The U.S. Food

and Drug Administration today approved ella (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

 

ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.

 

Patient Information for ella

 

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 it is not known if ella passes into breast milk.
• What should I tell my healthcare provider before taking ella?

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

Using other medicines may affect how ella works. These include St. John’s Wort, phenytoin, rifampin, phenobarbital, and carbamazepine. Talk to your healthcare provider if you are currently using these medications.

Talk to your healthcare provider if you use hormonal birth control. Using ella may make your regular hormonal birth control method less effective. After using ella, you should use a reliable barrier method of birth control (such as a condom with spermicide) during any other times that you have sex in that same menstrual cycle.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

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.
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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 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.