Class: Biological Therapy

Generic Name: Enorafenib
Trade Name: Braftovi

For which conditions is this drug approved? BRAFTOVI is approved in combination with Mektovi® (binimetinib) for the treatment of melanoma with a BRAF V600E or V600K mutation [as detected by an FDA-approved test} that has either metastasized or is unresectable.

What is the mechanism of action? BRAFTOVI is a kinase inhibitor. These drugs work by blocking the action of enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing. Specifically, BRAFTOVI targets BRAF V600 kinases, which may be involved in cancer cell growth in metastatic melanoma.

How is BRAFTOVI/Mektovi typically given (administered)? Braftovi is taken orally once daily with MEKTOVI.

How are patients typically monitored? Patients should be monitored for new skin malignancies before, after, and during treatment; tumor growth; symptoms of bleeding; blood clotting; changes in vision; heart and eye problems; fever; skin infection; and hyperglycemia (high blood sugar).

What are the common (occur in 20% or more of patients) side effects of treatment with BRAFTOVI in combination with MEKTOVI?

• Fever
• Chills
• Fatigue
• Nausea
• Rash
• Dizziness
• Vision problems
• Vomiting
• Diarrhea
• Abdominal pain
• Peripheral edema
• Constipation
• High blood pressure

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects? Tell your doctor if you have or have had any medical condition, with special attention to the following:

• Bleeding problems or blood clots
• Heart problems
• Eye problems
• Liver or kidney problems
• Diabetes
• A deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme (an inherited condition that can put you at risk for hemolytic anemia)
• You plan to have surgery, dental, or other medical procedures
• You are pregnant or plan to become pregnant

Take BRAFTOVI one time a day exactly as your healthcare provider tells you to take it. Swallow capsules whole; don’t open, crush, or break them. Do not change your dose or stop BRAFTOVI unless your healthcare provider tells you to do so. If you miss a dose, take it as soon as you remember. If it is within 12 hours of your next scheduled dose, skip the missed dose and take the next dose at your regular time. If you take too much BRAFTOVI, call your healthcare provider or go to the nearest hospital emergency room right away.

Are there any special precautions patients should be aware of before starting treatment? BRAFTOVI can harm your unborn baby, and women who are able to become pregnant should use effective birth control during treatment and for four months when taking BRAFTOVI in combination with MEKTOVI. Be aware that birth control using hormones (such as birth control pills, injections, or patches) may not work as well with BRAFTOVI, so use a non-hormonal effective method of birth control. Tell your doctor if you are breastfeeding or plan to breastfeed; because it is not known if BRAFTOVI passes into your breast milk, you should not take this drug while breastfeeding.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Also call your healthcare provider right away if:

• You have symptoms of severe high blood sugar, such as increased thirst urinating more often than normal, or urinating an increased amount of urine.
• You have symptoms of a heart problem, including feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, or feeling lightheaded.
• You have signs of a blood clot, including chest pain, sudden shortness of breath or trouble breathing, pain in your legs with or without swelling, swelling in your arms or legs, a cool or pale arm or leg
• You have unusual signs of bleeding, such as: headaches or dizziness; if you feel weak, cough up blood or blood clots, vomit blood; your vomit looks like coffee grounds; or your stools red or black stools and look like tar
• You have signs of eye problems, including: blurred vision; loss of vision; or other vision changes; seeing color dots, a halo (a blurred outline around objects); eye pain; swelling; or redness
• You any new lesions, changes to existing lesions on their skin, or other signs and symptoms of malignancies (including warts, moles, and sores).
• You have symptoms of a type of anemia called hemolytic anemia where the body does not have enough healthy red blood cells (a risk in people with G6PD deficiency). Signs of anemia or breakdown of red blood cells include: yellow skin (jaundice), weakness or dizziness, and shortness of breath.
• You develop a fever.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 07/2018.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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