Xermelo

Oral Administration

Take with food

When used in combination with short-acting octreotide, administer short-acting octreotide at least 30 minutes after telotristat ethyl

Discontinue if severe constipation develops

Missed dose

• If a dose is missed, take the next dose at the regular time
• Do not take 2 doses at the same time to make up for a missed dose

Storage

Store at controlled room temperature (25°C [77°F])

Excursions permitted to 15-30°C (59-86°F)

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

Stop using telotristat ethyl and call your doctor at once if you have:

• severe constipation; or
• severe or worsening stomach pain.

Common side effects may include:

• nausea, loss of appetite;
• bloating, 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.

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

Tell your doctor about all your current medicines and any you start or stop using, including prescription and over-the-counter medicines, vitamins, and herbal products. Telotristat ethyl can make other medications less effective. Your doctor may need to adjust your doses of certain other medicines.

Do not change your doses or medication schedule without your doctor's advice.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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

Patient Counseling Information

If patients experience severe constipation or severe persistent or worsening abdominal pain, advise them to discontinue telotristat etiprate and contact their healthcare provider. 1

Advise patients to take telotristat etiprate with food. 1

When short-acting octreotide is used in combination with telotristat etiprate, administer short-acting octreotide at least 30 minutes after administering telotristat etiprate. 1

If a dose is missed, take the next dose at the regular time. Do not take 2 doses at the same time to make up for a missed dose. 1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• It is used to treat carcinoid syndrome diarrhea.

• If you have an allergy to Xermelo (telotristat ethyl) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Xermelo with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Advise patients:

• If they experience severe constipation or severe persistent or worsening abdominal pain, to discontinue Xermelo and contact their healthcare provider [see Warnings and Precautions (5.1)].
• To take Xermelo with food [see Clinical Pharmacology (12.3), Clinical Studies (14)].
• When short-acting octreotide is used in combination with Xermelo, administer short-acting octreotide at least 30 minutes after administering Xermelo [see Clinical Pharmacology (12.3), Clinical Studies (14)].
• If a dose is missed, take the next dose at the regular time. Do not take 2 doses at the same time to make up for a missed dose.

Distributed by:
Lexicon Pharmaceuticals, Inc.
8800 Technology Forest Place
The Woodlands, TX 77381

Principal Display Panel - ShellPak Label

NDC 70183-125-03

Rx Only

To Open:

1. Press and hold button below

2. Pull out blister from the right

Xermelo™

(telotristat ethyl) tablets

250 mg
per tablet

This daily dose pack contains
3 TABLETS

For oral use only. As with all medications,
keep out of reach of children.

Principal Display Panel - 28 Day Case Label

NDC 70183-125-84            28 DAY CASE

Rx Only                              84 Tablets

Xermelo™
(telotristat ethyl) tablets

250 mg
per tablet

Lexicon®
pharmaceuticals

For oral use only.

As with all medications, keep out of reach of children.

Applies to telotristat: oral tablet

Along with its needed effects, telotristat (the active ingredient contained in Xermelo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking telotristat:

• Severe constipation
• severe stomach pain

Some side effects of telotristat may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• decreased appetite
• discouragement
• excess air or gas in the stomach or intestines
• feeling sad or empty
• fever
• full feeling
• headache
• irritability
• lack of appetite
• loss of interest or pleasure
• nausea
• passing gas
• rapid weight gain
• tingling of the hands or feet
• tiredness
• trouble concentrating
• trouble sleeping
• unusual weight gain or loss