Pexidartinib Capsules

What is this medication?

PEXIDARTINIB (PEX i DAR ti nib) treats noncancerous tumors that occur in joints. It works by blocking a protein that causes tumor cells to grow and multiply.

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 medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. Take with a low-fat meal. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Do not take this medication with grapefruit juice.

Take this medication 2 hours BEFORE or 2 hours AFTER antacids. Take this medication 2 hours BEFORE or 10 hours AFTER H2 receptor blocker medications.

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 care team about the use of this medication 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 medication with any of the following:

• Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
• Lonafarnib
• Mavacamten
• Ranolazine

This medication may also interact with the following:

• Certain medications for stomach problems, such as lansoprazole, omeprazole, pantoprazole
• Estrogen or progestin hormones
• Grapefruit juice
• Other medications that cause liver problems
• St. John's Wort

Take this medication 2 hours before or 2 hours after antacids to avoid decreasing its absorption.

Take this medication 2 hours before or 10 hours after H2 receptor blockers to avoid decreasing its absorption.

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?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

May need blood work while you are taking this medication.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 month after the last dose. You will need a negative pregnancy test before starting this medication. Estrogen and progestin hormones may not work as well while you are taking this medication. Contraception is recommended while taking this medication and for 1 month after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for at least 1 week after the last dose.

If your partner can get pregnant, use a condom during sex while taking this medication and for 1 week after the last dose. Tell your care team right away if you think your partner might be pregnant. This medication can cause serious birth defects.

This medication may cause infertility. Talk to your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

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

• Change in hair color
• Change in taste
• Fatigue
• Loss of appetite
• Swelling around the eyes
• Swelling of the ankles, hands, or feet
• Vomiting

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 and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.