Encorafenib

What it is used for

BRAFTOVI is a kinase inhibitor indicated: Melanoma in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1, 2.1 ) Colorectal Cancer (CRC) in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑authorized test.

( 1.2, 2.1 ) in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-authorized test, after prior therapy. ( 1.2, 2.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with binimetinib, for the treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-authorized test.

( 1.3, 2.1 ) Limitations of Use BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. ( 1.4, 5.2 ) 1.1 BRAF V600E or V600K Mutation–Positive Unresectable or Metastatic Melanoma BRAFTOVI is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test.

1.2 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (mCRC) BRAFTOVI is indicated, in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA- authorized test. BRAFTOVI is indicated, in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA- authorized test, after prior therapy.

1.3 BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) BRAFTOVI is indicated, in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Limitations of Use BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.

The most important thing to know

BRAFTOVI can cause serious side effects, including: Risk of new skin cancers. BRAFTOVI can 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 with BRAFTOVI. See "

How to take it

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 and grapefruit juice 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.

Side effects, and when to stop

" 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 medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults 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. Females who are able to become pregnant: o Use effective nonhormonal 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.

Who should not take it

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 can cause serious side effects, including: Heart problems, including heart failure. BRAFTOVI 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 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 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 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 treatment with BRAFTOVI 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.

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 diarrhea decreased appetite rash vomiting bleeding (hemorrhage) stomach-area (abdominal) pain pain or swelling of your joints (arthralgia) fever constipation The most common side effects of BRAFTOVI when taken in combination with cetuximab and FOLFIRI for colorectal cancer include: nausea diarrhea fatigue vomiting hair loss (alopecia) constipation stomach-area (abdominal) pain decreased appetite rash 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 combinat

Storing it

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.