Ella
(Ulipristal Acetate)Check Drug InteractionsCheck known drug interactions.
Check Drug InteractionsElla Prescribing Information
| 06/2021 |
| 06/2021 |
Ella
is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure[see
]
.- Take one tablet ofellaorally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.
- Takeellawith or without food.
- Takeellaat any time during the menstrual cycle.
Ella
is not intended for routine use as a contraceptive.- Take one tablet orally as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. Take with or without food. Take at any time during the menstrual cycle. ()
2.1 Recommended Dosage and Administration- Take one tablet ofellaorally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.
- Takeellawith or without food.
- Takeellaat any time during the menstrual cycle.
- Take one tablet of
- Afterellause, initiate or resume hormonal contraception no sooner than 5 days after the intake ofellaand use a reliable barrier method until the next menstrual period. ()
2.2 Recommendations Regarding Use with Hormonal ContraceptionAfter
ellause, initiate or resume hormonal contraception no sooner than 5 days after the intake ofellaand use a reliable barrier method until the next menstrual period. For known or suspected failure of hormonal contraception refer to the hormonal contraceptive’s prescribing information for instructions on what to do[see Warnings and Precautions (5.5), Drug Interactions (7.1)and Clinical Pharmacology (12.2)]. - If vomiting occurs within 3 hours of takingella, consider repeating the dose. ()
2.3 Recommendation in Case of Gastrointestinal DisturbancesIf vomiting occurs within 3 hours of taking
ella, consider repeating the dose.
The
ella
tablet is supplied as a white to off-white, round, curved tablet containing 30 mg of ulipristal acetate and is marked "ella
" on both sides.Risk Summary
Ella
is contraindicated for use during an existing or suspected pregnancy. No signal of concern regarding pregnancy complications was found in postmarketing studies [see Data
]. Isolated cases of major malformations inella-
exposed pregnancies were identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent use ofella
during pregnancy. Miscarriage was reported in 14% of the known pregnancy outcomes; a rate that is similar to the U.S. background rate for miscarriage. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.In animal reproduction studies, no malformations were observed during repeated administration of ulipristal acetate to pregnant rats, rabbits and monkeys at daily drug exposures ⅓, ½, and 3 times respectively, the human exposure at a dose of 30 mg [
see
Data
] .Data
Ella
is contraindicated for use in the case of known or suspected pregnancy[see
].
Risk Summary
Ella
is contraindicated for use during an existing or suspected pregnancy. No signal of concern regarding pregnancy complications was found in postmarketing studies [see Data
]. Isolated cases of major malformations inella-
exposed pregnancies were identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent use ofella
during pregnancy. Miscarriage was reported in 14% of the known pregnancy outcomes; a rate that is similar to the U.S. background rate for miscarriage. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.In animal reproduction studies, no malformations were observed during repeated administration of ulipristal acetate to pregnant rats, rabbits and monkeys at daily drug exposures ⅓, ½, and 3 times respectively, the human exposure at a dose of 30 mg [
see Data
] .Data
Human Data
Ella
pregnancy exposure data was collected in the U.S. and Europe from 1999 to 2015 and analyzed post-marketing using data from interventional clinical trials, observational studies and pharmacovigilance reports. Known pregnancy outcomes were available for 462/784 pregnancies in which women receivedella
at doses of 30 mg or greater during the conception cycle or during pregnancy. Data of pregnancies with known outcome were analyzed prospectively for 272 cases and retrospectively for 190 cases. Pregnancy outcomes included 302 elective abortions (2 for fetal anomalies including 1 with trisomy 21), 63 spontaneous abortions, and 13 ectopic pregnancies. No maternal or fetal deaths were reported. 84 pregnancies continued until birth, with congenital anomalies reported in 5 infants, including 4 major malformations (2/4 with genetic syndromes). Although these data do not allow estimation of the prevalence rate of congenital anomalies associated with inadvertent use ofella
in pregnancy or determination of a causal relationship between reported anomalies andella
, they show thatella
-exposed pregnancies were not associated with a pattern of increased risk of adverse outcomes.Animal Data
Ulipristal acetate was administered repeatedly to pregnant rats and rabbits during the period of organogenesis. Embryofetal loss was noted in all pregnant rats and in half of the pregnant rabbits following 12 and 13 days of dosing, at daily drug exposures 1/3 and 1/2 the human exposure, respectively, based on body surface area (mg/m2). There were no malformations of the surviving fetuses in these studies. Adverse effects were not observed in the offspring of pregnant rats administered ulipristal acetate during the period of organogenesis through lactation at drug exposures 1/24 the human exposure based on AUC. Administration of ulipristal acetate to pregnant monkeys for 4 days during the first trimester caused pregnancy termination in 2/5 animals at daily drug exposures 3 times the human exposure based on body surface area.
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