Pexidartinib capsules

What is this medication?

PEXIDARTINIB (pex i dar ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat tenosynovial giant cell tumor.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Turalio

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• kidney disease
• liver disease
• an unusual or allergic reaction to pexidartinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Swallow capsules whole. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Do not take with grapefruit juice. Avoid taking antacids within 2 hours of taking this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
• Ranolazine

This medicine may also interact with the following medications:

• certain medicines for stomach problems like cimetidine, famotidine, lansoprazole, esomeprazole, omeprazole, or pantoprazole
• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
• grapefruit juice
• itraconazole
• other medicines that cause liver problems
• probenecid
• rifampicin
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for 1 month after stopping it. Women should inform their healthcare professional if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 1 week after stopping it. There is potential for serious side effects to an unborn child. Talk to your healthcare professional for more information.

Do not breast-feed an infant while taking this medicine or for at least 1 week after stopping it.

This medicine may make it more difficult to get pregnant or father a child. Talk with your doctor or healthcare professional if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• fever
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• vomiting

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• changes in taste
• constipation
• pain, tingling, numbness in hands or feet
• swelling of arms or legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F).

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.