Ulipristal Acetate

SCOPE — this is the page's PRIMARY indication: uterine fibroids (Esmya), which the page leads with in its brand list, its dose line, its hepatic field, its monitoring list and its clinical pearls. §4.2 VERBATIM: '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.' Prescribing is restricted: 'Esmya treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids.' || WHEN TO START A COURSE, §4.2 verbatim: '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.' §4.4 adds: '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.' || ⚠️ THE PAGE'S '8 WEEKS' IS NOT IN THIS SOURCE. The page currently reads 'Fibroids: 5 mg once daily for up to 8 weeks pre-operatively'; the fetched SPC says courses 'of up to 3 months each' and describes repeated intermittent courses, not a single pre-operative 8-week block. The 5 mg once-daily figure itself matches. || MISSED DOSE, §4.2 verbatim: '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.' || MAX DOSE DELIBERATELY LEFT EMPTY: the fibroid regimen is a fixed 5 mg once daily and the SPC states no maximum daily dose. Its only cap is on course DURATION (3 months), which is not a dose ceiling and is recorded above instead. || CONTRACEPTION DURING TREATMENT, §4.4 verbatim: 'Concomitant use of progestagen-only pills, a progestagen-releasing intrauterine device or combined oral contraceptive pills is not recommended... Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment.' Pregnancy must be precluded before treatment, and 'If pregnancy is suspected prior to initiation of a new treatment course, a pregnancy test should be performed.' || SECONDARY INDICATION — EMERGENCY CONTRACEPTION — RECORDED HERE, NOT PUBLISHED IN THE DOSE FIELD, because it is not this page's primary indication and because the only source for it in this bundle is US labelling for a different product (Ella 30 mg; the UK EllaOne SPC was NOT fetched). US §2.1 verbatim: 'Take one tablet of ella orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. Take ella with or without food. Take ella at any time during the menstrual cycle.' The strength is pinned by US §3: 'The ella tablet is supplied as a white to off-white, round, curved tablet containing 30 mg of ulipristal acetate'. US §2.3: 'If vomiting occurs within 3 hours of taking ella, consider repeating the dose.' US §2.2: 'After ella use, initiate or resume hormonal contraception no sooner than 5 days after the intake of ella and use a reliable barrier method until the next menstrual period.' US §5.3: 'Ella is for occasional use as an emergency contraceptive. It should not replace a regular method of contraception. Repeated use of ella within the same menstrual cycle is not recommended' — the sentence is cut off by the source-fetch limit. || ⚠️ THE MHRA LIVER RESTRICTION THIS PAGE RELIES ON IS NOT IN THIS BUNDLE. The page's pearls and hepatic field state that LFTs must be normal before starting, with monthly monitoring and a single course only. No liver-function monitoring instruction appears anywhere in the fetched text: the retrieved §4.2 has no hepatic paragraph at all, and §4.4 is truncated at the source-fetch limit part-way through the bleeding-pattern subsection. The only hepatic statement retrieved is the §4.3 contraindication 'Underlying hepatic disorder.' Re-fetch the current full SPC before relying on this bundle for the liver-safety regimen. || CYP3A4: the UK §4.5 was not fetched. US §7.1 (for the EC product) lists CYP3A4 inducers to avoid — 'barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate' — and warns that 'Progestin-containing contraceptives may impair the ability of ella to delay ovulation.' || PAEDIATRIC: paedDose is null. §4.2 verbatim: '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.' For the SECONDARY emergency-contraception indication the US label does report adolescent data (§8.4: 'The clinical trials of ella enrolled 41 females under age 18, and a post-marketing observational study... enrolled 279 females under age 18, including 76 under age 16 years. In these studies, the safety and efficacy profile observed in adolescents aged 17 and younger was similar to that in adults. Use of ella before menarche is not indicated.'), but that belongs to the indication not published here, and the page's own claim that 'EC licensed from 16 years' appears nowhere in this bundle. US §8.5 also states: 'This product is not intended for use in postmenopausal women.'