Pexidartinib Oral Capsule (PEXIDARTINIB - ORAL)

Instructions

Swallow the medicine without crushing or chewing it.

Keep the medicine in its original container.

Take on empty stomach - 1 hour before or 2 hours after eating.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Keep the desiccant (drying) packet in the bottle and keep the bottle closed tightly.

Avoid grapefruit and grapefruit juice while on this medicine.

Do not take antacids 2 hours before or 2 hours after taking this medicine.

Medicines that lower stomach acid (used to treat indigestion, heartburn or ulcers) may prevent this medicine from working properly.

If you are taking medicines used to reduce stomach acid (H2 receptor blockers), take them at least 10 hours before or 2 hours after this medicine.

If you vomit after taking a dose, do not take an extra dose. Take your next dose at the usual time.

This medicine can make you sensitive to the sun. Use sunscreen or protective clothing when in sun.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

This medicine may decrease the effectiveness of some birth controls which use hormones (such as birth control pills and patches). Use an extra form of birth control, such as condoms, while on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 1 week after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 1 month after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 1 week after stopping to prevent pregnancy.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• blurry vision
• constipation
• feeling cold or numb, especially in arms and legs
• changes in hair color
• nausea and vomiting
• stomach upset or abdominal pain
• changes in taste or unpleasant taste
• loss of taste

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• cough that does not go away
• swelling of the legs, feet, and hands
• swelling around the eyes or eyelids
• fever or chills
• numbness or tingling in hands and feet
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• red, burning, or itchy skin
• shortness of breath
• sore throat
• vaginal bleeding or spotting between periods
• blurring or changes of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.