Safety

Ella (ulipristal acetate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

March 2015

Summary View

WARNINGS AND PRECAUTIONS

Fertility Following Use
  • added...After use of ella, a reliable barrier method of contraception should be used with subsequent acts of intercourse that occur in that same menstrual cycle.

 

June 2014

Summary View

WARNINGS AND PRECAUTIONS

CYP3A4 Inducers
  • 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

NURSING MOTHERS

  • 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. 

 

May 2012

Summary View

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.

 

Page Last Updated: 04/15/2015
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