered three times daily for 12 weeks. Concomitant anti-diarrheal medications (e.g., loperamide) were used by 43% (36% and 51% in the placebo and Xermelo group, respectively), pancreatic enzyme replacement medications by 39% (36% and 42% in the placebo and Xermelo group, respectively), and opioid analgesics by 29% (24% and 33% in the placebo and Xermelo group, respectively) of patients during the 12-week double-blind period of the trial.

Table 1 below lists adverse reactions occurring at an incidence of at least 5% in the Xermelo group (N=45) and at an incidence greater than placebo (N=45) during the 12-week placebocontrolled period of the trial.

Table 1: Percent Common Adverse Reactionsa by Treatment Group at 12-Weeks in a Double-Blind Placebo-Controlled Clinical Trial of Patients with Carcinoid Syndrome Diarrhea

Adverse ReactionXermelo 250 mg Three Times Daily,
N=45
(%)
Placebo,
N=45
(%)
Nausea1311
Headache114
Increased gammaglutamyl-transferase (GGT)90
Depressionb97
Peripheral edema72
Flatulence72
Decreased appetite74
Pyrexia74
a incidence of at least 5% in the Xermelo group and at an incidence greater than placebo
b including depression, depressed mood and decreased interest

In another placebo-controlled clinical trial of patients with carcinoid syndrome diarrhea and less than 4 bowel movements per day, the following additional adverse reactions, not listed in Table 1, of abdominal pain (including upper and lower abdominal pain, abdominal distention and gastrointestinal pain) and constipation were reported in at least 5% of patients in the Xermelo treated group and at an incidence greater than placebo [see WARNINGS AND PRECAUTIONS].

Less Common Adverse Reactions

The following is a list of adverse reactions occurring in less than 5% of patients receiving Xermelo during the 12-week placebo-controlled period of the clinical trial:

Investigations: increased alkaline phosphatase, increased alanine aminotransferase, and increased aspartate aminotransferase.

Fecaloma was reported in one patient treated with Xermelo during the 36-week open-label extension period following the 12-week double-blind period of the trial.

Read the entire FDA prescribing information for Xermelo (Telotristat Ethyl Tablets)

© Xermelo Patient Information is supplied by Cerner Multum, Inc. and Xermelo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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