Xermelo is a brand-name tablet prescribed for diarrhea related to carcinoid syndrome (a group of symptoms caused by carcinoid tumors). Xermelo contains the active drug telotristat ethyl.

Xermelo is FDA-approved to treat carcinoid syndrome diarrhea that hasn’t improved when treated with other drugs called somatostatin analogs. Xermelo is approved for use in combination with these drugs in adults.

Drug details

You’ll find key information about Xermelo below.

  • Drug class: Tryptophan hydroxylase inhibitor
  • Drug form: Oral tablet
  • Generic available? No
  • Prescription required? Yes
  • Controlled substance? No
  • Year of FDA approval: 2017

Xermelo is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Xermelo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Xermelo. These lists don’t include all possible side effects.

For more information about the possible side effects of Xermelo, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you’d like to notify the FDA about a side effect you’ve had with Xermelo, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Xermelo. To learn about other mild side effects, talk with your doctor or pharmacist, or view Xermelo’s prescribing information.

Mild side effects of Xermelo can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Xermelo, see “Allergic reaction” below.

Serious side effects

Serious side effects from Xermelo aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Severe constipation that may lead to a blockage or tear in the intestine. Symptoms can include:
    • severe constipation
    • severe abdominal pain that doesn’t go away or gets worse
    • loss of appetite
  • Depression. Symptoms can include:
    • mood changes
    • sadness or hopelessness that doesn’t go away
    • loss of interest in things you usually enjoy
    • lack of energy and motivation
  • Severe allergic reaction.*

* For details about allergic reaction and Xermelo, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Xermelo. This side effect wasn’t reported in clinical trials of this drug but has occurred since the drug was approved.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Xermelo, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The following information describes the Xermelo dosage that’s commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Xermelo comes as a tablet that you swallow. It’s available in one strength: 250 milligrams (mg).

Dosage for carcinoid syndrome diarrhea

The recommended dosage for carcinoid syndrome diarrhea is 250 mg (one tablet) three times per day.

If you take Xermelo in combination with short-acting octreotide injections (Sandostatin), you should take your octreotide injection at least 30 minutes after taking Xermelo.

About taking Xermelo

Below you’ll find information about key dosage issues.

  • When to take: You should take Xermelo three times per day. Spread the doses evenly over the day. Try to take Xermelo around the same time each day. Taking the medication around the same times each day helps keep a steady level of the drug in your body. This helps Xermelo work effectively.
  • If you miss a dose: If you miss a dose, take your next dose at your usual time. Do not take two doses together to make up for a missed dose.
  • Taking Xermelo with food: You should take Xermelo with food. This is because food helps the medication absorb into your body.
  • Crushing, splitting, or chewing Xermelo: Xermelo tablets are meant to be swallowed whole. You should not crush, split, or chew Xermelo. If you have trouble swallowing the tablets, talk with your doctor.
  • Length of use: Xermelo is meant to be a long-term treatment. If you and your doctor determine that Xermelo is safe and effective for you, you’ll likely take it long term.

Overdose

Do not use more Xermelo than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Xermelo

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

The Food and Drug Administration (FDA) approves prescription drugs such as Xermelo to treat certain conditions.

Xermelo for carcinoid syndrome diarrhea

Xermelo is FDA-approved to treat carcinoid syndrome diarrhea in adults.

Carcinoid syndrome is a group of symptoms caused by carcinoid tumors. These tumors (also called neuroendocrine tumors or NETs) are a rare type of cancer that typically develops in the digestive system. They release serotonin and other substances that cause various symptoms, including severe diarrhea.

Xermelo is FDA-approved for carcinoid syndrome diarrhea that hasn’t improved when treated with drugs called somatostatin analogs. Xermelo is used in combination with these drugs. Examples include lanreotide (Somatuline Depot) and octreotide (Sandostatin, Sandostatin LAR).

Xermelo and children

Xermelo is not FDA-approved as a treatment for children. It’s not known whether Xermelo is safe or effective for children.

As with all medications, the cost of Xermelo can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Xermelo or help to understand your insurance coverage, help is available.

The Xermelo Co-Pay Program is also available. For more information and to find out whether you’re eligible for support, visit the program website.

To learn more about saving money on prescriptions, check out this article.

Generic version: Xermelo isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Here are answers to some frequently asked questions about Xermelo.

Is Xermelo chemotherapy?

No, Xermelo is not a form of chemotherapy. Xermelo doesn’t treat cancer. Instead, the medication helps control diarrhea caused by carcinoid tumors, which are a rare type of cancer that typically develops in the digestive system.

Chemotherapy may be used to treat this type of cancer. However, Xermelo is a drug that helps reduce diarrhea caused by the cancer.

If you have questions about the conditions Xermelo is used to treat, talk with your doctor or pharmacist.

How does Xermelo work?

Xermelo helps control diarrhea caused by carcinoid tumors. These tumors produce high levels of a neurotransmitter called serotonin. (Neurotransmitters are chemicals that help pass messages between nerve cells.)

Serotonin has various functions and is involved in controlling digestion. High levels of serotonin can increase movement through the intestines and increase the amount of fluid in the intestines. This can cause diarrhea that can be severe, frequent, and unpredictable.

Xermelo works by blocking the action of an enzyme that’s involved in making serotonin, called tryptophan hydroxylase. (An enzyme is a type of protein that helps chemical reactions happen). Blocking this enzyme stops the carcinoid tumor cells making too much serotonin. This reduces the frequency and severity of diarrhea.

If you have questions about how Xermelo works, talk with your doctor or pharmacist.

Can Xermelo cause long-term side effects?

It’s possible. Xermelo can sometimes cause depression that may continue for a long time. However, most of Xermelo’s side effects either improve with continued treatment or get better quickly after stopping treatment.

Taking Xermelo for a long time isn’t known to increase the risk of side effects.

If you’re concerned about the risk of side effects with Xermelo, talk with your doctor.

Xermelo can interact with several other medications.

Before taking Xermelo, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications, foods, and supplements

Below is a list of medications that can interact with Xermelo. This list doesn’t contain all drugs that may interact with Xermelo. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Xermelo• short-acting octreotide (Sandostatin)*
• drugs that are CYP3A4 substrates,† such as midazolam (Seizalam, Nayzilam)
• drugs that are CYP2B6 substrates,† such as bupropion (Aplenzin, Wellbutrin, others) and efavirenz

* If you take Xermelo with a short-acting octreotide injection (Sandostatin), you should administer your octreotide injection at least 30 minutes after taking Xermelo.
† Drugs that are CYP3A4 and CYP2B6 substrates are broken down by liver enzymes (a type of protein) called CYP3A4 and CYP2B6.

Alcohol interaction

Alcohol is not known to interact with Xermelo. However, alcohol and Xermelo can both cause nausea and headache, so you may be more likely to have these side effects if you drink alcohol with Xermelo.

If you have carcinoid syndrome, which Xermelo treats, your doctor may recommend avoiding alcohol. Alcohol may worsen diarrhea and flushing that you may have with carcinoid syndrome.

If you drink alcohol and have questions about how much is safe to drink while taking Xermelo, talk with your doctor or pharmacist.

Other drugs are available that can treat your carcinoid syndrome diarrhea. Some may be a better fit for you than others. If you’re interested in finding an alternative to Xermelo, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs may sometimes be recommended as alternatives to Xermelo:

Note: Some of the drugs listed here are prescribed off-label to treat this specific condition. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Xermelo and pregnancy

It’s not known whether Xermelo should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

Xermelo and birth control

It’s not known if Xermelo is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Xermelo.

Xermelo and breastfeeding

It’s not known whether Xermelo should be taken while breastfeeding. If you’re breastfeeding or planning to do so, talk with your doctor before taking this medication.

This drug comes with several precautions.

Before taking Xermelo, discuss your health history with your doctor. Xermelo may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • liver or kidney problems
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding

Note: For more information about the potential negative effects of Xermelo, see the “Xermelo side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.