Healthcare Providers

A next-generation way to help your patients prevent pregnancy before it starts.

ella^® is a prescription emergency contraceptive that is indicated to prevent pregnancy by inhibiting or delaying ovulation for up to five days after unprotected intercourse or birth control failure.¹

ella^® is effective throughout more of a woman’s hormone cycle than other emergency contraceptives and is the first and only drug of its kind that can delay ovulation late in the follicular stage of the menstrual cycle – even when LH hormone already has started to rise.²

ella^® has been sold in Europe since 2009 under the name ellaOne^® and is the No. 1 morning after pill in Europe, where more than 1.8 million women have proven its safety and tolerability.³

ella^® Important Safety Information

The most common side effects of ella^® (ulipristal acetate) tablets include headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%), and dizziness (5%). ella^® is contraindicated in women with a known or suspected pregnancy, and should not replace a regular method of contraception. ella^® is not indicated for termination of an existing pregnancy. Women who become pregnant or complain of lower abdominal pain after taking ella^® should be evaluated for ectopic pregnancy. ella^® may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out. ella^® is not recommended for use in breastfeeding women. A rapid return of fertility is likely following treatment with ella^®, therefore, a reliable barrier method of contraception should be used with subsequent acts of intercourse 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 effectiveness. After using ella^®, if a woman wishes to use hormonal contraception, she should do so no sooner than 5 days after intake of ella^®. Repeated use of ella^® within the same menstrual cycle is not recommended. Drugs or herbal products that induce CYP3A4 decrease the effectiveness of ella^®. ella^® does not protect against STI/HIV.

• 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 contraceptives and to use a reliable barrier method of contraception after using ella, for any subsequent acts of intercourse that occur in the same menstrual cycle.

• Inform patients that ella does not protect against HIV infection (HIV) and other sexually transmitted diseases/infections.

•Advise patients that they should not use ella if they are breastfeeding.

PLEASE SEE FULL PRESCRIBING INFORMATION INCLUDING PRECAUTIONS, ADVERSE REACTIONS, AND PATIENT INFORMATION.

To report SUSPECTED ADVERSE REACTIONS, call 844-994-0329 or the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

©2020 HRA Pharma America, Morristown, New Jersey. All rights reserved. June 2020