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Overview: Tafinlar is used to treat certain types of cancers or tumors. Common side effects include thickening of the skin, headache, joint pain, and fever. Call your health care provider right away if you get a fever, rash,  unexplained bleeding, or shortness of breath. These could be symptoms of a serious side effect. Keep all appointments with your health care provider before, during, and after taking Tafinlar. Tafinlar comes as a capsule that is swallowed or a tablet that is mixed in water and swallowed.

Uses

What is Tafinlar used for?

Tafinlar (dabrafenib) is commonly used to treat certain kinds of cancers or tumors, including the following.

Your health care provider can do a test to see if your cancer should be treated with Tafinlar.

Tafinlar may also be used for other conditions as determined by your health care provider.

How does Tafinlar work (mechanism of action)?

Tafinlar is a type of medicine known as a kinase inhibitor. It works by targeting specific proteins in certain cancer or tumor cells. By blocking the action of these proteins, Tafinlar can help prevent cancer or tumor cells from growing or spreading.

How is Tafinlar supplied (dosage forms)?

Brands and other names

  • Tafinlar

Dosage forms and strengths

  • 50 mg and 75 mg oral capsules
  • 10 mg tablets for oral suspension

How should I store Tafinlar?

Tafinlar should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep Tafinlar in the original bottle. The bottles have a plastic canister called a desiccant to protect the medicine from moisture. Do not remove the drying canister.

Side Effects

What are the most common side effects of Tafinlar?

The most common side effects of Tafinlar are listed below. Side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Skin thickening (hyperkeratosis)
  • Headache
  • Fever (see below)
  • Joint pain
  • Warts
  • Hair loss
  • Hand-foot syndrome, which may cause symptoms of redness, swelling, tenderness, or peeling on the palms of your hands or soles of your feet

There may be other side effects of Tafinlar that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Tafinlar?

While less common, the most serious side effects of Tafinlar are described below, along with what to do if they happen.

Severe Allergic Reactions. Tafinlar may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking Tafinlar and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Cancer. Tafinlar can cause a new cancer to develop or cause a previously treated cancer to recur. Tell your health care provider about any new symptoms. Also tell your health care provider right away about any changes to your skin, such as changes to moles or new sores, bumps, or warts. Keep all appointments with your health care provider before, during, and after taking Tafinlar.

Severe Bleeding. Tafinlar can increase your risk of severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have any unusual bleeding, such as nosebleeds, or any of the following symptoms.

  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black poop (looks like tar)
  • Coughing up blood or blood clots
  • Feeling weak, dizzy, or having headaches

Thickened Heart Muscle. Tafinlar may cause your heart muscle to become thicker and not work as well, also known as cardiomyopathy. This may also increase your risk of heart failure. Keep all appointments with your health care provider to check your heart before starting and while taking Tafinlar. Tell your health care provider right away if you have any of the following symptoms of cardiomyopathy or heart failure.

  • Shortness of breath, coughing, or trouble breathing, especially while lying down
  • Swelling in your feet, ankles, legs, or hands
  • Unusually fast weight gain or bloating 
  • Unusual tiredness
  • A heartbeat that flutters or feels fast or pounding
  • Dizziness, lightheadedness, or fainting

Vision Problems. Tafinlar may cause eye inflammation (uveitis), which may be serious and lead to blindness. Keep all scheduled eye exams before starting and while taking Tafinlar. Call your health care provider right away if you have any of the following symptoms of uveitis.

  • Eye pain, redness, or swelling
  • Vision changes, such as blurred or double vision
  • Worsening vision
  • Sensitivity to light
  • Floaters (tiny dots or specks in your vision)

Fever. Tafinlar can commonly cause a fever, but it can sometimes cause a severe fever and other serious problems, including low blood pressure (hypotension), kidney damage, and dehydration. Call your health care provider right away if you get a fever or if you have any of the following symptoms.

  • Chills or shivering
  • Dizziness or lightheadedness
  • Weakness or unusual tiredness
  • Confusion
  • Unsteadiness
  • Peeing less than normal
  • Swelling in your legs, ankles, and feet
  • Loss of appetite or nausea
  • Trouble catching your breath or chest pain or pressure
  • Seizures
  • Extreme thirst

Severe Skin Reactions. Tafinlar can cause severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you get a rash, stop taking Tafinlar and call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms including fever, chills, and muscle aches

High Blood Sugar. Tafinlar may increase your blood sugar levels. Talk to your health care provider about how to maintain healthy blood sugar levels. Keep all appointments with your health care provider to check your blood work before starting and while taking Tafinlar. Call your health care provider if you have the following symptoms of high blood sugar.

  • Thirsty more than usual
  • Peeing more than usual
  • Increase in hunger
  • Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Overactive Immune Response. Tafinlar may cause a dangerous and life-threatening condition called hemophagocytic lymphohistiocytosis (HLH). This can occur when your immune system responds too much to medicines, cancer, or infection. Get emergency help if you have any of the following symptoms, even several weeks after you take Tafinlar. 

  • Fever or chills
  • Fast or racing heart
  • Dizziness or feeling lightheaded
  • Trouble breathing
  • Severe nausea, vomiting, or diarrhea
  • Reduced need to pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • Severe headache

Warnings & Precautions

Who should not use Tafinlar?

Allergies to Ingredients. People who are allergic to any of the following should not take Tafinlar.

  • Dabrafenib
  • Tafinlar
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Tafinlar.

What should I know about Tafinlar before using it?

Do not take Tafinlar unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Tafinlar with other people, even if they have the same condition as you. It may harm them.

Keep Tafinlar out of the reach of children.

Tafinlar should be taken at least one hour before or at least two hours after a meal. 

If you are taking Tafinlar capsules, do not crush, break, or open them. If you can not swallow the capsules whole, tell your health care provider.

If you are taking Tafinlar tablets for oral suspension, read and follow the instructions to mix Tafinlar tablets in water. Make sure you understand how to prepare, mix, and take it properly. Do not chew, crush, or swallow the tablets whole. After mixing Tafinlar tablets in water, the medicine should be taken within 30 minutes. If it is not used within 30 minutes, it should be thrown away. If you have any questions, talk to your health care provider.

If you throw up (vomit) after taking your Tafinlar dose, do not take another dose. Take your next dose at the usual time.

Tafinlar may make it hard for you to get pregnant or get your partner pregnant. Talk with your health care provider if this is a concern for you.

What should I tell my health care provider before using Tafinlar?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Tafinlar is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Bleeding problems
  • Heart problems, including cardiomyopathy, heart failure, or a heart attack
  • Skin problems
  • Eye problems
  • Diabetes or high blood sugar
  • Liver problems
  • Kidney problems
  • Planned surgeries or dental procedures
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Immune system problems or previous or current infections

Other Medicines and Supplements. Tafinlar may interact with other medicines and supplements. Before taking Tafinlar, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Tafinlar may cause harm to a fetus. If you can get pregnant, your health care provider will likely give you a test to make sure you are not pregnant before you start taking Tafinlar. If you can get pregnant, you should use effective non-hormonal birth control while taking Tafinlar and for two weeks after your last dose. Talk to your health care provider about your birth control options. If you are able to get a partner pregnant, you should use condoms while taking Tafinlar and for at least two weeks after your last dose. You need to use condoms even if you have had a vasectomy. Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant.

Breastfeeding. It is not known if Tafinlar passes into breast milk. You should not breastfeed while taking Tafinlar and for two weeks after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Tafinlar?

For more information about Tafinlar, you can visit the drugmaker’s website at www.us.tafinlarmekinist.com or call them at 888-669-6682.

Interactions

Does Tafinlar interact with foods or drinks?

Tafinlar should be taken at least one hour before or at least two hours after a meal.

Grapefruit may interact with Tafinlar. It is important to avoid eating grapefruit or drinking grapefruit juice while taking Tafinlar. Grapefruit can affect your body’s ability to break down Tafinlar, which can lead to high levels of the medicine and an increased risk of side effects.

It is unknown if drinking alcohol will affect Tafinlar, but heavy drinking can slow your immune response and make it harder for your body to fight cancer. Both Tafinlar and alcohol may also increase your risk of bleeding. It is best to limit the amount of alcohol you drink.

Does Tafinlar interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Tafinlar.

  • St. John’s wort, which is a supplement that may be used for depression
  • A birth control pill, patch, vaginal ring, implant, injection, or intrauterine device (IUD) that contains hormones
  • Midazolam, which is a medicine that may be used to make you sleepy before a procedure or to treat certain types of seizures
  • Itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which are used for fungal infections
  • A fibrate, such as gemfibrozil (Lopid), which is a medicine for high cholesterol
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Warfarin, which is a blood thinner
  • A statin, such as atorvastatin (Lipitor and others), which is a medicine to lower cholesterol
  • Dexamethasone, which is a medicine for certain inflammatory conditions

Many other medicines may alter the blood levels of Tafinlar and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Tafinlar. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Tafinlar?

If you or someone else has used too much Tafinlar, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Tafinlar?

If you miss a dose, take it as soon as you remember. If it is less than six hours until your next dose, skip the missed dose and only take the next dose at the usual time. Do not take double or extra doses.