GlobalRPh RX List - QFITLIA
- Product / population
- Subcutaneous fitusiran; selected renal evidence limits for the hemophilia product, not its antithrombin-based dose algorithm.
- Renal measure
- Indexed eGFR, mL/min/1.73 m2.
RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.
Renal dosing, restrictions and evidence limits
No dedicated study of renal impairment was conducted. Population pharmacokinetics found no exposure effect in mild impairment, defined as eGFR 60 to below 90 mL/min/1.73 m2. The pivotal studies included only one participant in the moderate category, eGFR 30 to below 60. These data do not establish a moderate/severe-impairment or dialysis dose. Use the product-specific antithrombin-guided hematology protocol; no renal dose has been calculated from the limited exposure data.