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Perform dermatologic evaluations prior to initiation of therapy and every 2 months while on therapy. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Consider dermatologic monitoring for 6 months following discontinuation of Vemurafenib.
Monitor patients receiving Vemurafenib closely for signs or symptoms of new non-cuSCC.
Monitor patients receiving Vemurafenib closely for signs or symptoms of other malignancies.
Monitoring complete blood count in ECD patients with co-existing myeloid malignancies is recommended.
In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells that are exposed to BRAF inhibitors. Confirm evidence of BRAF V600E mutation in tumor specimens prior to initiation of Vemurafenib.
Anaphylaxis and other serious hypersensitivity reactions can occur during treatment and upon re-initiation of treatment with Vemurafenib. Severe hypersensitivity reactions included generalized rash and erythema, hypotension, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Permanently discontinue Vemurafenib in patients who experience a severe hypersensitivity reaction.
Severe dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, can occur in patients receiving Vemurafenib. Permanently discontinue Vemurafenib in patients who experience a severe dermatologic reaction.
from FDA，2020.12
