ELLA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ELLA (ELLA).
Selective progesterone receptor modulator (SPRM) with antagonistic and partial agonistic activity. Delays or inhibits ovulation, alters endometrial receptivity, and impairs implantation.
| Metabolism | Primarily metabolized by CYP3A4 to active and inactive metabolites; also undergoes conjugation. |
| Excretion | Primarily fecal (≈86%) with minimal renal excretion (≈10%). Biliary elimination of metabolites is also significant. |
| Half-life | Terminal half-life is approximately 24.7 hours (range 20–30 hours), allowing for single-dose emergency contraception. |
| Protein binding | 97–98% bound to plasma proteins, primarily albumin and sex hormone-binding globulin (SHBG). |
| Volume of Distribution | Apparent Vd/F is approximately 2.3–2.5 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Oral bioavailability is approximately 100% (nearly complete absorption). |
| Onset of Action | Oral: onset of contraceptive effect occurs within 2–3 hours; maximal effect on ovulation inhibition within 24 hours. |
| Duration of Action | Contraceptive effect lasts at least 120 hours (5 days) after a single oral dose, though efficacy is highest when taken within 72 hours. |
30 mg orally as a single dose within 120 hours of unprotected intercourse.
| Dosage form | TABLET |
| Renal impairment | No dosage adjustment required for renal impairment; data insufficient for severe renal impairment. |
| Liver impairment | Contraindicated in severe hepatic impairment; use with caution in moderate impairment. |
| Pediatric use | Not recommended for use in children under 17 years; safety and efficacy not established. |
| Geriatric use | No specific geriatric dosing; postmenopausal women not indicated for emergency contraception. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ELLA (ELLA).
| Breastfeeding | Contraindicated during breastfeeding. Ulipristal acetate is excreted in human milk; M/P ratio not established. Potential for serious adverse reactions in breastfed infants, including hormonal disruption. |
| Teratogenic Risk | FDA Pregnancy Category X. Studies in animals and humans have demonstrated fetal abnormalities. Use is contraindicated in pregnancy. First trimester: high risk of teratogenicity (neural tube defects, congenital anomalies). Second and third trimesters: may cause fetal harm (androgenization of female fetus). |
■ FDA Black Box Warning
Not approved for use as a routine contraceptive. Pregnancy must be excluded before use.
| Serious Effects |
Known or suspected pregnancy; hypersensitivity to ulipristal acetate or any component.
| Precautions | Efficacy decreases with time elapsed since unprotected intercourse; not effective if ovulation has already occurred. Exclude ectopic pregnancy in patients with lower abdominal pain. May reduce efficacy of hormonal contraceptives. Caution in severe hepatic impairment. |
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| Fetal Monitoring |
| Pregnancy test required before administration. If pregnancy occurs after exposure, monitor fetal development with ultrasound and assess for potential anomalies. No routine monitoring during use due to contraindication. |
| Fertility Effects | Reversible inhibition of ovulation. Delays follicular maturation and LH surge. Fertility returns rapidly after discontinuation (next menstrual cycle). No long-term impact on fertility. |