Tafinlar (generic name: dabrafenib) can be used in combination with Mekinist (generic name: trametinib) to treat people with metastatic or unresectable melanomas that have the abnormal BRAF (V600E or V600K mutation-positive) gene. Tafinlar can also be used in combination with trametinib to help prevent the recurrence of melanomas in people with the BRAF gene after surgery.
Tafinlar and trametinib can be used in combination to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic NSCLC), and that have the abnormal BRAF V600E gene.
Tafinlar and trametinib can be used in combination to treat anaplastic thyroid cancer (ATC) which has metastasized, for which there is no other satisfactory treatment option and that has a specific abnormal BRAF gene.
The BRAF gene provides instructions for making a protein that is part of a signaling pathway known as the RAS/MAPK pathway. This controls several important cell functions that regulate the proliferation and growth of cells, cell differentiation and migration, as well as cell apoptosis (self-destruction). The BRAF gene belongs to a class of genes known as oncogenes, which when mutated have the potential to cause normal cells to become cancerous.
Precautions
Tafinlar should not be used to treat people with melanoma, NSCLC, or ATC associated with wild-type BRAF.
Serious side effects
This medication has been prescribed because your healthcare provider has judged that the benefits are greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tafinlar and trametinib in combination can cause:
- a range of different skin cancers, such as cutaneous squamous cell carcinoma, keratoacanthoma, basal cell carcinoma, or melanoma. Talk with your healthcare provider about your risk for these cancers. Patients should have their skin checked regularly (bi-monthly), and advise their healthcare provider immediately about any skin changes, such as:
- new warts
- skin sores
- reddish bumps that bleed or do not heal
- changes in the size or color of a mole.
- serious bleeding problems, especially in the brain or stomach. Talk to your healthcare provider and get medical help immediately if you have any signs that may indicate bleeding, such as:
- headaches, dizziness, or feeling weak
- coughing up blood or blood clots
- vomiting blood or when the vomit appears dark – like coffee grounds
- red or black stools that look like tar
- inflammation or perforation of the stomach or intestines. Talk to your healthcare provider and get medical help immediately if you have any of the following symptoms:
- bleeding (refer to the section on bleeding problems above)
- diarrhea or more bowel movements than usual
- pain or tenderness in the abdomen
- fever
- nausea
- peripheral blood clots in the arms or legs, which could travel to the lungs or brain. Get medical help immediately if you have any of the following symptoms:
- chest pain
- sudden shortness of breath or trouble breathing
- pain in your legs with or without swelling
- swelling in your arms or legs
- a cool, pale arm or leg
- heart problems, including heart failure. Your health care provider should check your heart function before you start taking Tafinlar and trametinib in combination, and during treatment. Get medical help immediately if you have any of the following symptoms of a heart problem:
- pounding or racing heartbeat
- shortness of breath
- swelling of ankles and feet
- feeling lightheaded
- eye problems. Talk to your healthcare provider and get medical help immediately if you have any of the following symptoms:
- blurred vision
- loss of vision
- sudden vision changes
- seeing colored dots
- seeing a halo around objects
- eye pain, swelling, or redness
- breathing problems such as shortness of breath and cough. Talk to your healthcare provider and get medical help immediately
- fever. Although mild fever is common during treatment with Tafinlar and trametinib, it could be serious if it happens often or is 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 immediately if you get a fever while under treatment.
- serious skin reactions. While skin rash is a common side effect of Tafinlar and trametinib, in some cases, these and other skin reactions can be severe or serious. Talk to your healthcare provider and get medical help immediately if you have any of the following symptoms:
- a skin rash or acne that bothers you or worsens
- blisters or peeling of your skin
- mouth sores
- high fever or flu-like symptoms
- blisters on your lips, or around your mouth or eyes
- enlarged lymph nodes
- increased blood sugar levels (hyperglycemia). Some people may develop high blood sugar or worsening diabetes during treatment with Tafinlar and trametinib in combination. 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 volume
- Tafinlar may cause healthy red blood cells to break down too early in people with G6PD deficiency, which may lead to hemolytic anemia. Tell your healthcare provider if you have any of the following signs or symptoms
- jaundice
- weakness or dizziness
- shortness of breath.
Common side effects
The most common side effects of Tafinlar in combination with trametinib include:
- fever
- nausea
- chills
- headache
- joint aches
- cough
- diarrhea
- rash
- vomiting
- high blood pressure (hypertension)
- swelling of the face, arms, or legs.
These side effects should clear up or reduce over time. If they persist or get worse, talk to your healthcare provider or pharmacist.
Contraindications
Tafinlar and trametinib in combination can harm a fetus. Talk to your healthcare provider about birth control methods that may be right for you during this time and tell your healthcare provider immediately if you become pregnant, or think you might be pregnant during treatment.
Tafinlar in combination with trametinib is prescribed for:
- treatment of patients with the BRAF V600E gene mutation with unresectable or metastatic melanoma
- treatment of patients with the BRAF V600E or V600K gene mutations with melanoma and involvement of the lymph nodes, to suppress secondary tumor formation after complete resection
- treatment of patients with the BRAF V600E gene mutation with metastatic non-small cell lung cancer (NSCLC)
- treatment of patients with the BRAF V600E gene mutation with locally advanced or metastatic anaplastic thyroid cancer (ATC) having no options of minimally invasive therapeutic procedures
Tafinlar in combination with trametinib is not indicated for the treatment of patients with wild-type BRAF gene mutation with melanoma, NSCLC, or ATC.
