Dabrafenib

Dabrafenib is a prescription medication used to treat a certain type of melanoma (a type of skin cancer). This medication is also used to treat those with a type of lung cancer, a type of skin cancer, and a type of thyroid cancer when given with another medication called trametinib. 

Dabrafenib belongs to a group of drugs called kinase inhibitors. These work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Dabrafenib comes as a capsule to 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.

Common side effects include thickening of the skin, headache, and joint aches.

Melanoma is cancer that forms in the cells of the skin. Some patients have BRAF V600E or BRAF V600K metastatic melanoma. BRAF is a special protein found inside skin cancer cells that controls cancer growth and spread.

When this BRAF protein is changed (or mutated), cells grow and divide more rapidly. BRAF testing is done to see whether treatment with dabrafenib is likely to be effective in treating metastatic melanoma. If testing is not done, treatment with dabrafenib may not be an effective treatment.

Dabrafenib is approved for treatment of BRAF V600E or BRAF V600K-mutated metastatic melanoma. It is specifically designed to target the BRAF protein. By blocking the BRAF protein, dabrafenib prevents the growth of cancer cells.

G6PD is an enzyme in your body that is responsible for helping red blood cells to work properly. Some patients are born with less of this enzyme in their bodies, leading to the destruction of red blood cells. When dabrafenib is used in patients with G6PD deficiency, they have a higher chance of experiencing hemolytic anemia (a condition in which the body does not have enough red blood cells to deliver oxygen to your tissues).

G6PD testing may be done to determine whether you are at a higher risk of experiencing hemolytic anemia if you are to be treated with dabrafenib.

Dabrafenib is a prescription medication used to treat a certain type of melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body.

Dabrafenib is a prescription medication used to treat a certain type of melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body.

This medication can also be given with trametinib, to treat those with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene. 

Furthermore, this medication, when given with trametinib, can help prevent a type of skin cancer called melanoma that has a certain type of abnormal “BRAF” gene from coming back after cancer has been removed by surgery.

Dabrafenib, when given with trametinib, is also approved to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has a certain type of abnormal “BRAF” gene.

Dabrafenib, when given with trametinib, is also approved to treat a type of thyroid cancer called anaplastic thyroid cancer (ATC) that has spread to other parts of the body and has a certain type of abnormal “BRAF” gene.

Dabrafenib, when given alone or with trametinib, is not approved to treat any of the listed types of cancers that have the wild-type BRAF gene. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Dabrafenib may be found in some form under the following brand names:

• Tafinlar

Common side effects include the following:

• thickening of the outer layers of the skin
• headache
• fever
• rash
• chills
• cough
• fatigue
• nausea/vomiting
• diarrhea
• joint/muscle aches
• warts
• hair loss
• decreased appetite
• redness, swelling, peeling, or tenderness of hands or feet

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of dabrafenib. For more information about side effects, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to GSK at 1-888-825-5249.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antacids, such as aluminum hydroxide/magnesium hydroxide (Maalox), calcium carbonate (Tums) or calcium carbonate and magnesium (Rolaids)
• certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek)
• clarithromycin (Biaxin, in PrevPac)
• dexamethasone (Decadron)
• gemfibrozil (Lopid)
• ketoconazole (Nizoral)
• medications to reduce stomach acid, such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), omeprazole (Prilosec, Prilosec OTC, Zegerid), pantoprazole (Protonix), and ranitidine (Zantac)
• midazolam (Versed)
• nefazodone
• rifampin 
• warfarin (Coumadin, Jantoven)

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with dabrafenib including the following:

Do not take dabrafenib if you are allergic to dabrafenib or to any of its ingredients.

• bleeding problems. Dabrafenib, in combination with trametinib, can cause serious bleeding problems, especially in your brain or stomach, and can lead to death. Call your healthcare provider and get medical help right away if you have any unusual signs of bleeding, including:
  • headaches, dizziness, or feeling weak
  • cough up blood or blood clots
  • vomit blood or your vomit looks like “coffee grounds”
  • red or black stools that look like tar
• heart problems, including heart failure. Your healthcare provider should check your heart function before you start taking dabrafenib in combination with trametinib and during treatment. Call your healthcare provider right away if you have any of the following signs and symptoms of a heart problem:
  • feeling like your heart is pounding or racing
  • shortness of breath
  • swelling of your ankles and feet
  • feeling lightheaded
• eye problems. Dabrafenib alone, or in combination with trametinib, can cause severe eye problems that can lead to blindness. Call your healthcare provider right away if you get these symptoms of eye problems:
  • blurred vision, loss of vision, or other vision changes
  • see color dots
  • halo (seeing blurred outline around objects)
  • eye pain, swelling, or redness

• fever. Dabrafenib alone or in combination with trametinib can cause a fever which may be serious. When taking dabrafenib, in combination with trametinib, fever may happen more often or may be more severe. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Call your healthcare provider right away if you get a fever while taking dabrafenib.

• serious skin reactions. Rash is a common side effect of dabrafenib alone, or when used in combination with trametinib. Dabrafenib alone, or in combination with trametinib, can also cause other skin reactions. In some cases, these rashes and other skin reactions can be severe and may need to be treated in a hospital. Call your healthcare provider if you get any of the following symptoms:
  • skin rash that bothers you or does not go away
  • acne
  • redness, swelling, peeling, or tenderness of hands or feet
  • skin redness

• increased blood sugar. Some people may develop high blood sugar or worsening diabetes during treatment with dabrafenib, alone or in combination with trametinib. If you are diabetic, your healthcare provider should check your blood sugar levels closely during treatment with dabrafenib alone or in combination with trametinib. Your diabetes medicine may need to be changed. Tell your healthcare provider if you have any of the following symptoms of severe high blood sugar:

• increased thirst
• urinating more often than normal, or urinating an increased amount of urine

Dabrafenib may cause healthy red blood cells to break down too early in people with G6PD deficiency. This may lead to a type of anemia called hemolytic anemia where the body does not have enough healthy red blood cells. Tell your healthcare provider if you have any of the following signs or symptoms of anemia or breakdown of red blood cells:

• yellow skin (jaundice)
• weakness or dizziness
• shortness of breath

Tafinlar, when used alone or with trametinib, may cause a type of skin cancer, called cutaneous squamous cell carcinoma (cuSCC) or cause new cancers including basal cell carcinoma. Talk with your healthcare provider about your risk for these cancers. Check your skin and tell your healthcare provider right away about any skin changes including a:

• new wart
• skin sore or reddish bump that bleeds or does not heal
• change in size or color of a mole

This medication may cause fertility problems in females and may cause lower sperm counts in males. As a result, this medication can affect your ability to become pregnant.

This is not a complete list of potential serious side effects.

Do not take dabrafenib if you are allergic to dabrafenib or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of dabrafenib, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking dabrafenib, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to this medication or to any of its ingredients
• have liver or kidney problems
• have diabetes
• plan to have surgery, dental, or other medical procedures
• have a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Dabrafenib can harm your unborn baby. Females who are able to become pregnant should use birth control during treatment and for 2 weeks after the last dose of dabrafenib alone, or for 4 months after the last dose when taking dabrafenib with trametinib.

Birth control using hormones (such as birth control pills, injections, or patches) may not work as well while you are taking dabrafenib. You should use another effective method of birth control while taking dabrafenib alone or with dabrafenib and trametinib. Talk to your healthcare provider about birth control methods that may be right for you.

Tell your healthcare provider right away if you become pregnant during treatment with dabrafenib.

Tell your healthcare provider right away if you become pregnant during treatment with dabrafenib.

It is not known if dabrafenib passes into your breast milk. You and your healthcare provider should decide if you will take dabrafenib or breastfeed. You should not do both.

Do not breastfeed during treatment and for 2 weeks after your last dose of dabrafenib alone, or for 4 months after your last dose of dabrafenib with trametinib. Talk to your healthcare provider about the best way to feed your baby during this time.

Take dabrafenib exactly as your healthcare provider tells you. Do not change your dose or stop dabrafenib unless your healthcare provider tells you.

• Take dabrafenib 2 times a day, about 12 hours apart.
• Take dabrafenib at least 1 hour before or 2 hours after a meal.
• Do not open, crush, or break dabrafenib capsules.
• If you miss a dose, take it as soon as you remember. If it is within 6 hours of your next scheduled dose, just take your next dose at your regular time. Do not make up for the missed dose. 
• Dabrafenib may be taken as a single agent or dabrafenib may be taken in combination with trametinib.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your side effects

The recommended dose of dabrafenib is 150 mg by mouth twice a day (about 12 hours apart). Take this medication at least 1 hour before or at least 2 hours after a meal.

If you take too much dabrafenib, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Keep all appointments with your doctor and the laboratory. 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.
• Store this medication at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep this and all other medications out of the reach of children.