Ella (Ulipristal Acetate Tablet)
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Ella (Ulipristal Acetate Tablet)

ELLA
(ulipristal acetate)

DRUG DESCRIPTION

The ella (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate [17αacetoxy-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:

ELLA (ulipristal acetate) Structural Formula Illustration

C30H37NO4

What are the possible side effects of ulipristal (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 if you have severe pain in your lower stomach (especially on only one side) 3 to 5 weeks after using ulipristal.

Less serious 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....

Read All Potential Side Effects and See Pictures of Ella »

What are the precautions when taking ulipristal acetate tablet (Ella)?

Before taking ulipristal, tell your doctor or pharmacist if you are allergic to it; or to progestins (such as levonorgestrel, norethindrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or suspected pregnancy, unexplained vaginal bleeding.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant,...

Read All Potential Precautions of Ella »

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.

DOSAGE AND ADMINISTRATION

Instruct patients to take one tablet 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.

If vomiting occurs within 3 hours of ella intake, consideration should be given to repeating the dose.

ella can be taken at any time during the menstrual cycle.

HOW SUPPLIED

Dosage Forms And Strengths

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.

Storage And Handling

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

NDC 52544-238-54 (1 tablet unit of use package)

Store at 20-25°C (68-77°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.

Distributed By: Watson Pharma, Inc. Parsippany, NJ 07054 USA. Manufactured By: Cenexi, 95520 Osny, France, or Laboratorios Le?n Farma S.A., 24008 Le?n, Spain. Revised: 04/2012

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

ella was studied in an open-label multicenter trial (Open-Label Study) and in a comparative, randomized, single-blind, multicenter trial (Single-Blind Comparative Study). In these studies, a total of 2,637 (1,533 + 1,104) women in the 30 mg ulipristal acetate groups were included in the safety analysis. The mean age of women who received ulipristal acetate was 24.5 years and the mean body mass index (BMI) was 25.3. The racial demographics of those enrolled were 67% Caucasian, 20% Black or African American, 2% Asian, and 12% other.

The most common adverse reactions ( ≥ 10%) in the clinical trials for women receiving ella were headache (18% overall) and nausea (12% overall) and abdominal and upper abdominal pain (12% overall). Table 1 lists those adverse reactions that were reported in ≥ 5% of subjects in the clinical studies (14).

Table 1: Adverse Reactions in ≥ 5% of Women (%) Receiving a Single Dose of ella (30 mg Ulipristal Acetate)

Most Common Adverse Reactions Open-Label Study
N = 1,533
Single-Blind Comparative Study
N = 1,104
Headache 18 19
Nausea 12 13
Abdominal and upper abdominal pain 15 8
Dysmenorrhea 7 13
Fatigue 6 6
Dizziness 5 5

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ella:

Skin and Subcutaneous Tissue Disorders: Acne

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the Ella (ulipristal acetate tablet) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No drug interaction studies have been conducted for ella in vivo. However, in vitro data indicate 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 enzymes, including CYP3A4, may decrease the plasma concentrations of ella, and may decrease its effectiveness. Some drugs or herbal products that may decrease the effectiveness of ella include:

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

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

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

Effects of ella on Co-Administered Drugs

In vitro studies demonstrated that ella does not induce or inhibit the activity of cytochrome P450 enzymes.

P-glycoprotein (P-gp) transporters: In vitro data indicate that ulipristal may be an inhibitor of P-gp at clinically relevant concentrations. Thus, co-administration of ulipristal acetate and P-gp substrates (e.g., dabigatran etexilate, digoxin), may increase the concentration of P-gp substrates.

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

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.

Fertility Following Use

A rapid return of fertility is likely following treatment with ella for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of ella to ensure ongoing prevention of pregnancy. While there are no data about use of ella with regular hormonal contraceptives, due to its high affinity binding to the progesterone receptor, use of ella may reduce the contraceptive action of regular hormonal contraceptive methods. Therefore, 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.

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).

Patient Counseling Information

[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.
  • Advise patients not to use ella as routine contraception, or to use it repeatedly in the same menstrual cycle.
  • Advise patients that ella may reduce the contraceptive action of regular hormonal contraceptive methods and to use a reliable barrier method of contraception after using ella, for any subsequent acts of intercourse that occur in that same menstrual cycle.
  • 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity

Carcinogenicity studies with ulipristal acetate have not been conducted.

Genotoxicity

Ulipristal acetate was not genotoxic in the Ames assay, in vitro mammalian assays utilizing mouse lymphoma cells and human peripheral blood lymphocytes, and in an in vivo micronucleus assay in mice.

Impairment of Fertility

Single oral doses of ulipristal acetate prevented ovulation in 50% of rats at 2 times the human exposure based on body surface area (mg/m²). Single doses of ulipristal acetate given on post-coital days 4 or 5 prevented pregnancy in 80-100% of rats and in 50% of rabbits when given on post-coital days 5 or 6 at drug exposures 4 and 12 times the human exposure based on body surface area. Lower doses administered for 4 days to rats and rabbits were also effective at preventing ovulation and pregnancy.

Use In Specific Populations

Pregnancy

Pregnancy Category X

[See CONTRAINDICATIONS.] Use of ella is contraindicated during an existing or suspected pregnancy. There are no adequate and well controlled studies in pregnant women.

Ulipristal acetate was administered repeatedly to pregnant rats and rabbits during the period of organogenesis. Embryofetal loss was noted in all pregnant rats and in half of the pregnant rabbits following 12 and 13 days of dosing, at daily drug exposures ⅓ and ½ the human exposure, respectively, based on body surface area (mg/m²). There were no malformations of the surviving fetuses in these studies. Adverse effects were not observed in the offspring of pregnant rats administered ulipristal acetate during the period of organogenesis through lactation at drug exposures 1/24 the human exposure based on AUC. Administration of ulipristal acetate to pregnant monkeys for 4 days during the first trimester caused pregnancy termination in 2/5 animals at daily drug exposures 3 times the human exposure based on body surface area.

Nursing Mothers

It is not known if ulipristal acetate is excreted in human milk. However, ulipristal acetate is detected in milk of lactating rats. Because many drugs are excreted in human milk, risk to the breast-fed child cannot be excluded. Use of ella by breastfeeding women is not recommended.

Pediatric Use

Safety and efficacy of ella have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents less than 18 years and for users 18 years and older. Use of ella before menarche is not indicated.

Geriatric Use

This product is not intended for use in postmenopausal women.

Race

While no formal studies have evaluated the effect of race, a cross-study comparison of two pharmacokinetic studies indicated that exposure in South Asians may exceed that in Caucasians and African Americans. However, no difference in efficacy and safety was observed for women of different races in clinical studies.

Hepatic Impairment

No studies have been conducted to evaluate the effect of hepatic disease on the disposition of ella.

Renal Impairment

No studies have been conducted to evaluate the effect of renal disease on the disposition of ella.

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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.

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. [See Use In Specific Populations]

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

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.

Pharmacodynamics

Ulipristal acetate is a selective progesterone receptor modulator with antagonistic and partial agonistic effects (a progesterone agonist/antagonist) at the progesterone receptor. It binds the human progesterone receptor and prevents progesterone from occupying its receptor.

The pharmacodynamics of ulipristal acetate depends on the timing of administration in the menstrual cycle. Administration in the mid-follicular phase causes inhibition of folliculogenesis and reduction of estradiol concentration. Administration at the time of the luteinizing hormone peak delays follicular rupture by 5 to 9 days. Dosing in the early luteal phase does not significantly delay endometrial maturation but decreases endometrial thickness by 0.6 ± 2.2 mm (mean ± SD).

Pharmacokinetics

Absorption

Following a single dose administration of ella in 20 women under fasting conditions, maximum plasma concentrations of ulipristal acetate and the active metabolite, monodemethyl-ulipristal acetate, were 176 and 69 ng/ml and were reached at 0.9 and 1 hour, respectively.

Figure 1: Mean (± SD) Plasma Concentration-time Profile of Ulipristal Acetate and Monodemethyl-ulipristal Acetate Following Single Dose Administration of 30 mg Ulipristal Acetate

Mean (± SD) Plasma Concentration-time Profile - Illustration

Table 2: Pharmacokinetic Parameter Values Following Administration of ella (ulipristal acetate) Tablet 30 mg to 20 Healthy Female Volunteers under Fasting Conditions

  Mean (± SD)
Cmax (ng/ml) AUC0-t (ng•hr/ml) AUC0-∞ (ng·hr/ml) tmax (hr)* t½ (hr)
Ulipristal acetate 176
(89)
548
(259)
556
(260)
0.9
(0.5-2.0)
32
(6.3)
Monodemethyl-ulipristal acetate 69
(26)
240
(59)
246
(59)
1.00
(0.8-2.0)
27
(6.9)
Cmax = maximum concentration
AUC0-t = area under the drug concentration curve from time 0 to time of last determinable concentration
AUC0-∞ = area under the drug concentration curve from time 0 to infinity
tmax = time to maximum concentration
t½ = elimination half-life
* Median (range)

Effect of food: Administration of ella together with a high-fat breakfast resulted in approximately 40 - 45% lower mean Cmax, a delayed tmax (from a median of 0.75 hours to 3 hours) and 20 - 25% higher mean AUC0-∞ of ulipristal acetate and monodemethyl-ulipristal acetate compared with administration in the fasting state. These differences are not expected to impair the efficacy or safety of ella to a clinically significant extent; therefore, ella can be taken with or without food.

Distribution

Ulipristal acetate is highly bound ( > 94%) to plasma proteins, including high density lipoprotein, alpha-l-acid glycoprotein, and albumin.

Metabolism

Ulipristal acetate is metabolized to mono-demethylated and di-demethylated metabolites. In vitro data indicate that this is predominantly mediated by CYP3A4. The mono-demethylated metabolite is pharmacologically active.

Excretion

The terminal half-life of ulipristal acetate in plasma following a single 30 mg dose is estimated to 32.4 ± 6.3 hours.

Clinical Studies

Two multicenter clinical studies evaluated the efficacy and safety of ella. An open-label study provided the primary data to support the efficacy and safety of ulipristal acetate for emergency contraception when taken 48 to 120 hours after unprotected intercourse. A single-blind comparative study provided the primary data to support the efficacy and safety of ulipristal acetate for emergency contraception when taken 0 to 72 hours after unprotected intercourse and provided supportive data for ulipristal acetate for emergency contraception when taken > 72 to 120 hours after unprotected intercourse. Women in both studies were required to have a negative pregnancy test prior to receiving emergency contraception. The primary efficacy analyses were performed on subjects less than 36 years of age who had a known pregnancy status after taking study medication.

Table 3: Summary of Clinical Trial Results for Women Who Received a Single Dose of ella (30 mg Ulipristal Acetate)

  Open-Label Study 48 to 120 Hours *
N = 1,242
Single-Blind Comparative Study 0 to 72 Hours *
N = 844
Expected Pregnancy Rate ** 5.5 5.6
Observed Pregnancy Rate ** (95% confidence interval) 2.2 (1.5, 3.2) 1.9 (1.1, 3.1)
* Time after unprotected intercourse when ella was taken
** Number of pregnancies per 100 women at risk for pregnancy

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.

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).

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 UPI. 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.

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.

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 it is not known if ella passes into 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 have an affect on how ella or the other medicine works. These include St. John's Wort, phenytoin, rifampin, phenobarbital, dabigatran etexilate, digoxin 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.

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.

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 1800-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 1-800-2221222. 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 Watson Medical Communications at 1-800272-5525.

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: WATSON Medical Communications, Parsippany, NJ 07054. 800-272-5525

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.

>

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 it is not known if ella passes into 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 have an affect on how ella or the other medicine works. These include St. John's Wort, phenytoin, rifampin, phenobarbital, dabigatran etexilate, digoxin 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.

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.

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 1800-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 1-800-2221222. 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 Watson Medical Communications at 1-800272-5525.

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: WATSON Medical Communications, Parsippany, NJ 07054. 800-272-5525

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Ella Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ULIPRISTAL - ORAL

(UE-li-PRIS-tal)

COMMON BRAND NAME(S): Ella

USES: This medication is used by women to prevent pregnancy after unprotected sex or birth control failure (such as a broken condom). This medication is an emergency contraceptive and should not be used as a regular form of birth control. It prevents pregnancy by preventing the release of an egg (ovulation) and changing the womb and cervical mucus to make it more difficult for an egg to meet sperm (fertilization) or attach to the wall of the womb (implantation).

Using this medication will not stop an existing pregnancy or protect you against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

HOW TO USE: Take 1 tablet by mouth, with or without food, as soon as possible after unprotected sex. This medication works best when it is taken within 120 hours (5 days) after unprotected sex. Take the medication exactly as prescribed by your doctor.

If you vomit within 3 hours of taking this medication, contact your doctor to discuss whether you need to repeat the dose.

The amount and timing of your period may be irregular after taking this medication. Tell your doctor immediately if your period is more than 7 days late. You may need to take a pregnancy test.

Because you can become pregnant soon after treatment with ulipristal, you should continue using your regular method of birth control immediately. Ulipristal may make other hormonal birth control less effective. Using a barrier-type birth control (such as condoms, diaphragm) is recommended every time you have sex during the same menstrual cycle that you took ulipristal.

Disclaimer

Ella Consumer (continued)

SIDE EFFECTS: Headache, nausea, abdominal pain, tiredness, dizziness, or painful menstrual periods may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this rare but serious side effect occurs: severe lower abdominal pain (especially 3 to 5 weeks after taking ulipristal).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Ella (ulipristal acetate tablet) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking ulipristal, tell your doctor or pharmacist if you are allergic to it; or to progestins (such as levonorgestrel, norethindrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or suspected pregnancy, unexplained vaginal bleeding.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Ella Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: drugs affecting liver enzymes that remove ulipristal from your body (such as bosentan, griseofulvin, modafinil, nevirapine, St. John's wort, HIV protease inhibitors including ritonavir, amprenavir, rifamycins including rifabutin, anti-seizure medicines including carbamazepine, phenytoin, phenobarbital).

OVERDOSE: Overdose with this medication is very unlikely. However, if overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised June 2011. Copyright(c) 2011 First Databank, Inc.

Ella Patient Information Including Side Effects

Brand Names: ella

Generic Name: ulipristal (Pronunciation: UE li PRIS tal)

What is ulipristal (Ella)?

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

What are the possible side effects of ulipristal (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 if you have severe pain in your lower stomach (especially on only one side) 3 to 5 weeks after using ulipristal.

Less serious 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.

Read the Ella (ulipristal acetate tablet) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ulipristal (Ella)?

Ulipristal is not to be used as a regular form of daily, weekly, or monthly birth control, and SHOULD NOT BE USED TO TERMINATE AN EXISTING PREGNANCY.

You should not use ulipristal if you are allergic to it, or if you have already confirmed that you are pregnant.

Before you take ulipristal, tell your doctor if you have a history of ectopic (tubal) pregnancy, or if your last menstrual period was less than 4 weeks ago. Also tell your doctor about all other medicines you use.

Call your doctor if your next menstrual period is more than 1 week late. You will need a pregnancy test to make sure you are not pregnant. Do not take a second course of ulipristal.

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

Side Effects Centers

Ella Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking ulipristal (Ella)?

You should not use ulipristal if you are allergic to it, or if you have already confirmed that you are pregnant.

Do not use ulipristal if you have not yet started having menstrual periods, or if you are past menopause.

To make sure you can safely take ulipristal, tell your doctor if you have any of these other conditions:

  • a history of ectopic (tubal) pregnancy; or
  • if your last menstrual period was more than 4 weeks ago.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use emergency contraception if you are already pregnant or think you might be pregnant.

It is not known whether ulipristal passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using ulipristal.

How should I take ulipristal (Ella)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Ulipristal is usually given as soon as possible after unprotected sex or failed birth control method. Follow your doctor's dosing instructions very carefully. Ulipristal can be taken any time during your menstrual cycle, but you must use the medicine within 5 days (120 hours) after unprotected sex.

You may take ulipristal with or without food.

If you vomit within 3 hours after taking ulipristal, your medication may not be as effective. Call your doctor to discuss the need for taking another ulipristal tablet.

Call your doctor if your next menstrual period is more than 1 week late. You will need a pregnancy test to make sure you are not pregnant. Do not take a second course of ulipristal.

Start or continue a barrier form of birth control (such as a condom or diaphragm with spermicide) as soon as possible after using ulipristal.

Ulipristal can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy for a short time after you take ulipristal.

Store at room temperature away from moisture and heat.

Side Effects Centers

Ella Patient Information including If I Miss a Dose

What happens if I miss a dose (Ella)?

Since ulipristal is used only once when needed, it does not have a daily dosing schedule.

What happens if I overdose (Ella)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ulipristal (Ella)?

Ulipristal will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What other drugs will affect ulipristal (Ella)?

Tell your doctor about all other medicines you use, especially:

  • bosentan (Tracleer);
  • griseofulvin (Fulvicin);
  • St. John's wort;
  • topiramate (Topamax);
  • rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);
  • antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or
  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with ulipristal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ulipristal.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision date: 7/14/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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