Page 30 - Practical Approaches to Managing Castration-Resistant Prostate Cancer (CRPC)
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          Abiraterone (ZYTIGA )
          Common toxicities  •  Peripheral    •  ALT ↑ ± AST ↑   •  Diarrhea  ↑
                              edema, fluid    •  Joint pain/   •  Urinary tract
                              retention      discomfort    infection
                            •  Hypokalemia   •  Hot flush    •  Cough


          Other notable     •  Hepatotoxicity  •  Hypertension   •  Myopathy/
          toxicities                                       rhabdomyolysis

          Monitoring        •  Baseline assessment (see page 21)

                            •  Monitor laboratory or clinical parameters per routine
                              practice
                            •  Hepatotoxicity - AST, ALT, and bilirubin
                              – At baseline, every 2 weeks x 3 months, then monthly
                            •  Mineralocorticoid excess
                              – Blood pressure monthly
                              – Serum potassium monthly
                              – Fluid retention monthly
                            •  For patients taking 5 mg/day of prednisone, if
                              hypokalemia persists despite optimal potassium
                              supplementation and adequate oral intake, or if any of
                              the other mineralocorticoid effects persist, the dose
                              of prednisone may be increased to 10 mg/day
                            •  If patients need to be withdrawn from prednisone,
                              monitor for adrenocortical insufficiency (signs and
                              symptoms could be masked by AEs associated with
                              mineralocorticoid excess)
          Dose reductions and   •  Hepatotoxicity
          discontinuation     –  Withhold abiraterone immediately until liver function
                               tests normalize
                              –  May re-treat following return of liver function
                                tests to the patient’s baseline, at a reduced dose of
                                500 mg once daily
                              –  For patients being re-treated, monitor ALT, AST,
                                and bilirubin at least every 2 weeks for 3 months,
                               then monthly
                              –  If hepatotoxicity recurs at the reduced dose of
                                500 mg daily, discontinue treatment
                              –  Permanently discontinue abiraterone if concurrent
                                elevation of ALT >3 x ULN AND total bilirubin
                                >2 x ULN in the absence of biliary obstruction or
                                other causes responsible for the concurrent elevation

          References        ZYTIGA (abiraterone acetate) Product Monograph.
                            March 9, 2018.
                            Abiraterone: Drug Information. UpToDate. 2019.
                            Topic 16083 Version 210.0.



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