Label Changes for:
Ella (ulipristal acetate)
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2012
7 DRUG INTERACTIONS
7.3 Effects of ella on Co-Administered Drugs
- P-glycoprotein (P-gp) transporters: In vitro data indicate that ulipristal may be an inhibitor of P-gp at clinically relevant concentrations. Thus, co-administration of ulipristal acetate and P-gp substrates (e.g., dabigatran etexilate, digoxin), may increase the concentration of P-gp substrates.