Ella (Page 5 of 6)

14.1 Open-Label Study

This study was a multicenter open-label trial conducted at 40 family planning clinics in the United States. Healthy women with a mean age of 24 years who requested emergency contraception 48 to 120 hours after unprotected intercourse received a dose of 30 mg ulipristal acetate (ella). The median BMI for the study subjects was 25.3 and ranged from 16.1 to 61.3 kg/m².

Twenty-seven pregnancies occurred in 1,242 women aged 18 to 35 years evaluated for efficacy. The number of pregnancies expected without emergency contraception was calculated based on the timing of intercourse with regard to each woman’s menstrual cycle. Ella statistically significantly reduced the pregnancy rate, from an expected rate of 5.5% to an observed rate of 2.2%, when taken 48 to 120 hours after unprotected intercourse.

14.2 Single-Blind Comparative Study

This study was a multicenter, single-blind, randomized comparison of the efficacy and safety of 30 mg ulipristal acetate (ella) to levonorgestrel (another form of emergency contraception). Subjects were enrolled at 35 sites in the U.S., the United Kingdom and Ireland, with the majority (66%) having been enrolled in the U.S. Healthy women with a mean age of 25 years who requested emergency contraception within 120 hours of unprotected intercourse were enrolled and randomly allocated to receive ella or levonorgestrel 1.5 mg. The median BMI for the study subjects was 25.3 and ranged from 14.9 to 70.0 kg/m².

In the ella group, 16 pregnancies occurred in 844 women aged 16 to 35 years when emergency contraception was taken 0 to 72 hours after unprotected intercourse. The number of pregnancies expected without emergency contraception was calculated based on the timing of intercourse with regard to each woman’s menstrual cycle; ella statistically significantly reduced the pregnancy rate, from an expected 5.6% to an observed 1.9%, when taken within 72 hours after unprotected intercourse. There were no pregnancies observed in the women who were administered ella more than 72 hours after unprotected intercourse (10% of women who received ella).

14.3 Pooled Analysis

Data from the two studies were pooled to provide a total efficacy population of women treated with ulipristal acetate up to 120 hours after unprotected intercourse. Time Trend analysis for the five 24-hour intervals from 0 to 120 hours between unprotected intercourse and treatment was conducted. There were no significant differences in the observed pregnancy rates across the five time intervals.

Subgroup analysis of the pooled data by BMI showed that for women with BMI > 30 kg/m² (16% of all subjects), the observed pregnancy rate was 3.1% (95% CI: 1.7, 5.7), which was not significantly reduced compared to the expected pregnancy rate of 4.5% in the absence of emergency contraception taken within 120 hours after unprotected intercourse. In the comparative study, a similar effect was seen for the comparator emergency contraception drug, levonorgestrel 1.5 mg. For levonorgestrel, when used by women with BMI > 30 kg/m² , the observed pregnancy rate was 7.4% (95% CI: 3.9, 13.4), compared to the expected pregnancy rate of 4.4% in the absence of emergency contraception taken within 72 hours after unprotected intercourse.

16 HOW SUPPLIED/STORAGE AND HANDLING

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

NDC 73302-456-01 (1 tablet unit of use package)

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°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.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-Approved patient Labeling (Patient Information).

Administration Instructions

• 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 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 that after using ella , a reliable barrier method of contraception should be used for all subsequent acts of intercourse until the next menstrual period.
  
• Advise patients that after using ella , additional levonorgestrel emergency contraceptive pills should not be used within 5 days of ella intake.
  
• Advise patients that after using ella , hormonal contraception should be initiated or resumed no sooner than 5 days after the intake of ella and to use a reliable contraceptive barrier method until the next menstrual period.
  
• Advise patients with known or suspected failure of a hormonal contraceptive to refer to the hormonal contraceptive’s prescribing information for instructions on what to do.
  

Ectopic Pregnancy
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 [see Warnings and Precautions (5.2)].

Effect on Menstrual Cycle
Advise women that after ella intake, menses may occur earlier or later than expected, by a few days. 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 [see Warnings and Precautions (5.6)].

Sexually Transmistted Infections/HIV
Inform women that ella does not protect against HIV infection (the virus that causes AIDS) and other sexually transmitted diseases/infections [see Warnings and Precautions (5.7)].

Drug InteractionsAdvise women to inform their healthcare provider if they take herbal supplements such as St. John’s wort [see Drug Interactions (7.1)].

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: June 2021
Patient Information ella (el-uh)(ulipristal acetate) tablet, for oral use
Read this Patient Information Leaflet before you take ella. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is ella?
●	Ella is a prescription emergency contraceptive that reduces your chance of becoming pregnant if your birth control fails or you have unprotected sex.
●	Ella should not be used as your regular birth control. It is very important that you have a reliable form of birth control that is right for you.
●	Ella will not protect you against HIV infection (the virus that causes AIDS) and other sexually transmitted infections (STIs).
Who should not take ella?
Do not take ella if:
●	you know or suspect you are already pregnant. Ella is not for use to end an existing pregnancy.
What should I tell my healthcare provider before taking ella? Before you take ella, tell your healthcare provider about all of your medical conditions, including if you:
●	have a history of pregnancy outside the womb, usually in a fallopian tube (ectopic pregnancy).
●	have taken ella during the same menstrual cycle for a different act of unprotected sex or birth control failure. Do not take ella more than 1 time in the same menstrual cycle.
●	are breastfeeding or plan to breastfeed. A small of amount of the hormones in ella may pass into your breast milk. Talk to healthcare provider about the best birth control for you while breastfeeding.
Tell your healthcare provider about all the medicines you take , including prescription and over-the counter medicines, vitamins, and herbal supplements.Using some other medicines may make ella less effective. Especially tell your healthcare provider if you take: a hormonal form of birth control such as birth control pills, implant, IUD (intrauterine device) or patch, St. John’s Wort, bosentan, griseofulvin, phenytoin, topiramate, oxcarbazepine, carbamazepine, barbiturates, rifampin, and felbamate. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How does ella work?
Ella is thought to work for emergency contraception primarily by stopping or delaying the release of an egg from the ovary. It is possible that ella may also work by preventing attachment (implantation) to the uterus.
How should I take ella?
●	Take ella as soon as possible within 5 days (120 hours) after unprotected sex or if you had a birth control failure.
●	Ella can be taken with or without food.
●	Contact your healthcare provider right away if you vomit within 3 hours of taking ella. Your healthcare provider may prescribe another dose of ella for you.
●	Ella can be taken at any time during the menstrual cycle.
●	Ella is meant for emergency contraception only and is not to be used frequently or as a regular birth control. If you need to use emergency contraception often, talk to your healthcare provider and learn about methods of birth control that are right for you and about sexually transmitted infection prevention.
●	After using ella , you should use a reliable barrier birth control method (such as condom with spermicide) each time you have sex until your next menstrual period.
●	After using ella, do not use any additional levonorgestrel emergency contraceptive pills within 5 days after taking ella.
●	After using ella , wait 5 days to start or resume hormonal birth control as a regular method (such as the pill, patch or vaginal ring). If you used ella because you had a problem with your hormonal birth control, follow the instructions provided for that specific hormonal birth control product or contact your healthcare provider for further information. Be sure to use a reliable barrier birth control method (such as a condom with spermicide) each time you have sex until your next menstrual period.
What are the possible side effects of ella?
●	Pregnancy outside of the womb (ectopic pregnancy). If you have severe lower stomach (abdominal) pain about 3 to 5 weeks after taking ella, you may have a pregnancy outside of the uterus (womb), which is called an ectopic or tubal pregnancy. An ectopic pregnancy is a serious condition that needs medical treatment right away. Call your healthcare provider or go to the nearest emergency room right away if you think you may have an ectopic pregnancy.
●	Changes in menstrual cycle. Some women taking ella may have their next period earlier or later than expected. If your period is more than a week late, you should take a pregnancy test and follow up with your healthcare provider.
The most common side effects of ella include: ○ headache ○ nausea ○ stomach (abdominal) pain ○ menstrual pain (dysmenorrhea) ○ tiredness ○ dizziness
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ella. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA 1-800-FDA-1088.
How should I store ella?
●	Store ella at room temperature between 68°F to 77°F (20°C to 25°C).
●	Protect ella from light. Keep ella in the blister card inside the original box until you are ready to take it.
Keep ella and all medicines out of the reach of children.
General information about the safe and effective use of ella: Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use ella for a condition for which it was not prescribed. Do not give ella to other people, even if they have the same symptoms that you have. It may harm them.This Patient Information Leaflet summarizes the most important information about ella. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ella that is written for health professionals.
What are the ingredients in ella? Active ingredients: ulipristal acetate, 30 mgInactive ingredients: lactose monohydrate, povidone, croscarmellose sodium, and magnesium stearate
Manufactured for: HRA Pharma America Inc. Morristown, NJ 07960 Under License From: Laboratoire HRA Pharma 92320 Chatillon, France ella ® is a registered trademark of Laboratoire HRA Pharma
Manufactured by: Cenexi, 95520 Osny, France, or Laboratorios León Farma S.A., 24008 León, Spain or Delpharm Lille SAS, 59452 Lys-Lez-Lannoy, France
For more information, go to www.ella-now.com or call 844-994-0329.

General information about the safe and effective use of ella: