250 mg film-coated tablets
telotristatethyl
What Xermelo is and what it is used for
What Xermelo is
This medicine contains the active substance telotristatethyl.
What Xermelo is used for
This medicine is used in adults with a condition called carcinoid syndrome. This occurs when a tumor, called a neuroendocrine tumor, releases the substance serotonin into the blood.
The doctor will prescribe this medicine if your diarrhea is not well controlled with injections of other medicines called somatostatin analogs (lanreotide or octreotide). You should continue injecting the other medicines while taking Xermelo.
How Xermelo works
When a tumor releases too much serotonin into the blood, you can get diarrhea.
This medicine works by reducing the amount of serotonin that the tumor produces. This reduces your diarrhea.
What you need to know before using Xermelo
Do not use Xermelo
- if you are allergic to telotristat or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Xermelo:
- if you have liver problems. This is because the medicine is not recommended for use in patients with serious liver problems. The doctor may decide to reduce your daily dose of Xermelo in cases where your liver problems are assessed as mild or moderate. The doctor will also check your liver.
- if you have end-stage kidney disease or are on dialysis, talk to your doctor. This is because this medicine has not been tested in patients with an end-stage renal disease requiring dialysis.
Be aware of side effects
Tell your doctor immediately if you experience any of the following signs or symptoms that your liver may not be working properly:
- nausea or vomiting (unexplained), abnormally dark urine, yellowish skin or yellow whites of the eyes, and pain in the upper right part of the stomach.
The doctor will take blood tests to check your liver function and decide whether you should continue to take this medicine.
Talk to your doctor or pharmacist:
- if you feel low, depressed, or if you feel that you are not interested in or do not enjoy doing your usual activities while taking this medicine because depression, low mood, and decreased interest have been reported in patients treated with telotristat.
- if you have signs of constipation, telotristat reduces the number of bowel movements.
Tests
- The doctor may take blood tests before you start taking this medicine and while you are taking it. This is to check that your liver is working normally.
Children and young people
This medicine is not recommended for patients under 18 years of age. This is because the drug has not been studied in this age group.
Other medicines and Xermelo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Xermelo can affect the way other medicines work, or other medicines can affect the way Xermelo works. This may mean that the doctor needs to change the dose you are taking. You must tell your doctor about each medicine. It includes:
- anti-diarrhea medicine. Xermelo and these medicines reduce the number of bowel movements and, if taken at the same time, can cause severe constipation. The doctor may need to change the dose of one of your medicines.
- medicines used to treat epilepsy, such as valproic acid.
- medicines used to treat your neuroendocrine tumors, such as sunitinib or everolimus.
- medicines used to treat depression, such as bupropion or sertraline.
- medicines used to avoid transplant rejection, such as cyclosporin.
- medicines used to reduce cholesterol levels, such as simvastatin.
- oral contraceptives such as ethinylestradiol.
- medicines used to treat high blood pressure such as amlodipine.
- medicines used to treat certain types of cancer, such as irinotecan, capecitabine, and flutamide.
- medicines used to reduce the risk of a blood clot forming, such as prasugrel
- octreotide. If you need treatment with an octreotide subcutaneous injection (injected under the skin), you should take the injection at least 30 minutes after taking Xermelo.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not take this medicine if you are pregnant or planning to become pregnant. It is not known how telotristat may affect the baby.
Women should use effective contraception while taking this medicine.
Do not breastfeed if you are taking Xermelo, as this medicine can be passed to the baby and may harm the baby.
Driving ability and use of machinery
Xermelo may have a small effect on your ability to drive or use tools or machines. If you feel tired, wait until you feel better before driving or using tools or machines.
Xermelo contains lactose
Xermelo contains lactose (a type of sugar). If you have an intolerance to some sugars, you should consult your doctor before taking this medicine
Xermelo contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is almost ‘sodium-free’.
How to take Xermelo
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
How much to take
The recommended dose is one tablet (250 mg) three times daily. The maximum amount of Xermelo is 750 mg in 24 hours.
The doctor will decide how long you should take Xermelo.
If you have liver problems, your doctor may decide to reduce your daily dose of Xermelo.
Taking this medicine
- Always take this medicine with a meal or with some food.
- You should continue to inject yourself with somatostatin analogs (lanreotide or octreotide) while taking Xermelo.
If you have taken too much Xermelo
You may feel sick or vomit, or have diarrhea or stomach pain. Talk to a doctor. Bring the medicine package with you.
If you forget to take Xermelo
If you forget to take a dose, take the next dose as planned and skip the missed dose.
Do not take a double dose to make up for a missed dose.
If you stop taking Xermelo
Do not stop taking Xermelo without first talking to your doctor.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following side effects:
- nausea or vomiting, abnormally dark urine, yellowish skin or yellow whites of the eyes, and pain in the upper right part of the stomach. These may be signs that your liver is not working correctly. This can also be shown by changes in your blood tests, such as an increase in liver enzymes: gamma-glutamyltransferase (very common, may affect more than 1 in 10 people), transaminases, and alkaline phosphatases in the blood (common, may affect up to 1 in 10 users).
Other side effects ar
Tell your doctor, pharmacist, or nurse if you experience any of the following side effects:
Very common side effects ( may affect more than 1 in 10 users):
- Stomach pain
- Feeling tired or weak
- Feeling sick (nausea)
Common side effects ( may affect up to 1 in 10 users):
- Gases
- Fever
- Headache
- Constipation
- Swollen stomach
- Decreased appetite
- Swelling (accumulation of fluid in the body)
- In depression, you may experience decreased self-confidence, lack of motivation, sadness, or low mood
Uncommon side effects (may affect up to 1 in 100 users) :
- Affected stool (intestinal obstruction, fecaloma). You may experience constipation, watery diarrhea, pale skin ( anemia ), nausea, vomiting, weight loss, back pain or stomach discomfort, especially after eating, or a decrease in urine (urination).
Talk to your doctor immediately if you experience any of the following side effects:
- Difficulty breathing, fast heartbeat, fever, incontinence (uncontrolled urination), confusion, dizziness, or restlessness.
Talk to your doctor, pharmacist, or nurse if you experience any of the side effects described above.
How to store Xermelo
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after EXP.
The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
This medicine does not require any special storage conditions.
Contents of the packaging and other information
Contents declaration
- The active substance is telotristatethyl. 1 film-coated tablet contains telotristate tip equivalent to 250 mg telotristatethyl.
- Other ingredients are Tablet core: lactose (see section 2 under ” Xermelo contains lactose”), hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, and colloidal anhydrous silica, Film coating: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521) and talc (E553b).
Appearance and package sizes of the medicine
Xermelo is white to off-white film-coated oval tablets. Each tablet is approx. 17mm long and 7.5mm wide with “TE” embossed on one side and “250” embossed on the other. The tablets are packed in PVC/PCTFE/PVC/Al blisters. The blisters are packed in an outer carton.
Packs of 90 and 180 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
SERB SAS
40 Avenue George V
75008 Paris
France
Manufacturer
Tjoapack Netherlands BV
Nieuwe Donk 9
4879AC Etten-Leur
Netherlands