ulipristal
Sources réglementaires consultées
Indications approuvées
- Contraception d’urgence dans les 120 heures suivant un rapport non protégé ou l’échec de la méthode contraceptive.
Contre-indications
Absolues
- Hypersensibilité à l’acétate d’ulipristal ou aux excipients.
Mises en garde cliniques
- Mise en garde majeure · Il n’est pas destiné à une contraception régulière et n’interrompt pas une grossesse existante. Si les règles ont plus de 7 jours de retard, sont anormales ou si des symptômes surviennent, exclure une grossesse et envisager une grossesse extra-utérine. — CIMA/AEMPS, ficha técnica 84451
- Mise en garde majeure · Il n’est pas recommandé en cas d’asthme sévère traité par glucocorticoïdes oraux ni après des inducteurs du CYP3A4 au cours des 4 semaines précédentes ; envisager un DIU au cuivre. — CIMA/AEMPS, ficha técnica 84451
- Mise en garde majeure · Des données limitées et non concluantes suggèrent une possible diminution de l’efficacité contraceptive lorsque le poids corporel ou l’indice de masse corporelle augmente ; administrer le plus tôt possible indépendamment du poids ou de l’IMC. — CIMA/AEMPS, ficha técnica 84451
Interactions médicamenteuses
- SévèreInducteurs du CYP3A4 utilisés au cours des 4 semaines précédentes
Mécanisme: Ils réduisent fortement l’exposition et peuvent diminuer l’efficacité.
Recommandation: Association non recommandée ; envisager une contraception d’urgence non hormonale par DIU au cuivre.
CIMA/AEMPS, ficha técnica 84451https://cima.aemps.es/cima/dochtml/ft/84451/FT_84451.html
- SévèreContraceptifs contenant un progestatif
Mécanisme: Le progestatif peut réduire la capacité de l’ulipristal à retarder l’ovulation.
Recommandation: Les recommandations diffèrent selon la juridiction. FDA/DailyMed : instaurer ou reprendre la contraception hormonale au plus tôt 5 jours après l’ulipristal et utiliser une méthode barrière fiable jusqu’aux règles suivantes. CIMA/AEMPS : elle peut être instaurée ou poursuivie immédiatement, mais une méthode barrière fiable doit être utilisée jusqu’aux règles suivantes.
CIMA/AEMPS, ficha técnica 84451https://cima.aemps.es/cima/dochtml/ft/84451/FT_84451.htmlDailyMed, ella, set ID 2bf93d23-cddd-4613-9066-5b5fa090404bhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2bf93d23-cddd-4613-9066-5b5fa090404b
- SévèreContraception d’urgence par lévonorgestrel
Mécanisme: L’activité progestative peut interférer avec la capacité de l’ulipristal à retarder l’ovulation.
Recommandation: Ne pas utiliser l’ulipristal avec une autre contraception d’urgence contenant du lévonorgestrel.
CIMA/AEMPS, ficha técnica 84451https://cima.aemps.es/cima/dochtml/ft/84451/FT_84451.html
Effets indésirables
Communs (≥1%)
Céphalées ou vertiges · Nausées · Douleur abdominale · Dysménorrhée ou douleur pelvienne · Fatigue
Rares mais graves
Réaction d’hypersensibilité, y compris angio-œdème · Grossesse extra-utérine en cas d’échec
Grossesse et allaitement
Ne pas prendre pendant une grossesse connue ou suspectée ; il ne l’interrompt pas. Interrompre l’allaitement pendant au moins une semaine ; tirer et jeter le lait pour maintenir la production.
Bibliographie récente (PubMed)
Emergency contraception (EC), or postcoital contraception, is a therapy aimed at preventing unintended pregnancy after an act of unprotected or under-protected sexual intercourse. Options include both emergency contraceptive pills (most commonly containing levonorgestrel or ulipristal acetate) and insertion of an intrauterine device. The aim of this paper is to summarize current evidence surrounding the use of emergency contraceptives and to present an evidence-based approach to EC provision. Emergency contraception is a safe and effective option in preventing unwanted pregnancy, irrespective of age, weight, or breastfeeding status. Efforts should be made to increase their availability, as well as knowledge of these methods, both among patients and healthcare providers. Ulipristal is a selective progesterone receptor modulator used in a single dose as an emergency postcoital contraceptive. No information is available on the clinical use of ulipristal during breastfeeding; however, amounts in milk are low. If ulipristal is required by the mother, it is not a reason to discontinue breastfeeding. Some older sources recommend withholding breastfeeding for 24 hours after a dose,[1] but this is no longer a requirement according to current FDA-approved labeling.
Premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) are common disorders of the luteal phase of the menstrual cycle and are characterized by moderate to severe physical, affective, or behavioral symptoms that impair daily activities and quality of life. PMS and PMDD have recently raised great interest in the research community for their considerable global prevalence. The etiology of PMS/PMDD is complex. Ovarian reproductive steroids (estradiol and progesterone) are considered pathogenetic effectors, but the key feature seems to be an altered sensitivity of the GABAergic central inhibitory system to allopregnanolone, a neurosteroid derived from progesterone produced after ovulation. Also, a reduced availability of serotonin seems to be involved. New insights point to a role for genetic and epigenetic modifications of hormonal and neurotransmitter pathways, and inflammation is the potential link between peripheral and neurological integrated responses to stressors. Thus, new therapeutic approaches to PMS/PMDD include inhibition of progesterone receptors in the brain (i.e., with ulipristal acetate), reduced conversion of progesterone to its metabolite allopregnanolone with dutasteride, and possible modulation of the action of allopregnanolone on the brain GABAergic system with sepranolone. Further research is needed to better understand the interaction between peripheral inflammatory molecules (cytokines, interleukins, C-reactive protein, and reactive oxygen species) and the brain neurotransmitter systems in women with PMS/PMDD. If confirmed, neuroinflammation could lead both to develop targeted anti-inflammatory therapies and to define prevention strategies for the associated chronic inflammatory risk in PMS/PMDD. Finally, the observed association between premenstrual disorders and psychological diseases may guide prompt and adequate interventions to achieve a better quality of life.
Emergency contraception includes several methods of contraception that can be used after unprotected sexual intercourse, after failure of any used method of contraception or in case of sexual abuse, to prevent pregnancy. The aim of the study was to analyze the available methods of emergency contraception, their mechanisms of action, efficacy, forms of administration, clinical applications and possible adverse effects. PubMed, Scopus and Cochrane datebases were searched for articles from 2010 to 2024 about emergency contraception. The analyzed types of emergency contraception included single oral dose of ulipristal acetate, single oral dose of levonorgestrel and intrauterine system releasing levonorgestrel or copper intrauterine device. Taking emergency contraception in the optimum time according to the drug characteristics allows for avoiding pregnancy in more than 90% of cases (depending on the type of emergency contraception and time from unprotected intercourse). The analyzed literature shows that intrauterine copper intrauterine device is the most effective method of emergency contraception, also together with intrauterine system releasing levonorgestrel leading to the lowest rate of adverse effects. Taking emergency contraception can result in various adverse effects, therefore it should be introduced after thorough analysis of woman's medical history, including gynecological and obstetric history and potential contraindications. Additionally, the patient should receive detailed information about the drug mechanism of efficacy and potential adverse effects.
This Review offers an evaluation of current treatments for symptomatic uterine fibroids, including uterine artery embolisation, MRI-guided high-intensity focused ultrasound, laparoscopic radiofrequency ablation, transcervical radiofrequency ablation, ulipristal acetate, and oral gonadotropin-releasing hormone antagonists with add-back therapy. Placing these therapies within the IDEAL (Idea, Development, Exploration, Assessment, And Long-Term Follow-Up) framework and the clinical phases of drug development framework, we highlight key gaps in the evidence such as the lack of head-to-head comparisons with standard care, scarce long-term data, and inadequate consideration of real-world fibroid and patient characteristics. We provide a clear overview, assess the strength of the available evidence, and propose a practical flowchart to help clinicians navigate treatment decisions, ensuring the best care for women with symptomatic fibroids at various stages of therapy development. Insight into these matters equips both patient and clinician with essential information to support the process of shared and fully informed decision making. Importantly, this Review also identifies knowledge gaps that contribute to the specification of the fibroid research agenda.