Tafinlar (dabrafenib) is a brand-name prescription medication. The Food and Drug Administration (FDA) has approved it to treat certain types of the following cancers:

The cancers must be BRAF-positive, which means the cancer cells have specific gene mutations (changes). For some conditions, your doctor may prescribe Tafinlar in combination with another medication called trametinib (Mekinist).

Here are some fast facts about Tafinlar:

  • Active ingredient: dabrafenib
  • Drug class: kinase inhibitor
  • Drug form: oral capsule

In most cases, you’ll take Tafinlar as a long-term treatment. However, if your doctor prescribes the drug as an adjuvant therapy for melanoma, they may recommend you take it for 1 year. (Adjuvant therapy means taking a drug after your cancer has been surgically removed to help prevent it from coming back.)

As with other drugs, Tafinlar can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Tafinlar, including details about its uses, see this article.

* Tafinlar received accelerated approval for this use based on early clinical trials. Continued approval of the drug will depend on additional clinical trial data.

To treat certain conditions, your doctor may prescribe Tafinlar with trametinib (Mekinist). In this case, you may experience different side effects because of the combination of drugs.

Side effects you experience from Tafinlar and Mekinist may depend on the condition the drugs are treating. Below are more common side effects of the two medications when used in combination in clinical trials.

Mild side effects in people taking Tafinlar and Mekinist for melanoma that’s metastatic (has spread to other body parts) or cannot be surgically removed include:

  • skin rash
  • cough
  • joint pain
  • headache*
  • fever or chills*

Mild side effects in people taking Tafinlar and Mekinist for adjuvant treatment of melanoma include:

  • fatigue
  • nausea, vomiting, or diarrhea
  • skin rash
  • joint or muscle pain
  • headache*
  • fever or chills*

Mild side effects in people taking Tafinlar and Mekinist for non-small cell lung cancer include:

  • fatigue
  • nausea, vomiting, or diarrhea
  • decreased appetite
  • swelling of the face, arms, or legs
  • rash or dry skin
  • cough
  • shortness of breath
  • fever or chills*
  • bleeding*

Mild side effects in adults taking Tafinlar and Mekinist for solid tumors include:

  • fatigue
  • nausea or vomiting
  • constipation or diarrhea
  • skin rash
  • cough
  • muscle or joint pain
  • swelling of the arms or legs
  • headache*
  • fever or chills*
  • bleeding*

Tafinlar and Mekinist are not chemotherapy drugs and likely cause fewer side effects than chemotherapy.

* For more information, see the “Side effect specifics” section below.

Tafinlar can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Tafinlar alone in clinical trials:

In some cases, your doctor may prescribe Tafinlar with another medication called trametinib (Mekinist). For common side effects of this drug combination, see “Tafinlar and Mekinist side effects” above.

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Tafinlar use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Tafinlar’s prescribing information.

Mild side effects that have been reported with Tafinlar when taken alone include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

In some cases, your doctor may prescribe Tafinlar with another medication called trametinib (Mekinist). For common side effects of this drug combination, see “Tafinlar and Mekinist side effects” above.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Tafinlar and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Tafinlar may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Tafinlar’s prescribing information.

If you develop serious side effects while taking Tafinlar, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

  • New cancer, such as skin cancer. Symptoms can include:
    • new skin growths
    • changes in moles
    • skin sores or bumps that don’t heal
  • Serious skin-related side effects, such as Stevens-Johnson syndrome. Symptoms can include:
    • skin rash
    • skin peeling
    • fever
  • Heart problems, such as cardiomyopathy (weakened heart muscle) and congestive heart failure. Symptoms can include:
    • difficulty breathing
    • swelling in your legs or feet
    • chest pain
    • dizziness
  • Hyperglycemia (high blood sugar), which can increase your risk of diabetes. Symptoms may include:
    • urinating more often than usual
    • fatigue
    • increased thirst
  • Eye and vision problems.*
  • Serious febrile reaction.†
  • Bleeding.*
  • Severe allergic reaction.*

In some cases, your doctor may prescribe Tafinlar with another medication called trametinib (Mekinist). For common side effects of this drug combination, see “Tafinlar and Mekinist side effects” above.

* For more information about this side effect, see “Side effect specifics” below.
† To learn more, see “Fever or chills” in the “Side effect specifics” section below.

Tafinlar can cause many of the same side effects in children as it does in adults. The most common side effects reported in children ages 6 years and older taking Tafinlar and Mekinist for solid tumors include:

  • skin rash, including a rash that looks like acne
  • dry skin
  • nausea or vomiting
  • constipation or diarrhea
  • fatigue
  • cough
  • abdominal pain
  • nail infection
  • headache*
  • fever or chills*
  • bleeding*

Tafinlar is not approved to treat solid tumors in children younger than age 6 years. The drug is also not approved to treat melanoma, non-small cell lung cancer, or anaplastic thyroid cancer in children.

* For more information, see the “Side effect specifics” section below.

Learn more about some of the side effects that Tafinlar may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Tafinlar.

Eye and vision problems

It’s possible for Tafinlar to cause ocular side effects (eye-related side effects) such as blurry vision. However, blurry vision can also be a symptom of a more serious eye-related side effect called uveitis. With uveitis, you have inflammation in parts of your eye.

Eye and vision problems, including uveitis, were not common side effects in people taking Tafinlar. You can experience eye and vision side effects whether you’re taking Tafinlar alone or in combination with dabrafenib (Mekinist).

Symptoms of uveitis can include:

  • blurry or cloudy vision
  • eye pain and redness
  • sensitivity to light
  • headache

If uveitis isn’t treated, it’s possible that loss of vision may occur.

What you can do

If you develop symptoms of any eye or vision problems, talk with your doctor right away. They can examine your eyes. Your doctor will want to treat uveitis as soon as possible.

If treatment doesn’t help your condition or if your uveitis is severe, your doctor may have you pause your use of Tafinlar until your condition improves. In some cases, they may prescribe a lower dose of Tafinlar when restarting your treatment. Other times, they may recommend a different treatment option.

Headache

Headache was a common side effect in people who took Tafinlar alone and in those who took Tafinlar in combination with trametinib.

What you can do

If you develop a headache during your Tafinlar treatment, talk with your doctor. They may recommend an over-the-counter pain medication such as acetaminophen (Tylenol).

Fever or chills

It’s possible to experience fever, chills, or both with Tafinlar. Mild fever and chills were common side effects in people who took the drug in clinical trials. These side effects were reported in people who took Tafinlar alone or in combination with trametinib.

A fever is when your body temperature is 100.4°F (38°C) or higher. Symptoms of a fever may include feeling warmer or colder than usual. Other possible symptoms include chills, sweating, and weakness.

Fever and chills can also be symptoms of a serious febrile reaction. This is a less common, severe side effect of Tafinlar. With a serious febrile reaction, a fever occurs along with other problems, such as:

Taking Tafinlar with trametinib may increase the risk of developing a mild fever or a serious febrile reaction.

What you can do

If you develop a fever during your treatment, talk with your doctor right away. They may recommend taking medication to reduce your fever, such as acetaminophen. Your doctor will also likely have you monitor your temperature. In addition, they may encourage you to drink plenty of fluids to help prevent dehydration.

If your fever is lower than 104°F, your doctor will likely pause your Tafinlar treatment until your fever goes away. Then they may prescribe the same or a lower dose of the drug when restarting your treatment.

If your fever is above 104°F or you develop a serious febrile reaction, your doctor will likely pause your Tafinlar treatment. In some cases, they may prescribe a steroid medication, such as prednisone (Rayos). Once your fever breaks (drops below 104°F), they may restart your treatment with a lower dose of Tafinlar. Other times, your doctor may switch you to a different medication for your condition.

Bleeding

Bleeding was often reported in people who took Tafinlar or Tafinlar in combination with trametinib. Serious bleeding was not common.

Examples of mild bleeding include nosebleeds, bleeding of the gums, and bruising. In some cases, bleeding can occur in your organs, which can be serious and possibly life threatening. Symptoms of serious bleeding can include:

  • headache
  • weakness
  • dizziness
  • coughing up blood
  • vomiting blood or a substance like coffee grounds
  • red or black, tarry stool

What you can do

If you develop any symptoms of bleeding, immediately see your doctor or go to the hospital so you can be treated. In most cases, your doctor will pause your Tafinlar treatment until your bleeding stops. They may restart your treatment by prescribing Tafinlar at a lower dose. However, if you have a serious bleed, they may switch you to a different medication.

Allergic reaction

As with most drugs, Tafinlar can cause an allergic reaction in some people.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Tafinlar. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Be sure to talk with your doctor about your health history before you take Tafinlar. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health. These are known as drug-condition or drug-factor interactions. The conditions and factors to consider include:

Bleeding problems. Tafinlar may cause bleeding. If you have a bleeding problem, such as hemophilia, you may be at an increased risk of bleeding during your treatment. Your doctor may monitor you more often than usual for symptoms of bleeding.

Heart problems. Tafinlar may cause heart problems. If you have a heart problem, such as congestive heart failure, tell your doctor before taking the medication. People with heart problems weren’t included in clinical trials of Tafinlar. So it’s not known what effects the drug may have on people with these problems. Your doctor can help determine whether Tafinlar is safe for you.

Eye or vision problems. Before starting treatment with Tafinlar, tell your doctor about any eye or vision problems you have. People with vision problems weren’t included in clinical trials of Tafinlar. So it’s not known what effects the drug may have on people with these problems.

In addition, Tafinlar can increase your risk of eye-related side effects, such as uveitis. If you already have an eye or vision condition, Tafinlar may worsen it.

You can talk with your doctor to determine what the right treatment option is for you.

Liver problems. Before starting treatment with Tafinlar, tell your doctor if you have a liver problem. The medication wasn’t studied in people with moderate to severe liver problems. So it’s not known how people with these problems may respond to treatment. Your doctor can determine how serious your liver condition is and whether it’s safe for you to take Tafinlar.

Allergic reaction. If you’ve had an allergic reaction to Tafinlar or any of its ingredients, your doctor will likely not prescribe Tafinlar. Taking the drug could cause another allergic reaction. Ask your doctor what other medications may be better options for you.

Kidney problems. If you have any kidney problems, tell your doctor before you start to take Tafinlar. Some people who took the drug have had serious febrile reactions (fever along with other problems, including kidney failure). If you already have a kidney condition, talk with your doctor to determine whether Tafinlar is right for you.

Diabetes. Before you start Tafinlar treatment, tell your doctor if you have diabetes or high blood sugar levels. Tafinlar may increase your blood sugar level. If you already have diabetes or high blood sugar, taking Tafinlar may make your condition worse. Your doctor may recommend monitoring your blood sugar level more often than usual.

Upcoming surgery or dental procedures. If you have any upcoming surgeries or dental procedures, tell your doctor before taking Tafinlar. This medication can increase your risk of bleeding. Your doctor and dentist should be aware of this risk before you have surgery or dental procedures.

Deficiency of G6PD enzyme. If you have a genetic disorder known as a G6PD deficiency, tell your doctor before taking Tafinlar. (G6PD stands for glucose-6-phosphate dehydrogenase.) You may be at an increased risk of developing a condition called hemolytic anemia if you have a G6PD deficiency. Due to this risk, your doctor will monitor you more often for symptoms of hemolytic anemia, such as dizziness or fever.

Alcohol with Tafinlar

There aren’t any known interactions between Tafinlar and alcohol. However, alcohol may make some of the side effects of Tafinlar worse. For example, Tafinlar may cause side effects such as:

  • headache
  • nausea or vomiting
  • fatigue

These effects may also be caused by drinking alcohol. So if you take Tafinlar and drink alcohol, you may have an increased risk of these side effects.

Talk with your doctor to determine whether it’s safe for you to drink alcohol during Tafinlar treatment.

Pregnancy and breastfeeding while taking Tafinlar

Here’s some information about pregnancy, breastfeeding, and Tafinlar.

Pregnancy. Tafinlar is not safe to take during pregnancy. There isn’t enough information from pregnant people who took Tafinlar to determine what risks the drug may cause. However, in animal studies, there was an increased risk of harm to the fetus when animals were exposed to the drug during pregnancy.

Due to these risks, if you can become pregnant, your doctor will have you take a pregnancy test before you start treatment. This is to confirm that you’re not pregnant.

You should also use an effective form of birth control during treatment and for at least 2 weeks after you stop taking Tafinlar. The drug can interact with hormonal contraceptives, such as the birth control injection or pill. Because of this, you should use nonhormonal birth control, such as condoms.

If you’re a male* and your partner can become pregnant, you should use condoms during treatment with Tafinlar. Be sure to keep using condoms for at least 2 weeks after your last dose of the medication.

Breastfeeding. There hasn’t been research to determine whether Tafinlar passes into breast milk or what effects the drug may have on a child who is breastfed. However, due to possible serious reactions that may occur in the child, breastfeeding during treatment is not recommended. You should also not breastfeed for at least 2 weeks after your last dose of Tafinlar.

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

In most cases, side effects you may experience with Tafinlar should be mild. However, it’s possible to experience serious side effects from this medication as well. Be sure to let your doctor know if you develop any serious side effects.

If you’d like to learn more about Tafinlar, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

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.