Annotation of European Medicines Agency (EMA) label information
for desloratadine
Summary
The EMA European Public Assessment Report (EPAR) highlights information regarding variation in the metabolism of desloratadine in different individuals, but does not mention pharmacogenetics or genetic testing. The genes/ enzymes involved are not known.
Annotation
Excerpt from the Desloratadine and Pseudoephedrine (Aerinaze) EPAR:
"In a series of pharmacokinetic and clinical trials, 6 % of the subjects reached a higher concentration of desloratadine. The prevalence of this poor metabolizer phenotype was greater among Blacks adults than Caucasians adults (18 % vs. 2 %) however the safety profile of these subjects was not different from that of the general population. In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult subjects, four subjects were found to be poor metabolisers of desloratadine. These subjects had a Cmax concentration about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours."
This information is highlighted in the following sections:
Pharmacokinetic properties.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the Desloratadine and Pseudoephedrine EMA drug label.
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