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Abstract: PO1871

Immune Checkpoint Inhibitor-Associated Electrolyte Disorders: Query of the FDA Adverse Event Reporting System

Session Information

Category: Onco-Nephrology

  • 1500 Onco-Nephrology

Authors

  • Sakhiya, Vipulbhai, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States
  • Wanchoo, Rimda, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States
  • Jhaveri, Kenar D., Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States
Background

Electrolyte disorders with immune checkpoint inhibitors(ICI) therapy are not well characterized. Single center studies have noted hyponatremia as the most common electrolyte disorder associated with ICI.

Methods

We performed a revised more recent query of the FAERS database with a more detailed look at electrolyte disorders only (search terms: hyponatremia, hypernatremia, hypokalemia, hypercalcemia, hypocalcemia, hypophosphatemia, hypomagnesemia, acidosis, hyperphosphatemia and renal tubular acidosis) from 2011-2021.

Results

A total of 2556 cases of electrolytes disorders were reported to the FAERS system. The most commonly reported abnormality is hyponatremia (53.7%), followed by hypokalemia (18.71%), hypercalcemia( 9.65%), hyperkalemia( 5.56%) and hypocalcemia at 4.68%. The remaining abnormalities were <4%. In all three groups of the agents ( CTLA4 inhibitors, PD and PDL1 inhibitors), the trend remained similar. Most events were reported at a median age of 64 in all 3 groups analyzed. Among reported events, proportions of events in male were statistically more significant (p<0.01) than females in all 3 drug groups. Nivolumab (n=1130) and ipilumumab( n=684) had the highest number of patients reported with electrolyte disorders. Hyponatremia persisted as the most common abnormality in each specific drug as well. Hypokalemia and hypercalcemia were faily common. Hyperphosphatemia, hypernatremia, hypophosphatemia along with acidosis made up the least number of cases reported.

Conclusion

Electrolyte disorders are an under-recognized cause of ICI therapy. Hyponatremia, hypokalemia and hypercalcemia seem to be the three most commonly reported events with these classes of drugs.

Review of the Food and Drug Administration Adverse Event Reporting System database for adverse events related to electrolytes by gender by different medication classes.