Important Safety Information

Indication: ella® (ulipristal acetate) 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 contraceptive use.

Contraindications: ella® should not be used in those who are pregnant or are suspected to be pregnant.

Warnings and Precautions:
Existing Pregnancy: ella® is not indicated for termination of an existing pregnancy.
Ectopic pregnancy: Women who become pregnant or complain of lower abdominal pain after taking ella® should be evaluated for the possibility of ectopic pregnancy.
Fertility Following Use: Rapid return of fertility is likely. Subsequent acts of intercourse should be protected by a reliable barrier method of contraception until the next menstrual period.
Effect on Menstrual Cycle: ella® may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out. ella® should not be taken more than once in the same menstrual cycle.
Breastfeeding: ella® is not recommended for use in those who are breastfeeding.

ella® does not protect against sexually transmitted infections (STIs) or HIV infection (AIDS).

The most common adverse reactions (≥5%) are: headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%), and dizziness (5%).

Drug Interactions: Because ella® and the progestin component of hormonal contraceptives both bind to the progesterone receptor, using them together could reduce their contraceptive effectiveness. Patients should be counseled that they should not use hormonal contraceptives for at least 5 days after intake of ella® and to use a reliable barrier method of contraception for subsequent acts of intercourse during this time period. Drugs or herbal products that induce CYP3A4 may decrease the effectiveness of ella®.

For more information, please see the full Prescribing Information.