ULIPRISTAL ACETATE

Ulipristal acetate received approval from the U.S. Food and Drug Administration (FDA) for emergency contraception under the brand name ella on August 13, 2010. It functions as a selective progesterone receptor modulator (SPRM), acting on progesterone receptors throughout the body.

Ulipristal acetate is used for emergency contraception and the treatment of uterine fibroids.

Ulipristal acetate is typically used as a single oral dose for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse. It's usually taken as one tablet daily with or without food for a specified treatment period for uterine fibroid treatment. To ensure effectiveness, follow your healthcare provider's instructions precisely. If using for emergency contraception, take it immediately after unprotected sex. If taking for fibroids, adhere to the prescribed schedule and consult your doctor for guidance on any missed doses or concerns.

Ulipristal acetate may lead to common side effects like headache, nausea, and abdominal discomfort. Less common but potentially serious side effects include severe abdominal pain, allergic reactions, and liver issues.

Ulipristal acetate comes with several warnings, including the risk of ectopic pregnancy, its potential impact on liver function, the possibility of allergic reactions, alterations in menstrual patterns, its incompatibility with breastfeeding and pregnancy, potential interactions with other medications, and its influence on hormonal contraception efficacy.

Caution is also advised for individuals with certain medical conditions, the age group under 18, and the risk associated with repeated use within a single menstrual cycle. Patients are urged to adhere to prescribed dosages and follow-up appointments and consult medical professionals promptly for severe symptoms or concerns.

Ulipristal acetate requires careful consideration in clinical use. Caution is warranted in patients with hepatic impairment, as the liver is responsible for metabolising this medication. Allergic reactions may occur, and immediate medical attention is necessary if symptoms such as rash, swelling, or difficulty breathing develop. Changes to menstrual cycles require monitoring, and any significant alterations or irregular bleeding patterns should be reported to a healthcare provider. This medication is contraindicated during pregnancy and breastfeeding due to potential risks. Patients must inform their healthcare provider of all concurrent medications to prevent interactions. This medication can interact with certain drugs, potentially reducing their effectiveness or producing adverse effects. Strong CYP3A4 inducers or inhibitors, including rifampicin and ketoconazole, may alter its metabolism, whilst hormonal contraceptives may demonstrate reduced efficacy if used concurrently. Repeated dosing within a single menstrual cycle and use in patients under 18 years of age require careful evaluation. Adherence to prescribed dosages, attendance at follow-up appointments, and prompt reporting of any concerning symptoms is essential.

Allergan Inc., [Revised on 3rd Jul 2019] [Accessed on 26th Aug 2023], https://allergan-web-cdn-prod.azureedge.net/allergancanadaspecialty/allergancanadaspecialty/media/actavis-canada-specialty/en/products/pms/2019-07-03-fibristal-pm-english.pdf Gedeon Richter Plc., Electronic Medicines Compendium (EMC), [Revised on Jan 2021] [Accessed on 26th Aug 2023], https://www.medicines.org.uk/emc/files/pil.3951.pdf Paweł Milart et al., Ulipristal acetate as a treatment option for uterine fibroids, Menopause Rev, 2017; 16(4): 133-136, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824685/pdf/MR-16-31511.pdf Ellis R. Levin, Wendy S. Vitek, and Stephen R. Hammes, Estrogens, Progestins, and the Female Reproductive Tract, Goodman & Gilman’s: The Pharmacological Basis of Therapeutics, 13th Edition, 2018, 803-831. Watson Pharma, Inc, Food and Drug Safety Administration (FDA) [Revised on August 2008] [Accessed on 26th Aug 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf