Drug Action
Ulipristal acetate is a progesterone receptor modulator with a partial progesterone antagonist effect.
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Drug reference
Ulipristal acetate is a progesterone receptor modulator with a partial progesterone antagonist effect.
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Pre-operative treatment of moderate to severe symptoms of uterine fibroids (initiated by a specialist) ▶BY MOUTH ▶Adult: 5 mg once daily for up to 3 months starting Genito-urinary system during the first week of menstruation Intermittent treatment of moderate to severe symptoms of uterine fibroids if surgery not appropriate (initiated by a specialist) ▶BY MOUTH ▶Adult: 5 mg once daily for up to 3 months starting during the first week of menstruation, treatment course may be repeated if necessary; re-treatment should start no sooner than during the first week of the second menstruation following completion of the previous course; maximum 4 courses Emergency contraception ▶BY MOUTH ▶Females of childbearing potential: 30 mg for 1 dose, to be taken as soon as possible after coitus, but no later than after 120 hours
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▶When used for uterine fibroids Breast cancer. cervical cancer. ovarian cancer. undiagnosed vaginal bleeding. uterine cancer. vaginal bleeding not caused by uterine fibroids
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Uncontrolled severe asthma
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The manufacturer of Esmya ® has provided a Physician’s Guide to Prescribing Esmya ®.
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MHRA/CHM ADVICE: ESMYA ® (ULIPRISTAL ACETATE): SUSPENSION OF THE LICENCE DUE TO RISK OF SERIOUS LIVER INJURY (MARCH 2020) Rare but serious cases of liver injury, including hepatic failure requiring liver transplantation, have been reported worldwide in women treated with Esmya ® for symptoms of uterine fibroids. The licence of Esmya ® has been suspended while a safety review is carried out, following a further case of liver injury requiring transplantation despite liver function monitoring. Healthcare professionals are advised not to start Esmya ® in new patients and to stop treatment in current patients; alternative treatment options for uterine fibroids should be considered. Liver function tests should be performed 2–4 weeks after stopping treatment, and patients advised to be vigilant for the signs and symptoms of liver injury and to seek immediate medical advice if these occur, even if 1–2 months after stopping treatment. There are currently no concerns with the use of the emergency contraceptive ellaOne ®—see Indications and Dose.
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→Appendix 1: ulipristal
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▶Common or very common Back pain. breast tenderness. dizziness. fatigue. gastrointestinal discomfort. headaches . menstrual cycle irregularities. mood altered. myalgia. nausea. pelvic pain. vomiting ▶Uncommon Anxiety. appetite disorder. chills. concentration impaired. diarrhoea. drowsiness. dry mouth. fever. flatulence. hot flush. increased risk of infection. insomnia. libido disorder. malaise. skin reactions. vision disorders. vulvovaginal disorders ▶Rare or very rare Abnormal sensation in eye. disorientation. dry throat. eye erythema. genital pruritus . ovarian cyst ruptured. painful sexual intercourse. syncope. taste altered. thirst. tremor. vertigo ▶Frequency not known Hepatic disorders
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When ulipristal is given for uterine fibroids non-hormonal contraceptive methods (barrier methods or intra-uterine device) should be used both during treatment and for 12 days after stopping, if required.
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▶When used for Emergency contraception Limited information available—if pregnancy occurs, manufacturer advises Genito-urinary system report to the ellaOne ® pregnancy registry. ▶When used for Uterine fibroids Manufacturer advises avoid— limited information available.
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▶When used for Emergency contraception Manufacturer advises avoid for 1 week after administration—present in milk. ▶When used for Uterine fibroids Manufacturer advises avoid— no information available.
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▶When used for Emergency contraception Manufacturer advises avoid in severe impairment (no information available). ▶When used for Uterine fibroids Manufacturer advises avoid (no information available).
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▶When used for Uterine fibroids Manufacturer advises avoid in severe impairment unless patient is closely monitored—no information available.
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▶When used for Uterine fibroids Manufacturer advises perform liver function tests before treatment initiation—do not initiate if transaminases exceed 2 times the upper limit of normal. During the first 2 treatment courses, monitor liver function monthly; for further treatment courses, perform liver function tests once before each new treatment course and when clinically indicated. At the end of each treatment course, perform liver function tests after 2–4 weeks. Discontinue treatment if serum transaminases exceed 3 times the upper limit of normal and closely monitor patient. Manufacturer advises periodic monitoring of the endometrium following repeated intermittent treatment.
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There can be variation in the licensing of different medicines containing the same drug. Tablet ▶Ellaone (HRA Pharma UK Ltd) Ulipristal acetate 30 mg EllaOne 30mg tablets | 1 tablet p £14.05 DT = £14.05 ▶Esmya (Gedeon Richter (UK) Ltd) Ulipristal acetate 5 mg Esmya 5mg tablets | 28 tablet P £114.13 DT = £114.13 3.4 Contraception, oral progestogen-only Other drugs used for Contraception, oral progestogen- only Norethisterone, p. 806 PROGESTOGENS
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▶When used for Emergency contraception When prescribing or supplying hormonal emergency contraception, manufacturer advises women should be told: . if vomiting occurs within 3 hours of taking a dose, a replacement dose should be taken; . that their next period may be early or late; . to seek medical attention promptly if any lower abdominal pain occurs because this could signify an ectopic pregnancy. The Faculty of Sexual and Reproductive Healthcare also advises women should be told: . that a barrier method of contraception needs to be used—see Emergency contraception p. 838 for further information; . that a pregnancy test should be performed if the next menstrual period is delayed by more than 7 days, is lighter than usual, or is associated with abdominal pain that is not typical of the woman’s usual dysmenorrhoea; . that a pregnancy test should be performed if hormonal contraception is started soon after use of emergency contraception even if they have bleeding; bleeding associated with the contraceptive method may not represent menstruation. ▶When used for Uterine fibroids Before initiation of Esmya ®, the MHRA advises that women are informed of the rare risk of liver damage and the need for liver function testing. Women should also be advised to seek urgent medical attention if they develop any symptoms or signs of liver injury (such as unusual tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting). Manufacturer advises prescribers should explain the requirement for treatment free intervals to women receiving intermittent treatment. ▶When used for Uterine fibroids Manufacturer advises a patient card should be provided. Missed doses ▶When used for Uterine fibroids Manufacturer advises if a dose is more than 12 hours late, the missed dose should not be taken and the next dose should be taken at the normal time.
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5 mg once daily for up to 3 months starting
First-line fragment. Read the complete Indications and Dose section above.
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5 mg once daily for up to 3 months starting
First-line fragment. Read the complete Indications and Dose section above.
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