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Tafinlar

Generic Name: dabrafenib (da bRAF e nib)
Brand Names: Tafinlar

Medically reviewed by P. Thornton, DipPharm Last updated on Oct 9, 2019.

What is Tafinlar?

Tafinlar (dabrafenib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Tafinlar is used alone or in combination with another medicine called trametinib (Mekinist) to treat certain types of cancer in people who have a "BRAF" gene mutation.

Tafinlar is for use in treating:

  • melanoma (skin cancer) that cannot be treated with surgery or has spread to other parts of the body, or to prevent melanoma from coming back after surgery;

  • non-small cell lung cancer that has spread to other parts of the body; or

  • advanced or metastatic thyroid cancer that has spread and for which there are no other treatment options.

Important Information

Using Tafinlar with trametinib may increase your risk of developing a certain type of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin symptoms.

Your healthcare provider should check your skin before you start taking Tafinlar, and every two months while taking this medicine to look for any new skin cancers.

Your healthcare provider may continue to check your skin for six months after you stop taking Tafinlar.

Before taking this medicine

You should not use Tafinlar if you are allergic to dabrafenib.

To make sure Tafinlar is safe for you, tell your doctor if you have ever had:

  • heart disease;

  • bleeding problems;

  • liver or kidney disease;

  • diabetes (dabrafenib may raise your blood sugar);

  • eye problems (especially a problem with your retina); or

  • a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Using dabrafenib with trametinib may increase your risk of developing a certain type of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin symptoms such as redness, warts, sores that will not heal, or a mole that has changed in size or color.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Dabrafenib can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 2 weeks after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using darbafenib.

If you use Tafinlar and trametinib together: Keep using birth control for at least 4 months after your last dose of these two medicines.

Tafinlar can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Tafinlar, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because dabrafenib can harm an unborn baby.

You should not breastfeed while using this medicine and for at least 2 weeks after your last dose (or 4 months after your last dose of dabrafenib with trametinib).

How should I take Tafinlar?

Tafinlar is usually taken twice daily. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Your doctor will perform blood tests to make sure you have the correct tumor type to be treated with Tafinlar.

Take this medicine on an empty stomach, at least 1 hour before or 2 hours after a meal.

Tafinlar should be taken at evenly spaced intervals, about every 12 hours.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you need surgery, dental work, or a medical procedure, tell the doctor you currently use dabrafenib.

Your doctor will need to check your skin every 2 months while you are using Tafinlar, and for up to 6 months after your treatment ends.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Use all your medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice.

Store at room temperature away from moisture and heat.

Tafinlar dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

150 mg orally twice a day, either used as monotherapy or in combination with trametinib.
Duration of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments: Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to treatment initiation with FDA-approved tests: http://www.fda.gov/CompanionDiagnostics.

Uses: Treatment of:
-BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma as a single agent.
-BRAF V600E OR V600K Mutation-Positive Unresectable or Metastatic Melanoma in combination with trametinib.
-BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) in combination with trametinib.

Usual Adult Dose for Melanoma - Metastatic:

150 mg orally twice a day, either used as monotherapy or in combination with trametinib.
Duration of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments: Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to treatment initiation with FDA-approved tests: http://www.fda.gov/CompanionDiagnostics.

Uses: Treatment of:
-BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma as a single agent.
-BRAF V600E OR V600K Mutation-Positive Unresectable or Metastatic Melanoma in combination with trametinib.
-BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) in combination with trametinib.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Tafinlar?

Dabrafenib can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Tafinlar side effects

Get emergency medical help if you have signs of an allergic reaction to Tafinlar: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects are more likely to occur if you take Tafinlar and trametinib together. Call your doctor at once if you have:

  • little or no urination;

  • fever, chills, feeling light-headed or short of breath;

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  • eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;

  • severe skin rash, skin pain or swelling, redness and peeling skin on your hands or feet;

  • increased thirst or urination;

  • signs of bleeding - weakness, dizziness, headache, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

  • signs of a heart problem - shortness of breath (even with mild exertion), pounding heartbeats, swelling in your feet or ankles.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Tafinlar side effects may include:

  • headache, muscle or joint pain;

  • bleeding;

  • fever, chills, tiredness;

  • dry skin, thickened skin, warts, rash;

  • swelling in the legs, arms, and face;

  • redness, swelling, peeling, or tenderness of hands or feet;

  • nausea, vomiting, diarrhea, decreased appetite;

  • cough, shortness of breath; or

  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tafinlar?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with dabrafenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Tafinlar only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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