The results of these studies may indicate that it is necessary to perform subsequent in vivo studies if CDER review of the in vitro data indicates that such studies are essential. To conduct analysis of pharmacokinetic differences between elderly and non-elderly, between males and females, and between ethnic groups. Fasting triglycerides should be normal or normalized with appropriate intervention prior to therapy.
Hyperlipidemia usually occurs within the initial two to four weeks.
Therefore, weekly lipid determinations are recommended during this interval. A white blood cell count with differential should be obtained at baseline and periodically during treatment. Baseline liver function tests should be obtained and should be carefully monitored after one, two and four weeks of treatment initiation, and if stable, periodically thereafter during treatment. In one clinical study, plasma bexarotene AUC and Cmax values were substantially higher following a fat-containing meal versus those following the administration of a glucose solution. Bexarotene oxidative metabolites appear to be formed by cytochrome P450 3A4.