WC500169468

Regulatory details:
PRAC Rapporteur: Martin Huber (DE)
Administrative details:
Procedure number(s): EMEA/H/C/002215/PSUV/0014 (without RMP)
MAH(s): Takeda Pharma A/S
Background
Ferumoxytol is a colloidal iron-carbohydrate complex indicated for the intravenous treatment of iron
deficiency anaemia in adult patients with chronic kidney disease (CKD).
The PRAC is currently reviewing the benefit-risk balance of Rienso (ferumoxytol), a centrally authorised
medicine, in the framework of a single assessment PSUR procedure due for PRAC recommendation in
July 2014.
Summary of recommendation(s) and conclusions
The PRAC Rapporteur presented the preliminary assessment of the currently ongoing PSUR procedure
identifying some risks that potentially impact on the overall benefit-risk balance of the products. The
PRAC was concerned by the higher rates for hypersensitivity reactions compared to other intravenous
iron containing products and the absolute number of serious and fatal cases for Rienso. The PRAC
noted that these reporting rates were based on spontaneous reports; the majority of the case reports
came from the US, where patient exposure is much higher than in Europe.
Considering the known limitations of comparing reporting rates from spontaneous reports, that
additional data will be available and given that the product information already includes warnings and
precautions on hypersensitivity reactions, the PRAC recommended as a first step a targeted
communication with emphasis on the existing risk minimisation measures and warnings on
hypersensitivity reactions included in the product information. The PRAC agreed a DHPC for distribution
to HCPs promptly. The PRAC recommendation is expected for July 2014.
Post-meeting note: On 19 May 2014, the PRAC adopted by written procedure a final DHPC and
communication plan.
6.1.7. Granisetron – SANCUSO (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Jolanta Gulbinovic (LT)
Administrative details:
Procedure number(s): EMEA/H/C/002296/PSUV/0030 (without RMP)
MAH(s): ProStrakan Limited
Background
Granisetron is a serotonin 5-HT 3 receptor antagonist indicated in adults for the prevention of nausea
and vomiting associated with moderately or highly emetogenic chemotherapy under certain conditions.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Sancuso, a
centrally authorised medicine containing granisetron (as a transdermal patch), and issued a
recommendation on its marketing authorisation(s).
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 37/73