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<p>Asciminib (ASC) is a novel BCR::ABL1 tyrosine kinase inhibitor that binds to the ABL myristoyl pocket. Although dose adjustments for renal impairment are generally considered unnecessary, pharmacokinetic data for patients with end-stage renal disease or those on dialysis are limited. A 72-year-old man with chronic phase chronic myeloid leukemia undergoing maintenance hemodialysis for chronic renal failure was treated with ASC. Owing to cardiovascular risk, treatment was initiated at a reduced dose of 40&#xa0;mg once daily. A major molecular response was achieved within 3 months without adverse events. Pharmacokinetic analysis revealed a delayed apparent T<sub>max</sub> (&gt; 4&#xa0;h), suggesting prolonged absorption. ASC concentrations did not decrease during dialysis sessions compared with non-dialysis days. The median trough concentration was 89.0 ng/mL, with a coefficient of variation of 30.9%. ASC demonstrated negligible dialyzability, likely because of its high plasma protein binding (97.3%). However, the study revealed a significantly delayed apparent T<sub>max</sub> and high intra-individual variability in plasma concentrations. These findings suggest that clinicians should prioritize monitoring for delayed gastrointestinal absorption and potentially reduced bioavailability in patients undergoing maintenance hemodialysis, rather than focusing on drug removal by dialysis.</p>

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Pharmacokinetics of asciminib in a patient with chronic myeloid leukemia undergoing maintenance hemodialysis

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  • 发表日期：

    2026年7月7日

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  • Maiko Abumiya,
  • Ko Abe,
  • Atsushi Watanabe,
  • Naoto Takahashi

摘要

Asciminib (ASC) is a novel BCR::ABL1 tyrosine kinase inhibitor that binds to the ABL myristoyl pocket. Although dose adjustments for renal impairment are generally considered unnecessary, pharmacokinetic data for patients with end-stage renal disease or those on dialysis are limited. A 72-year-old man with chronic phase chronic myeloid leukemia undergoing maintenance hemodialysis for chronic renal failure was treated with ASC. Owing to cardiovascular risk, treatment was initiated at a reduced dose of 40 mg once daily. A major molecular response was achieved within 3 months without adverse events. Pharmacokinetic analysis revealed a delayed apparent Tmax (> 4 h), suggesting prolonged absorption. ASC concentrations did not decrease during dialysis sessions compared with non-dialysis days. The median trough concentration was 89.0 ng/mL, with a coefficient of variation of 30.9%. ASC demonstrated negligible dialyzability, likely because of its high plasma protein binding (97.3%). However, the study revealed a significantly delayed apparent Tmax and high intra-individual variability in plasma concentrations. These findings suggest that clinicians should prioritize monitoring for delayed gastrointestinal absorption and potentially reduced bioavailability in patients undergoing maintenance hemodialysis, rather than focusing on drug removal by dialysis.