Encorafenib Oral Capsule (ENCORAFENIB - ORAL)

Instructions

This medicine may be taken with or without food.

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.

Store in original bottle, tightly closed and upright.

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

Avoid grapefruit and grapefruit juice while on this medicine.

If you forget to take a dose on time, take it as soon as you remember. If it is less than 12 hours to the next dose, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine 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.

Tell your doctor if symptoms do not get better or if they get worse.

Keep using this medicine for the full number of days that it is prescribed. Do not stop the medicine even if you start to feel better.

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.

Do not take the medicine more than once during 24 hours.

Cautions

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

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

There is an increased risk of bleeding while on this medicine, please tell your doctor or nurse if you notice any excessive bleeding or bruising.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting, especially after exercising or in hot weather. Be very careful when standing or sitting up quickly.

If possible, avoid using with marijuana or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

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.

Avoid becoming overheated during exercise or other activities. Try to stay cool in hot weather.

Do not breastfeed while on this medicine. You may safely start breastfeeding 2 weeks 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 must use reliable forms of birth control while taking this medicine and for 2 weeks after stopping to prevent pregnancy.

Do not take St. John's wort while on this medicine.

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.

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.

• diarrhea
• dizziness
• dry skin
• lack of energy and tiredness
• hair loss
• headaches
• pain in the joints
• nausea and vomiting
• stomach upset or abdominal pain

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

• bleeding or bruising
• coughing up blood or vomit that looks like coffee grounds
• swelling of the legs, feet, and hands
• fainting
• fast or irregular heart beats
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• menstruation changes (missed or fewer periods)
• shortness of breath
• skin changes - a darker area with uneven edges or coloring
• change in the size or color of a skin mole
• bloody or dark, tarry stools
• vaginal bleeding or spotting between periods
• blurring or changes of vision
• seeing halos or colors around lights
• sudden or unexplained change in weight

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.