The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Lopid (gemfibrozil, Pfizer) tablets to include new revisions to the prescribing information. The approved sNDA includes updates to the Contraindications, Warnings, and Drug Interactions sections.
The Contraindications section now states a contraindication for combination therapy of gemfibrozil with dasabuvir. The Warnings section now states that gemfibrozil, a CYP2C8 inhibitor, may increase exposure of CYP2C8 substrates when given concomitantly. It also includes information on OATP1B1 substrates, stating that gemfibrozil inhibits OATP1B1 and may increase exposure of OATP1B1 substrates.
The Drug Interactions section now has a precautionary statement for dose reduction of drugs that are mainly metabolized by CYP2C8 when gemfibrozil is used concomitantly, and a subsection to describe the impact of gemfibrozil on dasabuvir’s AUC and Cmax that supports the contraindication for concomitant gemfibrozil with dasabuvir use. It also includes data from in vitro studies demonstrating the effect of gemfibrozil on CYP and UGTA enzymes and the OATP1B1 transporter.
Lopid, a lipid regulating agent, is indicated for Type IV and V hyperlipidemias resistant to dietary management, when TG levels are >1000mg/dL and pancreatitis is likely; and for the reduction in risk of coronary artery disease in certain Type IIb patients with inadequate response to nonpharmacological management and other pharmacologic agents (eg, bile acid sequestrants, nicotinic acid) and have HDL-C levels <35mg/dL, elevated LDL-C and TG. It is supplied as 600mg scored tablets.
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