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Generic Name:

dabrafenib, Oral capsule

All Brands

  • Tafinlar
SECTION 1 of 5

Highlights for dabrafenib

Oral capsule
1

Dabrafenib is used to treat melanoma (skin cancer) only if you have a specific, abnormal BRAF gene.

2

This drug comes as a capsule you take by mouth.

3

Dabrafenib is available as the brand-name drug Tafinlar. It’s not available as a generic drug.

IMPORTANT INFORMATION

Other cancers

This drug can increase your risk of other skin and non-skin cancers. Your doctor may check your skin before treatment, every 2 months during treatment, and for up to 6 months after you stop taking this drug. They’ll do this to look for any new cancers. Tell your doctor right away about any skin changes you notice. These include a new wart, skin sore, or reddish bump that bleeds or doesn’t heal, or a change in size or color of a mole. Tell your doctor if you have a fever, tiredness, or weight loss while taking this drug.

Bleeding

This drug can increase your risk of bleeding, especially in your brain or stomach. This bleeding can be fatal (cause death). Tell your doctor if you plan to have surgery, dental procedures, or other procedures while taking this drug. You may bleed more during these procedures.

Fevers

This drug can cause severe fevers. These can cause chills, dehydration (lack of water in your body), kidney failure, and a drop in blood pressure. Call your doctor if you get a fever of 101.3°F or higher during treatment.

Wild-type BRAF melanoma

If you have wild-type BRAF melanoma, you should not use this drug. It can make your condition worse. This drug is only used to treat specific types of melanoma based on your genes. Your doctor will do tests to see which type of BRAF gene you have to see if you can take this drug.

What is dabrafenib?

Dabrafenib is a prescription drug. It comes as an oral capsule.

This drug is available as the brand-name drug Tafinlar. It’s not available as a generic drug.

This drug may be used as part of a combination therapy with another drug called trametinib.

Why it's used

Dabrafenib is used to treat melanoma (skin cancer). This drug is only used if you have a specific, abnormal BRAF gene. It’s given when the cancer has spread to other parts of your body or when it can’t be removed by surgery. This drug may be used alone or with another drug called trametinib.

How it works

This drug belongs to a class of drugs called kinase inhibitors. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

See Details

How it works

This drug belongs to a class of drugs called kinase inhibitors. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

This drug works by blocking B-Raf proteins in your body. This action decreases the growth of skin cancer cells.

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SECTION 2 of 5

dabrafenib Side Effects

Oral capsule

More common side effects

The more common side effects of dabrafenib can include:

  • thickening of your skin

  • headache

  • fever

  • joint aches

  • warts

  • hair loss

  • redness, swelling, and pain on the palms of your hands and soles of your feet

  • rash

  • cough

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include:

  • Major bleeding. Symptoms can include:

    • coughing up blood
    • blood in your vomit or vomit that looks like coffee grounds
    • stool that looks like tar
    • headache
    • dizziness
    • weakness
  • Heart problems. Symptoms can include:

    • heart palpitations (feeling like your heart is racing or pounding)
    • shortness of breath
    • swelling of your ankles or feet
    • dizziness
    • lightheadedness
  • Eye problems or blindness. Symptoms can include:

    • blurry vision, vision loss, or other vision changes
    • seeing colored dots
    • seeing halos (a blurred outline around objects)
    • eye pain, swelling, or redness
  • Fever. Symptoms can include:

    • chills
    • dehydration (lack of water in your body)
    • low blood pressure
    • dizziness
  • Skin reactions. Symptoms can include:

    • skin rash that bothers you or doesn’t go away
    • acne
    • redness, swelling, peeling, or tenderness of your hands or feet
    • skin redness
  • High blood sugar. Symptoms can include:

    • being thirstier than normal
    • urinating more often than normal or making more urine than normal
  • Anemia (decreased amount of healthy red blood cells). Symptoms can include:

    • yellowing of your skin
    • weakness or dizziness
    • shortness of breath
  • Infertility (difficulty becoming pregnant or fathering a child)

Pharmacist's Advice
Clinical Associate Professor, University of Illinois at Chicago College of Pharmacy

Dabrafenib doesn’t cause drowsiness.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 5

dabrafenib May Interact with Other Medications

Oral capsule

Dabrafenib can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Medications that might interact with dabrafenib

Interactions that increase your risk of side effects

Increased side effects from dabrafenib: Taking dabrafenib with certain medications raises your risk of side effects from dabrafenib. This is because the amount of dabrafenib in your body may be increased. Examples of these drugs include:

  • Ketoconazole, nefazodone, clarithromycin, and gemfibrozil
    • Taking these drugs with dabrafenib may increase your risk of thickened skin, headache, fever, body aches, warts, and hair loss. It may also increase your risk of cough and rash as well as redness, swelling, and pain on the palms of your hands and soles of your feet.

Interactions that can make your drugs less effective

When dabrafenib is less effective: When dabrafenib is used with certain drugs, it may not work as well to treat your condition. This is because the amount of dabrafenib in your body may be decreased. Examples of these drugs include:

  • Rifampin
  • Phenobarbital
  • Carbamazepine
  • St. John’s wort
  • Phenytoin

When other drugs are less effective: When certain drugs are used with dabrafenib, they may not work as well. This is because the amount of these drugs in your body may be decreased. Examples of these drugs include:

  • Midazolam
  • Warfarin
    • Your doctor should monitor your INR (a measure of the thinness of your blood) more often when you start and stop taking dabrafenib. If your warfarin isn’t working well, your INR will decrease.
  • Dexamethasone
  • Hormonal birth control
    • Birth control that contains hormones (such as birth control pills, injections, or patches) may not work as well during treatment with dabrafenib. You should use another non-hormonal method of birth control during your treatment with this drug.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
Drug warnings
diabetes warning
People with diabetes

This drug can further increase your blood sugar levels. Your doctor will test your blood sugar levels during your treatment. If your blood sugar level increases, your doctor may change your diabetes drugs or give you a new diabetes drug.

glucose-6-phosphate dehydrogenase deficiency
People with glucose-6-phosphate dehydrogenase deficiency

Ask your doctor if this drug is safe for you. This drug can increase unhealthy red blood cells. If your doctor gives you this drug, they will watch you closely for signs of hemolytic anemia.

heart problem warning
People with heart problems

This drug can harm your heart and keep it from working as well as it should. Ask your doctor if this drug is safe for you. If this drug affects your heart function, your doctor may temporarily stop your treatment with it.

wild-type BRAF melanoma
People with wild-type BRAF melanoma

You should not use this drug. It can make your condition worse.

reproduction warning
People with plans to have children

Talk to your doctor before taking this drug. This drug can cause fertility problems. This means it can lower a woman’s ability to get pregnant and it can lower sperm counts in men. This can lower a man’s ability to father a child. Women should not get pregnant during treatment with this drug.

pregnancy warning
Pregnant women

The Food and Drug Administration (FDA) hasn’t assigned a pregnancy category to this drug. However, studies suggest that this drug can harm a pregnancy.

Tell your doctor if you’re pregnant or plan to become pregnant. This drug should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

This drug can decrease the effectiveness of hormonal birth control methods, such as pills, injections, and patches. You should use a non-hormonal method of birth control, such as condoms and diaphragms.

Women shouldn’t become pregnant while taking this drug. Men and women should use effective birth control during treatment and for 2 weeks after taking the last dose of this drug. If you take this drug with trametinib, you should use effective birth control for 4 months after taking your last dose of this drug combination.

breast feeding warning
Women who are breast-feeding

This drug may pass into breast milk and cause side effects in a child who is breastfed.

You should not breastfeed during treatment and for 2 weeks after taking your last dose of this drug. If you’re taking this drug with trametinib, you should not breastfeed for 4 months after taking your last dose of this drug combination. Talk to your doctor about the best way to feed your child during this time.

childrens warning
For children

This drug has not been studied in children. It should not be used in people younger than 18 years.

call the doctor
When to call the doctor

Call your doctor right away if you become pregnant while taking this drug.

allergy warning
Allergies

This drug can cause a severe allergic reaction. Symptoms can include:

  • trouble breathing
  • swelling of your throat or tongue

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

SECTION 4 of 5

How to Take dabrafenib (Dosage)

Oral capsule

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What are you taking this medication for?

Advanced melanoma

Brand: Tafinlar

Form: Oral capsule
Strengths: 50 mg, 75 mg
Adult dosage (ages 18 years and older)
  • Typical starting dosage: 150 mg twice per day. Take each dose 12 hours apart.
  • Dosage adjustments: If you’re having certain side effects, your doctor may lower your dosage or temporarily or permanently stop your treatment with this drug.
Child dosage (ages 0–17 years)

This drug has not been studied in children. It should not be used in people younger than 18 years.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Clinical Associate Professor, University of Illinois at Chicago College of Pharmacy

This drug comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all

Your skin cancer won’t be treated. It may continue to progress or spread. This may eventually be fatal (cause death).

If you miss doses or don’t take the drug on schedule

Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much

You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

  • hair loss
  • hardening and thickening of your skin
  • headache
  • muscle and joint pain
  • back pain
  • constipation
  • cough
  • nose or throat irritation

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room right away.

What to do if you miss a dose

Take your dose as soon as you remember. But if it’s within 6 hours of your next scheduled dose, then take only the next dose at its regular time. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working

You may not be able to tell if this drug is working. You doctor will do tests to tell if this drug is treating your cancer.

This drug is used for long-term treatment.

Important considerations for taking this drug

Do not take this drug with food

Take this drug at least 1 hour before a meal or 2 hours after a meal.

Store this drug carefully

  • Store this drug at room temperature. Keep it between 59°F and 86°F (15°C to 30°C).
  • Keep this drug away from light.
  • Don’t store this medication in moist or damp areas, such as bathrooms.

A prescription for this medication is refillable

You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
  • Don’t worry about airport x-ray machines. They can’t hurt your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
  • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Self-management

Your doctor may have you check yourself for signs and symptoms of bleeding. Symptoms can include coughing up blood, blood in your vomit (or vomit that looks like coffee grounds), stool that looks like tar, headache, dizziness, and weakness.

Your doctor may also ask you to check for high blood sugar levels. They may ask you to test your blood sugar levels at home using a blood glucose meter. Your doctor will tell you where to get this device and how to use it. You may also need:

  • a safe needle disposal container
  • alcohol swabs
  • lancets (needles) to prick your finger
  • blood sugar test strips

Clinical monitoring

You and your doctor should monitor certain health issues during your treatment. This can help make sure you stay safe while you take this drug. These issues include:

  • Skin changes. Your doctor will do tests to see how your cancer is responding to treatment with this drug. They’ll also check you for any new warts, skin sores, and red bumps that bleed or don’t heal, and any changes in the size or color of a mole. You should check your skin for these symptoms as well. Tell your doctor about any skin changes you notice.
  • Heart function. This drug can harm your heart and can keep it from working as well as it should. Your doctor will check your heart function before and during your treatment with this drug.
  • Blood sugar levels. This drug can raise your blood sugar levels. Your doctor will test your blood sugar levels. If they increase, your doctor may prescribe insulin or oral diabetes drugs.
  • Pregnancy. If you’re a woman, your doctor may ask you to take pregnancy tests. You shouldn’t become pregnant during treatment with this drug.

Hidden costs

If your doctor tells you to monitor your blood sugar level at home, you may need to buy:

  • a safe needle disposal container
  • alcohol swabs
  • lancets (needles) to prick your finger
  • blood sugar test strips
  • a blood glucose monitor

If your doctor tells you to check if you’re pregnant, you may need to purchase pregnancy tests.

Insurance

Many insurance companies require a prior authorization for this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

SECTION 5 of 5

How Much Does dabrafenib Cost?

Oral capsule

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These prices represent the lowest priced national pharmacies for dabrafenib on GoodRx. They may be lower than your insurance.

Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on May 12, 2016

Disclaimer: Healthline 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 other 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.
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