Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1    Pharmacodynamic properties
Pharmacotherapeutic group: Anti-neoplastic and immunomodulating agents, Platinum compounds, ATC code: L01XA 02.

Carboplatin has biochemical properties similar to those of cisplatin, thus producing predominantly interstrand and intrastrand DNA crosslinks.

Paediatric population:
Safety and efficacy in children have not been established.

Pharmacokinetic Properties

5.2    Pharmacokinetic properties
Carboplatin Teva EM 12/2023 Notification
Following administration of carboplatin in man, a linear relationship exists between dose and plasma concentrations of total and free ultra-filterable platinum. The area under the plasma concentration versus time curve for total platinum also shows a linear relationship with the dose.

Repeated dosing during four consecutive days did not produce an accumulation of platinum in plasma.
Following the administration of carboplatin, reported values for the terminal elimination half-lives of free ultrafilterable platinum and carboplatin in man are approximately 6 hours and 1.5 hours, respectively. During the initial phase, most of the free ultra-filterable platinum is present as carboplatin. The terminal half-life for total plasma platinum is 24 hours. Approximately 87% of plasma platinum is protein bound within 24 hours following administration. Carboplatin is excreted primarily in the urine, with recovery of approximately 70% of the administered platinum within 24 hours. Most of the drug is excreted in the first 6 hours. Total body and renal clearance of free ultra- filterable platinum correlate with the rate of glomerular filtration but not tubular secretion.

Carboplatin clearance has been reported to vary by 3- to 4- fold in paediatric patients.
As for adult patients, literature data suggest that renal function may contribute to the variation in carboplatin clearance.