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BRAFTOVI + cetuximab is a combination oral and infusion treatmenT

BRAFTOVI (encorafenib) is a once-daily oral medication taken with cetuximab, which is an infusion therapy. Take BRAFTOVI exactly as your healthcare provider tells you. Do not change your dose or stop taking it unless your healthcare provider tells you to.

Once-daily oral treatment

BRAFTOVI

Take 4 (75-mg) capsules by mouth once a day.

Infusion therapy

Cetuximab

Your healthcare provider will administer your cetuximab infusion.

Set treatment reminders

Make it a habit by setting an alarm on your phone or watch to remind you to take your BRAFTOVI at the same time every day.

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.

WHAT TO DO IF YOU MISS A DOSE

Take your dose of BRAFTOVI 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 the regular time.

Make sure to ask your healthcare provider any questions you may have about your cetuximab infusions. If you stop treatment with cetuximab, talk to your healthcare provider about your BRAFTOVI treatment. Your treatment with BRAFTOVI may need to be stopped.

 
 
 
 

Important things to remember when taking BRAFTOVI + cetuximab

When starting a new treatment, it can be helpful to make it part of your daily routine.

TAKE WITH OR WITHOUT FOOD

Take BRAFTOVI (encorafenib) with or without a meal or snack. There is no need to fast.

DO NOT EAT GRAPEFRUIT

Avoid consuming grapefruit when taking BRAFTOVI. Grapefruit products may increase the amount of BRAFTOVI in your body.

STORE IN A DRY PLACE

Store BRAFTOVI in its original bottle and in a dry place at room temperature. Keep the bottle closed tightly to protect it from moisture. It does not need to be refrigerated.

DRINK ENOUGH WATER

Staying hydrated is important, especially for people living with cancer. Talk with your healthcare provider about how much water you should drink daily.

Remember, this website is being provided for your information only and does not replace the medical advice of your healthcare provider.

Be sure to consult your healthcare provider regarding any questions or concerns you may have about your specific medical condition or treatment plan.

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Important Safety Information and Indication

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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.