Question 1

What is Xermelo?

Accepted Answer

Xermelo is a tryptophan hydroxylase inhibitor that blocks the enzyme responsible for the first step in serotonin synthesis. By decreasing the amount of serotonin produced, the medication helps address chemical overproduction within the system.

This medication functions as a targeted therapy to help manage specific physiological symptoms. It works by regulating the levels of certain chemicals that the body produces in excess.

Question 2

What is Xermelo used for?

Accepted Answer

Xermelo is used to treat carcinoid syndrome diarrhea .

Question 3

How does Xermelo work?

Accepted Answer

How Xermelo Works

Xermelo is used to treat carcinoid syndrome diarrhea by targeting the underlying cause of the symptom. In people with carcinoid syndrome, certain tumors release excessive amounts of a chemical called serotonin into the system.

While serotonin is a natural chemical found in the body, too much of it can lead to various issues, including frequent and urgent bowel movements. Xermelo works through the following process:

Enzyme Inhibition: The medication is a tryptophan hydroxylase inhibitor. It works by blocking tryptophan hydroxylase, which is the primary enzyme the body and tumors use to manufacture serotonin.

Reducing Serotonin Levels: By interfering with this enzyme, Xermelo decreases the overall production of serotonin within the gastrointestinal tract and the tumors.

Symptom Management: High levels of serotonin cause the digestive system to work too quickly. By lowering these levels, Xermelo helps slow down the activity in the gut and reduces the frequency of bowel movements.

This medication specifically targets the production of serotonin within the tumors and the digestive tract, rather than just treating the symptoms of diarrhea directly. It is typically used in combination with somatostatin analog (SSA) therapy when those treatments alone are not enough to control the diarrhea.

Question 4

What are the active ingredients in Xermelo?

Accepted Answer

The active ingredient in Xermelo is telotristat ethyl .

Question 5

What are the side effects of Xermelo?

Accepted Answer

Common side effects of Xermelo may include:

Constipation

Nausea

Abdominal pain

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Xermelo?

Accepted Answer

Xermelo belongs to the tryptophan hydroxylase inhibitor drug class.

Question 7

What is the dosage of Xermelo and how do I take it?

Accepted Answer

How to Take Xermelo

Xermelo is taken by mouth, usually three times per day. It should be taken with food. Swallow the tablets whole; do not crush, chew, or break them before swallowing.

Missed Dose

If you miss a dose of Xermelo, skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time to make up for a missed one.

General Administration

This medication is intended to be used in combination with somatostatin analog (SSA) therapy. Continue taking your other medications as directed by your healthcare provider while using Xermelo.

Question 8

Is Xermelo safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There are no adequate or well-controlled studies on the use of Xermelo in pregnant women. In animal research, high doses of the medication were associated with reduced fetal weight and maternal toxicity, though these effects were observed at levels significantly higher than the recommended human dose. It is unknown if Xermelo can cause harm to an unborn baby when taken by a pregnant person.

Breastfeeding

It is not known if Xermelo or its metabolites are present in human breast milk. Because many drugs are excreted in milk and there is a potential for serious adverse reactions in nursing infants, breastfeeding is generally not recommended during treatment with Xermelo. Healthcare providers can help determine the safest options for infant feeding while taking this drug.

Question 9

What forms and strengths does Xermelo come in?

Accepted Answer

Xermelo is supplied in the following form:

Oral Tablet: A film-coated, oval-shaped tablet intended to be swallowed whole.

The tablets are typically provided in blister packs to help patients manage their daily schedule. This medication is used in combination with somatostatin analog therapy.

Question 10

What is the FDA approval status of Xermelo?

Accepted Answer

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Xermelo on February 28, 2017. It is indicated for the treatment of carcinoid syndrome diarrhea in adults whose symptoms are not adequately controlled by somatostatin analog (SSA) therapy alone. Xermelo must be used in combination with an SSA.

Regulatory History

During its clinical development, Xermelo received several regulatory designations from the FDA to expedite its availability:

Orphan Drug Designation: Granted for the treatment of rare diseases.

Fast Track Designation: Intended to facilitate the development of drugs for serious conditions with unmet medical needs.

Priority Review: Assigned to drugs that offer significant improvements in the safety or effectiveness of the treatment of serious conditions.

There are currently no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) associated with Xermelo.

Question 11

What should I know about Xermelo and cost?

Accepted Answer

Factors Affecting Cost

The actual price you pay for Xermelo is influenced by several factors:

Insurance Plan: Your specific health insurance coverage, including your deductible and co-payment amounts, will determine your out-of-pocket expenses.

Specialty Pharmacy: Xermelo is a specialty medication and is usually dispensed through specific pharmacies rather than local retail stores.

Prior Authorization: Many insurance companies require your doctor to submit a prior authorization request before they will cover the cost of the medication.

Financial Assistance

The manufacturer of Xermelo offers a support program that may help eligible patients with the cost of the drug. This can include co-pay assistance for those with commercial insurance or programs for individuals who are uninsured or underinsured. You should speak with your healthcare provider or a specialty pharmacist to learn more about these options.

Xermelo

Medication Quick Facts

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

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