Tafinlar is a type of targeted cancer drug that works by interfering with the growth and spread of cancer cells in the body.

Tafinlar is only used for the treatment of certain cancers that have a mutation in the BRAF gene.

Tafinlar works by targeting certain proteins made by the mutated BRAF gene that help cancer cells to grow. By blocking these proteins, Tafinlar stops or slows down the growth of the cancer cells.

What is Tafinlar used to treat?

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

• thyroid cancer (anaplastic thyroid cancer) that has spread to other parts of the body, and for which there are no other treatment options; or

• solid tumors (in adults and children 6 years and older) that cannot be removed with surgery, or have spread to other parts of the body, and that have gotten worse (progressed) and there are no other treatment options; or

• low-grade glioma (in children 1 year and older) that requires treatment with a medicine by mouth or injection (systemic therapy).

Your healthcare provider will perform a test for the BRAF V600E gene mutation to make sure this medicine is right for you.

It is not known if this medicine used alone is safe and effective in children.

It is not known if this medicine used in combination with trametinib is safe and effective in children younger than 1 year of age.

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 treatment, 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 treatment.

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.

Capsules

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

Tablets for Oral Suspension

If the tablets for oral suspension are prescribed for your child aged 1 year of age or older, the dose will be adjusted by their healthcare provider as your child grows.

The tablets for oral suspension are to be taken as a suspension only. Do not swallow whole, chew or crush the tablets for oral suspension.

See the detailed Instructions for Use leaflet that comes with the medicine for instructions on how to correctly prepare and take or give a dose of the oral suspension.

After the tablets for oral suspension are dispersed into an oral suspension, the medicine should be given or taken right away from a cup, oral dosing syringe or feeding tube.

Any prepared oral suspension that is not used within 30 minutes should be thrown away.

Additional Information

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.

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.

Usual Adult Dose for Melanoma, Non-Small Cell Lung Cancer, Thyroid Cancer, and Solid Tumors

150 mg (two 75 mg capsules) orally twice daily.

Uses:

as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation.

in combination with trametinib:
- for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations.
- for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations and involvement of lymph node(s), following complete resection.
- for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation.
- for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.
- for the treatment of patients with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Recommended duration of treatment:
- for patients with unresectable or metastatic melanoma or solid tumors, metastatic NSCLC, or locally advanced or metastatic anaplastic thyroid cancer is until disease progression or unacceptable toxicity.
- for patients in the adjuvant melanoma setting is until disease recurrence or unacceptable toxicity for up to 1 year.

Usual Pediatric Dose for Solid Tumors and Low-Grade Glioma

Capsules

Tablets for Oral Suspension

Uses:

in combination with trametinib:
- for the treatment of pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

Recommended duration of treatment:
- for pediatric patients with solid tumors is until disease progression or unacceptable toxicity.
- for pediatric patients with LGG is until disease progression or until unacceptable toxicity. 

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 problems;

• bleeding problems;

• liver or kidney problems;

• 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.

Pregnancy

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 Tafinlar.

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.

Breastfeeding

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).

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.

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

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.

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 in adults 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.

Common Tafinlar side effects in children may include:

• headache, muscle or joint pain;

• bleeding;

• fever or tiredness;

• dry skin or rash;

• nausea, diarrhea, or vomiting;

• constipation;

• cough;

• acne;

• skin infection around fingernails or toenails; or

• stomach-area (abdomen) pain

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.

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.