Precautions of Vemurafenib

1. New Primary Malignancies

Cutaneous Malignancies

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.

Non-Cutaneous Squamous Cell Carcinoma

Monitor patients receiving Vemurafenib closely for signs or  symptoms of new non-cuSCC.

Other Malignancies

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.

2. Tumor Promotion in BRAF Wild-Type Melanoma

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.  

3. Hypersensitivity Reactions

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.

4. Dermatologic Reactions

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