Drospirenone and Ethinyl Estradiol

Pharmacogenomic Information in the Context of the FDA-Approved Drug Label*

Drospirenone and ethinyl estradiol (Yasmin) is a combined oral contraceptive drug.

The FDA recommends, but does not require, genetic testing prior to initiating or reinitiating treatment with drospirenone and ethinyl estradiol.

Excerpt from the drospirenone and ethinyl estradiol (Yasmin) drug label:
"In in vitro studies DRSP did not affect turnover of model substrates of CYP1A2 and CYP2D6, but had an inhibitory influence on the turnover of model substrates of CYP1A1, CYP2C9, CYP2C19 and CYP3A4 with CYP2C19 being the most sensitive enzyme."

"The potential effect of DRSP on CYP2C19 activity was investigated in a clinical pharmacokinetic study using omeprazole as a marker substrate. In the study with 24 postmenopausal women including 12 women with homozygous (wild type) CYP2C19 genotype and 12 women with heterozygous CYP2C19 genotype the daily oral administration of 3 mg DRSP for 14 days did not affect the oral clearance of omeprazole (40 mg, single oral dose). Based on the available results of in vivo and in vitro studies it can be concluded that, at clinical dose level, DRSP shows little propensity to interact to a significant extent with cytochrome P450 enzymes."

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the Drospirenone and ethinyl estradiol (Yasmin) drug label PDF.