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Adverse Event Reporting System Indicates Renal Toxic Effects With BRAF Inhibitors Vemurafenib and Dabrafenib

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Key Points

  • Cases of acute kidney injury have been reported in patients receiving vemurafenib and dabrafenib.
  • Hypokalemia and hyponatremia have also been reported with the two agents.

In an analysis of FDA Adverse Event Reporting System data reported in JAMA Oncology, Jhaveri et al found that the BRAF inhibitors vemurafenib (Zelboraf) and dabrafenib (Tafinlar) were associated with nephrotoxicity. Their findings suggest a need to monitor renal function and electrolyte levels in all patients who receive these drugs.

Acute Kidney Injury

Data from the reporting system from July 2011 through June 2014 indicated 132 cases of acute renal injury in patients receiving vemurafenib for melanoma, with injury being more common in men (85 vs 47, P < .001). Between April 2013 and June 2014, 13 cases of renal injury in patients receiving dabrafenib for melanoma were reported (12 men vs 1 woman). Hypokalemia and hyponatremia were also reported in six and eight patients receiving vemurafenib and in two and six patients receiving dabrafenib, respectively.

The investigators concluded: “…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.”

Kenar D. Jhaveri, MD, of North Shore University Medical Center, Long Island Jewish Medical Center, is the corresponding author of the JAMA Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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