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Drugs and Lactation Database (LactMed) [Internet].

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Ulipristal

Last Revision: December 3, 2018.

Estimated reading time: 1 minute

CASRN: 159811-51-5

Chemical structure

Drug Levels and Effects

Summary of Use during Lactation

Ulipristal is a selective progesterone receptor modulator used in a single dose as an emergency postcoital contraceptive. No information is available on the clinical use of ulipristal during breastfeeding. The manufacturer recommends avoiding use of ulipristal acetate during breastfeeding; others recommend withholding breastfeeding for 24 hours after use, based on the low levels in breastmilk.[1][2]

Drug Levels

Ulipristal acetate is metabolized to mono- and di-demethylated metabolites by CYP3A4. Monodemethyl-ulipristal is pharmacologically active.

Maternal Levels. The breastmilk of 12 lactating women following administration of ulipristal (dosage not stated, but presumably 30 mg) was collected in 24-hour increments to measure the concentrations of ulipristal acetate and monodemethyl-ulipristal acetate in breastmilk. The mean daily concentrations of ulipristal acetate in breastmilk were 22.7 mcg/L (0-24 hours), 2.96 mcg/L (24-48 hours), 1.56 mcg/L (48-72 hours), 1.04 ng/mL (72-96 hours), and 0.69 mcg/L (96-120 hours). The mean daily concentrations of monodemethyl-ulipristal acetate in breastmilk were 4.49 mcg/L (0-24 hours), 0.62 mcg/L (24-48 hours), 0.28 mcg/lL (48-72 hours), 0.17 mcg/L (72-96 hours), and 0.10 mcg/L (96-120 hours).[2] Using these data, a fully breastfed infant would receive about 4.1 mcg/kg of drug plus active metabolite on the first day and a total of 5.2 mcg/kg over 5 days. Assuming a 30 mg dose and an average maternal weight of 60 kg, the infant would receive a weight-adjusted dosage of 0.8% of drug plus active metabolite on the first day and a total of 1% of the maternal dose over the 5-day period.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1.
Sridhar A, Salcedo J. Optimizing maternal and neonatal outcomes with postpartum contraception: Impact on breastfeeding and birth spacing. Matern Health Neonatol Perinatol. 2017;3:1. [PMC free article: PMC5237348] [PubMed: 28101373]
2.
Afaxys Inc. Ella Package Insert. 2014.

Substance Identification

Substance Name

Ulipristal

CAS Registry Number

159811-51-5

Drug Class

  • Breast Feeding
  • Contraceptive Agents
  • Contraceptives, Postcoital
  • Contraceptive Agents, Female

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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