INDICATIONS AND USAGE（适应症）

BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

MEKINIST® is indicated, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib, 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

MEKINIST is indicated, in combination with dabrafenib, 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

MEKINIST is indicated, in combination with dabrafenib, 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

MEKINIST is indicated, in combination with dabrafenib, 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 MEKINIST is 2 mg orally taken once daily, as a single agent or in combination with dabrafenib, until disease progression or unacceptable toxicity. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

Recommended Dosage for the Adjuvant Treatment of Melanoma

The recommended dosage of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity for up to 1 year. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

Recommended Dosage for NSCLC

The recommended dosage of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

Recommended Dosage for ATC

The recommended dosage of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

ADVERSE REACTIONS（不良反应）

New Primary Malignancies

Hemorrhage

Colitis and Gastrointestinal Perforation

Venous Thromboembolism

Cardiomyopathy

Ocular Toxicities

Interstitial Lung Disease

Serious Febrile Reactions

Serious Skin Toxicities

Hyperglycemia

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/0002ad27-779d-42ab-83b5-bc65453412a1/spl-doc?hl=trametinib

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