Understanding why BRAFTOVI + MEKTOVI may be right for you

BRAFTOVI (braf-TOE-vee) + MEKTOVI (mek-TOE-vee) is a targeted oral combination therapy used to treat people with melanoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable) and has a certain type* of abnormal BRAF gene.

BRAFTOVI + MEKTOVI is not chemotherapy or immunotherapy. BRAFTOVI and MEKTOVI are two targeted therapies that, when taken together, can be used to treat this specific type of melanoma.

BRAFTOVI + MEKTOVI is a kinase (KIGH-nase) inhibitor combination. By targeting the signaling pathway at different points, BRAFTOVI + MEKTOVI helps to inhibit increased activity that causes melanoma cells to grow out of control.

The good news is that,

Patients who have a certain type of BRAF+ metastatic melanoma have BRAFTOVI + MEKTOVI—a targeted oral combination therapy.

How BRAFTOVI + MEKTOVI may work infographic

Cancer cells multiply and
the tumor may grow

How BRAFTOVI + MEKTOVI may work infographic

Helps inhibit out-of-control
cancer cell growth

*BRAF V600E or V600K mutation.

It’s important that the two medicines be taken exactly as prescribed by your doctor.

Learn more about dosing
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How BRAFTOVI + MEKTOVI may help

How BRAFTOVI + MEKTOVI were studied

A clinical trial studied 577 patients who had melanoma that:

  • Had a certain type of abnormal BRAF gene (V600E or V600K mutation), and
  • Had spread to other parts of the body or could not be removed with surgery

To understand the benefit of BRAFTOVI + MEKTOVI, this clinical trial measured how long patients lived without their cancer getting worse.

BRAFTOVI + MEKTOVI helped people live 2x longer without their cancer worsening

In the trial, patients (192 total) receiving BRAFTOVI + MEKTOVI lived without their cancer worsening for a median of 14.9 months vs 7.3 months for patients (191 total) who were taking vemurafenib, another targeted treatment, alone. Median is defined as the middle number in a group of numbers arranged from the lowest to the highest.

How long patients lived without their cancer worsening infographic

These results were from a clinical trial and may not be the same as what you experience.

BRAFTOVI + MEKTOVI has been shown to be more effective at helping tumors shrink or even disappear

In the same clinical trial, the overall response rate showed that 63% of patients taking BRAFTOVI + MEKTOVI saw their tumors shrink or disappear, compared with only 40% taking vemurafenib alone.

Complete response means that all signs of cancer are gone after treatment. It doesn’t mean that the cancer is cured.

Partial response means that the amount of cancer in the body, or the size of the tumor, has decreased after treatment.

Overall response rate is the percentage of patients whose cancer shrinks or disappears after treatment.

Response rates infographic

These results were from a clinical trial and may not be the same as what you experience.

Possible serious side effects of BRAFTOVI + MEKTOVI

Ask your healthcare provider about any information you do not understand or find unclear. If you experience any of the symptoms below while taking BRAFTOVI + MEKTOVI, it’s important to call your healthcare provider immediately.

Skin cancer icon

Risk of new skin cancers. New wart; skin sore or reddish bump that bleeds or does not heal; change in size or color of a mole

Heart icon

Heart problems, including heart failure. Feeling like your heart is pounding or racing; shortness of breath; swelling of your ankles and feet; feeling light-headed

Blood icon

Blood clots. Can lead to death. Symptoms include chest pain; sudden shortness of breath or trouble breathing; pain in your legs with or without swelling; swelling in your arms and legs; a cool, pale arm or leg

Blood icon

Bleeding problems. Can lead to death. Symptoms include headaches, dizziness, or feeling weak; coughing up blood or blood clots; vomiting blood or your vomit looks like “coffee grounds”; red or black stools that look like tar

Eye icon

Eye problems. Blurred vision, loss of vision, or other vision changes; see colored dots; see halos (blurred outline around objects); eye pain, swelling, or redness

Lungs icon

Lung or breathing problems. Shortness of breath; cough

Liver icon

Liver problems. Yellowing of your skin or the white part of your eyes (jaundice); dark or brown (tea-colored) urine; nausea or vomiting; loss of appetite

Muscle icon

Muscle problems (rhabdomyolysis). Weakness; muscle aches or pain; dark, reddish urine

Heart icon

Changes in the electrical activity of your heart (QT prolongation). Can be life-threatening. Symptoms include feeling faint, light-headed, dizzy, or if you feel your heart beating irregularly or fast

These are not all of the possible side effects of BRAFTOVI + MEKTOVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Array BioPharma Inc. at 1-844-792-7729.

Possible common side effects of BRAFTOVI + MEKTOVI

Side effects that occurred in ≥ 20% of patients in a clinical trial:

BRAFTOVI
+ MEKTOVI
Vemurafenib
Fatigue 43% 46%
Headache 22% 20%
Abdominal pain 28% 16%
Nausea 41% 34%
Vomiting 30% 16%
Joint pain 26% 46%
Fever and chills 18% 30%
Rash 22% 53%
Diarrhea 36% 34%
Constipation 22% 6%
Muscle weakness, cramps, or stiffness 23% 22%
Thickening skin 23% 49%
Dry skin 16% 26%
Itchiness 13% 21%
Visual impairment 20% 4%
Hair loss 14% 38%

The most common side effects of BRAFTOVI when taken with MEKTOVI, include:

fatigue, nausea, diarrhea, vomiting, abdominal pain, and pain or swelling of your joints.

As with any medicine, it’s possible you could experience side effects. It’s important to:

Write down icon
Know what side effects (if any) you are experiencing with BRAFTOVI + MEKTOVI. Write them down as they occur. Make sure you share this information with your healthcare provider.
Exclamation point icon
Tell your doctor if you experience any side effects, especially those that may be harmful or unpleasant. Your doctor may need to adjust your dose or discontinue treatment.

Patients in the same clinical trial experienced some of the following common side effects.

Remember, the information below does not replace directions from your healthcare provider. Always talk to him or her about possible side effects and ways to manage them. Before taking any medications, speak with your healthcare provider.

Fatigue

Talk to your healthcare provider if you are experiencing fatigue. He or she may recommend ways to combat fatigue, including a daily regimen of exercise or activities, as well as scheduled rest times. Your healthcare provider will have ideas on how to incorporate these activities into your day to get the most out of them.

Headache

Your headache may be caused by a serious issue. Speak to your healthcare provider immediately for ways to relieve it.

Abdominal pain/nausea

Recommendations to avoid the foods that commonly cause these issues can be suggested by your healthcare provider. Such foods may vary with different people and with what you are accustomed to eating, leading to adjustments in your daily diet. One suggestion is having smaller meals throughout the day.

Vomiting

It is important to stay hydrated throughout your treatment. Make sure you are drinking enough fluids and ask your healthcare provider about other kinds of liquids that may be right for you. To prevent dehydration, be sure to drink fruit juices, ginger ale, water, and/or sports drinks during the day.

Joint pain

Joint pain can be managed with self-care and recommendations from your healthcare team. Your healthcare provider may recommend physical therapy. A physical therapist can teach you simple exercises to help your joints work like they used to. Light stretching and hot or cold compresses (think heating pad or ice packs) may also help reduce joint pain. If needed, your healthcare provider may also recommend certain medications to reduce swelling and inflammation.

Fever and chills

As soon as you sense a fever coming on, or if you are experiencing chills or feeling uncommonly warm, check your temperature immediately and keep a record of it in your journal. Fever and chills should be promptly reported to your healthcare provider, who may recommend rest, fluids, and over-the-counter anti-fever medications.

Rash

Report any rashes you may experience immediately to your healthcare provider and describe the symptoms in detail. Your healthcare provider may recommend using creams or lotions to soothe your skin or wearing clothing of a different material, as well as avoiding exposure to the sun.

Diarrhea

A change in diet and over-the-counter medications may be recommended by your healthcare provider. But be sure to report diarrhea immediately in order to get treatment options that might be as practical as avoiding dairy products or spicy and greasy foods. It is important to stay hydrated throughout your treatment. Sports drinks are often recommended as they contain replacement electrolytes and salts.

These are not all of the possible side effects of BRAFTOVI + MEKTOVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Array BioPharma Inc. at 1-844-792-7729.

Important Safety
Information and Indication

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) may cause serious side effects, including:

  • Risk of new skin cancers. BRAFTOVI, when used alone or with MEKTOVI, may cause skin cancers called cutaneous squamous cell carcinoma or basal cell carcinoma. Talk to your healthcare provider about your risk for these cancers.

    Check your skin and tell your healthcare provider right away about any skin changes, including a:

    • new wart
    • skin sore or reddish bump that bleeds or does not heal
    • change in size or color of a mole

    Your healthcare provider should check your skin before and every 2 months during treatment, and for up to 6 months after you stop treatment to look for any new skin cancers.

    Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment.

  • Heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment with MEKTOVI. Call your healthcare provider right away if you have any of the following signs and symptoms of a heart problem:
    • feeling like your heart is pounding or racing
    • shortness of breath
    • swelling of your ankles and feet
    • feeling light-­headed
  • Blood clots. MEKTOVI can cause blood clots in your arms or legs, which can travel to your lungs and can lead to death. Get medical help right away if you have the following symptoms:
    • chest pain
    • sudden shortness of breath or trouble breathing
    • pain in your legs with or without swelling
    • swelling in your arms and legs
    • a cool, pale arm or leg
  • Bleeding problems. BRAFTOVI, when taken with MEKTOVI, can cause serious bleeding problems, including in your stomach or brain, that can lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, including:
    • headaches, dizziness, or feeling weak
    • cough up blood or blood clots
    • vomit blood or your vomit looks like “coffee grounds”
    • red or black stools that look like tar
  • Eye problems. MEKTOVI can cause serious eye problems that might lead to blindness. Call your healthcare provider right away if you develop any of these symptoms of eye problems:
    • blurred vision, loss of vision, or other vision changes
    • see colored dots
    • see halos (blurred outline around objects)
    • eye pain, swelling, or redness
  • Lung or breathing problems. MEKTOVI can cause lung or breathing problems. Tell your healthcare provider if you have any new or worsening symptoms of lung or breathing problems, including:
    • shortness of breath
    • cough
  • Liver problems. Your healthcare provider should perform blood tests to check your liver function before and during treatment with MEKTOVI. Tell your healthcare provider if you have any of the following signs and symptoms of a liver problem:
    • yellowing of your skin or the white part of your eyes (jaundice)
    • dark or brown (tea­-colored) urine
    • nausea or vomiting
    • loss of appetite
  • Muscle problems (rhabdomyolysis). MEKTOVI can cause muscle problems that can be severe. MEKTOVI may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can be a sign of muscle damage. Your healthcare provider should perform a blood test to check your CPK levels before and during treatment. Tell your healthcare provider right away if you develop any of these symptoms:
    • weakness
    • muscle aches or pain
    • dark, reddish urine
  • Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider should do tests before you start taking BRAFTOVI with MEKTOVI and during your treatment to check your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, light-­headed, dizzy, or if you feel your heart beating irregularly or fast while taking BRAFTOVI with MEKTOVI. These symptoms may be related to QT prolongation.

Tell your healthcare team if you are pregnant or plan to become pregnant. BRAFTOVI and MEKTOVI can harm your unborn baby. Females who are able to become pregnant should use effective non-hormonal birth control (contraception) during and for at least:

    • 2 weeks after the last dose of BRAFTOVI
    • 30 days after the last dose of MEKTOVI
    • Birth control methods that contain hormones (such as birth control pills, injections, or transdermal systems) may not work as well during treatment with BRAFTOVI.
    • Your healthcare team will do a pregnancy test before you start taking BRAFTOVI and MEKTOVI. Tell your healthcare provider right away if you become pregnant or think you might become pregnant during treatment.

Talk to your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment with BRAFTOVI and MEKTOVI and for:

    • 2 weeks after the final dose of BRAFTOVI
    • 3 days after the final dose of MEKTOVI

BRAFTOVI may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.

The most common side effects of BRAFTOVI when taken with MEKTOVI, include: fatigue, nausea, diarrhea, vomiting, abdominal pain, and pain or swelling of your joints.

Before taking BRAFTOVI + MEKTOVI, tell your healthcare provider about all of your medical conditions, including if you:

  • have had bleeding problems
  • have eye problems
  • have heart problems, including a condition called long QT syndrome
  • have been told that you have low blood levels of potassium, calcium, or magnesium
  • have liver or kidney problems
  • have had blood clots
  • have lung or breathing problems
  • have any muscle problems
  • have high blood pressure (hypertension)
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over­-the­-counter medicines, vitamins, and herbal supplements. BRAFTOVI and certain other medicines can affect each other, causing side effects or affecting how BRAFTOVI or other medicines work. You should also avoid grapefruit products during treatment with BRAFTOVI.

These are not all the possible side effects of BRAFTOVI and MEKTOVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Array BioPharma Inc. at 1-844-792-7729.

Please see both BRAFTOVI full Prescribing Information, including Medication Guide, and MEKTOVI full Prescribing Information, including Patient Information for additional information.

What is BRAFTOVI + MEKTOVI?

BRAFTOVI and MEKTOVI are prescription medicines used together to treat people with a type of skin cancer called melanoma:

  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat people with wild­type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

Important Safety
Information and Indication

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) may cause serious side effects, including:

  • Risk of new skin cancers. BRAFTOVI, when used alone or with MEKTOVI, may cause skin cancers called cutaneous squamous cell carcinoma or basal cell carcinoma. Talk to your healthcare provider about your risk for these cancers.

    Check your skin and tell your healthcare provider right away about any skin changes, including a:

    • new wart
    • skin sore or reddish bump that bleeds or does not heal
    • change in size or color of a mole

    Your healthcare provider should check your skin before and every 2 months during treatment, and for up to 6 months after you stop treatment to look for any new skin cancers.

    Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment.

  • Heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment with MEKTOVI. Call your healthcare provider right away if you have any of the following signs and symptoms of a heart problem:
    • feeling like your heart is pounding or racing
    • shortness of breath
    • swelling of your ankles and feet
    • feeling light-­headed
  • Blood clots. MEKTOVI can cause blood clots in your arms or legs, which can travel to your lungs and can lead to death. Get medical help right away if you have the following symptoms:
    • chest pain
    • sudden shortness of breath or trouble breathing
    • pain in your legs with or without swelling
    • swelling in your arms and legs
    • a cool, pale arm or leg
  • Bleeding problems. BRAFTOVI, when taken with MEKTOVI, can cause serious bleeding problems, including in your stomach or brain, that can lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, including:
    • headaches, dizziness, or feeling weak
    • cough up blood or blood clots
    • vomit blood or your vomit looks like “coffee grounds”
    • red or black stools that look like tar
  • Eye problems. MEKTOVI can cause serious eye problems that might lead to blindness. Call your healthcare provider right away if you develop any of these symptoms of eye problems:
    • blurred vision, loss of vision, or other vision changes
    • see colored dots
    • see halos (blurred outline around objects)
    • eye pain, swelling, or redness
  • Lung or breathing problems. MEKTOVI can cause lung or breathing problems. Tell your healthcare provider if you have any new or worsening symptoms of lung or breathing problems, including:
    • shortness of breath
    • cough
  • Liver problems. Your healthcare provider should perform blood tests to check your liver function before and during treatment with MEKTOVI. Tell your healthcare provider if you have any of the following signs and symptoms of a liver problem:
    • yellowing of your skin or the white part of your eyes (jaundice)
    • dark or brown (tea­-colored) urine
    • nausea or vomiting
    • loss of appetite
  • Muscle problems (rhabdomyolysis). MEKTOVI can cause muscle problems that can be severe. MEKTOVI may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can be a sign of muscle damage. Your healthcare provider should perform a blood test to check your CPK levels before and during treatment. Tell your healthcare provider right away if you develop any of these symptoms:
    • weakness
    • muscle aches or pain
    • dark, reddish urine
  • Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider should do tests before you start taking BRAFTOVI with MEKTOVI and during your treatment to check your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, light-­headed, dizzy, or if you feel your heart beating irregularly or fast while taking BRAFTOVI with MEKTOVI. These symptoms may be related to QT prolongation.

Tell your healthcare team if you are pregnant or plan to become pregnant. BRAFTOVI and MEKTOVI can harm your unborn baby. Females who are able to become pregnant should use effective non-hormonal birth control (contraception) during and for at least:

    • 2 weeks after the last dose of BRAFTOVI
    • 30 days after the last dose of MEKTOVI
    • Birth control methods that contain hormones (such as birth control pills, injections, or transdermal systems) may not work as well during treatment with BRAFTOVI.
    • Your healthcare team will do a pregnancy test before you start taking BRAFTOVI and MEKTOVI. Tell your healthcare provider right away if you become pregnant or think you might become pregnant during treatment.

Talk to your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment with BRAFTOVI and MEKTOVI and for:

    • 2 weeks after the final dose of BRAFTOVI
    • 3 days after the final dose of MEKTOVI

BRAFTOVI may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.

The most common side effects of BRAFTOVI when taken with MEKTOVI, include: fatigue, nausea, diarrhea, vomiting, abdominal pain, and pain or swelling of your joints.

Before taking BRAFTOVI + MEKTOVI, tell your healthcare provider about all of your medical conditions, including if you:

  • have had bleeding problems
  • have eye problems
  • have heart problems, including a condition called long QT syndrome
  • have been told that you have low blood levels of potassium, calcium, or magnesium
  • have liver or kidney problems
  • have had blood clots
  • have lung or breathing problems
  • have any muscle problems
  • have high blood pressure (hypertension)
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over­-the­-counter medicines, vitamins, and herbal supplements. BRAFTOVI and certain other medicines can affect each other, causing side effects or affecting how BRAFTOVI or other medicines work. You should also avoid grapefruit products during treatment with BRAFTOVI.

These are not all the possible side effects of BRAFTOVI and MEKTOVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Array BioPharma Inc. at 1-844-792-7729.

Please see both BRAFTOVI full Prescribing Information, including Medication Guide, and MEKTOVI full Prescribing Information, including Patient Information for additional information.

What is BRAFTOVI + MEKTOVI?

BRAFTOVI and MEKTOVI are prescription medicines used together to treat people with a type of skin cancer called melanoma:

  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat people with wild­type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.