Telotristat

Brand Name(s): Xermelo®

WHY is this medicine prescribed?

Telotristat is used in combination with another medication (a somatostatin analog [SSA] such as lanreotide, octreotide, pasinreotide) to control diarrhea caused by carcinoid tumors (slow-growing tumors that release natural substances that can cause symptoms like diarrhea) in patients with diarrhea not controlled by a somatostatin analog alone. Telotristat is in a class of medications called antidiarrheal agents. It works by blocking the formation of a certain natural substance in the body that is released by the carcinoid tumors and causes diarrhea.

HOW should this medicine be used?

Telotristat comes as a tablet to take by mouth. It is usually taken with food three times a day. Take telotristat at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take telotristat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking telotristat,

• tell your doctor and pharmacist if you are allergic to telotristat, any other medications, or any of the ingredients in telotristat tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking telotristat. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• If you are using short-acting octreotide (Sandostatin), use it at least 30 minutes after taking telotristat.
• tell your doctor if you have or have ever had liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking telotristat, call your doctor. If you are breastfeeding while taking telotristat, call your doctor if you child becomes constipated.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking telotristat.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a later dose or a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Telotristat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• headache
• depression
• swelling of your hands, feet, or legs
• gas
• decreased appetite
• fever

• constipation
• abdominal pain
• rash or itching
• swelling around the lips or eyes, difficulty breathing

Telotristat may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

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