same menstrual cycle.
5.5 Effect on Menstrual Cycle
After ella intake, menses sometimes occur earlier or later than expected by a few days. In clinical trials, cycle length was increased by a mean of 2.5 days but returned to normal in the subsequent cycle. Seven percent of subjects reported menses occurring more than 7 days earlier than expected, and 19% reported a delay of more than 7 days. If there is a delay in the onset of expected menses beyond 1 week, rule out pregnancy.
Nine percent of women studied reported intermenstrual bleeding after use of ella.
5.6 Sexually Transmitted Infections/HIV
ella does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).
6 ADVERSE REACTIONS
6.1 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
Single-Blind Comparative Study
N = 1,533
N = 1,104
Headache
18
19
Nausea
12
13
Abdominal and
upper abdominal pain
15
8
Dysmenorrhea
7
13
Fatigue
6
6
Dizziness
5
5
6.2 Postmarketing Experience
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.
7 DRUG INTERACTIONS
No drug interaction studies have been conducted for ella in vivo. However, in vitro data indicate that ella is predominantly metabolized by CYP3A4.
7.1 Changes in Emergency Contraceptive Effectiveness Associated with Co-Administration of Other Products
Drugs or herbal products that induce enzymes, including CYP3A4, may decrease the plasma concentrations of ella, and may decrease its effectiveness. Some drugs or herbal products that may decrease the effectiveness of ella include:
barbiturates
bosentan
carbamazepine
felbamate
griseofulvin
oxcarbazepine
phenytoin
rifampin
St. John |
