INDICATIONS AND USAGE（适应症）

BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

BRAFTOVI® is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)

BRAFTOVI is indicated, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy].

DOSAGE（服用剂量）

Recommended Dosage for BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

The recommended dosage of BRAFTOVI is 450 mg (six 75 mg capsules) orally once daily in combination with binimetinib until disease progression or unacceptable toxicity. Refer to the binimetinib prescribing information for recommended binimetinib dosing information.

Recommended Dosage for BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)

The recommended dosage of BRAFTOVI is 300 mg (four 75 mg capsules) orally once daily in combination with cetuximab until disease progression or unacceptable toxicity. Refer to the cetuximab prescribing information for recommended cetuximab dosing information.

ADVERSE REACTIONS（不良反应）

New Primary Malignancies

Hemorrhage

Uveitis

QT Prolongation

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/235dfc38-0f0b-4037-b501-7a9f4294740c/spl-doc?hl=Braftovi

Braftoviinformation