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Tafinlar (dabrafenib)

Tafinlar® (dabrafenib) is used to treat certain kinds of advanced melanoma. Dabrafenib can be used alone or in combination with a drug called Mekinist® (trametinib).1 Dabrafenib alone is used for melanoma with a mutation called BRAF V600E. The combination of Dabrafenib and trametinib is used to treat melanoma with BRAF V600E or V600K mutation. Your doctor will test for BRAF mutation. Dabrafenib is not used for melanoma with a normal BRAF gene.

Dabrafenib is used when the melanoma:1

  • Cannot be removed with surgery (unresectable) or
  • Has spread to distant parts of the body (metastasized)
  • Adjuvant treatment for melanoma with BRAF V600E or V600K mutations and involvement of lymph nodes following a complete resection (in combination with trametinib).

Dabrafenib does not come in generic form. Dabrafenib is similar to Zelboraf® (vemurafenib), another drug that is approved to treat unresectable or metastatic melanoma.

How does Dabrafenib work?

Dabrafenib is a type of medication called a kinase inhibitor.1 It works by blocking certain proteins that pass along signals for cell growth. One of the proteins is called BRAF.

Mutations in the gene (instructions) for BRAF are found in 10% of melanomas that develop on sun-exposed skin.2 BRAF mutations are found in 50% of melanomas that occur in skin that rarely has sun exposure.2 V600E and V600K are mutation subtypes. V600E is more common. This subtype makes up 80% to 90% of the BRAF mutations in melanoma.3 About 8% of BRAF mutations are the V600K subtype.4

BRAF proteins have a role in a pathway called MAPK (also called ERK). These proteins are part of a chain of events that allow cells to grow and survive. Normally, there are mechanisms that turn each protein “on” and “off,” keeping the cell processes under control. Certain mutations cause BRAF to stay “on,” sending continuous signals for uncontrolled cell growth.5

Dabrafenib turns the BRAF protein off. It is called a targeted therapy because it targets one feature that makes cancer cells different from normal cells.

Trametinib is a drug that inhibits a protein called MEK. Dabrafenib and trametinib can be used together to target the MAPK pathway at two points. This combination stops or slows the growth of melanomas with BRAF mutations better than either drug alone.1

How do I take Dabrafenib?

Before taking Dabrafenib, read the Medication Guide that comes in the package. Follow your doctor’s instructions for taking Dabrafenib.

Dabrafenib comes as a capsule that you take by mouth.1 Do not open, crush, or break the capsules. Take Dabrafenib twice a day, approximately 12 hours apart. Take Dabrafenib at least 1 hour before or 2 hours after a meal.

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 regimen.

You will continue taking Dabrafenib until the cancer progresses or the side effects are unacceptable.1

What are the side effects of Dabrafenib?

Taking dabrafenib alone or with trametinib can cause other cancers, such as another type of skin cancer called squamous cell carcinoma, new melanoma lesions, or new basal cell carcinoma. Dabrafenib with trametinib is linked with new basal cell carcinoma. Possible signs of new cancers include: new wart, skin sore, reddish bump, or mole that changes in size or color.

The most common side effects of Dabrafenib alone or with trametinib include:

  • Thickening of the skin
  • Headache
  • Joint aches
  • Cough
  • Warts
  • Hair loss
  • Skin reaction on the hands or feet
  • Rash

Less common but serious side effects are:

  • Bleeding problems in the brain or stomach
  • Heart problems
  • Eye problems
  • Fever
  • Severe skin reaction
  • Increased blood sugar
  • Low red blood cells (anemia)

Dabrafenib may make it difficult to get pregnant or father a child. If this is a concern for you, discuss this with your doctor.

This is not a complete list of adverse effects.

Who should not take Dabrafenib?

Pregnant women should not take Dabrafenib.1 Women who could become pregnant should use birth control during treatment. Continue using birth control for at least 2 weeks after the last dose of Dabrafenib or 4 months after taking Dabrafenib with Mekinist. Hormonal birth control (pills, injections, patches) may not work during treatment. Discuss effective birth control options with your doctor.

Do not breastfeed while taking Dabrafenib. Do not breastfeed for 2 weeks after the last dose of Dabrafenib or 4 months after Dabrafenib with Mekinist.

Tell your doctor about any other medical conditions you have, especially:1

  • Bleeding problems
  • Heart problems
  • Eye problems
  • Liver problems
  • Kidney problems
  • Diabetes
  • An enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD)

Tell your doctor if you have had or are planning to have surgery, dental work, or other medical procedures.

What precautions are needed when taking Dabrafenib?

Regular skin exams are needed while taking Dabrafenib.1 Your doctor will do a skin exam before you start this medication. You will need skin exams every 2 months while taking Dabrafenib and for up to 6 months afterward. Your doctor will also look for non-skin cancers.

During treatment and for at least 2 weeks after the last dose of Dabrafenib or 4 months after Dabrafenib and Mekinist:1

  • Women who can become pregnant should use non-hormonal birth control, such as condoms.
  • Women should not breastfeed.
Written by: Sarah O'Brien | Last reviewed: June 2019.
  1. Tafinlar® [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2016.
  2. Lovly C, Pao W, Sosman J. 2016. Molecular profiling of melanoma. My Cancer Genome. https://www.mycancergenome.org/content/disease/melanoma/ (Updated January 26).
  3. Lovly C, Pao W, Sosman J. 2015. BRAF c.1799T>A (V600E) mutation in melanoma. My Cancer Genome. https://www.mycancergenome.org/content/disease/melanoma/braf/54/ (Updated June 16).
  4. Lovly C, Pao W, Sosman J. 2015. BRAF c.1798_1799delGTinsAA (V600K) mutation in melanoma. My Cancer Genome. https://www.mycancergenome.org/content/disease/melanoma/braf/116/ (Updated June 16).
  5. Lo JA, Fisher DE. The melanoma revolution: from UV carcinogenesis to a new era in therapeutics. Science. 2014;346:945-949.