Table 2.
Renal adverse events associated with CDK4/6 inhibitors from the Food and Drug Administration adverse event reporting system
| Name of medication | Reaction | Male (n = 5), n/N (%) | Female (n = 195), n/N (%) | Missing (n = 10), n/N (%) | Overall (N = 210), n/N (%) |
|---|---|---|---|---|---|
| Ribociclib (N = 210) | Renal injurya | 3 (60) | 82 (42) | 8 (80) | 93 (44) |
| Hypokalemia | 1 (20) | 29 (15) | 1 (10) | 31 (15) | |
| Hypocalcemia | 1 (20) | 29 (15) | 0 (0) | 30 (14) | |
| Hyponatremia | 0 (0) | 31 (16) | 1 (10) | 32 (15) | |
| Hyperkalemia | 0 (0) | 9 (5) | 0 (0) | 9 (4) | |
| Hypophosphatemia | 0 (0) | 7 (4) | 0 (0) | 7 (3) | |
| Hypercalcemia | 0 (0) | 6 (3) | 0 (0) | 6 (3) | |
| Hypomagnesemia | 0 (0) | 2 (1) | 0 (0) | 2 (1) |
| Male (N = 1) n/N (%) | Female (N = 77) n/N (%) | Missing (N = 6) n/N (%) | Overall (N = 84) n/N (%) | ||
|---|---|---|---|---|---|
| Abemaciclib (N = 84) | Renal injury | 1 (100) | 45 (58) | 4 (67) | 50 (60) |
| Hypokalemia | 0 (0) | 16 (21) | 2 (33) | 18 (21) | |
| Hyponatremia | 0 (0) | 10 (13) | 0 (0) | 10 (12) | |
| Hypercalcemia | 0 (0) | 2 (3) | 0 (0) | 2 (2) | |
| Hypocalcemia | 0 (0) | 2 (3) | 0 (0) | 2 (2) | |
| Acidosis | 0 (0) | 1 (1) | 0 (0) | 1 (1) | |
| Hyperkalemia | 0 (0) | 1 (1) | 0 (0) | 1 (1) |
| Male (n = 14), n/N (%) | Female (n = 470), n/N (%) | Missing (n = 5), n/N (%) | Overall (n = 489), n/N (%) | ||
|---|---|---|---|---|---|
| Palbociclib (N = 489) | Renal injury | 7 (50) | 279 (59) | 4 (80) | 290 (59) |
| Hypokalemia | 3 (21) | 62 (13) | 0 (0) | 65 (13) | |
| Hyponatremia | 3 (21) | 39 (8) | 0 (0) | 42 (9) | |
| Hypercalcemia | 1 (7) | 34 (7) | 0 (0) | 35 (7) | |
| Hypocalcemia | 0 (0) | 25 (5) | 1 (20) | 26 (5) | |
| Hyperkalemia | 0 (0) | 20 (4) | 0 (0) | 20 (4) | |
| Hypomagnesemia | 0 (0) | 4 (1) | 0 (0) | 4 (1) | |
| Hypophosphatemia | 0 (0) | 4 (1) | 0 (0) | 4 (1) | |
| Hypernatremia | 0 (0) | 3 (1) | 0 (0) | 3 (1) |
There are limitations to the Food and Drug Administration adverse event reporting system. The events are reported by providers and/or patients and may therefore be subject to reporting bias. In addition, not all demographic and comorbidity information is available to help identify whether other nephrotoxic risk factors are present (e.g., use of nonsteroidal anti-inflammatory agents, history of hypertension or diabetes mellitus, known chronic kidney disease, recent use of contrast agent, and recent use of chemotherapy with nephrotoxic potential). It is not possible to determine whether an event is truly caused by the drug as opposed to the underlying disease, concomitant medications, or previous chemotherapies administered to these patients. Finally, there is no denominator for the number of patients who received these agents, and therefore, a percent risk of the adverse outcome cannot be computed.
Renal injury comprises proteinuria, renal failure acute, acute kidney injury, elevated creatinine, hypercreatinemia, and nephritis.