pexidartinib

What is the most important information I should know about pexidartinib?

Pexidartinib can harm your liver. You will need frequent blood tests to check your liver function before and during treatment with this medicine.

Tell your doctor if you have other symptoms of liver problems, such as loss of appetite, stomach pain (upper right side), nausea, vomiting, tiredness, itching, or fever.

What is pexidartinib?

Pexidartinib is used in adults to treat giant cell tumor of the tendon sheath (also called tenosynovial giant cell tumor, or pigmented villonodular synovitis) not likely to improve with surgery.

Pexidartinib is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Pexidartinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking pexidartinib?

Tell your doctor if you have or have ever had:

• liver or kidney disease.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 1 month after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How should I take pexidartinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Pexidartinib 125 mg capsules are usually taken twice per day with a low-fat meal (about 11 to 14 grams of fat).

If you vomit shortly after taking pexidartinib, do not take another dose. Take your next dose as scheduled.

You will need blood tests to check your liver function before and during treatment with this medicine.

Your next dose may be delayed based on the results of your liver function tests.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking pexidartinib?

Grapefruit may interact with pexidartinib and cause side effects. Avoid consuming grapefruit products.

What are the possible side effects of pexidartinib?

Tell your doctor if you have other symptoms of liver problems, such as:

• right-sided upper stomach pain;
• loss of appetite, nausea, vomiting;
• rash;
• fever, tiredness; or
• itching.

Your pexidartinib doses may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• abnormal lab results;
• tiredness;
• puffy eyes;
• changes in the color of your hair;
• rash, itching, hives, skin redness, acne; or
• decreased or altered sense of taste.

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.

What other drugs will affect pexidartinib?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Pexidartinib can harm your liver, especially if you also use certain medicines for infections, tuberculosis, depression, birth control, hormone replacement, high cholesterol, heart problems, high blood pressure, seizures, pain, or arthritis (including Tylenol, Advil, Motrin, or Aleve).

Some medicines should be taken separately from your dose of pexidartinib:

• If you take an antacid, take your pexidartinib dose 2 hours before or 2 hours after you take the antacid.
• If you take medicine for heartburn or stomach acid (such as ranitidine, cimetidine, famotidine, Pepcid, Tagamet, or Zantac), take your pexidartinib dose 2 hours before or 10 hours after you take the antacid.

You may not be able to take a proton pump inhibitor stomach acid reducer such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

This list is not complete and many other drugs may affect pexidartinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about pexidartinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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