Pexidartinib

Pexidartinib may cause serious or life threatening liver damage. Tell your doctor if you have or ever have had liver disease. Tell your doctor and pharmacist about the medications you are taking so they can check whether any of your medications may increase the risk that you will develop liver damage during your treatment with pexidartinib. If you experience any of the following symptoms, call your doctor immediately: extreme tiredness, loss of appetite, weight loss, nausea, vomiting, unusual bleeding or bruising, rash, itching, fever, yellowing of the skin or eyes, dark yellow or brown-colored urine, pale stools, or pain in the upper right part of the stomach. Your doctor may have to decrease your dose of pexidartinib or permanently or temporarily stop your treatment.

A program called Turalio Risk Evaluation and Mitigation Strategy (REMS) has been set up to manage the risks of this medication. You will only be able to receive pexidartinib if you and the doctor who prescribes your medication is enrolled are the program. You can only receive the medication from a pharmacy that participates in the program. Ask your doctor if you have any questions about participating in the program or how to get your medication.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to be sure that it is safe for you to take pexidartinib and to check your body’s response to the medication.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with pexidartinib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of taking pexidartinib.

🔔 Why is this medication prescribed?

Pexidartinib is used to treat tenosynovial giant cell tumors (TGCT; tumors in or around a joint that can cause pain, swelling, and reduce movement) in adults that cannot be treated by surgery. Pexidartinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that may help the tumor to shrink.

Patients, too, are unhappy with the care they receive during those brief interactions with their doctors. Healthcare communications company West Corporation reported that 25% of patients don’t feel that their provider cares about them as an individual and nearly 20% aren’t convinced their doctor is focused on improving their health – even though 93% of doctors strongly agree that patient satisfaction is important.

🔔 How should this medicine be used?

Pexidartinib comes as a capsule to take by mouth. It is usually taken two times a day with a low-fat meal or snack (about 400 calories, 11–14 grams fat). Ask your doctor for examples of foods that contain 11–14 grams of fat that you can eat when you take pexidartinib. Taking pexidartinib with a high-fat meal (about 800–1000 calories, 55–65 grams fat) may cause side effects. Do not take pexidartinib without food. Take pexidartinib at around the same time(s) 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 pexidartinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, chew, or crush them.

If you vomit after taking pexidartinib, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose of pexidartinib or permanently or temporarily stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with pexidartinib.

🔔 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 pexidartinib,

• tell your doctor and pharmacist if you are allergic to pexidartinib, any other medications, or any of the ingredients in pexidartinib capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids containing magnesium or aluminum (Maalox, Mylanta, Tums, others), take the antacid 2 hours before or at least 2 hours after you take pexidartinib.
• if you are taking a medication for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid, in Duexis), nizatidine (Axid), or ranitidine (Zantac), take it at least 10 hours before or at least 2 hours after you take pexidartinib.
• The following nonprescription or herbal products may interact with pexidartinib: esomeprazole (Nexium 24HR), lansoprazole (Prevacid 24HR), omeprazole (Prilosec OTC, Zegerid OTC), and St. John’s wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking pexidartinib. Do not start any of these medications while taking pexidartinib without discussing you’re your healthcare provider.
• tell your doctor if you have or have ever had high cholesterol, high blood pressure, or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. If you are female, you will need to take a pregnancy test before you start treatment and use non-hormonal birth control to prevent pregnancy during your treatment and for 1 month after your final dose. Pexidartinib may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). If you are a male, you and your partner should use birth control during your treatment with pexidartinib and for 1 week after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. Pexidartinib may decrease fertility in men and women. However, you should not assume that you or your partner cannot become pregnant. If you or your partner become pregnant while taking pexidartinib, call your doctor immediately. Pexidartinib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking pexidartinib and for 1 week after your final dose.

🔔 What special dietary instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.