INDICATIONS AND USAGE（适应症）

BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma

TAFINLAR® is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.

Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma

TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.

BRAF V600E Mutation-Positive Metastatic NSCLC

TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.

BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer

TAFINLAR is indicated, in combination with trametinib, 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.

DOSAGE（服用剂量）

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.

ADVERSE REACTIONS（不良反应）

New Primary Malignancies

Tumor Promotion in BRAF Wild-Type Melanoma

Hemorrhage

Cardiomyopathy  

Uveitis

Serious Febrile Reactions

Serious Skin Toxicities

Hyperglycemia

Glucose-6-Phosphate Dehydrogenase Deficiency

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea/spl-doc?hl=Dabrafeni

Phodabrainformation