ELLA (ulipristal acetate)

Initial U.S. Approval: 2010
DESCRIPTION
The ella (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate [17α-acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione], a synthetic progesterone agonist/antagonist. The inactive ingredients are lactose monohydrate, povidone K-30, croscarmellose sodium and magnesium stearate.

CLINICAL PHARMACOLOGY
Mechanism of Action
When taken immediately before ovulation is to occur, ella postpones follicular rupture. The likely primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy.

ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.

Known or suspected pregnancy.

WARNINGS AND PRECAUTIONS
ella is not indicated for termination of an existing pregnancy. Exclude pregnancy before administering.

Ectopic pregnancy: Women who become pregnant or complain of lower abdominal pain after taking ella should be evaluated for ectopic pregnancy.

Effect on menstrual cycle: ella may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out.

ella does not protect against STI/HIV.

DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of ella.

USE IN SPECIFIC POPULATIONS
Nursing mothers: ella is not recommended for use by breastfeeding women.
ella is not intended for use in premenarcheal  or postmenopausal women.

The most common adverse reactions (≥ 5%) in the clinical trials were headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%) and dizziness (5%).

One tablet taken orally as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.
The tablet can be taken with or without food.

ella (ulipristal acetate) tablet, 30 mg is supplied in a PVC-PE-PVDC-aluminum blister. The tablet is a white to off-white, round, curved tablet marked with "ella" on both sides.

NDC 52544-238-54 (1 tablet unit of use package)

Store at 20-25°C (68-77°F). [See USP controlled room temperature.]

Keep the blister in the outer carton in order to protect from light. Keep out of reach of children.

PATIENT COUNSELING INFORMATION - Information for Patients

• Instruct patients to take ella as soon as possible and not more than 120 hours after unprotected intercourse or a known or suspected contraceptive failure.
• Advise patients that they should not take ella if they know or suspect they are pregnant and that ella is not indicated for termination of an existing pregnancy.
• Advise patients to contact their healthcare provider immediately in case of vomiting within 3 hours of taking the tablet, to discuss whether to take another tablet.
• Advise patients to seek medical attention if they experience severe lower abdominal pain 3 to 5 weeks after taking ella, in order to be evaluated for an ectopic pregnancy.
• Advise patients to contact their healthcare provider and consider the possibility of pregnancy if their period is delayed after taking ella by more than 1 week beyond the date it was expected.
• Advise patients not to use ella as routine contraception, or to use it repeatedly in the same menstrual cycle.
• Advise patients that ella may reduce the contraceptive action of regular hormonal contraceptive methods and to use a reliable barrier method of contraception after using ella, for any subsequent acts of intercourse that occur in that same menstrual cycle. 
• Inform patients that ella does not protect against HIV infection (AIDS) and other sexually transmitted diseases/infections.
• Advise patients that they should not use ella if they are breastfeeding.