Kengrexal 50 mg powder for concentrate for solution for injection / infusion

Paediatric population

4.2 The safety and efficacy of cangrelor in children aged less than 18 years has not yet been established. Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.

5.1 Paediatric Population

In a prospective, open-label, single-arm, multi-center, Phase I study, cangrelor was evaluated at 2 dose levels of 0.5 and 0.25 micrograms/kg/min in 15 neonates ≤28 days of life with congenital heart disease requiring palliation with a systemic-to-pulmonary artery shunt, a right ventricle-to-pulmonary artery shunt, or a ductus arteriosus stent (see section 4.2). Platelet aggregation inhibition was assessed by light transmission aggregometry (LTA) in response to stimulation with 20 and 5 µM ADP. The % inhibition of maximal aggregation 45 minutes into cangrelor infusion and the number of subjects who achieved >90% of maximal platelet aggregation inhibition are summarized in the table below.

5.2 Paediatric population

Cangrelor infusion has been evaluated in neonatal patients (age from birth to 28 days) at a dose level of 0.25 and 0.5 micrograms/kg/min. The maximum concentrations were 19 ng/mL and 60 ng/mL, respectively, and were observed approximately 45 minutes following start of infusion. In neonates, cangrelor is rapidly metabolised into its primary metabolite AR-C69712XX. Very low or non-detectable levels of cangrelor were found 5-10 minutes post-infusion and relatively high levels of the primary metabolite were detected