EllaOne

What it is

EllaOne is a tablet containing 30 mg of ulipristal acetate. It is a white to marble creamy, round tablet engraved on both faces with the code "ella". Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator that acts via high-affinity binding to the human progesterone receptor. When used for emergency contraception, the mechanism of action is inhibition or delay of ovulation via suppression of the luteinising hormone surge.

Approved indications

— Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

Dosing overview

The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure. EllaOne is more effective if taken in the first 24 hours following unprotected intercourse. EllaOne can be taken at any time during the menstrual cycle. The tablet can be taken with or without food. If vomiting occurs within 3 hours of EllaOne intake, another tablet should be taken.

Key safety warnings

EllaOne does not prevent pregnancy every time as it inhibits or postpones ovulation. If ovulation has already occurred, EllaOne is no longer effective. The timing of ovulation cannot be predicted and therefore EllaOne should be taken as soon as possible after unprotected intercourse. If a woman's menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before EllaOne is administered. After EllaOne intake, menstrual periods can sometimes occur a few days earlier or later than expected. In approximately 7% of women, menstrual periods occurred more than 7 days earlier than expected. In 18.5% of women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days. The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea. The vast majority of adverse reactions were mild or moderate and resolved spontaneously.

Contraindications

Hypersensitivity to the active substance or to any of the listed excipients. EllaOne should not be given to pregnant women. If menstrual bleeding is overdue, if the last menstrual period was abnormal in timing or character or if pregnancy is suspected for any other reason, pregnancy should be excluded before treatment is given. Use in women with severe asthma treated with oral glucocorticoids is not recommended. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Regulatory history

EllaOne 30 mg tablet containing ulipristal acetate was first listed on the ARTG on 6 March 2015. The delegate of the Secretary of the Department of Health and Ageing approved the application for registration on 25 February 2015, indicating the drug's suitability for its approved therapeutic use as emergency contraception. The quality and nonclinical evaluations for ulipristal acetate were satisfactory, with no outstanding issues identified. Clinical data supported the efficacy and safety of ulipristal acetate 30 mg for emergency contraception when taken within 120 hours of unprotected intercourse or contraceptive failure.