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Ulipristal Acetate (EllaOne) as an emergency hormonal contraceptive and Breastfeeding

Ulipristal is used as an emergency contraceptive for up to 120 hours (5 days) after intercourse. It is a single tablet.

The manufacturer (patient information leaflet and SPC)  recommends that breastfeeding should be avoided for 1 week after administration as it is present in milk.

This does not seem to be justified by pharmacokinetic data which supports the recommendations by expert sources that breastfeeding can continue as normal.

Pharmacokinetics

It is highly plasma protein bound (98-99.5%)

Relative Dose     0.8 – 1    % (significantly below 10% regarded as compatible with breastfeeding)

The manufacturer reports that after this medication was given to 12 breastfeeding women for emergency contraception mean levels in milk were measured as shown

 ulipristal level in breastmilk
24 hours22.7 ng/mL
24-48 hours2.6ng/ml
48-72 hours1.56 ng/mL
72-96 hours1.04 ng/mL
96-120 hours0.69 ng/mL

The manufacturer did not report any neonatal outcomes as the infants in this report were not breastfed.

Recommendations on compatibility of breastfeeding

  • 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,[ Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep. 2016;65:1–66]but this is no longer a requirement according to current FDA-approved labeling. https://www.ncbi.nlm.nih.gov/books/NBK500655/
  • Intestinal absorption by the infant of the low dose excreted in breastmilk would be hindered, since oral bioavailability decreases up to 45% if administered with fat-rich foods, such as breastmilk.

Given the minimal excretion of the product in breastmilk and the absence of adverse effects recorded during breastfeeding, it is difficult to justify the recommendation proposed by other authors or health agencies such as CDC to interrupt breastfeeding for 24 hours (Curtis 2016 CDC) or 36 hours (Mansour 2009).

https://www.e-lactancia.org/breastfeeding/ulipristal-acetate-contraceptive/product/
  • A single dose of 30mg ulipristal acetate is licensed to be taken within 120 hours (5 days) after unprotected intercourse or contraceptive failure. Ulipristal is not the preferred emergency contraceptive during breastfeeding, however, based on pharmacokinetic data, UKDILAS do not consider it necessary to withhold breastfeeding if a single dose has been taken. https://www.sps.nhs.uk/articles/emergency-contraception-and-breast-feeding/

Patient advice

  • if vomiting occurs within 3 hours of taking a dose, a replacement dose should be taken;
  • the next period may be early or late;
  • seek medical attention promptly if any lower abdominal pain occurs because this could signify an ectopic pregnancy.
  • Take a pregnancy test if the next menstrual period is delayed by more than 7 days, is lighter than usual, or is associated with abdominal pain which is not normal for a period pain

Further sources of information