What is Tafinlar and how is it used?

Tafinlar is a prescription medicine used to treat the symptoms of Melanoma, Non-Small Cell Lung Cancer, locally advanced or metastatic Thyroid Cancer. Tafinlar may be used alone or with other medications.

Tafinlar belongs to a class of drugs called Antineoplastics, BRAF Kinase Inhibitor.

It is not known if Tafinlar is safe and effective in children.

What are the possible side effects of Tafinlar?

Tafinlar may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• little or no urination,
• fever,
• chills,
• lightheadedness,
• shortness of breath,
• pale or yellowed skin,
• dark colored urine,
• fever,
• confusion,
• 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,
• dizziness,
• headache,
• bloody or tarry stools,
• coughing up blood,
• vomit that looks like coffee grounds,
• pounding heartbeats, and
• swelling in your feet or ankles

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Tafinlar 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, and
• hair loss

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Tafinlar. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Dabrafenib mesylate is a kinase inhibitor. The chemical name for dabrafenib mesylate is N-{3-[5-(2-amino-4pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzene sulfonamide, methanesulfonate salt. It has the molecular formula C₂₃H₂₀F₃N₅O₂S₂•CH₄O₃S and a molecular weight of 615.68. Dabrafenib mesylate has the following chemical structure:

Dabrafenib mesylate is a white to slightly colored solid with three pKas: 6.6, 2.2, and -1.5. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media.

TAFINLAR (dabrafenib) capsules for oral use are supplied as 50 mg and 75 mg capsules for oral administration. Each 50 mg capsule contains 59.25 mg dabrafenib mesylate equivalent to 50 mg of dabrafenib free base. Each 75 mg capsule contains 88.88 mg dabrafenib mesylate equivalent to 75 mg of dabrafenib free base. The inactive ingredients of TAFINLAR are colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Capsule shells contain hypromellose, red iron oxide (E172), and titanium dioxide (E171).

DOSAGE AND ADMINISTRATION

Patient Selection

Melanoma

• Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR as a single agent [see WARNINGS AND PRECAUTIONS, Clinical Studies].
• Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see WARNINGS AND PRECAUTIONS, Clinical Studies].
• Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.

NSCLC

• Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies].
• Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

ATC

• Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies]. An FDA-approved test for the detection of BRAF V600E mutation in ATC is not currently available.

Recommended Dosage For Unresectable Or Metastatic Melanoma

The recommended dosage of TAFINLAR is 150 mg orally taken twice daily, as a single agent or in combination with trametinib, until disease progression or unacceptable toxicity. Refer to the trametinib prescribing information for recommended trametinib dosing information.

Recommended Dosage For The Adjuvant Treatment Of Melanoma

The recommended dosage of TAFINLAR is 150 mg orally taken twice daily in combination with trametinib until disease recurrence or unacceptable toxicity for up to 1 year. Refer to the trametinib prescribing information for recommended trametinib dosing information.

Recommended Dosage For NSCLC

The recommended dosage of TAFINLAR is 150 mg orally taken twice daily, in combination with trametinib until disease recurrence or unacceptable toxicity. Refer to the trametinib prescribing information for recommended trametinib dosing information.

Recommended Dosage For ATC

The recommended dosage of TAFINLAR is 150 mg orally taken twice daily, in combination with trametinib until disease recurrence or unacceptable toxicity. Refer to the trametinib prescribing information for recommended trametinib dosing information.

Administration

• Take TAFINLAR at doses approximately 12 hours apart.
• Take TAFINLAR at least 1 hour before or 2 hours after a meal [see CLINICAL PHARMACOLOGY].
• Do not take a missed dose of TAFINLAR within 6 hours of the next dose of TAFINLAR.
• Do not open, crush, or break TAFINLAR capsules.

• HOW SUPPLIED

  Dosage Forms And Strengths

  Capsules

  • 50 mg: Dark red capsule imprinted with ‘GS TEW’ and ‘50 mg’
  • 75 mg: Dark pink capsule imprinted with ‘GS LHF’ and ‘75 mg’

  Storage And Handling

  50 mg capsules: Dark red capsule imprinted with ‘GS TEW’ and ‘50 mg’ available in bottles of 120 (NDC 0078-0682-66). Each bottle contains a silica gel desiccant.

  75 mg capsules: Dark pink capsule imprinted with ‘GS LHF’ and ‘75 mg’ available in bottles of 120 (NDC 0078-0681-66). Each bottle contains a silica gel desiccant.

  Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].