Presentation and Status in Health Basket
1 X 30 mg
The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure.
The tablet can be taken at any time during the menstrual cycle.
If vomiting occurs within 3 hours of the tablet intake, another tablet should be taken.
If a woman’s menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before the tablet is administered.
Renal impairment: No dose adjustment is necessary.
Hepatic impairment: In the absence of specific studies, no alternate dose recommendations for Ella can be made.
Severe hepatic impairment: In the absence of specific studies, Ella is not recommended.
Paediatric population: There is no relevant use of Ella for children of prepubertal age in the indication emergency contraception.
Method of administration: Oral use. The tablet can be taken with or without food.
Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Hypersensitivity to the active substance or to any of the excipients.
Ella is for occasional use only. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception.
Ulipristal acetate is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant. However, Ella does not interrupt an existing pregnancy.
Ella does not prevent pregnancy in every case: In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in character or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test should be performed. As with any pregnancy, the possibility of an ectopic pregnancy should be considered. It is important to know that the occurrence of uterine bleeding does not rule out ectopic pregnancy. Women who become pregnant after taking ulipristal acetate should contact their doctor.
ulipristal acetate inhibits or postpones ovulation. If ovulation has already occurred, it is no longer effective. The timing of ovulation cannot be predicted and therefore the tablet should be taken as soon as possible after unprotected intercourse.
No data are available on the efficacy of ulipristal acetate when taken more than 120 hours (5 days) after unprotected intercourse.
Limited and inconclusive data suggest that there may be reduced efficacy of Ella with increasing body weight or body mass index (BMI). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman’s body weight or BMI.
After the tablet intake menstrual periods can sometimes occur a few days earlier or later than expected. In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected. In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days.
Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended.
Contraception after Ella intake: Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotected intercourse but does not confer contraceptive protection for subsequent acts of intercourse. Therefore, after using emergency contraception, women should be advised to use a reliable barrier method until her next menstrual period.
Although the use of ulipristal acetate for emergency contraception does not contraindicate the continued use of regular hormonal contraception, Ella may reduce its contraceptive action. Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so after using Ella, however, she should be advised to use a reliable barrier method until the next menstrual period.
Specific populations: Concomitant use of Ella with CYP3A4 inducers is not recommended due to interaction (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicinal products containing Hypericum perforatum (St. John’s wort), rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine, and long term use of ritonavir).
Use in women with severe asthma treated by oral glucocorticoid is not recommended.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea.
See prescribing information for full details.
Potential for other medicinal products to affect ulipristal acetate:
Ulipristal acetate is metabolized by CYP3A4 in vitro.
• CYP3A4 inducers: In vivo results show that the administration of ulipristal acetate with a strong CYP3A4 inducer such as rifampicin markedly decreases Cmax and AUC of ulipristal acetate by 90% or more and decreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure. Concomitant use of Ella with CYP3A4
inducers (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John’s wort), rifampicin, rifabutin, griseofulvin, efavirenz and nevirapine) therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of Ella. For women who have used enzyme-inducing drugs in the past 4 weeks, Ella is not recommended and non-hormonal emergency contraception (i.e. a copper intrauterine device (Cu-IUD)) should be considered.
• CYP3A4 inhibitors: In vivo results show that administration of ulipristal acetate with a potent and a moderate CYP3A4 inhibitor increased Cmax and AUC of ulipristal acetate with a maximum of 2- and 5.9-fold, respectively. The effects of CYP3A4 inhibitors are unlikely to have any clinical consequences.
The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is used for a longer period. In such cases ritonavir might reduce plasma concentrations of ulipristal acetate. Concomitant use is therefore not recommended. Enzyme induction wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if a woman has stopped taking an enzyme inducer in the past 4 weeks.
Medicinal products affecting gastric pH: Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC. The clinical relevance of this interaction for single dose administration of ulipristal acetate as emergency contraception is not known.
Potential for ulipristal acetate to affect other medicinal products:
Hormonal contraceptives: Because ulipristal acetate binds to the progesterone receptor with high affinity, it may interfere with the action of progestogen-containing medicinal products:
– Contraceptive action of combined hormonal contraceptives and progestogen-only contraception may be reduced
– Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended.
In vitro data indicate that ulipristal acetate and its active metabolite do not significantly inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, at clinically relevant concentrations. After single dose administration induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is not likely. Thus, administration of ulipristal acetate is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.
P-gp (P-glycoprotein) substrates: In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant concentrations. Results in vivo with the P-gp substrate fexofenadine were inconclusive. The effects of the P-gp substrates are unlikely to have any clinical consequences.
Pregnancy and Lactation
Pregnancy: Ella is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant. Ulipristal acetate does not interrupt an existing pregnancy.
Breast-feeding: Ulipristal acetate is excreted in breast milk. The effect on newborn/infants has not been studied. A risk to the breastfed child cannot be excluded. After intake of ulipristal acetate for emergency contraception, breastfeeding is not recommended for one week. During this time it is recommended to express and discard the breast milk in order to stimulate lactation.
See prescribing information for full details.
Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg have been used in women without safety concern. Such high doses were well-tolerated; however, these women had a shortened menstrual cycle (uterine bleeding occurring 2-3 days earlier than would be expected) and in some women, the duration of bleeding was prolonged, although not excessive in amount (spotting).
There are no antidotes and further treatment should be symptomatic.