Dosing and uses of Ella (ulipristal)
Adult dosage forms and strengths
tablet
- 30mg
Emergency Contraception
30 mg (1 tablet) PO as soon as possible (within 120 hr [5 days]) after unprotected intercourse or a known/suspected contraceptive failure
If vomiting occurs within 3 hr after the dose, consider repeating the regimen
Higher efficacy if administered within first 72 hr postcoitus
Pediatric dosage forms and strengths
Premenarche: Not indicated
<18 year: Safety and efficacy not established
Ella (ulipristal) adverse (side) effects
>10%
Headache (18-19%)
Abdominal and upper abdominal pain (8-15%)
Nausea (12-13%)
Menstruation occurring ≥7 days than expected (19%)
Dysmenorrhea (7-13%)
1-10%
Intermenstrual bleeding (9%)
Fatigue (6%)
Dizziness (5%)
Menstruation occuring ≥7 days earlier than expected
Postmarketing Reports
Acne
Warnings
Contraindications
Known or suspected pregnancy
Cautions
Not indicated for termination of existing pregnancy
Exclude pregnancy before prescribing
Consider possibility of ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking ulipristaL
Not for replacement of regular contraceptive methods; for occasional use as an emergency contraceptive only
The possibility of ectopic pregnancy should be considered in patients with abdominal pain after administration of ulipristat
Repeated use within the same menstrual cycle not recommended
Does not protect against sexually transmitted diseases
Fertility following use
- A rapid return of fertility is likely following treatment; therefore, routine contraception should be continued or initiated as soon as possible following use
- After use of ulapristal, a reliable barrier method of contraception should be used with subsequent acts of intercourse that occur in that same menstrual cycle
- Because ella and the progestin component of hormonal contraceptives both bind to the progesterone receptor, using them together could reduce their contraceptive effect
- After using ella, if a woman wishes to use hormonal contraception, she should do so no sooner than 5 days after the intake of ella, and she should use a reliable barrier method until the next menstrual period
Effect on menses
- After use of ulipristal, menses sometimes occur earlier or later than expected by a few days; if there is a delay in the onset of expected menses beyond 1 week, rule out pregnancy
- 9% of women in clinical trials reported intermenstrual bleeding after use
Pregnancy and lactation
Pregnancy category: X
Lactation: Not recommended for use by breastfeeding women
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Ella (ulipristal)
Mechanism of action
Selective progesterone receptor modulator with antagonistic and partial agonistic effects
When taken immediately before ovulation, postpones follicular rupture
It is thought that the primary mechanism of action for emergency contraception is inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also occur
Pharmacokinetics
Protein binding: >94%
Half-life: 32hr (ulipristal); 27 hr (monodemethylated metabolite)
Peak serum time:1hr
Peak Plasma Concentration: 176 ng/mL
Metabolism: predominantly by CYP3A4 to active metabolite monodemethyl-ulipristal acetate
AUC: 548 ng•hr/mL
