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IMPORTANT SAFETY INFORMATION

DOSAGE AND ADMINISTRATION

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.

DOSAGE FORMS AND STRENGTHS

30 mg tablet

CONTRAINDICATIONS

ella is contraindicated for use in the case of known or suspected pregnancy. The risks to a fetus when ella is administered to a pregnant woman are unknown. If this drug is inadvertently used during pregnancy, the woman should be apprised of the potential hazard to the fetus. 

WARNINGS AND PRECAUTIONS

Existing Pregnancy

ella is not indicated for termination of an existing pregnancy. Pregnancy should be excluded before prescribing ella. If pregnancy cannot be excluded on the basis of history and/or physical examination, pregnancy testing should be performed. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking ella.

Ectopic Pregnancy

A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method.  Healthcare providers, however, should consider the possibility of ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking ella.  A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking ella.

Repeated Use

ella is for occasional use as an emergency contraceptive. It should not replace a regular method of contraception. Repeated use of ella within the same menstrual cycle is not recommended, as safety and efficacy of repeat use within the same cycle has not been evaluated.

CYP3A4 Inducers

A CYP3A4 inducer, rifampin, decreases the plasma concentration of ella significantly. Ella should not be administered with CYP3A4 inducers

Fertility Following Use

A rapid return of fertility is likely following treatment with ella for emergency contraception.

After use of ella, a reliable barrier method of contraception should be used with subsequent acts of intercourse that occur 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 effect. After using ella, if a woman wishes to use hormonal contraception, she should do so no sooner than 5 days after the intake of ella, and she should use a reliable barrier method until the next menstrual period.

Effect on Menstrual Cycle

After ella intake, menses sometimes occur earlier or later than expected by a few days. In clinical trials, cycle length was increased by a mean of 2.5 days but returned to normal in the subsequent cycle. Seven percent of subjects reported menses occurring more than 7 days earlier than expected, and 19% reported a delay of more than 7 days. If there is a delay in the onset of expected menses beyond 1 week, rule out pregnancy.

Nine percent of women studied reported intermenstrual bleeding after use of ella.

Sexually Transmitted Infections/HIV

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

ADVERSE REACTIONS

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%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Afaxys, Pharma LLC,. at 1-855-888-2467 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DRUG INTERACTIONS

Several in vivo drug interaction studies have shown that ella is predominantly metabolized by CYP3A4.

Changes in Emergency Contraceptive Effectiveness Associated with Co-Administration of Other Products

Drugs or herbal products that induce CYP3A4 decrease the plasma concentrations of ella, and may decrease its effectiveness. Avoid co-administration of ella and drugs or herbal products such as:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's Wort
• topiramate

Hormonal contraceptives: Progestin-containing contraceptives may impair the ability of ella to delay ovulation. Avoid co-administration of ella and hormonal contraceptives. If a woman wishes to start or resume hormonal contraception after the intake of ella, she should do so no sooner than 5 days afterwards, and she should use a reliable barrier method until the next menstrual period.

Increase in Plasma Concentrations of ella Associated with Co-Administered Drugs

CYP3A4 inhibitors such as itraconazole or ketoconazole increase plasma concentrations of ella.

Effects of ella on Co-Administered Drugs

Hormonal contraceptives: ella may impact the effect of the progestin component of hormonal contraceptives. Therefore, if a woman wishes to use hormonal contraception after using ella, she should use a reliable barrier method for subsequent acts of intercourse until her next menstrual period.

OVERDOSAGE

Experience with ulipristal acetate overdose is limited. In a clinical study, single doses equivalent to up to 4 times ella were administered to a limited number of subjects without any adverse reactions.

FDA APPROVED PATIENT LABELING

Patient Information

Ella (“el-uh”)

(ulipristal acetate) tablet

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 (AIDS) and other sexually transmitted diseases (STDs).

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.  Talk to your healthcare provider before taking ella if you think you are pregnant. 
• Do not take ella if you are breastfeeding because ella gets into the breast milk

What should I tell my healthcare provider before taking ella?

See "Who should not take ella?"

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Using some other medicines may make ella less effective.  These include St. John's Wort, phenytoin, rifampin, phenobarbital and carbamazepine.  Talk to your healthcare provider about whether ella is right for you if you are currently using these medications. Know the medicines you take.  Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. 

What should I do about birth control after I take ella?

Using ella with hormonal contraceptives such as birth control pills could reduce the effectiveness of both drugs to prevent pregnancy. After using ella, if you wish to use hormonal contraception, you should do so no sooner than 5 days after the intake of ella. Be sure to use a reliable barrier contraceptive method (such as a condom with spermicide) each time you have sex until your hormonal birth control has taken effect. 

If you do not use hormonal contraception, after using ella, you should use a reliable barrier contraceptive method (such as condom with spermicide) each time you have sex. 

When is it not appropriate to use ella?

• Do not use ella as a regular birth control method. It does not work as well as most other forms of birth control when they are used consistently and correctly.
• Do not use ella if you are already pregnant.
• Do not use ella more than one time in the same menstrual cycle for different acts of unprotected sex or birth control failure. 

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.

How effective is ella?

If ella is taken as directed, it will reduce the chance that you will get pregnant. ella is not effective in every case. ella is only to be used for a single episode of unprotected intercourse. Be sure to use a regular birth control method the next time you have sex.

ella and other emergency contraceptives may be less effective in women with a body mass index (BMI) > 30 kg/m2.

What if I am already pregnant and use ella?

ella should not be taken if you are already pregnant. There is little information on whether ella would harm a developing baby. Contact your healthcare provider if you think you may be pregnant and have taken ella. 

ella is not for use to terminate an existing pregnancy.

What should I do if my menstrual period is delayed beyond 1 week or I have severe lower stomach (abdominal) pain?

After taking ella, your next menstrual period may begin a few days earlier or later than expected. If your period is more than 7 days later than expected, you may be pregnant. You should get a pregnancy test and follow up with your healthcare provider.

If you are pregnant and have taken ella, you are encouraged to provide information on your pregnancy on a dedicated website.  See "What if I am already pregnant and use ella?"

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.

How often can I use ella?

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 for birth control and sexually transmitted disease prevention that are right for you.

What are the possible side effects of ella?

The most common side effects of ella include:

• headache
• nausea
• stomach (abdominal) pain
• menstrual pain (dysmenorrhea)
• tiredness
• dizziness

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 get a pregnancy test. 

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 healthcare provider 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 68-77°F (20-25°C).
• Protect ella from light. Keep ella in the blister card inside the original box until you are ready to take it.

Do not use ella if the package is torn or broken.

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 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.

In the case of an overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Overdose experience with ella is limited.

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.

For more information you can contact Afaxys Pharma LLC,. Medical Communications at 1-855-888-2467.

What are the ingredients in ella?

Active ingredients:  ulipristal acetate, 30 mg

Inactive ingredients:  lactose monohydrate, povidone, croscarmellose sodium, and magnesium stearate

For all medical inquiries contact:
Afaxys Pharma LLC,.
Medical Communications
Charleston, SC, 29403, USA
1-855-888-2467

Distributed By:
Afaxys, Inc. Charleston, SC, 29403, USA
Under License From:
Laboratoire HRA Pharma
75003 Paris, 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, 59390 Lys-Lez-Lannoy, France

Please see Full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088