dabrafenib

What is the most important information I should know about dabrafenib?

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.

What is dabrafenib?

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. This medicine 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.

What should I discuss with my healthcare provider before taking dabrafenib?

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.

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.

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.

How should I take dabrafenib?

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.

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

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking dabrafenib?

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

What are the possible side effects of dabrafenib?

• 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 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.

What other drugs will affect dabrafenib?

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.

Where can I get more information?

Your pharmacist can provide more information about dabrafenib.