Important Safety Information and Indication

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

• Risk of new skin cancers. BRAFTOVI, when used alone or with 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:

  • 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 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.

• Bleeding problems. BRAFTOVI, when taken with cetuximab, 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 taking BRAFTOVI with cetuximab 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 cetuximab. These symptoms may be related to QT prolongation.

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 team 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 final dose of BRAFTOVI.

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 in combination with cetuximab include: fatigue, nausea, diarrhea, acne-like rash (dermatitis acneiform), 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 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-10881-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see BRAFTOVI full Prescribing Information, including Medication Guide, for additional information.

What is BRAFTOVI?

BRAFTOVI is a prescription medicine used:

• in combination with a medicine called cetuximab, for the treatment of adults with cancer of your colon or rectum (colorectal cancer):

  • that has been previously treated, and
  • 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.