Treatment Name: Encorafenib (Braftovi®) + Binimetinib (Mektovi®)
Encorafenib (Braftovi®) + Binimetinib (Mektovi®) is a Chemotherapy Regimen for Melanoma
How does encorafenib (Braftovi®) + binimetinib (Mektovi®) work?
Encorafenib and binimetinib (enco-bini) are chemotherapy drugs designed to not only kill melanoma cells, but also prevent the development of new skin cancers. They work by shutting off signals within the cancer cell that constantly tell the cancer cells to grow and divide. These signals are known as “RAF” and “MEK” signals.
Goals of therapy:
Encorafenib and binimetinib are chemotherapy drugs taken to shrink melanoma cells and decrease symptoms from melanoma. The combination of encorafenib and binimetinib is not commonly given with the goal of cure.
Before starting treatment with encorafenib and binimetinib, you MUST be tested for a BRAF V600E and BRAF V600K mutation by an FDA-approved test. If you do not have one of these mutations, therapy with encorafenib and binimetinib will not work and can actually speed up the progression of the disease.
- Usual encorafenib (Braftovi®) starting dose: 450 mg (six 75 mg capsules) by mouth ONCE daily
- Usual binimetinib (Mektovi®) starting dose: 45 mg (three 15 mg tablets) by mouth TWICE daily
- Each dose should be taken 12 hours apart
Encorafenib and binimetinib are usually taken at home. Treatment is continued every day until it no longer works or until unacceptable side effects occur.
*It is important to note, one of these medications (binimetinib) is taken TWICE daily, while the other (encorafenib) is taken ONCE daily. The once daily encorafenib dose may be taken at the same time as one of the binimetinib doses.
In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most commonly reported drug side effects of encorafenib + binimetinib are shown here:
- Nausea (42%)
- Diarrhea (37%)
- Vomiting (30%)
- Fatigue (29%)
- Joint pain (26%)
- Constipation (22%)
- Headache (22%)
- Weakness (19%)
- Fever (19%)
- Stomach pain (17%)
- Blurry vision (16%)
- Anemia [low red blood cells] (16%)
- Dry skin (14%)
- Skin thickening (15%)
- Skin rash (15%)
- Hair loss (14%)
- Muscle pain (14%)
- Dizziness (13%)
- High blood pressure (11%)
- Pain in arms or legs (11%)
- Itching (11%)
- Back pain (10%)
- Trouble sleeping (9%)
- Decreased appetite (8%)
- Skin redness (7%)
- Redness and peeling of skin on palms of hands or soles of feet (7%)
- Benign skin growth (6%)
- Dry, bumpy areas of the skin (5%)
- Sensitivity to light (4%)
On average, 8% of patients discontinue treatment due to unacceptable side effects.
How often is monitoring needed?
Labs (blood tests) may be checked before chemo treatment then monthly during treatment or more often at the discretion of your doctor. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), Creatine Phosphokinase (CPK), plus any others your doctor may order.
How often is imaging needed?
Imaging may be checked if there are concerns for side effects or progression of disease. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans. An echocardiogram or MUGA scan is done prior to starting treatment to asses heart function and is repeated one month after starting treatment, then every 2 to 3 months until treatment is stopped. An eye exam may also be recommended before starting treatment. Notify your doctor if you experience any change in vision, eye pain, or increased sensitivity to light.
How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue encorafenib + binimetinib as planned, reduce the dose of future treatments, delay treatment until the side effect goes away, or switch to an alternative therapy.
- As many as 8% of patients who take encorafenib alone may develop a second type of skin cancer known as “squamous cell carcinoma.” When combined with binimetinib, the number of patients that develop new skin cancers is approximately 3% and these usually develop between 1 to 9 months after starting treatment. Additional surgical procedures may be needed to remove these cancers and therapy with encorafenib may usually continue. Skin exams are usually done before starting therapy, every two months during therapy, and for up to 6 months after stopping treatment
- Approximately 7% of patients who take encorafenib and binimetinib experience a decrease in the heart's ability to effectively pump blood; however, this effect is usually not permanent. Heart function is monitored periodically during therapy with echocardiograms or MUGA scans
- An eye problem known as “uveitis” can develop in about 4% of patients taking encorafenib with binimetinib. Uveitis may cause problems tolerating any light as well as blurred vision. Treatment may consist of steroid eye drops, with or without a medication to dilate the pupils. Other very rare but serious eye problems such as retinal detachment and blockage of the veins in the eye have also been reported
- Therapy with encorafenib and binimetinib may increase the risk of experiencing blood clots. Contact your doctor if you are experiencing pain and swelling in your arms or legs or if you have severe chest pain or shortness of breath
- Encorafenib may decrease the effectiveness of oral birth control pills. Women of child bearing age should talk to their doctor about alternative forms of contraception
- Contact your doctor immediately if you notice any signs of unusual bleeding such as blood in the stool, black tarry stools, or vomit that looks like black coffee grounds
- A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
- Clinical trials may exist for melanoma. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications
Patient Assistance & Co-payment Coverage
Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Encorafenib (Braftovi®) + Binimetinib (Mektovi®), we have provided links that may help.
Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Encorafenib (Braftovi®) + Binimetinib (Mektovi®). Depending upon your income, they may be able to help cover the cost of:
For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.
- If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.
Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Encorafenib (Braftovi®) + Binimetinib (Mektovi®) and are the best source to help you understand drug cost.
- Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.
What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.
Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.
Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.
Learn more about pursuing emotional wellness while receiving treatment with Encorafenib (Braftovi®) + Binimetinib (Mektovi®)