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Use of Ulipristal Acetate (ellaOne®) in Breastfeeding Women

Update from the Clinical Effectiveness Unit

March 2013

There has been a change in the manufacturer ’s advice on use of ulipristal

acetate (ellaOne®) in breastfeeding woman. Previous advice was that

breastfeeding was not recommended for 36 hours after taking ulipristal. The

Summary of Product Characteristics (SPC) for ellaOne® now states that ulipristal

acetate can be detected in breast milk up to 5 days after ingestion, and that

breastfeeding should be avoided for one week after use of ellaOne® (1). In order

to stimulate lactation during this time, it is advised that women express and

discard the breast milk (1).

In postpartum women, emergency contraception (EC) is not indicated until day

21 onwards(2). Breastfeeding in itself can provide some protection against an

unintended pregnancy. The lactational amenorrhoea method (LAM) is over 98%

effective if a woman is 6 months postpartum(4). Health

professionals should also consider the following factors when assessing a

woman’s need for EC:

● The timing of all episodes of UPSI in the current cycle

● The most likely date of ovulation based on the date of the last menstrual period

and the usual cycle length

● Details of potential contraceptive failure (e.g. how many pills were missed and

when)

● Use of medications that may affect contraceptive efficacy.

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There are three methods, which can be used for EC available in the UK:

  Copper intrauterine device

  Levonorgestrel (Levonelle One step®, Levonelle 1500®)

  Ulipristal acetate (ellaOne®)

The copper intrauterine device (Cu-IUD) is considered the most effective form of

EC and can be inserted up to 5 days after unprotected sexual intercourse (UPSI)

or 5 days of earliest expected ovulation(5). In breastfeeding women, it can be

inserted from 4 weeks postpartum without restriction(2).

Levonorgestrel EC is licensed for up to 72 hours after UPSI, although FSRH

guidance supports its use beyond this(5). There are no restrictions on the use of

levonorgestrel EC in breastfeeding women(2).

Ulipristal acetate is a progesterone receptor modulator licensed for use as EC up

to 120 hours after unprotected sexual intercourse(1). In a meta-analysis, ulipristal

acetate was shown to prevent more pregnancies than levonorgestrel(6).However, as a relatively new drug, there are more restrictions on its use. In

addition, as a progesterone receptor modulator, there is potential for ulipristal

acetate to interact with ongoing progestogen containing contraceptive

methods and possibly vice versa.

The decision as to which method to use is not always solely dependent on

efficacy. Other factors to consider include:

  Medical eligibility

  Last menstrual period and cycle length

 

Number and timing of episodes of UPSI  Previous EC use within cycle

  Need for additional precautions/ongoing contraception

  Drug interactions

  Individual choice.

The CEU supports the use of all three methods of EC (5). In breastfeeding women

the benefits and risks of EC must be considered in the context of the woman’s

low risk of pregnancy if fully breastfeeding, the disadvantages of stopping

breastfeeding for one week after ulipristal, and the availability/acceptability of

other methods.

More detailed information on each of the methods of EC can be found in

Faculty Guidance(5).

References

(1) HRA Pharma UK and Ireland Limited. ellaOne 30mg: Summary of product

characteristics.

http://www.medicines.org.uk/EMC/medicine/22280/SPC/ellaOne+30+mg

/. 2013.

http://www.medicines.org.uk/EMC/medicine/22280/SPC/ellaOne+30+mg/http://www.medicines.org.uk/EMC/medicine/22280/SPC/ellaOne+30+mg/http://www.medicines.org.uk/EMC/medicine/22280/SPC/ellaOne+30+mg/http://www.medicines.org.uk/EMC/medicine/22280/SPC/ellaOne+30+mg/http://www.medicines.org.uk/EMC/medicine/22280/SPC/ellaOne+30+mg/

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(2) Faculty of Sexual and Reproductive Health Care. UK Medical Eligibility

Criteria for Contraceptive Use. (UKMEC 2009).

http://www.fsrh.org/admin/uploads/UKMEC2009.pdf  2009.

(3) Knight J, Pyper C. Postnatal contraception: what are the choices? Nursingin Practice 2002;May:23-5.

(4) Faculty of Sexual and Reproductive Healthcare CEU. Postnatal Sexual and

Reproductive Health.

http://www.fsrh.org.uk/admin/uploads/CEUGuidancePostnatal09.pdf  

2009.

(5) Faculty of Sexual & Reproductive Health Care Clinical Effectiveness Unit.

Emergency Contraception.

http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf  

2011.

(6) Glasier AF, Cameron ST, Logan SJS, Casale W, Van Horn J, Sogar L, et al.

Ulipristal acetate versus levonorgestrel for emergency contraception: a

randomised non-inferiority trial and meta-analysis. The Lancet

2010;375:555-62.

http://www.fsrh.org/admin/uploads/UKMEC2009.pdfhttp://www.fsrh.org/admin/uploads/UKMEC2009.pdfhttp://www.fsrh.org.uk/admin/uploads/CEUGuidancePostnatal09.pdfhttp://www.fsrh.org.uk/admin/uploads/CEUGuidancePostnatal09.pdfhttp://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdfhttp://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdfhttp://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdfhttp://www.fsrh.org.uk/admin/uploads/CEUGuidancePostnatal09.pdfhttp://www.fsrh.org/admin/uploads/UKMEC2009.pdf