Why is this medication prescribed?

Xermelo (telotristat ethyl) is a medication prescribed for the treatment of carcinoid syndrome diarrhea in adults whose symptoms are not adequately controlled by somatostatin analog (SSA) therapy. Carcinoid syndrome is a rare condition that can occur in individuals with carcinoid tumors, which are slow-growing tumors that usually originate in the gastrointestinal tract or lungs.

Carcinoid syndrome is associated with the overproduction of serotonin, a chemical that can cause diarrhea, abdominal pain, flushing, and other symptoms. Xermelo works by inhibiting the production of serotonin in the gastrointestinal tract, helping to reduce the symptoms of carcinoid syndrome diarrhea.

How should this medicine be used?

Here are general guidelines on how Xermelo should be used:

• Dosage: The typical recommended dose is 250 mg taken orally three times daily with food.
• Administration: Xermelo comes as a tablet to take by mouth. Xermelo should be taken with food to enhance its absorption.
• Compliance: It’s important to take Xermelo exactly as prescribed by your healthcare provider. Do not change the dose or stop taking the medication without consulting your doctor.
• Monitoring: Your healthcare provider may monitor your symptoms and adjust the dose of Xermelo as needed to achieve the best results.
• Combination with SSA: Xermelo is often prescribed in combination with a somatostatin analog (SSA), such as octreotide or lanreotide. The SSA helps control the symptoms of carcinoid syndrome, and Xermelo can be added to further address diarrhea.
• Side Effects: Like any medication, Xermelo may cause side effects. Common side effects include nausea, headache, increased gamma-glutamyl transferase (GGT), depression, and peripheral edema. It’s important to report any unusual or severe side effects to your healthcare provider.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding, as the safety of Xermelo in these situations is not well-established.

Always follow your healthcare provider’s instructions and consult with them if you have any questions or concerns about the use of Xermelo. They will be able to provide guidance based on your specific medical history and condition.

Other uses for this medicine

Regarding other uses, it’s important to note that medications may be prescribed off-label for conditions beyond their FDA-approved indications. However, decisions to prescribe a medication off-label should be made by healthcare professionals based on their clinical judgment and an assessment of potential benefits and risks.

What special precautions should I follow?

As for special precautions with Xermelo, here are some key considerations:

• Liver Function Monitoring: Xermelo may cause an increase in liver enzyme levels. Regular monitoring of liver function is typically recommended during treatment. If significant elevations are observed, dose adjustments or discontinuation of Xermelo may be necessary.
• Interaction with Other Medications: Inform your healthcare provider about all the medications, including over-the-counter drugs, supplements, and herbal products, that you are taking. Xermelo may interact with certain medications, and adjustments in the dosages of other medications may be needed.
• Pregnancy and Breastfeeding: The safety of Xermelo during pregnancy and breastfeeding has not been well-established. It’s important to inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding.
• Allergies: If you have a known allergy to any of the ingredients in Xermelo, you should avoid using it. Allergic reactions can be serious and may require immediate medical attention.
• Psychiatric Effects: Xermelo may cause depression. Patients should be monitored for signs of depression, and healthcare providers should be informed of any changes in mood or behavior.
• Renal Impairment: There is limited information on the use of Xermelo in patients with severe renal impairment. It’s important to inform your healthcare provider if you have kidney problems.

Always follow your healthcare provider’s instructions and discuss any concerns or questions you may have about Xermelo. Individual patient circumstances can vary, and healthcare providers will take these into consideration when prescribing and monitoring the use of this medication. If you have specific questions about Xermelo or its potential off-label uses, it’s best to consult with your healthcare provider.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Xermelo. However, it’s generally advisable to take Xermelo with food to enhance its absorption. If you have any specific dietary concerns or restrictions, it’s a good idea to discuss them with your healthcare provider or pharmacist.

What should I do if I forget a dose?

If you forget to take a dose of Xermelo, follow these general guidelines:

• If it’s close to the time of your next scheduled dose: Skip the missed dose and take the next one at the regularly scheduled time.
• If there is a significant time gap until your next dose: Take the missed dose as soon as you remember, and then resume your regular dosing schedule.
• Do not double up on doses: Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Xermelo (telotristat ethyl) may cause various side effects. It’s important to note that not everyone will experience these side effects, and some individuals may experience effects that are not listed here. Common side effects and potential adverse reactions associated with Xermelo include:

• Nausea: Feeling of discomfort or inclination to vomit.
• Headache: Pain or discomfort in the head.
• Increased Gamma-Glutamyl Transferase (GGT): Elevated levels of GGT, an enzyme found in the liver.
• Depression: Xermelo has been associated with depressive symptoms. Patients should be monitored for changes in mood or behavior.
• Peripheral Edema: Swelling, usually in the legs or arms, due to fluid accumulation.
• Flatulence: Accumulation of gas in the digestive tract leading to bloating or increased passage of gas.
• Decreased Appetite: A reduction in the desire to eat.
• Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Elevations: These are enzymes released when the liver is damaged. Elevated levels may indicate liver issues.
• Constipation: Difficulty or infrequency in bowel movements.

It’s important to promptly report any unusual or severe side effects to your healthcare provider. Additionally, this list is not exhaustive, and individual responses to medications can vary. If you have concerns or experience any unexpected symptoms while taking Xermelo, contact your healthcare provider for guidance.

Patients should inform their healthcare providers of their complete medical history and any other medications or supplements they are taking to minimize the risk of interactions and side effects. Always follow your healthcare provider’s instructions regarding the use of Xermelo and attend regular check-ups to monitor your response to the medication and any potential side effects.

What should I know about storage and disposal of this medication?

Storage and Disposal of Xermelo:

• Storage:
  • Store Xermelo at room temperature between 20°C to 25°C (68°F to 77°F).
  • Keep the medication in its original container, and protect it from light and moisture.
• Disposal:
  • Dispose of Xermelo in accordance with local regulations and guidelines.
  • Do not flush medications down the toilet or pour them into a drain unless specifically instructed to do so.
  • If you have questions about proper disposal, consult with your pharmacist or healthcare provider.

In case of emergency/overdose

In case of an overdose or emergency, contact your local poison control center at 1-800-222-1222 or seek emergency medical attention immediately. Overdose symptoms may include nausea, vomiting, and severe constipation.

What other information should I know?

• Missed Dose: If you miss a dose of Xermelo, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to make up for a missed one.
• Follow-up: Attend all scheduled follow-up appointments with your healthcare provider to monitor your response to the medication and assess for any side effects or changes in your condition.
• Interactions: Inform your healthcare provider about all medications, including over-the-counter drugs, supplements, and herbal products, that you are taking, as Xermelo may interact with certain medications.
• Allergies: If you are allergic to any ingredients in Xermelo, inform your healthcare provider.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding, as the safety of Xermelo in these situations is not well-established.
• Psychiatric Effects: Be aware of potential depressive symptoms and report any changes in mood or behavior to your healthcare provider.
• Liver Function Monitoring: Regular monitoring of liver function may be recommended during treatment with Xermelo.
• Kidney Function: If you have kidney problems, discuss this with your healthcare provider, as there is limited information on the use of Xermelo in patients with severe renal impairment.

Always follow your healthcare provider’s instructions and guidance. If you have specific questions or concerns about Xermelo or its use, consult with your healthcare provider or pharmacist.