Resources for You
Ella (ulipristal acetate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
- A CYP3A4 inducer, rifampin, decreases the plasma concentration of Ella significantly. Ella should not be administered with CYP3A4 inducers [see Drug interactions (7.1) and Pharmacokinetics (12.3)].
USE IN SPECIFIC POPULATIONS
- The breast milk of 12 lactating women following administration of Ella was collected in 24-hour increments to measure the concentrations of ulipristal acetate and monodemethyl-ulipristal acetate in breast milk. The mean daily concentrations of ulipristal acetate in breast milk were 22.7 ng/mL [0-24 hours], 2.96 ng/mL [24-48 hours], 1.56 ng/mL [48-72 hours], 1.04 ng/mL [72-96 hours], and 0.69 ng/mL [96-120 hours]. The mean daily concentrations of monodemethyl-ulipristal acetate in breast milk were 4.49 ng/mL [0-24 hours], 0.62 ng/mL [24-48 hours], 0.28 ng/mL [48-72 hours], 0.17 ng/mL [72-96 hours], and 0.10 ng/mL [96-120 hours]. The effect of this exposure on newborns/infants has not been studied; therefore, risk to the breast-fed child cannot be excluded. Therefore, use of ella by breastfeeding women is not recommended.
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.