Telotristat ethyl is used in adults to treat carcinoid syndrome diarrhea, in combination with another medicine such as octreotide (Sandostatin).

Telotristat ethyl may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Telotristat ethyl is usually taken 3 times per day with food.

Telotristat ethyl comes in a monthly case that contains 4 weekly boxes; 1 box of 7 daily doses for use each week. Keep each tablet in the package until you are ready to take a dose.

Octreotide is usually given at least 30 minutes after taking telotristat ethyl.

Telotristat ethyl is only part of a complete treatment program that may also include other medications. Do not change your doses or medication schedule without your doctor's advice.

Store at room temperature away from moisture and heat.

Do not share telotristat ethyl with another person, even if they have the same symptoms you have.

Usual Adult Dose for Carcinoid Tumor:

250 mg orally 3 times a day

Comments:
-Patients should take this drug with food.
-If needed, short-acting octreotide should be given at least 30 minutes after administration of this drug.

Use: Treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in patients whose diarrhea is inadequately controlled by SSA therapy

Usual Adult Dose for Carcinoid Syndrome:

250 mg orally 3 times a day

Comments:
-Patients should take this drug with food.
-If needed, short-acting octreotide should be given at least 30 minutes after administration of this drug.

Use: Treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in patients whose diarrhea is inadequately controlled by SSA therapy

Tell your doctor if you have ever had liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Not approved for use by anyone younger than 18 years old.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Telotristat ethyl may cause serious side effects. Stop using telotristat ethyl and call your doctor at once if you have:

• severe constipation; or

• severe or worsening stomach pain.

Common side effects of telotristat ethyl may include:

• nausea, loss of appetite, gas;

• headache, depressed mood;

• swelling in your hands or feet;

• fever; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect telotristat ethyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.