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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
ella was studied in an open-label multicenter trial (Open-Label Study) and in a comparative, randomized, single-blind, multicenter trial (Single-Blind Comparative Study). In these studies, a total of 2,637 (1,533 + 1,104) women in the 30 mg ulipristal acetate groups were included in the safety analysis. The mean age of women who received ulipristal acetate was 24.5 years and the mean body mass index (BMI) was 25.3. The racial demographics of those enrolled were 67% Caucasian, 20% Black or African American, 2% Asian, and 12% other.
The most common adverse reactions (≥ 10%) in the clinical trials for women receiving ella were headache (18% overall) and nausea (12% overall) and abdominal and upper abdominal pain (12% overall). Table 1 lists those adverse reactions that were reported in ≥ 5% of subjects in the clinical studies (14).
Table 1: Adverse Reactions in ≥ 5% of
Women (%) Receiving a Single Dose of ella (30 mg Ulipristal Acetate)
|Most Common Adverse Reactions||Open-Label Study
N = 1,533
|Single-Blind Comparative Study
N = 1,104
|Abdominal and upper abdominal pain||15||8|
Adolescents: the safety profile observed in adolescents aged 17 and younger in studies and post-marketing is similar to the safety profile in adults [see Pediatric Use].
The following adverse reactions have been identified during post-approval use of ella:
Skin and Subcutaneous Tissue Disorders: Acne
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the Ella (ulipristal acetate tablet) Side Effects Center for a complete guide to possible side effects
Several in vivo drug interaction studies have shown that ella is predominantly metabolized by CYP3A4.
Changes In Emergency Contraceptive Effectiveness Associated With Co-Administration Of Other Products
Drugs or herbal products that induce CYP3A4 decrease the plasma concentrations of ella, and may decrease its effectiveness [see WARNINGS AND PRECAUTIONS and Pharmacokinetics]. Avoid co-administration of ella and drugs or herbal products such as:
- St. John's Wort
Hormonal contraceptives: Progestin-containing contraceptives may impair the ability of ella to delay ovulation [see WARNINGS AND PRECAUTIONS and Pharmacodynamics]. Avoid co-administration of ella and hormonal contraceptives. If a woman wishes to start or resume hormonal contraception after the intake of ella, she should do so no sooner than 5 days afterwards, and she should use a reliable barrier method until the next menstrual period.
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].
Effects Of ella On Co-Administered Drugs
Hormonal contraceptives: ella may impact the effect of the progestin component of hormonal contraceptives. Therefore, if a woman wishes to use hormonal contraception after using ella, she should use a reliable barrier method for subsequent acts of intercourse until her next menstrual period [see WARNINGS AND PRECAUTIONS and Pharmacodynamics].
Read the Ella Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/30/2015
Additional Ella Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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