Tafinlar (dabrafenib)

Dabrafenib (Tafinlar^®) is a kinase inhibitor and used in the treatment of certain melanomas with BRAF V600E or V600K mutation, and locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation with no locoregional treatment options.

Dabrafenib is also used in combination with trametinib for the treatment of metastatic (has spread to other parts of the body) non-small cell lung cancer (NSCLC) with the BRAF V600E mutation.¹

How does dabrafenib work?

The BRAF V600E mutation is a specific change in the BRAF gene that has been found in some types of cancer, including NSCLC, melanoma, and colorectal cancer. The BRAF gene normally makes a protein that is involved in cell growth, and the mutation may increase the growth and spread of cancer cells.²

Dabrafenib is an inhibitor of the BRAF protein. When used in combination with trametinib, the two medications block different proteins along the same pathway that leads to the growth of cancer cells. By blocking these proteins, the combination of dabrafenib and Mekinist inhibit the growth of the cancer.¹

What are the possible side effects of dabrafenib?

Dabrafenib may cause serious side effects, including tears of stomach/intestine. Patients are advised to watch for the following symptoms: bleeding, diarrhea, stomach pain, fever, and nausea. Dabrafenib may increase the risk of developing new cancers. When used alone or with trametinib, dabrafenib may cause skin cancers such as cutaneous squamous cell carcinoma, melanoma, keratoacanthoma, or basal cell carcinoma. Patients should also be monitored for cancers that may not be visible on a patient’s skin.^1,3

Dabrafenib can cause serious bleeding issues, including brain or stomach bleeds, and this can lead to death. Seek immediate medical attention if you have any signs of bleeding, including:

• Headaches
• Dizziness
• Feeling weak
• Coughing up blood or blood clots
• Vomiting blood (may look like coffee grinds)
• Red or black stools (may look like tar)³

Tafinlar can cause heart problems, including heart failure. Your doctor should check your heart function before and during treatment with dabrafenib. Call your doctor if you have any signs of a heart problem, including:

• Racing heartbeat
• Shortness of breath
• Swelling in the feet or ankles
• Lightheadedness³

Dabrafenib can cause serious eye problems, and some can lead to blindness. Call your doctor if you have any signs of eye problems, including:

• Blurry vision, loss of vision, or other changes
• Seeing colored dots
• Seeing a halo around objects
• Eye pain, swelling, or redness³

Dabrafenib frequently causes a fever. Occasionally, a fever can be serious, if it causes dehydration, low blood pressure, dizziness, or kidney problems. Tell your doctor right away if you experience a fever with Tafinlar.³

Dabrafenib can cause serious skin reactions, like a rash. Call your doctor if you have any signs of skin reactions, including:

• A rash or redness that bothers you or doesn’t go away
• Acne
• Redness, blistering or peeling of the skin³

Dabrafenib can cause increased blood sugar (hyperglycemia). If you have diabetes, you will need to check your blood sugar levels closely, as dabrafenib may worsen your diabetes. Call your doctor if you have any signs of severe high blood sugar, including:

• Increased thirst
• Urinating more frequently or urinating an increased amount of urine³

Dabrafenib can cause hemolytic anemia in people with G6PD deficiency. Call your doctor if you have any signs of anemia, including:

• Jaundice (yellow skin or eyes)
• Weakness
• Dizziness
• Shortness of breath³

The most common side effects experienced by NSCLC patients in clinical trials taking dabrafenib in combination with trametinib include:

• Fever
• Fatigue
• Nausea
• Vomiting
• Swelling of the face, arms, and legs
• Chills
• Bleeding
• Diarrhea
• Dry skin
• Decreased appetite
• Rash
• Cough
• Shortness of breath³

Dabrafenib can cause fertility problems in women, which may affect your ability to become pregnant.³ This is not an exhaustive list of all potential side effects of dabrafenib. Talk to your healthcare provider or pharmacist for further information.

Tafinlar can cause low sperm counts in men, which can affect your ability to father a child.³

Things to know about dabrafenib

Tafinlar should only be used in in NSCLC patients who have the BRAF V600E mutation. Your doctor will perform a test to see if your NSCLC has this mutation.³

Because of the increased risk of developing some kinds of skin cancer, you should have your skin checked by a doctor before starting treatment with dabrafenib, every two months during treatment, and for up to six months after you stop taking Tafinlar for any new skin cancers. In addition, you should check your skin regularly and contact your doctor if you see any skin changes, such as a new wart, a sore or reddish bump that bleeds or doesn’t heal, or a change in the size or color of a mole.^1,3

Before starting treatment with dabrafenib, talk to your doctor about all your health conditions, including:

• Bleeding problems
• Heart (cardiovascular) problems
• Eye problems
• Liver or kidney problems
• Diabetes
• Plans to have surgery, dental, or other medical procedures
• Deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme
• Pregnancy or planning to become pregnant^1,3

Talk to your doctor about all medications you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Dabrafenib may change how other medicines work, and certain combinations of medicine can cause side effects.³

If you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed, talk with your doctor. Dabrafenib can cause harm to a developing fetus and should not be taken by women who are pregnant. While taking dabrafenib, males with female partners who can become pregnant, and females who can become pregnant, should both use contraceptives during treatment and for a period of time after completing treatment (patients should discuss appropriate birth control methods, and how long they need to use them, with their doctor). Females should not breastfeed during dabrafenib treatment and for a period of time following the final dose (patients should discuss breastfeeding considerations with their doctor).^1,3

Dabrafenib should only be used in adults, as it is not known if dabrafenib is safe or effective for use in children.³

Receiving dabrafenib

Dabrafenib comes in a capsule that is taken by mouth. Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their dabrafenib (or trametinib) regimen.¹

For more information, read the full prescribing information for Taflinlar.