GlobalRPh RX List - XOSPATA
- Product / population
- Adult XOSPATA oral treatment; selected renal PK and differentiation-syndrome warning.
- Renal measure
- CrCl, mL/min; categories as printed in the selected PK section.
RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.
Renal dosing, restrictions and evidence limits
Mild (CrCl 50-80 mL/min) and moderate (30-50) impairment did not meaningfully alter gilteritinib pharmacokinetics. The effect of severe impairment (CrCl <=29) is unknown. This PK statement does not provide a severe-impairment or dialysis dose. Treatment-emergent renal dysfunction can occur with differentiation syndrome; do not interpret an unchanged baseline PK assessment as permission to ignore new toxicity.