WC500169468

Summary of recommendation(s) and conclusions
Based on the review of the data on safety and efficacy, the risk-benefit balance of Votrient
(pazopanib) in the approved indication(s) remains favourable.
The current terms of the marketing authorisation(s) should be maintained.
In the next PSUR, the MAH should provide a detailed review of cases of retinal tear and retinal
detachment as well as of cases of pericardial effusion. The MAH should also further evaluate
the reported fatal hepatic serious events and the potential relatedness of combining pazopanib
with gemcitabine. In addition, based on data from clinical trials, the MAH should discuss if
vinorelbine and temsirolimus should also be included in the warning section of the product
information regarding combination with other systemic anti-cancer therapies. The MAH should
also closely monitor any racial differences in the efficacy and risks with regard to pazopanib
treatment. The MAH should propose to update the product information as warranted.
The MAH should submit to EMA an updated RMP as described in the assessment report to add
serotonin syndrome as an important potential risk at the next procedure opportunity.
The next PSUR should be submitted in accordance with the requirements set out in the list of Union
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC.
6.1.12. Regadenoson – RAPISCAN (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Julie Williams (UK)
Administrative details:
Procedure number(s): EMEA/H/C/001176/PSU 012 (with RMP version 5.0)
MAH(s): Rapidscan Pharma Solutions EU Ltd.
Background
Regadenoson is a low affinity agonist for the A 2A adenosine receptor indicated as a selective coronary
vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging
(MPI) in adult patients unable to undergo adequate exercise stress.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Rapiscan, a
centrally authorised medicine containing regadenoson, and issued a recommendation on its marketing
authorisation(s).
Summary of recommendation(s) and conclusions
Based on the review of the data on safety and efficacy, the risk-benefit balance of Rapiscan
(regadenoson) in the approved indication(s) remains favourable.
Nevertheless, the product information should be updated to reflect that aminophylline, used to
attenuate severe and/or persistent adverse reactions to regadenoson, should not be
administered solely for the purpose of terminating a seizure induced by regadenoson. The
product information should be also amended to reflect that consideration should be given to
delaying regadenoson administration in patients with elevated blood pressure until the latter is
well controlled. Finally, the risk of transient ischaemic attack (TIA) and cerebrovascular
accident (CVA) associated with regadenoson administration should be added as a warning and
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 41/73