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Braftovi™ (encorafenib) and Mektovi® (binimetinib)

Braftovi and Mektovi are a combination targeted therapy to treat melanoma that cannot be surgically removed (unresectable) or metastatic melanoma with a BRAF V600E or V600K mutation. This mutation is detected through a test of the cancerous cells. When this mutation is present, it can stimulate cancerous growth.1,2

What are the ingredients in Braftovi and Mektovi?

The active ingredient in Braftovi is encorafenib, a kinase inhibitor that blocks the protein mitogen-activated extracellular signal regulated kinase (MEK). The active ingredient in Mektovi is binimetinib, a kinase inhibitor that targets the BRAF V600E protein.1-3

How does the combination of Braftovi and Mektovi work?

Braftovi and Mektovi block two different proteins in a particular pathway that is involved in cancer cell growth. Approximately half of all melanomas have a BRAF mutation. This mutation can cause cancer cells to grow out of control. The MEK protein is also involved in how cells grow and divide, and it is signaled by the BRAF protein. By targeting these proteins in combination, Braftovi and Mektovi can help shrink melanoma tumors and help patients live longer.1-3

What are the possible side effects of Braftovi and Mektovi?

In some people, Braftovi may cause serious side effects, including:1,4

  • An increased risk of new skin cancers (cutaneous squamous cell carcinoma or basal cell carcinoma)
  • Bleeding problems, such as bleeding in the stomach or brain which may be fatal
  • Eye problems, leading to blurred vision, loss of vision, or other changes in vision
  • Changes in heart rhythm, called QT prolongation

Mektovi can also cause serious side effects, including:2,4

  • Heart problems or heart failure
  • Blood clots, which can cause chest pain, trouble breathing, swelling in the arms or legs, and may lead to death
  • Eye problems which may lead to blindness
  • Lung or breathing problems
  • Liver problems, which may cause jaundice (yellowing of the whites of the eyes or skin)
  • Muscle problems (rhabdomyolysis), which may be severe
  • Bleeding problems, such as bleeding in the stomach or brain which may be fatal

The most common side effects of Braftovi and Mektovi experienced by patients taking the combination therapy in clinical trials included:4

  • Fatigue
  • Nausea and vomiting
  • Abdominal pain
  • Joint pain

Things to know about Braftovi and Mektovi

Before starting treatment with Braftovi and Mektovi, patients should talk to their doctor about all their health conditions, including:1,2,4

  • Bleeding problems
  • Eye problems
  • Heart problems
  • Low levels of potassium, calcium, or magnesium
  • Liver or kidney problems
  • History of blood clots
  • Lung or breathing problems
  • Muscle problems
  • High blood pressure (hypertension)

Women who are pregnant or planning to become pregnant should not take Braftovi and Mektovi, as these medications can harm an unborn baby. Women who can become pregnant should use effective, non-hormonal birth control during treatment and for at least 30 days after the final dose.1,2,4

Women who are breastfeeding or plan to breastfeed should talk to their doctor. Women should not breastfeed while taking Braftovi and Mektovi or for 2 weeks after the final dose.1,2,4

Because Braftovi may increase the risk of developing new skin cancers, people taking Braftovi should receive regular skin examinations by a dermatologist or other healthcare professional before, during, and after treatment.1,2,4

Braftovi should not be used by people with a wild-type BRAF mutation, as it may cause these types of cancers to grow more. The BRAF mutation should be determined prior to starting treatment with a FDA-approved test.1,4

Grapefruit products should be avoided while taking Braftovi, as they may increase the amount of the medication in the body and cause more side effects.1,4

Dosing information

Braftovi and Mektovi come in tablets which should be taken by mouth, with or without food. Braftovi should be taken once daily, and Mektovi should be taken in two doses about 12 hours apart (morning and evening). Patients should not stop taking Braftovi and Mektovi without talking to their doctor. Patients should also talk to their doctor if they have questions about how to take Braftovi and Mektovi.4

For more information, read the full prescribing information of Braftovi and the full prescribing information of Mektovi.

  1. Braftovi prescribing information. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf. Accessed 12/5/18.
  2. Mektovi prescribing information. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210498lbl.pdf. Accessed 12/5/18.
  3. Encorafenib (Braftovi™) + Binimetinib (Mektovi®). Melanoma Research Alliance. Available at https://www.curemelanoma.org/patient-eng/melanoma-treatment/combination-therapy-for-melanoma/encorafenib-braftovi-binimetinib-mektovi/. Accessed 12/5/18.
  4. Braftovi + Mektovi product website. Available at https://www.braftovimektovi.com/. Accessed 12/7/18.