dabrafenib

Pronunciation: da bRAF e nib

Brand: Tafinlar

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 a cancer medication that interferes with the growth and spread of cancer cells in the body.

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 medicines 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?

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.

Do not use dabrafenib if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant during treatment. Use effective birth control to prevent pregnancy while you are using this medicine.

  • If you use dabrafenib alone: Keep using birth control for at least 2 weeks after your last dose.
  • 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 birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

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

You should not breast-feed 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).

How should I take dabrafenib?

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

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

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

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 darbafenib.

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.

Store at room temperature away from moisture and heat.

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?

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

What should I avoid while taking dabrafenib?

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of dabrafenib?

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:

  • fever, chills, feeling light-headed or short of breath;
  • pale or yellowed skin, dark colored urine;
  • 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.

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;
  • nausea, vomiting, diarrhea, loss of appetite;
  • cough, trouble breathing; or
  • temporary 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?

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.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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