Nephrotoxicity of the BRAF Inhibitors Vemurafenib and Dabrafenib.

IMPORTANCE: The selective BRAF inhibitors vemurafenib and dabrafenib have shown significant improvement in patient survival compared with standard therapy in BRAF V600-mutant metastatic melanoma. OBSERVATIONS: We reviewed Food and Drug Administration Adverse Event Reporting System (FAERS) data for both agents for renal toxic effects. From July 2011 through June 2014, 132 cases of acute kidney injury in patients receiving vemurafenib therapy were reported. Renal injury was more common in men (85 men vs 47 women; P<.001). From April 2013 through June 2014, 13 cases of renal injury in patients receiving dabrafenib therapy were reported (12 men and 1 woman). Hypokalemia (6 cases in patients receiving vemurafenib and 2 cases in patients receiving dabrafenib) and hyponatremia (8 and 6 cases, respectively) were also reported. CONCLUSIONS AND RELEVANCE: Vemurafenib seems to be more nephrotoxic than dabrafenib. This renal toxicity seems to be more prevalent among male patients with melanoma. On the basis of the few published case reports, the mode of injury seems to be tubular interstitial injury. Our findings suggest a need to monitor renal function and electrolyte levels in all patients who receive these drugs. Dermatologists, oncologists, and nephrologists need to be aware of this potential hazard.