Annotation

Please note that the information contained within this drug label annotation is available through a collaboration with the Japanese Society of Pharmacogenomics, who provided a translation of the pharmacogenetic information contained in the PMDA package insert.

Excerpt from the package insert for clopidogrel:

In clinical pharmacological studies conducted overseas in healthy adults, the inhibition level of 5 µM ADP-induced platelet aggregation at 24 hours after an initial dose of 300 mg was 40 ± 21%, 39 ± 28%, 37 ± 21% and 24 ± 26% in ultrarapid metabolizers (UMs), extensive metabolizers (EMs), intermediate metabolizers (IMs) and poor metabolizers (PMs), respectively, by CYP2C19 metabolizer status. The initial dose was followed by 75 mg per day for 4 days, and this resulted in platelet aggregation inhibition of 56 ± 13%, 58 ± 19%, 60 ± 18% and 37 ± 23%, respectively, indicating diminished inhibition of platelet aggregation in PMs.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the clopidogrel package insert (in Japanese).

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