Dabrafenib is used alone or in combination with another medicine called trametinib (Mekinist) to treat certain types of cancer in people who have a "BRAF" gene mutation. dabrafenib is for use in treating:

• melanoma (skin cancer) that cannot be treated with surgery or has spread to other parts of the body, or to prevent melanoma from coming back after surgery;

• non-small cell lung cancer that has spread to other parts of the body; or

• advanced or metastatic thyroid cancer that has spread and for which there are no other treatment options.

Dabrafenib may also be used for purposes not listed in this medication guide.

Using dabrafenib with trametinib may increase your risk of developing a certain type of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin symptoms.

Dabrafenib comes as a capsule to take by mouth and as a tablet to suspend in water and take by mouth. It is usually taken twice a day on an empty stomach, 1 hour before or 2 hours after a meal. Take dabrafenib about 12 hours apart at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dabrafenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Do not stop taking dabrafenib without talking to your doctor.

Swallow the capsules whole; do not open, break, or crush them. Tell your doctor if you cannot swallow the capsules whole.

If you are taking the tablets for oral suspension, you will need to mix them with water before use. Do not swallow these tablets whole, and do not chew or crush them. If you are taking 1 to 4 tablet(s), place 1 teaspoonful (5 mL) of cool drinking water in a dosing cup. If you are taking 5 to 15 tablets, place 2 teaspoons (10 mL) of water in a dosing cup. Place the prescribed number of tablets into the water in the cup and stir for 3 minutes or until the mixture is completely dissolved; the mixture will appear cloudy. Drink the mixture right after mixing it or within 30 minutes. Add 1 teaspoonful (5 mL) of water to the dosing cup, stir, and drink the liquid to rinse out any particles that are still in the cup; repeat rinsing dosing with another teaspoonful of water if you are taking 5 to 15 tablets. Dispose of the mixture if it is not used after 30 minutes.

If you vomit after you take dabrafenib, do not take another dose. Continue your regular dosing schedule.

Your doctor may adjust your dose or temporarily or permanently stop your treatment depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with dabrafenib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your doctor will perform blood tests to make sure you have the correct tumor type to be treated with dabrafenib.

Take dabrafenib on an empty stomach, at least 1 hour before or 2 hours after a meal.

Dabrafenib should be taken at evenly spaced intervals, about every 12 hours.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you need surgery, dental work, or a medical procedure, tell the doctor you currently use dabrafenib.

Your doctor will need to check your skin every 2 months while you are using dabrafenib, and for up to 6 months after your treatment ends.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Use all your medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice.

Store at room temperature away from moisture and heat.

You should not use dabrafenib if you are allergic to it.

Tell your doctor if you have ever had:

• heart disease;

• bleeding problems;

• liver or kidney disease;

• diabetes (dabrafenib may raise your blood sugar);

• eye problems (especially a problem with your retina); or

• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Using dabrafenib with trametinib may increase your risk of developing a certain type of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin symptoms such as redness, warts, sores that will not heal, or a mole that has changed in size or color.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using dabrafenib should use effective birth control to prevent pregnancy. Dabrafenib can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 2 weeks after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using dabrafenib.

If you use dabrafenib and trametinib together: Keep using birth control for at least 4 months after your last dose of these two medicines.

Dabrafenib can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using dabrafenib, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because dabrafenib can harm an unborn baby.

You should not breastfeed while using this medicine and for at least 2 weeks after your last dose (or 4 months after your last dose of dabrafenib with trametinib).

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not store dabrafenib capsules or tablets in a pillbox or pill organizer. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects are more likely to occur if you take dabrafenib and trametinib together. Call your doctor at once if you have:

• little or no urination;

• fever, chills, feeling light-headed or short of breath;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;

• severe skin rash, skin pain or swelling, redness and peeling skin on your hands or feet;

• increased thirst or urination;

• signs of bleeding--weakness, dizziness, headache, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• signs of a heart problem--shortness of breath (even with mild exertion), pounding heartbeats, swelling in your feet or ankles.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of dabrafenib may include:

• headache, muscle or joint pain;

• bleeding;

• fever, chills, tiredness;

• dry skin, thickened skin, warts, rash;

• swelling in the legs, arms, and face;

• redness, swelling, peeling, or tenderness of hands or feet;

• nausea, vomiting, diarrhea, decreased appetite;

• cough, shortness of breath; or

• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect dabrafenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with dabrafenib. Your doctor will order certain lab tests before and during your treatment to check your body's response to dabrafenib. Your doctor will check your skin for any changes before, every 2 months during your treatment, and for up to 6 months after treatment.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.