Dabrafenib Oral capsule

What is this medicine?

DABRAFENIB (da braf e nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat melanoma, a type of skin cancer.

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

What should I tell my health care provider before I take this medicine?

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

• diabetes

• G6PD deficiency

• 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 medicine?

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.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've 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 medicine?

This medicine may interact with the following medications:

• carbamazepine

• certain medications for stomach problems like cimetidine, famotidine, ranitidine, esomeprazole, dexlansoprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole

• clarithromycin

• dexamethasone

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• gemfibrozil

• grapefruit juice

• ketoconazole

• nefazodone

• phenobarbital

• phenytoin

• rifampin

• St. John’s Wort

• 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 medicine?

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 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 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 medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• dizziness

• eye pain

• fever

• increased thirst

• increased urination

• redness, swelling, or sores on hands or feet

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

• headache

• joint pain

• hair loss

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 medicine?

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.