PrandiMet (repaglinide/metformin HCl fixed-dose combination) tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) May 2010, March and April 2012

 

April 2012

Summary View

 

• Repaglinide is partly metabolized by CYP2C8 and CYP3A4 and appears to be a substrate for active hepatic uptake transporter (organic anion transporting protein OATP1B1). Drugs that inhibit CYP2C8, CYP3A4, or OATP1B1 (e.g., cyclosporine) may increase plasma concentrations of repaglinide. Dose reduction of repaglinide may be needed.

USE IN SPECIFIC POPULATIONS

Pregnancy

• There are no adequate and well-controlled studies in pregnant women with Prandimet or its individual components. Because animal reproduction studies are not always predictive of human response, Prandimet like other antidiabetic medications, should be used during pregnancy only if clearly needed. No animal studies have been conducted with the combined products in Prandimet. The following data are based on findings in studies performed with repaglinide or metformin individually.

 

 

March 2012

Summary View

PRECAUTIONS

Drug Interactions

• Deferasirox: Co-administration of deferasirox (30 mg/kg/day for 4 days) and repaglinide (single dose of 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold ofontrol and an increase in Cmax of 62%   

 

 

May 2010 

Summary View

 

CONTRAINDICATIONS

• PrandiMet is contraindicated in: Patients receiving gemfibrozil

WARNINGS AND PRECAUTIONS

Drug Interactions

• Gemfibrozil significantly increased repaglinide exposure. Therefore, patients should not take PrandiMet with gemfibrozil
• Drugs that inhibit OATP1B1 (e.g., cyclosporine) may have the potential to increase plasma concentrations of repaglinide