Encorafenib capsules

What is this medication?

ENCORAFENIB (en koe raf e nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat melanoma and colorectal cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): BRAFTOVI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorders
• eye disease, vision problems
• heart disease
• history of irregular heartbeat
• kidney disease
• liver disease
• low levels of potassium, calcium, or magnesium in the blood
• an unusual or allergic reaction to encorafenib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

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 pediatrician regarding the use of this medicine 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, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• Cisapride
• Dronedarone
• Fluconazole
• Pimozide
• Thioridazine
• Voriconazole

This medicine may also interact with the following medications:

• Certain medicines for fungal infections like itraconazole, ketoconazole, or posaconazole
• Diltiazem
• Dofetilide
• Female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
• Grapefruit juice
• Other medicines that prolong the QT interval
• Rosuvastatin
• Ziprasidone

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 doctor or health care professional for regular checks on your progress. You may need blood work done while you are taking this medicine.

Tell your doctor or health care professional right away if you have any change in your eyesight.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancer if you take this medicine.

Do not become pregnant while taking this medicine or for 2 weeks after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after stopping it.

This medicine may interfere with your ability to father a child. You should talk to your doctor or healthcare professional 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 or hives, swelling of the face, lips, or tongue
• Changes in vision
• Coughing up blood
• Headache
• Pain, tingling, numbness in the hands or feet
• Bleeding—bloody or black, tarry stools, red or dark-brown urine, spitting up blood or brown material that looks like coffee grounds, red spots on the skin, unusual bruising or bleeding from the eyes, gums, or nose
• Heartbeat rhythm changes—trouble breathing, chest pain, dizziness, fast or irregular heartbeat, feeling faint or lightheaded, falls
• High blood sugar—increased hunger, thirst, or urination, unusually weak or tired, blurry vision

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

• Constipation
• Hair loss
• Joint pain
• 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). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

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 health care provider. 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.