| Question, remark or suggestion |
Geachte,
In de SPC van Riociguat staat onderstaande informatie. Kloppen de genoemde percentages (53%, 139% or 54%). Het lijkt vreemd dat <30 mL/min de riociguat plasmaconcentratie minder toeneemt dan bij een creatinine klaring 30-50 mL/min. Moet het bijvoorbeeld niet 154% zijn?
Vriendelijke groet,
Tjerk Geersing
Apotheker medicatiebewaking Health Base
5.2 Renal impairment
Overall, mean dose- and weight- normalised exposure values for riociguat were higher in subjects with
renal impairment compared to subjects with normal renal function. Corresponding values for the main
metabolite were higher in subjects with renal impairment compared to healthy subjects. In nonsmoking
individuals with mild (creatinine clearance 80-50 mL/min), moderate (creatinine clearance
<50-30 mL/min) or severe (creatinine clearance <30 mL/min) renal impairment, riociguat plasma
concentrations (AUC) were increased by 53%, 139% or 54%, respectively.
Data in patients with creatinine clearance <30 mL/min are limited and there are no data for patients on
dialysis.
Due to the high plasma protein binding riociguat is not expected to be dialysable. |