ESMYA® ESMYA®
(ULIPRISTAL ACETATE)
TRANSFORMS THE MANAGEMENT OF UTERINE FIBROIDS
treatment for the long-term management of moderate to severe symptoms of uterine fibroids.1
is the first medical
PRESCRIBING INFORMATION Esmya (ulipristal acetate) Please refer to the SmPC before prescribing. Presentation: 5mg tablet. Indication: Pre-operative or intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Dose and administration: One tablet of 5mg to be taken orally once a day for a maximum of 3 months, starting during first week of menstrual cycle. This 3 month treatment course can be repeated. Re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion. Each treatment course should not exceed 3 months. Treatment free intervals are required between courses. Repeated intermittent treatment has been studied for up to 4 intermittent treatment courses. Please refer to SmPC for missed dose information. Patients with renal or hepatic impairment: No dose adjustment in mild to moderate renal impairment or mild hepatic impairment. Not recommended for patients with severe renal impairment and moderate or severe hepatic impairment unless patient is closely monitored. Children and adolescent under 18 years:
No relevant use.
Contraindications: Pregnancy, Breastfeeding, Genital bleeding of unknown aetiology. Uterine, Cervical, Ovarian or Breast cancer. Hypersensitivity to active substance or any excipients. Pregnancy and lactation: Contraindicated during pregnancy and lactation. Warnings and Precautions: Should only be prescribed after careful diagnosis and pregnancy should be precluded prior to treatment. Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not
recommended. Concomitant use of hormonal contraceptives are not
recommended hence a non-hormonal contraceptive method should be used. Reversible histological changes of the endometrium: ‘Progesterone Receptor Modulator Associated Endometrial Changes’ (PAEC) may be observed in patients. Also, reversible thickening of the endometrium may occur during treatment. If it persists beyond 3 months following the end of treatment and return of
UK/ESM5/1015/0150 October 2015 O Licensed for intermittent use1
O Fast, reliable and sustained control of bleeding2
O Significant and sustained reductions in fibroid volume from baseline2
menstruations, and/or an altered bleeding pattern is noted, this may need to be investigated as per usual clinical practice. Please refer to SmPC for further details on endometrial changes and management of the same. In case of repeated intermittent treatment, periodic monitoring of the endometrium is recommended. This includes an annual ultrasound to be performed after resumption of menstruation during off-treatment period. Treatment leads to significant reduction in menstrual blood loss within 10 days and patients should notify their physician if heavy bleeding persists. Drug interactions: Hormonal contraceptives and progestogens are likely to reduce the efficacy of ulipristal acetate by competitive action on progesterone receptors, hence co-administration is not recommended. Not recommended for patients receiving moderate or potent CYP3A4 inhibitors or potent CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, St John’s wort). Co-administration of P-gp substrates (e.g. dabigatran etexilate, digoxin) should be separated in time by at least 1.5 hours. Undesirable effects: The following adverse reactions have been reported during first treatment courses: Very Common (>1/10) Amenorrhea, Endometrial thickening; Common (>1/100 to <1/10) Headache, Vertigo, Abdominal pain, Nausea, Acne, Musculoskeletal pain, Hot flush, Pelvic pain, Ovarian cyst, Breast tenderness/pain, Fatigue, Weight gain.; Uncommon (>1/1000 to <1/100) Anxiety, Emotional disorder, Dizziness, Dry mouth, Constipation, Alopecia, Dry skin, Hyperhidrosis, Back pain, Urinary incontinence, Uterine haemorrhage, Metrorrhagia, Genital discharge, Breast discomfort, Oedema, Asthenia, Increase in cholesterol level Increased triglycerides, Rare (≥1/10,000 to <1/1,000) Epistaxis, Dyspepsia, Flatulence, Rupture of ovarian cyst, Breast swelling. When comparing repeated treatment courses, overall adverse reaction rates were less frequent in subsequent treatment courses than during the first one and each adverse reaction was less frequent or remained in the same frequency category (except dyspepsia which was classified as uncommon). Overdose: Limited experience. Single doses of up to 200mg and
daily doses of 50mg for 10 consecutive days administered to a limited number of subjects, and no severe or serious adverse reactions were reported. Special precautions for storage: Keep the blisters in the outer carton to protect from light. Legal Category: POM Basic UK NHS cost: £114.13 per pack of 28 tabs. Marketing Authorisation Numbers: EU/1/12/750/001, EU/1/12/750/002, EU/1/12/750/003, EU/1/12/750/004, EU/1/12/750/005.
Marketing
Authorisation Holder: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary. Further information is available from: Gedeon Richter UK Ltd, 127 Shirland Road, London W9 2EP. Tel: 0207 604
info.uk@
gedeonrichter.eu Date of Authorisation: 27th of May 2015. Date of Preparation: 16th of June 2015.
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Women’s Health Division of Gedeon Richter (UK) Ltd on 0207 604 8806 or
drugsafety.uk@
gedeonrichter.eu
References 1. ESMYA®
SmPC. May 2015.
2. Donnez, J; Hudecek, R; Donnez, 0, et al. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril 2015; 103(2):519-27.
8800. Email:
O Improved quality of life compared to baseline2
O Well-tolerated2
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