Annotation of FDA Label for rabeprazole and CYP2C19
PharmGKB ID
Summary
The FDA-approved drug label for rabeprazole (ACIPHEX) provides evidence from a study showing that gastric acid suppression was higher in CYP2C19 poor metabolizers as compared to extensive metabolizers, possibly due to higher rabeprazole levels in poor metabolizers.
Annotation
Excerpts from the rabeprazole (ACIPHEX) drug label:
Pharmacogenomics...In a clinical study in evaluating ACIPHEX delayed-release tablets in Japanese adult patients categorized by CYP2C19 genotype (n=6 per genotype category), gastric acid suppression was higher in poor metabolizers as compared to extensive metabolizers. This could be due to higher rabeprazole plasma levels in poor metabolizers. The clinical relevance of this is not known. Whether or not interactions of rabeprazole sodium with other drugs metabolized by CYP2C19 would be different between extensive metabolizers and poor metabolizers has not been studied.
CYP2C19 exhibits a known genetic polymorphism due to its deficiency in some sub-populations (e.g., 3 to 5% of Caucasians and 17 to 20% of Asians). Rabeprazole metabolism is slow in these sub-populations, therefore, they are referred to as poor metabolizers of the drug.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the rabeprazole drug label.
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FDA PGx Associations
| Category | Drug | Gene | Affected Subgroup | Interaction Description |
|---|---|---|---|---|
| PK | Rabeprazole | CYP2C19 | poor metabolizers | Results in higher systemic concentrations. |
Evidence for Clinical Annotations
This annotation has been used as evidence for the following clinical annotations.