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Esmya is a brand name for Ulipristal. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women who have not reached menopause when uterine fibroid embolisation and/or surgical treatment options are not suitable or have failed.
Verbatim from this product's EMA label. Tap a section to expand.
Esmya treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids. Posology The treatment consists of one tablet of 5 mg to be taken once daily for treatment courses of up to 3 months each.
Tablets may be taken with or without food. Treatments should only be initiated when menstruation has occurred: - The first treatment course should start during the first week of menstruation. - Re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion.
The treating physician should explain to the patient the requirement for treatment free intervals. Repeated intermittent treatment has been studied up to 4 intermittent courses. If a patient misses a dose, the patient should take ulipristal acetate as soon as possible.
If the dose was missed by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. Special population Renal impairment No dose adjustment is recommended in patients with mild or moderate renal impairment.
2). Paediatric population There is no relevant use of ulipristal acetate in the paediatric population. The safety and efficacy of ulipristal acetate was only established in women of 18 years and older. Method of administration Medicinal product no longer authorised 3 Oral use.
Tablets should be swallowed with water.
Summary of the safety profile The safety of ulipristal acetate has been evaluated in 1,053 women with uterine fibroids treated with 5 mg or 10 mg ulipristal acetate during Phase III studies. 4). The most frequent adverse reaction was hot flush.
0%) and resolved spontaneously. Among these 1,053 women, the safety of repeated intermittent treatment courses (each limited to 3 months) has been evaluated in 551 women with uterine fibroids treated with 5 or 10 mg ulipristal acetate in two phase III studies (including 446 women exposed to four intermittent treatment courses of whom 53 were exposed to eight intermittent treatment courses) and demonstrated a similar safety profile to that observed for one treatment course.
Tabulated list of adverse reactions Based on pooled data from four phase III studies in patients with uterine fibroids treated for 3 months, the following adverse reactions have been reported. Adverse reactions listed below are classified according to frequency and system organ class.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data).
Medicinal product no longer authorised 7 System Organ Class Adverse reactions during treatment course 1 Very common Common Uncommon Rare Frequency Not known Immune system disorders Drug hypersensitivity* Psychiatric disorders Anxiety Emotional disorder Nervous system disorders Headache* Dizziness Ear and labyrinth disorders Vertigo Respiratory, thoracic and mediastinal disorders Epistaxis Gastrointestinal disorders Abdominal pain Nausea Dry mouth Constipation Dyspepsia Flatulence Hepatobiliary disorders Hepatic failure* Skin and subcutaneous tissue disorders Acne Alopecia** Dry skin Hyperhidrosis Angioedema Musculoskeletal and connective tissue disorders Musculoskeletal pain Back pain Renal and urinary disorders Urinary incontinence Reproductive system and breast disorders Amenorrhea Endometrial thickening* Hot flush* Pelvic pain Ovarian cyst* Breast tenderness/pain Uterine haemorrhage* Metrorrhagia Genital discharge Breast discomfort Ovarian cyst ruptured* Breast swelling General disorders and administration site conditions Fatigue Oedema Asthenia Investigations Weight increased Blood cholesterol increased Blood triglycerides increased * see section "Description of selected adverse reactions" ** The verbatim term “mild hair loss” was coded to the term “alopecia” When comparing repeated treatment courses, overall adverse reactions rate was 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 for dyspepsia which was classified as uncommon in treatment course 3 based on one patient occurence).
Ulipristal acetate should only be prescribed after careful diagnosis. Pregnancy should be precluded prior to treatment. If pregnancy is suspected prior to initiation of a new treatment course, a pregnancy test should be performed. 5).
Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment. Endometrial changes Ulipristal acetate has a specific pharmacodynamic action on the endometrium: Changes in the histology of the endometrium may be observed in patients treated with ulipristal acetate.
These changes are reversible after treatment cessation. 1). In addition, reversible increase of the endometrium thickness may occur under treatment. In case of repeated intermittent treatment, periodic monitoring of the endometrium is recommended.
This includes annual ultrasound to be performed after resumption of menstruation during off-treatment period. If endometrial thickening is noted, which persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, and/or an altered bleeding pattern is noted (see section "Bleeding pattern" below), investigation including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
g. a follow-up control 3 months later) would be recommended. In case of atypical hyperplasia, investigation and management as per usual clinical practice should be performed. The treatment courses should each not exceed 3 months as the risk of adverse impact on the endometrium is unknown if treatment is continued without interruption.
Bleeding pattern Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment. Should the excessive bleeding persist, patients should notify their physician.
1. Pregnancy and breastfeeding. Genital bleeding of unknown aetiology or for reasons other than uterine fibroids. Uterine, cervical, ovarian or breast cancer. Underlying hepatic disorder.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Description of selected adverse reactions Hepatic failure During the post-marketing experience, cases of hepatic failure have been reported. In a small number of these cases, liver transplantation was required. The frequency of occurrence of hepatic failure and patient risk factors are unknown.
Medicinal product no longer authorised 8 Endometrial thickening In 10-15% of patients, thickening of the endometrium (> 16 mm by ultrasound or MRI at end of treatment) was observed with ulipristal acetate by the end of the first 3-month treatment course.
5% of patients by the end of second and fourth treatment course, respectively). The endometrial thickening reverses when treatment is stopped and menstrual periods resume. In addition, reversible changes to the endometrium are denoted PAEC and are different from endometrial hyperplasia.
1). 1% of patients but the rates varied across trials. 6% moderate or severe) for leuprorelin-treated patients. 0% for ulipristal acetate and 0% for placebo. 8% for ulipristal acetate, respectively. 4% of patients in Phase III trials. 8% of patients.
0% of patients and in most of the cases spontaneously disappeared within a few weeks. Uterine haemorrhage Patients with heavy menstrual bleeding due to uterine fibroids are at risk of excessive bleeding, which may require surgical intervention.
A few cases have been reported during ulipristal acetate treatment or within 2-3 months after ulipristal acetate treatment was stopped. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Menstrual periods generally return within 4 weeks after the end of each treatment course. If, during repeated intermittent treatment, after the initial reduction in bleeding or amenorrhea, an altered persistent or unexpected bleeding pattern occurs, such as inter-menstrual bleeding, investigation of the endometrium including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Medicinal product no longer authorised 4 Repeated intermittent treatment has been studied up to 4 intermittent treatment courses. Renal impairment Renal impairment is not expected to significantly alter the elimination of ulipristal acetate.
2). 3). Liver function tests must be performed before starting treatment. Treatment must not be initiated if transaminases (alanine transaminase (ALT) or aspartate aminotransferase (AST)) exceed 2 x ULN (isolated or in combination with bilirubin >2 x ULN).
During treatment, liver function tests must be performed monthly during the first 2 treatment courses. For further treatment courses, liver function must be tested once before each new treatment course and when clinically indicated.
If a patient during treatment shows signs or symptoms compatible with liver injury (fatigue, asthenia, nausea, vomiting, right hypochondrial pain, anorexia, jaundice), treatment should be stopped and the patient should be investigated immediately, and liver function tests performed.
Patients who develop transaminase levels (ALT or AST) > 3 times the upper limit of normal during treatment should stop treatment and be closely monitored. In addition liver testing should be performed 2- 4 weeks after treatment has stopped.
g. g. 5). g. 5). Asthma patients Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.