Dabrafenib oral capsules

What is this medication?

DABRAFENIB (da BRAF e nib) treats melanoma. It may be used to treat non-small cell lung cancer. It is also used to treat thyroid cancer and solid tumors with a specific genetic marker. It works by slowing down the growth of cancer cells.

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

COMMON BRAND NAME(S): Tafinlar

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

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

• diabetes
• eye disease, vision problems
• G6PD deficiency
• having surgery
• history of bleeding problems
• kidney disease
• liver disease
• an unusual or allergic reaction to dabrafenib, 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. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Do not take with grapefruit juice. Do not cut, crush, or chew this medicine. Avoid taking H2 blockers or antacids within 2 hours of taking this medicine. 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 6 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?

• clarithromycin
• dexamethasone
• estrogens or progestins
• gemfibrozil
• grapefruit juice
• ketoconazole
• midazolam
• nefazodone
• warfarin

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.

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

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

Do not become pregnant while taking this medicine or for at least 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.

Males who get this medicine must use a condom during sex with females who can get pregnant. If you get a women pregnant, the baby could have birth defects. The baby could die before they are born. You will need to continue wearing a condom for at least 2 weeks after stopping the medicine. Tell your healthcare provider right away if your partner becomes pregnant while you are taking this medicine.

This medicine may interfere with the ability to have a child. You should talk with your doctor or health care 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 doctor or health care professional as soon as possible:

• allergic reactions like itching or hives, swelling of the face, lips, or tongue
• changes in vision
• dizziness
• eye pain
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• severe headaches
• signs and symptoms of bleeding such as 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
• signs and symptoms of heart failure like breathing problems; fast, irregular heartbeat; sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired
• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision
• yellowing of the skin

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

• diarrhea
• hair loss
• joint pain
• muscle 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?

Store between 20 and 25 degrees C (68 and 77 degrees F). Your healthcare provider or pharmacist should throw away any unused medicine after the expiration date.

Keep out of the reach of children.

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.