Patient Medication Information: uses, side effects, how to take - Xermelo
What is XERMELO used for?
- This medicine is used in adults to treat diarrhea caused by a condition called ‘carcinoid syndrome’.
- XERMELO is used if your diarrhea is not well controlled with injections of other medicines called ‘somatostatin analogues’ (lanreotide or octreotide). You should keep having injections of these other medicines when taking XERMELO.
How does XERMELO work?
Carcinoid syndrome happens when a cancerous tumour releases chemicals into your bloodstream causing symptoms, such as:
- Diarrhea and stomach (abdominal) pain
- Flushing of your skin, particularly the face
- Low blood pressure
- Rash
- Weight loss
The symptoms are not the same for everyone. XERMELO works by reducing the amount of a chemical called serotonin, made by the tumour. This can reduce the number of bowel movements you are having.
What are the ingredients in XERMELO?
Medicinal ingredients: telotristat ethyl (as telotristat etiprate)
Non-medicinal ingredients: croscarmellose sodium, hydroxypropylcellulose, lactose anhydrous, macrogol 3350, magnesium stearate, polyvinyl alcohol - partially hydrolysed, silica, colloidal anhydrous, talc, titanium dioxide
XERMELO comes in the following dosage forms:
Tablets: 250 mg Telotristat ethyl (as telotristat etiprate)
Do not use XERMELO if:
- you are allergic to telotristat or any of the other ingredients of this medicine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take XERMELO. Talk about any health conditions or problems you may have, including if you:
- have liver problems.
- have severe kidney problems, end-stage kidney disease and/or are on dialysis.
- are intolerant to some sugars, since lactose is an ingredient in XERMELO.
are pregnant, think you may be pregnant or are planning to become pregnant. XERMELO is not recommended during pregnancy.
are breastfeeding or planning to breastfeed. You should not breastfeed while taking
XERMELO. It is not known if XERMELO passes into breastmilk.
- have a gastrointestinal obstruction including constipation or narrowing of the large intestine (strictures) or any disease that affects the movement of your bowels. This is because taking XERMELO can cause intestinal obstruction. This is a blockage that stops or impairs food and liquid from passing through your intestines. These conditions may make you at a higher risk for an intestinal obstruction during your treatment.
Other warnings you should know about:
Liver Problems
Your healthcare professional will do blood tests before you start taking XERMELO and while you are taking it. This is to check that your liver is working normally.
Tell your healthcare professional immediately if you notice any of the following signs and symptoms. These can suggest a problem with your liver:
- feeling or being sick (unexplained nausea or vomiting), abnormally dark urine, yellow skin or eyes, pain in the upper right belly.
Constipation
XERMELO reduces the number of bowel movements you are having. In some cases however, it can reduce the number of bowel movements too much causing constipation. Sometimes, the constipation can be severe. If you notice you are not having very many bowel movements or you think you might be constipated talk to your healthcare professional.
Depression
Some patients taking XERMELO have had symptoms of depression, depressed mood and loss of interest.
Birth Control
Women should use effective methods of birth control while taking XERMELO. Talk to your healthcare professional about the birth control options that are right for you.
Children and Adolescents
XERMELO is not recommended in patients below 18 years old.
Driving and Using Machines
XERMELO may affect your ability to drive or use any tools or machines. If you feel tired, you should wait until you feel better before driving or using any tools or machines.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with XERMELO:
- medicines for diarrhea. XERMELO and these medicines both reduce the number of bowel movements you have and taken together, they can cause severe constipation.
- medicines used to treat epilepsy, such as valproic acid
- medicines used to treat your neuroendocrine tumour, such as sunitinib or everolimus
- medicines to treat depression, such as bupropion or sertraline
- medicines used to avoid transplant rejection, such as cyclosporine
- medicines used to lower cholesterol levels, such as simvastatin
- oral birth control that contains estrogen
- medicines used to treat high blood pressure, such as amlodipine
- midazolam, used before surgery to make you sleepy and less anxious
- medicines used to treat some types of cancers, such as irinotecan, capecitabine and flutamide
- medicines used to reduce the chance of a blood clot forming, such as prasugrel
- octreotide, which is used in the treatment of cancerous tumours called carcinoid tumours.
How to take XERMELO:
- Always take XERMELO exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Your healthcare professional will decide how long you should take XERMELO. Do not stop taking XERMELO without talking to your healthcare professional.
Always take XERMELO with a meal or some food.
You should keep having injections of somatostatin analogues (lanreotide or octreotide)
when taking XERMELO.
- If you are being treated with short-acting octreotide subcutaneous injection, it must be given 30 minutes after XERMELO.
Usual dose:
The recommended adult dose is one tablet (250 mg) three times a day. If you have liver problems, your healthcare professional may decide to reduce your daily dose of XERMELO.
Overdose:
If you take too much XERMELO you may feel sick, vomit, have diarrhea or a stomach ache. If this happens, talk to a healthcare professional. Take the medicine pack with you.
If you think you, or a person you are caring for, have taken too much XERMELO, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to take a dose, skip that dose and take your next dose when it is due. Do not take a double dose to make up for a forgotten dose.
What are possible side effects from using XERMELO?
These are not all the possible side effects you may feel when taking XERMELO. If you experience any side effects not listed here, contact your healthcare professional.
- Stomach (abdominal) pain
- Dizziness
- Feeling tired or weak (fatigue)
- Gas
- Fever
- Headache
- Swollen stomach
- Decreased appetite
- Nausea
- Dry skin
- Rash
- Flushing
- Urinary tract infection
XERMELO can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
UNKNOWN Liver Problems: yellow skin or eyes, abnormally dark urine, pain in upper right belly, nausea, vomiting, loss of appetite | X | ||
COMMON Constipation: passing a small number of stools in a week or no stool at all, hard, lumpy stool, straining to have a bowel movement | X | ||
| Peripheral Edema: swelling of the legs, ankles or feet | X | ||
| Depression: feeling sad, depressed mood, loss of interest in daily activities | X | ||
VERY RARE Intestinal obstruction (blockage that stops or impairs food and liquid from passing through your intestines): | X | ||
cramping pain in abdomen that may begin suddenly, bloating, loss of appetite, pain that comes and goes but will then last, nausea and vomiting, constipation or diarrhea |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Last Revised: JAN 10, 2023
Storage:
Store at room temperature (15°C and 30°C).
Keep out of reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.
If you want more information about XERMELO:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website at
| https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- | |
| products/drug-product-database.html | |
or by calling the importer Methapharm Inc. at 1-800-287-7686.