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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.
CASRN: 159811-51-5
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; however, amounts in milk are low. If ulipristal is required by the mother, it is not a reason to discontinue breastfeeding. Some older sources recommend withholding breastfeeding for 24 hours after a dose,[1] but this is no longer a requirement according to current FDA-approved labeling.
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 to 24 hours), 2.96 mcg/L (24 to 48 hours), 1.56 mcg/L (48 to 72 hours), 1.04 mcg/L (72 to 96 hours), and 0.69 mcg/L (96 to 120 hours). The mean daily concentrations of monodemethyl-ulipristal acetate in breastmilk were 4.49 mcg/L (0 to 24 hours), 0.62 mcg/L (24 to 48 hours), 0.28 mcg/L (48 to 72 hours), 0.17 mcg/L (72 to 96 hours), and 0.10 mcg/L (96 to 120 hours). 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).[2] 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.
Alternate Drugs to Consider
References
- 1.
- Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep. 2016;65:1–66. [PubMed: 27467319]
- 2.
- Afaxys Inc. Ella Package Insert. January 27, 2020.
Substance Identification
Substance Name
Ulipristal
CAS Registry Number
159811-51-5
Drug Class
Breast Feeding
Lactation
Milk, Human
Contraceptive Agents
Contraceptives, Postcoital
Contraceptive Agents, Female
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- Review Ulipristal acetate for emergency contraception.[Ann Pharmacother. 2011]Review Ulipristal acetate for emergency contraception.Snow SE, Melillo SN, Jarvis CI. Ann Pharmacother. 2011 Jun; 45(6):780-6. Epub 2011 Jun 10.
- Review Dienogest.[Drugs and Lactation Database (...]Review Dienogest.. Drugs and Lactation Database (LactMed®). 2006
- Review Ulipristal acetate in emergency contraception.[Coll Antropol. 2014]Review Ulipristal acetate in emergency contraception.Goldstajn MS, Baldani DP, Skrgatić L, Radaković B, Vrbić H, Canić T. Coll Antropol. 2014 Mar; 38(1):379-84.
- Immunopharmacology of ulipristal as an emergency contraceptive.[Int J Womens Health. 2011]Immunopharmacology of ulipristal as an emergency contraceptive.Miech RP. Int J Womens Health. 2011; 3:391-7. Epub 2011 Nov 22.
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