Healthcare Providers

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

What is ella®?

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.

  • Only emergency contraceptive approved for use up to five days after unprotected sex or birth control failure1,4

  • Delays or prevents ovulation even after LH hormone has started to rise2

  • Convenient single dose with one tablet containing 30mg ulipristal acetate2

  • Ample national supply to fill any prescription


Patient Counseling Information

• 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.

References:

1. ella® Prescribing Information, HRA Pharma America, June 2020.

2. Gemzell-Danielsson K, Berger C, Lalitkumar PGL. Emergency contraception – mechanisms of action. Contraception. 2012; 87: 300-308.

3. ellaOne EHC Europe Vol claim YE 2018.

4. Glasier A, Cameron S, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta analysis. Lancet. 2010; 375: 555-562.

ella US logo v2 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