Understanding BRAFTOVI + MEKTOVI

What is BRAFTOVI + MEKTOVI?

BRAFTOVI (braf-TOE-vee) + MEKTOVI (mek-TOE-vee) is a targeted oral combination therapy used to treat metastatic melanoma or melanoma for which surgery is not an option and a BRAF mutation is present.

BRAFTOVI + MEKTOVI is not chemotherapy or immunotherapy. BRAFTOVI and MEKTOVI are two targeted therapies that, when taken together, do a better job at delivering the therapies' strength with manageable side effects.

How does BRAFTOVI + MEKTOVI work?

BRAFTOVI + MEKTOVI is a kinase (KIGH-nase) inhibitor. Kinases are enzymes that change how proteins work. By targeting BRAF and MEK kinases, BRAFTOVI + MEKTOVI helps to inhibit overactive signals that cause melanoma cells to grow out of control. Studies have shown that BRAF and MEK kinases are important in the cell processes specific to BRAF-mutated metastatic melanoma.

The good news is that

Patients who have metastatic melanoma with a BRAF mutation have BRAFTOVI + MEKTOVI—a targeted oral combination therapy.

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

BRAFTOVI and MEKTOVI are two targeted oral therapies that are designed to be taken together to help fight your metastatic melanoma with a BRAF mutation.

Learn more about dosing

Take information about BRAFTOVI + MEKTOVI on the go

Download the Patient Brochure

How BRAFTOVI + MEKTOVI may help

In a clinical trial of 577 patients with metastatic melanoma, 192 patients received BRAFTOVI + MEKTOVI and 191 patients were given another targeted oral melanoma therapy (vemurafenib).

BRAFTOVI + MEKTOVI paused disease progression

BRAFTOVI + MEKTOVI helped people live more than a median of 2x LONGER without their cancer worsening

Patients receiving BRAFTOVI + MEKTOVI lived without their cancer worsening for a median of nearly 15 months vs 7 months for patients given another targeted therapy.

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

BRAFTOVI + MEKTOVI
63%
Overall response rate
Complete response: 8%    Partial response: 55%
Vemurafenib
40%
Overall response rate
Complete response: 6%    Partial response: 35%
vs.

In the same clinical trial of patients with metastatic melanoma, the overall response rate showed that 63% of patients taking BRAFTOVI + MEKTOVI saw their tumors shrink or disappear, compared with only 40% of patients taking another targeted oral melanoma therapy (vemurafenib).

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

Partial response means that the amount of cancer in the body, or the size of the tumor, has decreased after treatment. It is also called partial remission.

Median is defined as the middle number in a group of numbers arranged from the lowest to the highest.

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

What you should know about side effects

Patients taking BRAFTOVI + MEKTOVI had lower rates of:


Fever and chills


Joint pain


Rash

In a clinical trial of 577 patients with metastatic melanoma, 192 patients received BRAFTOVI + MEKTOVI and 191 patients were given another targeted oral melanoma therapy (vemurafenib). Those patients who took BRAFTOVI + MEKTOVI reported a lower incidence of adverse reactions compared with those who took vemurafenib.

Because certain side effects of BRAFTOVI + MEKTOVI, such as fever and chills, joint pain, and rash, have been shown to be more manageable than those of another targeted oral melanoma treatment (vemurafenib), you may be able to stay on this medicine longer and get the most benefits from your therapy.

Of the patients receiving BRAFTOVI + MEKTOVI, 5% had an adverse reaction that resulted in permanent discontinuation of BRAFTOVI and MEKTOVI. The most common side effects leading to discontinuation were hemorrhage in 2% and headache in 1% of patients.

The most common side effects of BRAFTOVI in combination with MEKTOVI include:

BRAFTOVI: Fatigue, nausea, vomiting, pain or swelling of your joints, abdominal pain

MEKTOVI: Fatigue, nausea, diarrhea, vomiting, abdominal pain

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%

Common and serious side effects may occur

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

Know what side effects (if any) you are experiencing with BRAFTOVI + MEKTOVI. Write them down in your journal as they occur. Make sure you share this information with your healthcare provider.
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.

Common Side Effects

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 swelling and pain

Your healthcare provider may suggest avoiding salty foods such as bacon, chips, or some canned soups to help reduce swelling. Another recommendation is to wear loose clothing and shoes. Special support gloves or stockings may help circulation, as well as not crossing your legs when you sit. Resting the affected areas may help. Try using pillows to raise your feet when you’re sitting or lying down. Some exercises, such as walking, may help as long as you don’t overdo it. Your healthcare provider may prescribe a medicine to reduce the fluid in your body (called a diuretic). Be sure to take it as directed.

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 antifever 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.

Possible Serious Side Effects

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.

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

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

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

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

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

Lung or breathing problems. Shortness of breath; cough

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

These are not all of the possible side effects with 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

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

BRAFTOVI 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, or change in size or color of a mole

    Your healthcare provider should check your skin before and 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

  • 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. Tell 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
  • 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 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

MEKTOVI may cause serious side effects, including:

  • Heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment. 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
  • 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. 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. Your healthcare provider should perform a blood test to check your levels of an enzyme in your blood called creatine phosphokinase (CPK) 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
  • Bleeding problems. MEKTOVI, when taken with BRAFTOVI, can cause serious bleeding problems, including in your brain or stomach, 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

The most common side effects of BRAFTOVI and MEKTOVI when taken in combination: fatigue, nausea, diarrhea, vomiting, pain or swelling of your joints, abdominal pain BRAFTOVI may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.

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.

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. BRAFTOVI + MEKTOVI can harm your unborn baby.
    • Females who are able to become pregnant should use effective nonhormonal birth control (contraception) during treatment and for at least 30 days after the final dose. Birth control methods that contain hormones (such as birth control pills, injections, or transdermal systems) may not work as well during treatment with BRAFTOVI
    • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with BRAFTOVI + MEKTOVI
  • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time

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.

Please see both full BRAFTOVI Prescribing Information, including Medication Guide, and full MEKTOVI 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 wild-type 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

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

BRAFTOVI 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, or change in size or color of a mole

    Your healthcare provider should check your skin before and 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

  • 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. Tell 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
  • 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 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

MEKTOVI may cause serious side effects, including:

  • Heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment. 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
  • 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. 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. Your healthcare provider should perform a blood test to check your levels of an enzyme in your blood called creatine phosphokinase (CPK) 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
  • Bleeding problems. MEKTOVI, when taken with BRAFTOVI, can cause serious bleeding problems, including in your brain or stomach, 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

The most common side effects of BRAFTOVI and MEKTOVI when taken in combination: fatigue, nausea, diarrhea, vomiting, pain or swelling of your joints, abdominal pain BRAFTOVI may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.

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.

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. BRAFTOVI + MEKTOVI can harm your unborn baby.
    • Females who are able to become pregnant should use effective nonhormonal birth control (contraception) during treatment and for at least 30 days after the final dose. Birth control methods that contain hormones (such as birth control pills, injections, or transdermal systems) may not work as well during treatment with BRAFTOVI
    • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with BRAFTOVI + MEKTOVI
  • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time

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.

Please see both full BRAFTOVI Prescribing Information, including Medication Guide, and full MEKTOVI 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 wild-type 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.