Braftovi is a brand-name oral capsule prescribed for certain forms of melanoma, colorectal cancer, and lung cancer. Braftovi contains the active ingredient encorafenib.

Specifically, the Food and Drug Administration (FDA) has approved Braftovi to treat:

Braftovi is approved to treat these cancers if they test positive for a particular genetic mutation (abnormal change in a gene). For more information, see the section called “Braftovi uses.”

Drug details

You’ll find key information about Braftovi here:

  • Drug class: kinase inhibitor, which is a type of targeted cancer therapy
  • Drug form: oral capsule
  • Generic available? no
  • Prescription required? yes
  • Controlled substance? no
  • Accelerated approval? yes, for certain uses (see “Braftovi uses” for details)

Braftovi is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.

The Braftovi dosage your doctor prescribes will depend on several factors. These include:

  • the type of cancer you’re taking Braftovi to treat
  • other medical conditions you may have
  • other medications you may take
  • whether you have certain side effects with Braftovi

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Braftovi comes as an oral capsule. It’s available in one strength of 75 milligrams (mg).

Dosage for melanoma

Braftovi is used to treat melanoma in adults in certain situations. It’s prescribed with another medication called binimetinib (Mektovi).

The recommended dosage of Braftovi for this use is 450 mg (six capsules) taken once per day.

Dosage for metastatic colorectal cancer

Braftovi is prescribed for metastatic colorectal cancer in adults in certain situations. (Metastatic means the cancer has spread from the bowel to other parts of the body.)

For this use, your doctor may prescribe Braftovi with cetuximab (Erbitux) and a chemotherapy regimen called mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin). If you’ve had past treatment for colorectal cancer, your doctor may prescribe Braftovi with cetuximab alone.

The recommended dosage of Braftovi for this use is 300 mg (four capsules) taken once per day.

Dosage for metastatic non-small cell lung cancer

Braftovi is prescribed for metastatic non-small cell lung cancer in adults in certain situations. (Metastatic means the cancer has spread from the lungs to other parts of the body.) For this use, your doctor will prescribe Braftovi with binimetinib (Mektovi).

The recommended dosage is 450 mg (six capsules) taken once per day.

About taking Braftovi

You’ll find information about key dosage issues here:

  • When to take: You should take Braftovi once per day.Taking the medication around the same time of day helps keep a steady level of the drug in your body. This helps Braftovi work effectively.
  • If you miss a dose: If you miss a dose and it’s more than 12 hours until your next dose is due, take the missed dose as soon as possible. But if it’s less than 12 hours until your next dose is due, skip the missed dose. Then take your next dose as usual when it’s due. Do not take two doses together or any extra doses to make up for missing a dose.
  • If you vomit: If you vomit after taking a dose of Braftovi, do not take any extra doses. Just continue to follow your usual dosing schedule.
  • Taking Braftovi with food: You can take Braftovi either with or without food.
  • Crushing, splitting, or chewing Braftovi: Ideally, you should swallow Braftovi capsules whole. The manufacturer doesn’t give advice on whether it’s safe to crush, split open, or chew the capsules. If you have trouble swallowing Braftovi, talk with your doctor or pharmacist.
  • Length of use: Braftovi is meant to be a long-term treatment. If you and your doctor determine that Braftovi is safe and effective for you, you’ll likely take it long term.
  • Length of time to work: Braftovi starts working as soon as you start taking it. However, it may take several weeks or months before it’s clear whether the medication is effective for you. Your doctor will likely order scans or other tests during your treatment to check how well the medication is working to treat your cancer.

Overdose

Do not take more Braftovi than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Braftovi

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number or go to the nearest emergency room right away.

Braftovi can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Braftovi. These lists do not include all possible side effects.

For more information about the possible side effects of Braftovi, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking Braftovi and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Mild side effects

Here is a partial list of mild side effects of Braftovi. To learn about other mild side effects, talk with your doctor or pharmacist, or view Braftovi’s prescribing information.

Mild side effects of Braftovi can include:

  • fatigue
  • nausea and vomiting
  • abdominal pain
  • joint or muscle pain
  • rash or itching
  • dry skin
  • hair loss
  • constipation or diarrhea
  • reduced appetite
  • headache
  • dizziness
  • numbness, tingling, burning, or pain in the hands or feet
  • fever

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Braftovi aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency phone number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects can include:

  • heart problems, such as heart failure or an abnormal heart rhythm called QT prolongation
  • liver damage
  • new cancers, including skin cancers and other types of cancer
  • bleeding, including bleeding in the stomach, intestine, or brain
  • eye problems such as uveitis
ALLERGIC REACTION

For some people, Braftovi can cause an allergic reaction.

In general, symptoms of an allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Braftovi, your doctor may recommend a different medication instead.

The Food and Drug Administration (FDA) approves prescription drugs such as Braftovi to treat certain conditions. Braftovi may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Braftovi for melanoma

Braftovi is FDA approved to treat melanoma (a type of skin cancer) in adults in certain situations. Specifically, it’s prescribed for melanoma that:

  • cannot be removed with surgery or is metastatic (has spread to other parts of the body, such as the lymph nodes or bone), and
  • has a certain genetic mutation (abnormal change in a gene) called a BRAF V600E or V600K mutation. Before prescribing Braftovi, your doctor will take a tissue sample from the tumor to check whether the cancer has this mutation. Your doctor will not prescribe Braftovi if tests show the cancer tissue does not have a BRAF mutation. This is also called wild-type BRAF melanoma.

Melanoma is a type of skin cancer that affects skin pigment-producing cells. Symptoms of melanoma can include:

  • new mole or mark on the skin
  • change in the size, shape, or color of an existing mole
  • skin sore that doesn’t heal
  • skin mark, lump, or mole that bleeds, itches, is painful, or crusts
  • mark or lump that looks shiny, waxy, smooth, or pale

Braftovi is a targeted cancer therapy that kills the cancer cells. For this purpose, Braftovi is prescribed with another targeted cancer therapy called binimetinib (Mektovi).

Braftovi for colorectal cancer

Braftovi is FDA approved to treat colorectal cancer (also called bowel cancer) in adults in certain situations. Specifically, it’s prescribed for colorectal cancer that:

  • is metastatic (has spread to other parts of the body, such as the liver or lungs), and
  • has a certain genetic mutation (abnormal change in a gene) called a BRAF V600E mutation. Before prescribing Braftovi, your doctor will take a tissue sample from the tumor to check whether the cancer has this mutation. Your doctor will not prescribe Braftovi if tests show your cancer tissue does not have a BRAF mutation. This is also called wild-type BRAF colorectal cancer.

Colorectal cancer starts in the colon (large intestine) and/or rectum. Symptoms of colorectal cancer can include:

  • change in bowel habits, such as constipation or diarrhea
  • bleeding from the rectum
  • blood in the stool, which may look black or dark brown
  • feeling that the bowel doesn’t empty completely
  • abdominal pain
  • feeling full or bloated
  • unexpected weight loss
  • fatigue

Braftovi is a targeted cancer therapy that kills the cancer cells. For this purpose, Braftovi is prescribed with another targeted cancer therapy called cetuximab (Erbitux) and a chemotherapy regimen called mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin). If you’ve had past treatment for colorectal cancer, your doctor may prescribe Braftovi with cetuximab alone.

Note that Braftovi received accelerated approval for treating metastatic colorectal cancer in combination with cetuximab (Erbitux) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin). This approval was based on data from early clinical trials. The FDA may fully approve this use or withdraw approval based on data from further clinical trials.

Braftovi for non-small cell lung cancer

Braftovi is FDA approved to treat non-small cell lung cancer (NSCLC) in adults in certain situations. Specifically, it’s prescribed for NSCLC that:

  • is metastatic (has spread to other parts of the body, such as the bones or brain), and
  • has a certain genetic mutation (abnormal change in a gene) called a BRAF V600E mutation. Before prescribing Braftovi, your doctor will take a tissue sample from your tumor to check whether the cancer has this mutation. Your doctor will not prescribe Braftovi if tests show your cancer tissue does not have a BRAF mutation. This is also called wild-type BRAF NSCLC.

NSCLC is the most common type of lung cancer. Symptoms can include:

  • ongoing cough
  • coughing up blood
  • shortness of breath
  • chest pain
  • fatigue
  • unexpected weight loss

Braftovi is a targeted cancer therapy that kills the cancer cells. For this purpose, Braftovi is prescribed with another targeted cancer therapy called binimetinib (Mektovi).

Braftovi and children

Braftovi is not FDA approved for use in children. It’s not known whether the drug is safe or effective in children.

Braftovi can interact with several other medications. It can also interact with certain supplements and foods.

Before taking Braftovi, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications, foods, and supplements

Here is a list of medications, supplements, and foods that can interact with Braftovi. This list does not contain all drugs that may interact with Braftovi. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Braftovi• certain antifungals, such as itraconazole (Sporanox) and ketoconazole
• certain antibiotics, such as clarithromycin, erythromycin (EryTab, others), ciprofloxacin (Cipro), and rifampin (Rifadin, Rimactane)
• certain HIV medications, such as ritonavir (Norvir) and cobicistat (Tybost)
• certain calcium channel blockers, such as diltiazem (Cardizem CD, others) and verapamil (Verelan)
• certain seizure medications, such as carbamazepine (Tegretol, others) and phenytoin (Dilantin, Phenytek)
• hormonal contraceptives, such as the combined pill, mini pill, or patch
• antiarrhythmics, such as amiodarone (Pacerone) and dronedarone (Multaq)
• certain antipsychotics, such as quetiapine (Seroquel) and ziprasidone (Geodon)
• certain statins, such as rosuvastatin (Crestor) and simvastatin (Zocor, Flolipid)
• blood thinners, such as warfarin (Jantoven)
Vitamins or supplements that can interact with Braftovi• St. John’s wort
Foods that can interact with Braftovi• grapefruit

Alcohol interaction

Alcohol is not known to interact with Braftovi. However, drinking alcohol may worsen certain Braftovi side effects, such as nausea, diarrhea, headache, and liver problems. If you have questions about the safety of drinking alcohol while taking Braftovi, talk with your doctor or pharmacist.

As with all medications, the cost of Braftovi can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Braftovi or help understanding your insurance coverage, help is available.

A program called Pfizer Oncology Together is available for Braftovi. For more information and to find out if you’re eligible for support, call 877-744-5675 or visit the program website.

Generic version: Braftovi is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in an alternative to Braftovi, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Braftovi:

  • bevacizumab (Avastin)
  • binimetinib (Mektovi)
  • cetuximab (Erbitux)
  • cobimetinib (Cotellic)
  • dabrafenib (Tafinlar)
  • panitumumab (Vectibix)
  • regorafenib (Stivarga)
  • trametinib (Mekinist)
  • vemurafenib (Zelboraf)

If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.

Braftovi and pregnancy

Braftovi can cause fetal harm and should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor may suggest birth control options to use during treatment with Braftovi.

Braftovi and fertility

Based on studies in animals, Braftovi may reduce fertility in males taking the medication. It’s not known whether Braftovi may reduce fertility in females. If you have concerns about Braftovi’s effect on your future fertility, talk with your doctor about your options.

Braftovi and birth control

Braftovi is not safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control options while you’re taking Braftovi.

Note: The use of binary terms such as “male” and “female” or “men” and “women” in this article reflects the language of the sources we’ve used. Unless otherwise noted, it’s unclear whether the research we reference included participants with expansive gender identities.

For females using Braftovi

If you are able to become pregnant, you should use a nonhormonal form of birth control while taking Braftovi and for 2 weeks after stopping treatment. Braftovi can make hormonal forms of birth control, such as the pill or patch, less effective.

For males using Braftovi

Braftovi’s manufacturer doesn’t recommend whether males taking the medication should use birth control. If you have a sexual partner who is able to become pregnant, talk with your doctor.

Braftovi and breastfeeding

It’s not known whether Braftovi is safe to take while breastfeeding. Due to the possible risk to a child who is breastfed, the manufacturer recommends that you should not breastfeed while taking Braftovi and for 2 weeks after stopping treatment.

If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may suggest a different treatment for your condition or recommend other ways to feed a child.

Braftovi is a targeted cancer therapy. This means it works by blocking specific proteins or processes that help cancer cells multiply.

Braftovi treats certain forms of melanoma, colorectal cancer, and lung cancer that test positive for a mutation (abnormal change) in a gene called BRAF. Cells that contain mutated forms of this gene produce abnormal proteins that help the cells grow and multiply faster than usual. This can lead to cancer.

Braftovi works by blocking the abnormal BRAF proteins produced by the mutated BRAF gene. It also blocks certain other proteins that help the cancer cells grow and multiply. These effects kill the cancer cells and help shrink the tumors. They help to stop the cancer from growing and spreading.

Braftovi is used with other targeted therapies that block different proteins that help cancer cells grow and spread. Combining the treatments is more effective than using them on their own.

Here are answers to some frequently asked questions about Braftovi.

Is Braftovi chemotherapy or immunotherapy?

No, Braftovi is not chemotherapy or immunotherapy. Instead, it’s a targeted cancer therapy.

Chemotherapy is a treatment that kills cells in your body that are multiplying rapidly. This can include healthy cells as well as cancer cells. As a result, chemotherapy can cause many side effects. In particular, it can affect your blood cells.

Targeted cancer therapies like Braftovi work by blocking specific proteins or processes that help cancer cells multiply. This allows them to more effectively target and kill cancer cells over healthy cells. Note that these therapies can still cause some serious side effects.

If you have colorectal cancer, your doctor will prescribe Braftovi with another targeted therapy, called cetuximab (Erbitux). They may also prescribe a chemotherapy regimen called mFOLFOX6 with this combination. If you have melanoma or non-small cell lung cancer, your doctor will prescribe Braftovi with a targeted therapy called binimetinib (Mektovi).

Immunotherapy is a type of treatment that helps your immune system find and kill cancer cells. As with both other treatments, immunotherapy can also cause some serious side effects. Immunotherapy can be used to treat the same cancers that Braftovi treats.

Note that although Braftovi is not classified as immunotherapy, it does have some effects that help your immune system fight the cancer.

How long does Braftovi work?

How long Braftovi will work for you depends on many different factors. These include the type and severity of your cancer, other medications you take with Braftovi, and past treatments you may have had.

In people whose cancer responded to Braftovi in clinical trials, the length of time the drug worked for them ranged from over 1 month to over 4 years.

For more details about how long Braftovi worked for people in clinical trials, see the drug’s prescribing information or the manufacturer’s website.

Keep in mind that Braftovi may not work for everyone, and you may have different results from those seen in clinical trials. For more information about what you may be able to expect from treatment with Braftovi, talk with your doctor.

Before taking Braftovi, discuss your health history with your doctor. Braftovi may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • liver problems
  • heart problems, such as heart failure or an abnormal heart rhythm (including long QT syndrome)
  • raised risk of bleeding
  • low potassium or magnesium levels
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding

Note: For more information about the potential negative effects of Braftovi, see the “Braftovi side effects” section.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.