Ella

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once or seek emergency medical attention if you have severe pain in your lower stomach (especially on only one side) 3 to 5 weeks after using ulipristal.

Common side effects may include:

• headache;
• dizziness, tired feeling;
• nausea, stomach pain; or
• menstrual pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ella is a prescription medication used to as emergency contraceptive to prevent pregnancy. Ella belongs to a group of drugs called contraceptives, which work to prevent pregnancy by stopping or delaying ovulation.

This medication comes in tablet form and is taken as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.

Common side effects of Ella include headache, stomach pain, nausea, and dizziness. Do not drive or operate heavy machinery until you know how Ella affects you.

Ulipristal is an emergency contraceptive. It works by stopping or delaying the release of an egg from an ovary. Ulipristal may also make it harder for a fertilized egg to attach to the uterus.

Ulipristal is used to prevent pregnancy after having sex without using a condom or other effective birth control method. Ulipristal is also used to prevent pregnancy after a regular form of birth control has failed. Ulipristal is not to be used as a regular form of daily, weekly, or monthly birth control.

ULIPRISTAL SHOULD NOT BE USED TO TERMINATE AN EXISTING PREGNANCY.

Ulipristal may also be used for purposes not listed in this medication guide.

Ulipristal is not to be used as a regular form of daily, weekly, or monthly birth control.

THIS MEDICINE SHOULD NOT BE USED TO TERMINATE AN EXISTING PREGNANCY.

Ulipristal can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ulipristal, especially:

• bosentan;

• griseofulvin;

• St. John's Wort;

• rifampin;

• topiramate;

• a barbiturate--butabarbital, secobarbital, pentobarbital, phenobarbital; or

• seizure medicine--carbamazepine, felbamate, oxcarbazepine, phenytoin.

This list is not complete. Other drugs may interact with ulipristal, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Postcoital Contraception

Prevention of unintended pregnancy after unprotected intercourse or known or suspected contraceptive failure as an emergency contraceptive.1 2 3 6 13 14 Postcoital (emergency) contraceptive regimens are not as effective as most other methods of long-term contraception;not intended for routine use as a contraceptive.1 5 14

Levonorgestrel currently is the preferred postcoital contraceptive when the drug is initiated within 72 hours of unprotected intercourse.5 14 15 16 17 Ulipristal is an effective alternative to levonorgestrel for postcoital contraception when used within 120 hours after unprotected intercourse.1 2 3

To make using emergency contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Use this medicine exactly as directed by your doctor. This medicine is for occasional use as an emergency birth control. It should not replace your regular birth control method. You may use this medicine at any time during your monthly period, but do not use this medicine more than one time in the same monthly period.

You may take this medicine with or without food.

If you vomit within 3 hours of taking this medicine, call your doctor right away. Your doctor may prescribe another tablet for you.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For emergency contraception:
    • Adults—One tablet as soon as possible within 5 days (120 hours) after unprotected sex or after failure of another birth control method.
    • Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check you closely to make sure this medicine is working properly and does not cause unwanted effects.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. Your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine is not recommended in breastfeeding women.

Call your doctor right away if you have severe lower abdominal or stomach pain 3 to 5 weeks after taking this medicine. You may have a pregnancy outside of the uterus (womb), which is called an ectopic pregnancy. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

This medicine may make your next monthly period earlier or later than expected by a few days. If your next period after taking this medicine is more than 1 week late, check with your doctor right away for a pregnancy test.

Your regular birth control method such as birth control pills or patch may not work as well while you are using this medicine. You should not start taking hormonal contraceptives until at least 5 days after using this medicine and you must use a barrier method such as a condom with spermicide, diaphragm, or contraceptive foam or jelly, until the next menstrual cycle.

This medicine may not work as well in women with a body mass index (BMI) of more than 66 pounds per square meter.

This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

The Ella tablet is supplied as a white to off-white, round, curved tablet containing 30 mg of ulipristal acetate and is marked "Ella" on both sides.

[See FDA-Approved Patient Labeling]

Information for Patients

• 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.
• A web-based study has been established to collect information on the pregnancy outcomes of women who inadvertently receive Ella during the cycle in which pregnancy started or at any time during pregnancy. Notify patients that they can enroll by completing the forms available at www.ellipse2.com where voluntary reports from health care providers or consumers are received.
• Advise patients not to use Ella as routine contraception, or to use it repeatedly in the same menstrual cycle.
• Advise patients that using Ella and hormonal contraceptives together can affect the effectiveness of each.  Advise patients to use a reliable barrier method for all subsequent acts of intercourse until the next menstrual period.  If a woman wishes to use hormonal contraception, she should do so no sooner than 5 days after intake of Ella, and she should use a reliable barrier method until the next menstrual period.
• Advise patients not to use Ella if they are taking a CYP3A4 inducer.
• Inform patients that Ella does not protect against HIV infection (AIDS) and other sexually transmitted diseases/infections.
• Advise patients that they should not use Ella if they are breastfeeding because Ella enters the breast milk. 

Common side effects of ella include: menstruation. Other side effects include: intermenstrual bleeding. See below for a comprehensive list of adverse effects.

Applies to ulipristal: oral tablet

Along with its needed effects, ulipristal (the active ingredient contained in ella) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ulipristal:

• Cramps
• heavy bleeding
• pain

Some side effects of ulipristal may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• headache
• nausea
• unusual tiredness or weakness

• Dizziness

• Blemishes on the skin
• pimples

Ella(R) and ellaOne(R): During the week after drug treatment, breastfeeding is not recommended and patients are advised to express and discard breast milk in order to stimulate lactation.

SEVERITY: MAJOR LEVEL 1: Ella(R) and ellaOne(R): Use is not recommended. Esmya(R): Use is contraindicated. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.