Faculty of Sexual and Reproductive Healthcare

Statement on Drug Interactions between Hormonal

Contraception and Ulipristal Products: ellaOne and Esmya

November 2012

Background
Ulipristal acetate is now available as Esmya, a treatment for uterine fibroids, in
addition to ellaOne the emergency contraceptive. The two products contain
different strengths of ulipristal acetate and have different dosage regimens
(table 1).

Table 1 Ulipristal Products Licensed in UK

Ulipristal
Product Esmya ellaOne

Indication Pre-operative treatment of Emergency contraception

moderate to severe symptoms of
uterine fibroids.

Dose 5mg tablet 30mg tablet (micronized ulipristal)

Regimen One tablet daily (for up to 3 One tablet stat

months)

Drug Interactions
The summaries of product characteristics (SPCs) for Esmya(1) and ellaOne(2) give
different advice on drug interactions with hormonal contraception (table 2). The
inconsistencies reflect the lack of drug interactions data in humans. The advice
given for Esmya is more cautious and is not consistent with current Faculty
recommendations on the length of time additional contraceptive precautions
are required following missed contraceptive pills or when quick starting hormonal
contraception after ellaOne. The inconsistencies have been raised with the
European Medicines Agency.

Until further data/recommendations are available, the Faculty of Sexual &

Reproductive Healthcare advises following the SPC recommendations, including
avoiding use of hormonal contraceptives with Esmya. Esmya should not be
used outside the product licence (e.g. for longer than 3 months) at present. For
use of ellaOne, Faculty advice is as per Emergency Contraception(3) and Quick
Starting Contraception Guidance(4)(table 3).
Table 2 Manufacturers advice on drug interactions between ulipristal acetate
and hormonal contraception(1)(2)
Ulipristal
Product Esmya ellaOne

Advice Hormonal contraceptives and Because ulipristal acetate binds the

progestagens are likely to reduce progesterone receptor with high
ulipristal acetate efficacy by affinity, it may interfere with the
competitive action on the action of progestogen-containing
progesterone receptor. Therefore medicinal products. Contraceptive
concomitant administration of action of combined hormonal
medicinal products containing contraceptives and progestogen-
progestogen is not recommended. only contraception may be
reduced.

Concomitant use of progestogen- Although the use of ellaOne does

only pills, a progestogen-releasing not contraindicate the continued
intrauterine device or combined use of regular hormonal
oral contraceptive pills is not contraception, ellaOne may
recommended. Although a majority reduce its contraceptive action.
of women taking a therapeutic Therefore, after using emergency
dose of ulipristal acetate have contraception, it is recommended
anovulation, a non hormonal that subsequent acts of intercourse
contraceptive method is be protected by a reliable barrier
recommended during treatment. method until the next menstrual
period starts.

Medicinal products containing Concomitant use of ulipristal

progestogen should not be taken acetate and emergency
within 12 days after cessation of contraception containing
ulipristal acetate treatment. levonorgestrel is not recommended.
Table 3 Faculty of Sexual & Reproductive Healthcare recommendations on
additional contraception after emergency contraception in women using
hormonal contraception
EC Options Additional contraceptive precautions (condom or avoidance of sex)
Cu-IUD No additional contraception required

LNG 7 days (2 for POP, 9 for Qlaira)

UPA 14 days (9 for POP, 16 for Qlaira)

References

(1) Preglem UK a Division of Gedeon Richter (UK) Ltd. Esmya 5mg tablets
(ulipristal acetate): Summary of Product Characteristics.
http://www.medicines.org.uk/EMC/medicine/26068/SPC/. 2012.

(2) HRA Pharma UK Ltd. ellaOne: Summary of Product Characteristics (SPC).

www.medicines.org.uk/emc. 2011.

(3) Faculty of Sexual & Reproductive Health Care Clinical Effectiveness Unit.
Emergency Contraception.
http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf.
2011.

(4) Faculty of Sexual and Reproductive Healthcare CEU. Quick Starting

Contraception.
http://www.fsrh.org/admin/uploads/678_CEUGuidanceQuickStartingContra
ception.pdf. 2010.