INDICATIONS AND USAGE（适应症）

Unresectable or Metastatic Melanoma

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

Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma.

Erdheim-Chester Disease

ZELBORAF® is indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.

DOSAGE（服用剂量）

Confirm the presence of BRAF V600E mutation in melanoma tumor specimens prior to initiation of treatment with ZELBORAF.

Recommended Dose

The recommended dose of ZELBORAF is 960 mg (four 240 mg tablets) orally every 12 hours with or without a meal. A missed dose can be taken up to 4 hours prior to the next dose.

Treat patients with ZELBORAF until disease progression or unacceptable toxicity occurs.

Do not take an additional dose if vomiting occurs after ZELBORAF administration, but continue with the next scheduled dose.

Do not crush or chew the tablets.

ADVERSE REACTIONS（不良反应）

New Primary Malignancies

Hypersensitivity Reactions

Dermatologic Reactions

QT Prolongation

Hepatotoxicity

Photosensitivity

Ophthalmologic Reactions

Radiation Sensitization and Radiation Recall

Renal Failure

Dupuytren's Contracture and Plantar Fascial Fibromatosis

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/38eea320-7e0c-485a-bc30-98c3c45e2763/spl-doc?hl=vemurafenib

Zelborafinformation