When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to dabrafenib or if you are pregnant.

How to Use This Medicine:
Capsule

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine at least 1 hour before or 2 hours after a meal. Allow about 12 hours between each dose.
• Swallow the capsule whole. Do not open, crush, or break it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If it is more than 6 hours until the time you normally take a dose, take it as soon as you remember. If it is less than 6 hours until your regular time, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how dabrafenib works. Tell your doctor if you are also using St John's wort, carbamazepine, clarithromycin, dexamethasone, gemfibrozil, ketoconazole, midazolam, nefazodone, phenobarbital, phenytoin, rifampin, a blood thinner (such as warfarin), or birth control pills.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use a second form of birth control along with your pills. Use birth control for at least 2 weeks after the last dose of this medicine.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, diabetes, or glucose-6-phosphate dehydrogenase (G6PD) deficiency. Tell your doctor if you plan to have surgery, including dental surgery.
• This medicine may cause the following problems:
  
  • Other skin cancers
  • High blood sugar
  • Eye or vision problems
  • Fever (which may be serious)
  • Lower sperm production
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Eye pain, vision changes, sensitivity to light
• Fever, especially with stiff muscles, dizziness or lightheadedness, and decrease in how much or how often you urinate
• Increased hunger or thirst
• Redness, swelling, peeling, or tenderness of the hands or feet
• Warts, skin sores, or reddish bumps that do not heal

If you notice these less serious side effects, talk with your doctor:

• Back, joint, or muscle pain
• Constipation
• Hair loss
• Headache
• Rash
• Thickened skin

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088