Selective progesterone receptor modulator (SPRM)
Updated · Methodology
First line
Emergency contraception within 120 h of unprotected sex or method failure. Per SEGO 2023 and FIGO 2023, first-line. Single 30 mg oral tablet ASAP. Pregnancy rate 1.4% (vs 2.2% for levonorgestrel). Preferred for BMI ≥30. After dosing – barrier method backup for 5 days, then resume usual contraception.
Sources
ICD-10: Z30.0 · ICD-11: QA21
Second line
Ulipristal while breastfeeding. Per EllaOne SmPC and SEGO 2023, pump and discard milk for 7 days after a dose – infant safety data are limited. Hale L3. For breastfeeding women, levonorgestrel 1.5 mg is preferred (Hale L2, RID about 1.3%, no feeding interruption) or a copper IUD.
Sources
ICD-10: Z30.0 · ICD-11: QA21
Selective progesterone receptor modulator. For emergency contraception, 30 mg blocks the LH surge and delays ovulation by 5 days, even when taken immediately before expected ovulation. Effective up to 120 h post-coitus. Per Lancet 2010 meta-analysis, more effective than levonorgestrel, especially at 72–120 h and in BMI ≥30.
Do not use in confirmed pregnancy. Accidental use is not linked to birth defects – pregnancy may safely continue.
Pump and discard milk for 7 days after a dose. RID not precisely estimated, Hale L3 due to limited data. For breastfeeding women, prefer levonorgestrel 1.5 mg (Hale L2) or copper IUD.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Verbatim lines from the interaction sections, in the language of the label
«No se recomienda el uso concomitante de acetato de ulipristal con inductores de CYP3A4, debido a las interacciones (por ejemplo, barbitúricos [incluyendo primidona y fenobarbital], fenitoína…»AEMPS, section 4.4 · Open on CIMA
«No se recomienda el uso concomitante de acetato de ulipristal con inductores de CYP3A4, debido a las interacciones (por ejemplo, barbitúricos [incluyendo primidona y fenobarbital], fenitoína…»AEMPS, section 4.4 · Open on CIMA
«No se recomienda el uso concomitante de acetato de ulipristal con inductores de CYP3A4, debido a las interacciones (por ejemplo, barbitúricos [incluyendo primidona y fenobarbital], fenitoína…»AEMPS, section 4.4 · Open on CIMA
«Inductores de CYP3A4: En mujeres que han utilizado fármacos inductores enzimáticos durante las últimas 4 semanas, no se recomienda Ulipristal Exeltis (ver sección 4.4) y debe considerarse el uso de…»AEMPS, section 4.5 · Open on CIMA
«Anticonceptivos hormonales: No se recomienda el uso concomitante de acetato de ulipristal con otro anticonceptivo de urgencia que contenga levonorgestrel (ver sección 4.4).»AEMPS, section 4.5 · Open on CIMA
«No se recomienda el uso concomitante de acetato de ulipristal con inductores de CYP3A4, debido a las interacciones (por ejemplo, barbitúricos [incluyendo primidona y fenobarbital], fenitoína…»AEMPS, section 4.4 · Open on CIMA
«No se recomienda el uso concomitante de acetato de ulipristal con inductores de CYP3A4, debido a las interacciones (por ejemplo, barbitúricos [incluyendo primidona y fenobarbital], fenitoína…»AEMPS, section 4.4 · Open on CIMA
«No se recomienda el uso concomitante de acetato de ulipristal con inductores de CYP3A4, debido a las interacciones (por ejemplo, barbitúricos [incluyendo primidona y fenobarbital], fenitoína…»AEMPS, section 4.4 · Open on CIMA
«No se recomienda el uso concomitante de acetato de ulipristal con inductores de CYP3A4, debido a las interacciones (por ejemplo, barbitúricos [incluyendo primidona y fenobarbital], fenitoína…»AEMPS, section 4.4 · Open on CIMA
«Inhibidores de CYP3A4: El inhibidor de la CYP3A4 ritonavir también puede ejercer un efecto inductor sobre la CYP3A4 si se usa durante un periodo más prolongado. En tales casos, el ritonavir podría…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: • barbiturates»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: • carbamazepine»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: CYP3A inducers»FDA, section 7 · Open on DailyMed
«Increase in Plasma Concentrations of ella Associated with Co-Administered Drugs: CYP3A4 inhibitors such as itraconazole or ketoconazole increase plasma concentrations of ella [see Pharmacokinetics…»FDA, section 7 · Open on DailyMed
«Medicamentos que afectan al pH gástrico: La administración de acetato de ulipristal (comprimido de 10 mg) junto con el inhibidor de la bomba de protones esomeprazol (20 mg diarios durante 6 días) dio…»AEMPS, section 4.5 · Open on CIMA
«Sustratos de la glucoproteína P (Pgp): Los datos in vitro indican que el acetato de ulipristal puede ser un inhibidor de Pgp en concentraciones clínicamente relevantes. Los resultados in vivo con…»AEMPS, section 4.5 · Open on CIMA
«Increase in Plasma Concentrations of ella Associated with Co-Administered Drugs: CYP3A4 inhibitors such as itraconazole or ketoconazole increase plasma concentrations of ella [see Pharmacokinetics…»FDA, section 7 · Open on DailyMed
«Increase in Plasma Concentrations of ella Associated with Co-Administered Drugs: CYP3A4 inhibitors such as itraconazole or ketoconazole increase plasma concentrations of ella [see Pharmacokinetics…»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: • phenytoin»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: • topiramate»FDA, section 7 · Open on DailyMed
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Ulipristal acetate is evaluated for the following indications with varying evidence strength: Emergency contraception (evidence tier A), Contraception during breastfeeding (evidence tier B). See the full indication matrix with dosing and citations above on this page.
Common side effects of Ulipristal acetate (≥ 1 in 100): Headache (18%), Nausea (12%), Abdominal pain, Menstrual irregularity, Fatigue. See the Safety section for uncommon and serious reactions.
Do not use in confirmed pregnancy. Accidental use is not linked to birth defects – pregnancy may safely continue.
Pump and discard milk for 7 days after a dose. RID not precisely estimated, Hale L3 due to limited data. For breastfeeding women, prefer levonorgestrel 1.5 mg (Hale L2) or copper IUD.
Ulipristal acetate is contraindicated in: Hypersensitivity; Confirmed pregnancy; Severe hepatic impairment; Severe asthma on systemic steroids. Full list in the Safety section.
Direct links to regulator labels. Open in a new tab.
Cyproterone acetate, Cyproterone acetate + Ethinylestradiol, Desogestrel, Drospirenone + ethinylestradiol, Dydrogesterone, Ethinylestradiol + Desogestrel, Follitropin alfa, Norethisterone