Ella
Generic name: ulipristal
Drug class: Progesterone receptor modulators
Medically reviewed by A Ras MD.
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).
Description
The ella (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate [17α-acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione], a synthetic progesterone agonist/antagonist. The inactive ingredients are lactose monohydrate, povidone K-30, croscarmellose sodium and magnesium stearate.
Ulipristal acetate is a white to yellow crystalline powder which has a molecular weight of 475.6. The structural formula is:
C30H37NO4
Mechanism of Action
When taken immediately before ovulation is to occur, ella postpones follicular rupture. The likely primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy.
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.
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.
What if I am already pregnant and use Ella?
Ella should not be taken if you are already pregnant. Currently there is no information suggesting that Ella would harm a developing baby. Contact your healthcare provider if you think you may be pregnant and have taken Ella.
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, bosentan, griseofulvin, phenytoin, topiramate, oxcarbazepine, carbamazepine, barbitarates, rifampin, and felbamate. 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.
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.
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.
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.
What are the possible side effects of Ella?
The most common side effects of Ella include:
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.
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, go to www.Ella-rx.com or you can contact Afaxys Pharma LLC, Health and Safety Team at 1-855-888-2467.
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.
What are the ingredients in Ella?
Active ingredients: ulipristal acetate
Inactive ingredients: lactose monohydrate, povidone, croscarmellose sodium, and magnesium stearate
Label
ULIPRISTAL ACETATE
