Kengrexal 50 mg powder for concentrate for solution for injection / infusion *
Pharmacy Only: Prescription

  • Company:

    Chiesi Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 16 May 2022

File name

6282544556d10.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Updated on 20 April 2021

File name

Kengrexal EU CP0058-3_1618932313.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 April 2021

File name

Kengrexal EU CS0091-2_1618932200.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)