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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.

Schedule

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  • 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.

Side Effects

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.

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue PainPainConstipationConstipationAnemiaAnemiaHair LossHair Loss

Monitoring

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.

ChemoExperts Tips

  • 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:

  • Encorafenib
  • Binimetinib

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.

Emotional Wellness

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®)

Individual Drug Label Information

Encorafenib (Braftovi®)

  • ​Is an oral capsule available in 75 mg
  • Can be taken with or without food
  • If you miss a dose, take as soon as possible if it has been less than 12 hours from when the dose was supposed to be taken. If it has been more than 12 hours, skip the missed dose and take your next dose at the regularly scheduled time. DO NOT take two doses to make up for the missed dose
  • Should be stored at 68°F to 77°F (20°C to 25°C)
  • Dosage adjustments may be required for certain side effects or drug interactions
  • May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions
  • May interact with grapefruit and grapefruit juice, pomegranate, star fruit, or seville oranges (in marmalade) causing increased blood levels of encorafenib. This could increase your risk of experiencing side effects. Avoid eating or drinking these foods during treatment 
  • Avoid therapy with St. Johns Wort, carbamazepine, or phenytoin as they will decrease blood levels of encorafenib and could decrease its effectiveness
  • May cause irregular heart rhythms due to affecting the “QTc interval”. Talk with your doctor or pharmacist to see if you are taking any other medications that may affect the QTc interval and increase your risk of experiencing potentially fatal irregular heart rhythms
  • May cause fetal harm if taken while pregnant. Encorafenib may cause birth control pills to be ineffective so alternative methods of birth control should be used during treatment for 2 weeks after stopping treatment
  • Do not breastfeed during treatment and for 2 weeks after stopping treatment
General side effects from encorafenib
  • New skin growths (benign and malignant)
  • Nausea and vomiting
  • Diarrhea
  • Constipation
  • Skin changes (rash, redness, dryness, peeling, bumps)
  • Eye changes (blurry vision, double vision, sensitivity to light)
  • Irregular heart rhythm
  • Bleeding
  • Fatigue
  • Click on the encorafenib (Braftovi®) package insert below for reported side effects, possible drug interactions, and other encorafenib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

Binimetinib (Mektovi®)

  • Is an oral tablet available in 15 mg
  • Can be taken with or without food
  • If you miss a dose, take as soon as possible if it has been less than 6 hours from when the dose was to be taken. If it has been more than 6 hours, skip the missed dose and take your next dose at the regularly scheduled time. DO NOT take two doses to make up for the missed dose
  • Should be stored at 68°F to 77°F (20°C to 25°C)
  • Dosage adjustments may be required for certain side effects
  • May cause fetal harm if taken while pregnant. Use effective birth control methods during treatment and for one month after stopping treatment
  • Do not breastfeed during treatment and for 3 days after stopping treatment
General side effects from binimetinib
  • Nausea and vomiting
  • Diarrhea
  • Constipation
  • Skin changes (rash, redness, dryness, peeling, bumps)
  • Eye changes (blurry vision, double vision, sensitivity to light)
  • Blood clots
  • Decreased heart function
  • Bleeding
  • Fatigue
  • Click on the binimetinib (Mektovi®) package insert below for reported side effects, possible drug interactions, and other binimetinib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemiaBlood ClotsBlood Clots

See DailyMed package insert.

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References

1) Dummer R, Ascierto PA, Gogas HJ, et al. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol 2018;19(5):603-615

Created: September 9, 2019 Updated: September 9, 2019

What is Melanoma?

A disease of the melanocytes found in the skin. Melanoma is a rare diagnosed condition. The risk of melanoma may increase with increased exposure to UV light. Melanoma may be hereditary. Melanoma may occur in areas that do not receive much sun light, such as the bottom of a foot. It may also occur in places other than skin, such as the eye. The stage of melanoma can vary at diagnosis and throughout treatment. Stages of melanoma include Stage I, II, III, and IV. The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is Creatine phosphokinase (CPK)?

Creatine phosphokinase (CPK) is a muscle breakdown product and can increase in the blood if the either muscle is rapidly breaking down, the kidneys are not working well, or both. An elevation well above the normal range, may suggest muscle damage