BRAFTOVI® Medication Guide

(encorafenib)

MEDICATION GUIDE
BRAFTOVI (braf-TOE-vee)
(encorafenib)
capsules

Important information: BRAFTOVI is used in combination with other medicines, including binimetinib, cetuximab, or cetuximab and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin). Read the Medication Guide that comes with binimetinib if BRAFTOVI is used with binimetinib. Talk to your healthcare provider about cetuximab, or cetuximab and mFOLFOX 6 if used with BRAFTOVI.

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 binimetinib or cetuximab, 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:

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

Your healthcare provider should check your skin before treatment with BRAFTOVI, every 2 months during treatment, and for up to 6 months after you stop treatment with BRAFTOVI 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 with BRAFTOVI.

See "What are the possible side effects of BRAFTOVI?" for more information about side effects.

What is BRAFTOVI?
BRAFTOVI is a prescription medicine used:

•
in combination with a medicine called binimetinib to treat people with a type of skin cancer called melanoma:
o
that has spread to other parts of the body or cannot be removed by surgery, and
o
that has a certain type of abnormal "BRAF" gene
•
in combination with a medicine called cetuximab and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) to treat people with cancer of the colon or rectum (colorectal cancer):
o
that has spread to other parts of the body, and
o
that has a certain type of abnormal “BRAF” gene
•
in combination with a medicine called cetuximab to treat adults with cancer of the colon or rectum (colorectal cancer) after past treatment:
o
that has spread to other parts of the body, and
o
that has a certain type of abnormal "BRAF" gene
•
in combination with a medicine called binimetinib to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):
o
that has spread to other parts of the body, and
o
that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat people with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI is right for you.
It is not known if BRAFTOVI is safe and effective in children.

Before taking BRAFTOVI, 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
•
are pregnant or plan to become pregnant. BRAFTOVI can harm your unborn baby.
o
Females who are able to become pregnant should use effective non-hormonal birth control (contraception) during treatment with BRAFTOVI and for 2 weeks after the last dose of BRAFTOVI. Birth control methods that contain hormones (such as birth control pills, injections or transdermal systems) may not work as well during treatment with BRAFTOVI.
o
Talk to your healthcare provider about birth control methods that may be right for you during this time.
o
Your healthcare provider will do a pregnancy test before you start taking BRAFTOVI. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with BRAFTOVI.
•
are breastfeeding or plan to breastfeed. It is not known if BRAFTOVI passes into your breast milk. Do not breastfeed during treatment with BRAFTOVI and for 2 weeks after the last dose of BRAFTOVI. 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 the other medicines work.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take BRAFTOVI?

•
Take BRAFTOVI exactly as your healthcare provider tells you. Do not change your dose or stop taking BRAFTOVI unless your healthcare provider tells you to.
•
Take BRAFTOVI by mouth 1 time each day.
•
BRAFTOVI may be taken with or without food.
•
Avoid grapefruit during treatment with BRAFTOVI. Grapefruit products may increase the amount of BRAFTOVI in your body.
•
If you miss a dose of BRAFTOVI, take it as soon as you remember. If it is within 12 hours of your next scheduled dose, take your next dose at your regular time. Do not make up for the missed dose.
•
Do not take an extra dose if you vomit after taking your scheduled dose. Take your next dose at your regular time.
•
If you stop treatment with binimetinib or cetuximab, talk to your healthcare provider about your BRAFTOVI treatment. Your BRAFTOVI dose may need to be changed or stopped.

What are the possible side effects of BRAFTOVI?
BRAFTOVI may cause serious side effects, including:

•
See "What is the most important information I should know about BRAFTOVI?"
•
Heart problems, including heart failure. BRAFTOVI, when taken with binimetinib, can cause heart problems. Your healthcare provider will check your heart function before and during treatment with BRAFTOVI. Tell your healthcare provider right away if you get any of the following signs and symptoms of a heart problem:
o
feeling like your heart is pounding or racing
o
shortness of breath
o
swelling in your hands, ankles legs or feet
o
feeling faint or lightheaded
•
Liver problems. BRAFTOVI, when taken with binimetinib, can cause liver problems. Your healthcare provider will perform blood tests to check your liver function before and during treatment with BRAFTOVI. Tell your healthcare provider if you get any of the following signs and symptoms of a liver problem:
o
yellowing of your skin or your eyes
o
dark or brown (tea-colored) urine
o
nausea or vomiting
o
loss of appetite
o
tiredness
o
bruising
o
bleeding
•
Bleeding problems. BRAFTOVI, when taken with binimetinib or cetuximab, can cause serious bleeding problems, including in your stomach or brain, that can lead to death. Tell your healthcare provider and get medical help right away if you develop any signs of bleeding, including:
o
headaches, dizziness, or feeling weak
o
cough up blood or blood clots
o
vomit blood or your vomit looks like “coffee grounds”
o
red or black stools that look like tar
o
nose bleeds
•
Eye problems. BRAFTOVI, when taken with binimetinib, can cause eye problems. Your healthcare provider should perform an eye exam regularly. Tell your healthcare provider right away if you develop any new or worsening symptoms of eye problems, including:
o
blurred vision, loss of vision, or other vision changes
o
see colored dots
o
see halos (blurred outline around objects)
o
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 taking BRAFTOVI with binimetinib or cetuximab and during your treatment to check your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy or if you feel your heart beating irregularly or fast during treatment with BRAFTOVI and binimetinib or cetuximab. These symptoms may be related to QT prolongation.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with BRAFTOVI if you have certain side effects.

The most common side effects of BRAFTOVI when taken in combination with binimetinib for melanoma include:

•
fatigue
•
nausea
•
vomiting
•
abdominal pain
•
pain or swelling of your joints (arthralgia)

The most common side effects of BRAFTOVI when taken in combination with cetuximab and mFOLFOX6 for colorectal cancer include:

•
numbness, tingling or burning in your hands or feet (peripheral neuropathy)
•
nausea
•
fatigue
•
rash
•
diarrhea
•
decreased appetite
•
vomiting
•
bleeding (hemorrhage)
•
stomach-area (abdominal) pain
•
fever

The most common side effects of BRAFTOVI when taken in combination with cetuximab for colorectal cancer include:

•
fatigue
•
nausea
•
diarrhea
•
acne-like rash (dermatitis acneiform)
•
stomach-area (abdominal) pain
•
decreased appetite
•
pain or swelling of your joints (arthralgia)
•
rash

The most common side effects of BRAFTOVI when taken in combination with binimetinib for NSCLC include:

•
fatigue
•
nausea
•
diarrhea
•
muscle or joint pain
•
vomiting
•
stomach-area (abdominal) pain
•
blurred vision, loss of vision, or other vision changes
•
constipation
•
shortness of breath
•
rash
•
cough

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

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

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 Pfizer Inc. at 1-800-438-1985.

How should I store BRAFTOVI?

•
Store BRAFTOVI at room temperature between 68°F to 77°F (20°C to 25°C).
•
Store BRAFTOVI in the original bottle.
•
Keep the BRAFTOVI bottle tightly closed and protect it from moisture.
•
BRAFTOVI comes with a desiccant packet in the bottle to help protect your medicine from moisture. Do not remove the desiccant packet from the bottle.

Keep BRAFTOVI and all medicines out of the reach of children.

General information about the safe and effective use of BRAFTOVI.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRAFTOVI for a condition for which it was not prescribed. Do not give BRAFTOVI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about BRAFTOVI that is written for health professionals.

What are the ingredients in BRAFTOVI?
Active ingredient: encorafenib
Inactive ingredients: copovidone, poloxamer 188, microcrystalline cellulose, succinic acid, crospovidone, colloidal silicon dioxide, and magnesium stearate of vegetable origin
Capsule shell: gelatin, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide, monogramming ink (pharmaceutical glaze, ferrosoferric oxide, propylene glycol)
Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc. Boulder, Colorado 80301.
BRAFTOVI is a registered trademark of Array BioPharma Inc. in the United States and various other countries.
LAB-1429-4.0
For more information, go to www.BRAFTOVIMEKTOVI.com or call 1-844-792-7729.
© 2024 Array BioPharma Inc. All rights reserved.

This Medication Guide has been approved by the U.S. Food and Drug Administration.     Revised: 12/2024

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Health Professional Information

Medication Guide

MEDICATION GUIDE
BRAFTOVI (braf-TOE-vee)
(encorafenib)
capsules

Important information: BRAFTOVI is used in combination with other medicines, including binimetinib, cetuximab, or cetuximab and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin). Read the Medication Guide that comes with binimetinib if BRAFTOVI is used with binimetinib. Talk to your healthcare provider about cetuximab, or cetuximab and mFOLFOX 6 if used with BRAFTOVI.

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 binimetinib or cetuximab, 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:

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

Your healthcare provider should check your skin before treatment with BRAFTOVI, every 2 months during treatment, and for up to 6 months after you stop treatment with BRAFTOVI 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 with BRAFTOVI.

See "What are the possible side effects of BRAFTOVI?" for more information about side effects.

What is BRAFTOVI?
BRAFTOVI is a prescription medicine used:

•
in combination with a medicine called binimetinib to treat people with a type of skin cancer called melanoma:
o
that has spread to other parts of the body or cannot be removed by surgery, and
o
that has a certain type of abnormal "BRAF" gene
•
in combination with a medicine called cetuximab and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) to treat people with cancer of the colon or rectum (colorectal cancer):
o
that has spread to other parts of the body, and
o
that has a certain type of abnormal “BRAF” gene
•
in combination with a medicine called cetuximab to treat adults with cancer of the colon or rectum (colorectal cancer) after past treatment:
o
that has spread to other parts of the body, and
o
that has a certain type of abnormal "BRAF" gene
•
in combination with a medicine called binimetinib to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):
o
that has spread to other parts of the body, and
o
that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat people with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI is right for you.
It is not known if BRAFTOVI is safe and effective in children.

Before taking BRAFTOVI, 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
•
are pregnant or plan to become pregnant. BRAFTOVI can harm your unborn baby.
o
Females who are able to become pregnant should use effective non-hormonal birth control (contraception) during treatment with BRAFTOVI and for 2 weeks after the last dose of BRAFTOVI. Birth control methods that contain hormones (such as birth control pills, injections or transdermal systems) may not work as well during treatment with BRAFTOVI.
o
Talk to your healthcare provider about birth control methods that may be right for you during this time.
o
Your healthcare provider will do a pregnancy test before you start taking BRAFTOVI. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with BRAFTOVI.
•
are breastfeeding or plan to breastfeed. It is not known if BRAFTOVI passes into your breast milk. Do not breastfeed during treatment with BRAFTOVI and for 2 weeks after the last dose of BRAFTOVI. 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 the other medicines work.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take BRAFTOVI?

•
Take BRAFTOVI exactly as your healthcare provider tells you. Do not change your dose or stop taking BRAFTOVI unless your healthcare provider tells you to.
•
Take BRAFTOVI by mouth 1 time each day.
•
BRAFTOVI may be taken with or without food.
•
Avoid grapefruit during treatment with BRAFTOVI. Grapefruit products may increase the amount of BRAFTOVI in your body.
•
If you miss a dose of BRAFTOVI, take it as soon as you remember. If it is within 12 hours of your next scheduled dose, take your next dose at your regular time. Do not make up for the missed dose.
•
Do not take an extra dose if you vomit after taking your scheduled dose. Take your next dose at your regular time.
•
If you stop treatment with binimetinib or cetuximab, talk to your healthcare provider about your BRAFTOVI treatment. Your BRAFTOVI dose may need to be changed or stopped.

What are the possible side effects of BRAFTOVI?
BRAFTOVI may cause serious side effects, including:

•
See "What is the most important information I should know about BRAFTOVI?"
•
Heart problems, including heart failure. BRAFTOVI, when taken with binimetinib, can cause heart problems. Your healthcare provider will check your heart function before and during treatment with BRAFTOVI. Tell your healthcare provider right away if you get any of the following signs and symptoms of a heart problem:
o
feeling like your heart is pounding or racing
o
shortness of breath
o
swelling in your hands, ankles legs or feet
o
feeling faint or lightheaded
•
Liver problems. BRAFTOVI, when taken with binimetinib, can cause liver problems. Your healthcare provider will perform blood tests to check your liver function before and during treatment with BRAFTOVI. Tell your healthcare provider if you get any of the following signs and symptoms of a liver problem:
o
yellowing of your skin or your eyes
o
dark or brown (tea-colored) urine
o
nausea or vomiting
o
loss of appetite
o
tiredness
o
bruising
o
bleeding
•
Bleeding problems. BRAFTOVI, when taken with binimetinib or cetuximab, can cause serious bleeding problems, including in your stomach or brain, that can lead to death. Tell your healthcare provider and get medical help right away if you develop any signs of bleeding, including:
o
headaches, dizziness, or feeling weak
o
cough up blood or blood clots
o
vomit blood or your vomit looks like “coffee grounds”
o
red or black stools that look like tar
o
nose bleeds
•
Eye problems. BRAFTOVI, when taken with binimetinib, can cause eye problems. Your healthcare provider should perform an eye exam regularly. Tell your healthcare provider right away if you develop any new or worsening symptoms of eye problems, including:
o
blurred vision, loss of vision, or other vision changes
o
see colored dots
o
see halos (blurred outline around objects)
o
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 taking BRAFTOVI with binimetinib or cetuximab and during your treatment to check your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy or if you feel your heart beating irregularly or fast during treatment with BRAFTOVI and binimetinib or cetuximab. These symptoms may be related to QT prolongation.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with BRAFTOVI if you have certain side effects.

The most common side effects of BRAFTOVI when taken in combination with binimetinib for melanoma include:

•
fatigue
•
nausea
•
vomiting
•
abdominal pain
•
pain or swelling of your joints (arthralgia)

The most common side effects of BRAFTOVI when taken in combination with cetuximab and mFOLFOX6 for colorectal cancer include:

•
numbness, tingling or burning in your hands or feet (peripheral neuropathy)
•
nausea
•
fatigue
•
rash
•
diarrhea
•
decreased appetite
•
vomiting
•
bleeding (hemorrhage)
•
stomach-area (abdominal) pain
•
fever

The most common side effects of BRAFTOVI when taken in combination with cetuximab for colorectal cancer include:

•
fatigue
•
nausea
•
diarrhea
•
acne-like rash (dermatitis acneiform)
•
stomach-area (abdominal) pain
•
decreased appetite
•
pain or swelling of your joints (arthralgia)
•
rash

The most common side effects of BRAFTOVI when taken in combination with binimetinib for NSCLC include:

•
fatigue
•
nausea
•
diarrhea
•
muscle or joint pain
•
vomiting
•
stomach-area (abdominal) pain
•
blurred vision, loss of vision, or other vision changes
•
constipation
•
shortness of breath
•
rash
•
cough

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

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

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 Pfizer Inc. at 1-800-438-1985.

How should I store BRAFTOVI?

•
Store BRAFTOVI at room temperature between 68°F to 77°F (20°C to 25°C).
•
Store BRAFTOVI in the original bottle.
•
Keep the BRAFTOVI bottle tightly closed and protect it from moisture.
•
BRAFTOVI comes with a desiccant packet in the bottle to help protect your medicine from moisture. Do not remove the desiccant packet from the bottle.

Keep BRAFTOVI and all medicines out of the reach of children.

General information about the safe and effective use of BRAFTOVI.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRAFTOVI for a condition for which it was not prescribed. Do not give BRAFTOVI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about BRAFTOVI that is written for health professionals.

What are the ingredients in BRAFTOVI?
Active ingredient: encorafenib
Inactive ingredients: copovidone, poloxamer 188, microcrystalline cellulose, succinic acid, crospovidone, colloidal silicon dioxide, and magnesium stearate of vegetable origin
Capsule shell: gelatin, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide, monogramming ink (pharmaceutical glaze, ferrosoferric oxide, propylene glycol)
Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc. Boulder, Colorado 80301.
BRAFTOVI is a registered trademark of Array BioPharma Inc. in the United States and various other countries.
LAB-1429-4.0
For more information, go to www.BRAFTOVIMEKTOVI.com or call 1-844-792-7729.
© 2024 Array BioPharma Inc. All rights reserved.

This Medication Guide has been approved by the U.S. Food and Drug Administration.     Revised: 12/2024
Medication Guide

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