Pronunciation: braf-TOE-vee
Generic name: encorafenib
Dosage form: oral capsule
Drug class: Multikinase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 25, 2023.

What is Braftovi?

Braftovi (encorafenib) is an oral kinase inhibitor that may be used to treat certain types of cancer in combination with other medications. It is approved to treat adults:

• with melanoma skin cancer with a confirmed BRAF V600E or V600K mutation that cannot be treated with surgery or has spread to other parts of the body (metastasized) in combination with binimetinib
• who have had prior treatment for metastatic colorectal cancer with a confirmed BRAF V600E mutation, in combination with cetuximab
• with metastatic non-small cell lung cancer (NSCLC) with a confirmed BRAF V600E mutation in combination with binimetinib.

Braftovi is only used for patients with an abnormal BRAF gene (this is a specific genetic marker). Your doctor will test you for this gene. This medicine is not for treating wild-type BRAF cancers, such as wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.

Braftovi was FDA-approved on June 27, 2018.

Warnings

Although Braftovi is used to treat melanoma, it may increase your risk of developing other types of cancer including skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin or other symptoms. 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 to look for any new skin or other cancers.

Braftovi can harm an unborn baby. Do not use it if you are pregnant. Your doctor may conduct a pregnancy test before you start treatment if you are a woman of childbearing age. Use a non-hormonal form of birth control to prevent pregnancy while using Braftovi and for at least 2 weeks after your last dose.

Avoid it in BRAF wild-type tumors because of the risk of increased cell proliferation.

May not be suitable for patients with cardiomyopathy when used in combination with binimetinib. Your healthcare provider will assess your left ventricular ejection fraction (LVEF) before initiating treatment, then after one month of treatment, and then every 2 to 3 months thereafter.

May cause liver toxicity when used in combination with binimetinib. Your healthcare provider will conduct liver function tests before treatment, and then monitor your liver function during treatment.

There is also a risk of major bleeding events, uveitis (inflammation inside the eye), and QT prolongation. Your doctor may perform certain tests before starting treatment, and then monitor you throughout treatment. Electrolyte abnormalities may need correcting before starting Braftovi. Braftovi is not recommended to be used as a single agent.

Before taking this medicine

You should not use Braftovi if you are allergic to encorafenib or any of the other ingredients in the capsules.

To make sure Braftovi is safe for you, tell your doctor if you have ever had:

• heart problems including a condition called long QT syndrome (in you or a family member)
• lung disease
• liver or kidney disease
• eye problems (especially a problem with your retina) or
• bleeding problems, or a blood clot
• have had bleeding problems
• have been told that you have low blood levels of potassium, calcium, or magnesium
• are pregnant or plan to become pregnant. Braftovi can harm your unborn baby.

This medicine may affect fertility (the ability to have children) in men.

Pregnancy

If you are a woman of childbearing potential, your healthcare provider will do a pregnancy test before you start taking Braftovi. Females who can become pregnant should use effective non-hormonal birth control (contraception) during treatment with Braftovi and for 2 weeks after the last dose.

Braftovi can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Braftovi, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Talk to your healthcare provider about birth control methods that may be right for you during this time.

If you inadvertently become pregnant while taking Braftovi, tell your healthcare provider right away.

Breastfeeding

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

How should I take Braftovi?

Take Braftovi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

• Braftovi is usually taken once per day
• It may be taken with or without food.
• You may need to take 4 to 6 capsules at one time for a complete dose. Follow your doctor's dosing instructions very carefully.
• If you vomit shortly after taking Braftovi, do not take another dose. Wait until your next scheduled dose time to take the medicine again.
• Do not change your dose or dosing schedule without your doctor's advice.

Dosing information

• May be taken with or without food.
• Avoid grapefruit during treatment with Braftovi. Grapefruit products may increase the amount of encorafenib in your body.

Usual adult dose for melanoma or NSCLC

• 450 mg orally once a day in combination with binimetinib.

Usual adult dose for colorectal cancer

• 300 mg orally once daily in combination with cetuximab.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

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 dose may need to be changed or stopped.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Grapefruit may interact with Braftovi and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the side effects of Braftovi?

Get emergency medical help if you have signs of an allergic reaction to Braftovi such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Braftovi may cause serious side effects, including an increased risk of new skin cancers, such as cutaneous squamous cell carcinoma or basal cell carcinoma. 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 the size or the color of a mole.

Your healthcare provider should also check your skin before treatment, then 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 with Braftovi.

Some side effects are more likely to occur with Braftovi and binimetinib together.

Call your doctor at once if you develop:

• eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision
• a severe skin rash, skin pain or swelling, redness, and peeling skin on your hands or feet;
• a fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or
• signs of bleeding, such as weakness, dizziness, headache, nosebleeds, rectal bleeding, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds
• signs of liver problems, such as yellowing of your skin or your eyes, dark or brown (tea-colored) urine, nausea or vomiting, loss of appetite, tiredness, bruising, or bleeding.

Common Braftovi side effects that affect more than 25% of patients, depending on the condition being treated include:

• fatigue
• nausea
• diarrhea/constipation
• dermatitis acneiform
• cough
• shortness of breath
• vomiting
• abdominal pain
• joint pain
• musculoskeletal pain
• rash
• visual impairment such as blurred vision.

Although this medicine is used to treat melanoma, using encorafenib may increase your risk of developing other types of skin cancer. Tell your doctor if you notice any new skin symptoms such as redness, warts, sores that will not heal, or a mole that has changed in size or color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What other drugs will affect Braftovi?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, including:

• Strong or moderate CYP3A4 inhibitors, such as clarithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, or saquinavir. Avoid coadministration, but if unavoidable, reduce the dosage of Braftovi
• Strong or moderate CYP3A4 inducers, such as phenobarbital, phenytoin, rifampicin, St. John's Wort, or glucocorticoids. Avoid coadministration.
• Sensitive CYP3A4 substrates, such as lenacapavir or hormonal contraceptives. Coadministration may increase the toxicity or decrease the efficacy of these agents. Avoid hormonal contraceptives.
• Substrates of OATP1B1, OATP1B3, or BCRP transporters, such as statins, rifampicin, bosentan, valsartan, and thyroid hormones. Dose reductions may be required.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Related/similar drugs

methotrexate, Keytruda, pembrolizumab, capecitabine, Avastin, cisplatin, Xeloda, nivolumab, Tagrisso, Opdivo

Storage

Store at room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).

Do not use it if the safety seal under the cap is broken or missing. Do not remove the desiccant. Protect from moisture. Keep the container tightly closed and out of reach of children.

Ingredients

Active: encorafenib 75mg

Inactive: copovidone, poloxamer 188, microcrystalline cellulose, succinic acid, crospovidone, colloidal silicon dioxide, magnesium stearate (vegetable origin).

Capsule shell: Gelatin, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide, monogramming ink (pharmaceutical glaze, ferrosoferric oxide, propylene glycol).

Manufacturer

Array BioPharma Inc.

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