What is BRAFTOVI?
- BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) to treat people with cancer of the colon or rectum (colorectal cancer):
- that has spread to other parts of the body,
and
- that has a certain type of abnormal
“BRAF” gene
- BRAFTOVI in combination with cetuximab and mFOLFOX6 was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of BRAFTOVI in combination with cetuximab and mFOLFOX6.
- BRAFTOVI is a prescription medicine used in combination with a medicine called cetuximab to treat adults with cancer of the colon or rectum (colorectal cancer) after past treatment:
- that has spread to other parts of the body,
and
- that has a certain type of abnormal
"BRAF" gene
BRAFTOVI should not be used to treat people with wild-type BRAF colorectal cancer. 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.
IMPORTANT SAFETY INFORMATION
BRAFTOVI (encorafenib) may cause serious side effects, including:
-
Risk of new skin cancers. BRAFTOVI combination therapy 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 treatment, 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 will check your heart function before and during treatment. Tell 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 in your hands, ankles, legs, or feet
- feeling faint or light-headed
-
Liver problems. Your healthcare provider will 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 your eyes
- dark or brown (tea-colored) urine
- nausea or vomiting
- loss of appetite
- tiredness
- bruising
- bleeding
-
Bleeding problems. BRAFTOVI combination therapy 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:
- 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
- nose bleeds
-
Eye problems. Your healthcare provider should perform an eye exam regularly during treatment. Tell your healthcare provider right away if you develop any new or worsening symptoms of eye problems, including:
- 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 taking BRAFTOVI combination therapy 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 during treatment with BRAFTOVI combination therapy. 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.
Tell your healthcare team if you are pregnant or plan to become pregnant. BRAFTOVI can harm your unborn baby.
- 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
- 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 become pregnant during treatment
Talk to your healthcare team if you 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.
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.
The most common side effects of BRAFTOVI when taken in combination with cetuximab and mFOLFOX6 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, and fever.
The most common side effects of BRAFTOVI when taken in combination with cetuximab include: fatigue, nausea, diarrhea, acne-like rash (dermatitis acneiform), stomach-area (abdominal) pain, decreased appetite, pain or swelling of your joints (arthralgia), and rash.
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
- 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 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 or visit
www.fda.gov/medwatch. You may also report side effects to Pfizer Inc. at
1-800-438-1985.
What is BRAFTOVI?
- BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) to treat people with cancer of the colon or rectum (colorectal cancer):
- that has spread to other parts of the body,
and
- that has a certain type of abnormal
“BRAF” gene
- BRAFTOVI in combination with cetuximab and mFOLFOX6 was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of BRAFTOVI in combination with cetuximab and mFOLFOX6.
- BRAFTOVI is a prescription medicine used in combination with a medicine called cetuximab to treat adults with cancer of the colon or rectum (colorectal cancer) after past treatment:
- that has spread to other parts of the body,
and
- that has a certain type of abnormal
"BRAF" gene
BRAFTOVI should not be used to treat people with wild-type BRAF colorectal cancer. 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.
