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Summary of recommendation(s) and conclusions
Based on the review of the data on safety and efficacy, the risk-benefit balance of Victrelis
(boceprevir) in the approved indication(s) remains favourable.
Nevertheless, the product information should be updated to add under special warnings and
precautions for use a recommendation for patients with advanced liver disease and detailed
advice for laboratory testing to be performed during therapy. In addition, a recommendation to
avoid the co-administration of boceprevir with doxazosin or tamsulosin due to the risk of drugdrug
interactions should be added to the product information. Finally, the product information
should be amended to include cross-references relevant for the treatment of patients with
hepatic impairment. Therefore the current terms of the marketing authorisation(s) should be
varied 23 .
In the next PSUR, the MAH should include detailed analyses of cases of boceprevir-induced
renal impairment and cases of reactivation of latent tuberculosis. In addition, the MAH should
provide further information, in particular, the MAH should closely monitor cases of anaemia.
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.
6.1.4. Deferasirox – EXJADE (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Isabelle Robine (FR)
Administrative details:
Procedure number(s): EMEA/H/C/000670/PSUV/0037 (with RMP version 9.0)
MAH(s): Novartis Europharm Ltd
Background
Deferasirox is an orally active chelating agent highly selective for iron (III), indicated for the treatment
of chronic iron overload due to blood transfusions in patients with beta thalassaemia major under
certain conditions.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Exjade, a
centrally authorised medicine containing deferasirox, 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 Exjade
(deferasirox) in the approved indication(s) remains favourable.
Nevertheless, the product information should be updated to add metabolic acidosis and
gastrointestinal perforation as warnings and undesirable effects with a frequency unknown. In
addition, a warning on severe skin reactions should be added. Finally, neutropenia, renal
tubular necrosis and nephrolithiasis should be added to the product information as undesirable
23 Update of SmPC sections 4.2, 4.4, 4.5 and 5.1. The package leaflet is updated accordingly. The PRAC AR and PRAC
recommendation are transmitted to the CHMP for adoption of an opinion.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 32/75