Pexidartinib (pex-i-DAR-ti-nib)

Treats giant cell tumor of the tendon sheath.

Brand Name(s):

Turalio

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Do not crush, chew, or open it.
• Take this medicine at least 1 hour before or 2 hours after eating a meal or snack.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you vomit after taking your medicine, or if you miss a dose, take your next dose at your regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with esomeprazole, omeprazole, St John's wort, or birth control pills.
• Some medicines can affect how this medicine works. Tell your doctor if you are using digoxin, efavirenz, fluconazole, itraconazole, midazolam, probenecid, rifampicin, or tolbutamide.
• If you are taking antacids, take them at least 2 hours before or 2 hours after using pexidartinib. If you are also taking an H2 blocker (including cimetidine), it is best to take it at least 10 hours before or 2 hours after using pexidartinib.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (including condoms or spermicide) along with your pills during treatment and for at least 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose.
• Do not breastfeed during treatment and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease or liver disease.
• This medicine may cause liver problems.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine, pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste
• Constipation
• Hair color changes
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088