Dabrafenib

Dabrafenib is used alone or together with trametinib to treat certain types of cancer affecting the skin, lung, or thyroid.

Dabrafenib is for adults and children who are at least 1 year old to treat solid tumors or a type of brain tumor known as low grade glioma.

Dabrafenib is also used when the cancer has worsened, spread to other parts of the body (metastatic), when surgery is not possible, or to prevent the cancer from coming back after surgery.

Your doctor will confirm that you have the correct type of tumor to be treated with dabrafenib.

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

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

Doses for children and teenagers are based on weight. Your child's dose may change if they gain or lose weight.

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

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

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

If you vomit shortly after taking dabrafenib, do not take another dose. Take your next dose as scheduled.

Read and carefully follow any Instructions for Use provided to you on how to prepare a mixture using dabrafenib tablets for oral suspension.

Do not swallow, crush, or chew a tablet for oral suspension.

The mixture made from the tablets for oral suspension can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Tell your doctor if you have a planned surgery, dental, or medical procedure.

You will need frequent medical tests while using dabrafenib. Your dose or medication schedule may be changed based on the results. Keep all follow-up visits with your healthcare provider.

Your doctor should check your skin before starting, during treatment, and up to 6 months after treatment with dabrafenib. You should also check your skin regularly. Tell your doctor if you notice any new skin changes such as redness, sores that will not heal, or a new wart or mole that has changed in size or color.

Do not change your dose or dosing schedule without your doctor's advice.

Keep the medicine in the original container, along with the canister of moisture-absorbing preservative. Store at room temperature away from moisture and heat.

Using dabrafenib alone or with trametinib may raise your chance of getting other types of cancer. Inform your doctor if you see any new skin symptoms.

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

Tell your doctor if you have or have ever had:

• heart disease;
• bleeding problems;
• diabetes;
• planned surgery, dental, or medical procedure;
• eye problems (especially a problem with your retina or uveitis);
• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency; or
• liver or kidney disease.

Using dabrafenib alone or together with trametinib may increase your risk of developing other types of cancer. Ask your doctor about this risk.

Dabrafenib can harm an unborn baby if the mother or the father is using dabrafenib.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 2 weeks after your last dose.
• If you are a man, use condoms if your sex partner is able to get pregnant. Keep using birth control, even if you had a vasectomy for at least 2 weeks after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Dabrafenib can make hormonal birth control less effective, such as birth control pills, injections, implants, skin patches, and vaginal rings. Ask your doctor about other barrier birth control options such as condom, diaphragm, cervical cap, or contraceptive sponge.

Dabrafenib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Using dabrafenib with trametinib may increase the likelihood of certain side effects, including serious skin reactions. Seek medical treatment if you experience a serious drug reaction that can affect multiple parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Dabrafenib can cause serious side effects. Call your doctor immediately if you have:

• unusual bruising or bleeding, new signs of infection (fever, weakness, cough, diarrhea, problems urinating);
• worsening acne or skin rash, flu-like symptoms, mouth sores;
• high blood sugar—more thirst, more urination, dry mouth, fruity breath odor;
• hemolytic anemia—pale or yellowed skin, dark urine, fever, confusion or weakness;
• signs of eye problems—eye pain or swelling, severe eye redness, small white or yellow patches on your eye, changes in vision, seeing halos around lights, seeing color "dots" in your vision;
• signs of bleeding inside the body—weakness, dizziness, headache, red or pink urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• signs of a heart problem—feeling light-headed, shortness of breath (even with mild activity), fast heartbeats, swelling in your feet or ankles.

Your cancer treatments may be changed, delayed, or stopped permanently if you experience certain side effects.

Common side effects of dabrafenib may include:

• muscle, bone, or joint pain;
• stomach pain;
• headache, fever, chills, tiredness;
• bleeding;
• acne, skin infection around nails, 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, constipation, loss of 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.

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.

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

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Other drugs may affect dabrafenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.