If You Had Your Period Before Taking Ella When Will Your Period Come Again

What is Ella and how is it used?

Ella is a prescription medicine used as Emergency Contraception to forestall pregnancy. Ella may exist used solitary or with other medications.

Ella belongs to a class of drugs called Progestins Receptor Modulators.

It is non known if Ella is safe and constructive in children younger than eighteen years of age.

What are the possible side furnishings of Ella?

Ella may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your confront, lips, tongue, or throat, and
• astringent pain in your lower stomach 3 to five weeks afterward using the medicine

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Ella include:

• headache,
• dizziness,
• tiredness,
• nausea,
• stomach pain, and
• menstrual pain

Tell the medico if yous have whatsoever side effect that bothers you or that does not go abroad.

These are not all the possible side furnishings of Ella. For more than information, inquire your doctor or chemist.

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

DESCRIPTION

The ella (ulipristal acetate) tablet for oral use contains 30 mg of a unmarried agile steroid ingredient, ulipristal acetate [17αacetoxy- 11β-(four-North,N-dimethylaminophenyl)-19-norpregna-four,9-diene-iii,20-dione], a synthetic progesterone agonist/adversary. The inactive ingredients are lactose monohydrate, povidone Thousand-30, croscarmellose sodium and magnesium stearate.

Ulipristal acetate is a white to xanthous crystalline powder which has a molecular weight of 475.6. The structural formula is:

C₃₀H₃₇NO_four

3 pharmacies nearly 11430 have coupons for Ella (Brand Names:Ella for ane Tablets)

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 before long every bit possible within 120 hours (5 days) subsequently unprotected intercourse or a known or suspected contraceptive failure.

The tablet can be taken with or without food.

If vomiting occurs inside 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, thirty mg is supplied in a PVC-PE-PVDC or PVC-PVDC-aluminum cicatrice. The tablet is a white to off-white, round, curved tablet marked with "ella" on both sides.

NDC 50102-911-01 (1 tablet unit of apply bundle)

Store at 20-25°C (68-77°F). [See USP controlled room temperature.]

Keep the blister in the outer carton in society to protect from calorie-free. Go along out of reach of children.

Manufactured by: Cenexi, 95520 Osny, France, or Laboratorios León Farma Southward.A., 24008 León, Spain or Delpharm Lille SAS, 59452 Lys-Lez-Lannoy, France. Revised: May 2018

QUESTION

Which of the following are methods for contraception? See Answer

SIDE EFFECTS

Clinical Trials Experience

Considering clinical trials are conducted nether 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 reverberate the rates observed in clinical exercise.

ella was studied in an open-label multicenter trial (Open-Label Written report) and in a comparative, randomized, single-blind, multicenter trial (Single-Blind Comparative Study). In these studies, a total of 2,637 (i,533 + 1,104) women in the 30 mg ulipristal acetate groups were included in the safety analysis. The hateful age of women who received ulipristal acetate was 24.v years and the hateful body mass alphabetize (BMI) was 25.3. The racial demographics of those enrolled were 67% Caucasian, xx% Blackness or African American, ii% Asian, and 12% other.

The almost common agin 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 agin reactions that were reported in ≥ five% of subjects in the Clinical Studies.

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

Most Mutual Adverse Reactions	Open-Label Study	Single-Bullheaded Comparative Study
	N = 1,533	Due north = 1,104
Headache	18	nineteen
Nausea	12	13
Intestinal and upper abdominal pain	xv	eight
Dysmenorrhea	7	13
Fatigue	half dozen	6
Dizziness	5	v

Postmarketing Experience

Adolescents: the condom profile observed in adolescents anile 17 and younger in studies and post-marketing is similar to the safety profile in adults [see Pediatric Utilize].

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

Skin and Subcutaneous Tissue Disorders: Acne

Considering these reactions are reported voluntarily from a population of uncertain size, it is non always possible to reliably estimate their frequency or establish a causal human relationship to drug exposure.

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 [see WARNINGS AND PRECAUTIONS and Pharmacokinetics]. Avoid co-administration of ella and drugs or herbal products such every bit:

• 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 [see WARNINGS AND PRECAUTIONS and Pharmacodynamics]. Avert co-administration of ella and hormonal contraceptives. If a adult female wishes to start or resume hormonal contraception after the intake of ella, she should practice so no sooner than 5 days later, and she should use a reliable barrier method until the next menstrual catamenia.

Increase In Plasma Concentrations Of Ella Associated With Co-Administered Drugs

CYP3A4 inhibitors such as itraconazole or ketoconazole increase plasma concentrations of ella [run across Pharmacokinetics].

Effects Of Ella On Co-Administered Drugs

Hormonal contraceptives: ella may bear upon the effect of the progestin component of hormonal contraceptives. Therefore, if a woman wishes to use hormonal contraception afterwards using ella, she should utilise a reliable bulwark method for subsequent acts of intercourse until her next menstrual period [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

WARNINGS

Included as office of the "PRECAUTIONS" Section

PRECAUTIONS

Existing Pregnancy

ella is non indicated for termination of an existing pregnancy

Ectopic Pregnancy

A history of ectopic pregnancy is not a contraindication to utilize of this emergency contraceptive method. Healthcare providers, even so, should consider the possibility of ectopic pregnancy in women who become pregnant or complain of lower intestinal pain after taking ella. A follow-upwardly physical or pelvic examination is recommended if there is any uncertainty apropos the general health or pregnancy status of any adult female after taking ella.

Repeated Use

ella is for occasional use equally an emergency contraceptive. Information technology should not replace a regular method of contraception. Repeated utilize of ella within the same menstrual bike is non recommended, equally safety and efficacy of repeat use within the aforementioned 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 [run into DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Fertility Post-obit Employ

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

After employ of ella, a reliable barrier method of contraception should be used with subsequent acts of intercourse that occur in that aforementioned menstrual bicycle.

Because ella and the progestin component of hormonal contraceptives both bind to the progesterone receptor, using them together could reduce their contraceptive outcome. Subsequently using ella, if a woman wishes to use hormonal contraception, she should practise so no sooner than 5 days after the intake of ella, and she should use a reliable barrier method until the adjacent menstrual period [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Effect On Menstrual Bike

After ella intake, menses sometimes occur before or later than expected by a few days. In clinical trials, cycle length was increased by a mean of 2.five days but returned to normal in the subsequent cycle. Seven per centum of subjects reported catamenia occurring more than 7 days earlier than expected, and 19% reported a delay of more than 7 days. If at that place is a filibuster in the onset of expected menses beyond 1 week, rule out pregnancy.

Ix percentage of women studied reported intermenstrual bleeding after utilize 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 Data]

Information For Patients

• Instruct patients to take ella as presently every bit possible and not more than 120 hours after unprotected intercourse or a known or suspected contraceptive failure.
• Suggest patients that they should not take ella if they know or suspect they are pregnant and that ella is non 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 three to five weeks after taking ella, in guild to be evaluated for an ectopic pregnancy.
• Suggest patients to contact their healthcare provider and consider the possibility of pregnancy if their period is delayed after taking ella by more than 1 calendar week beyond the date information technology was expected.
• Advise patients non to use ella as routine contraception, or to apply it repeatedly in the same menstrual cycle.
• Suggest patients that using ella and hormonal contraceptives together can bear upon the effectiveness of each. Suggest patients to utilize a reliable barrier method for all subsequent acts of intercourse until the next menstrual menses. If a woman wishes to apply hormonal contraception, she should practise and so no sooner than 5 days later on intake of ella, and she should use a reliable barrier method until the next menstrual period.
• Advise patients not to apply 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenicity

Carcinogenicity potential was evaluated in rats and mice.

Sprague Dawley rats were exposed to ulipristal acetate daily for 99-100 weeks at doses of 1, 3, or 10 mg/kg/day, representing exposures up to 31 times higher than exposures at the maximum recommended human dose (MRHD). There were no drug-related neoplasms in male rats. In female rats, potential treatment-related neoplastic findings were limited to adrenal cortical adenomas in the intermediate dose group (iii mg/kg/day). Despite the increase, this incidence of adrenal cortical adenomas in females may not exist relevant to clinical use.

Tg.rasH2 transgenic mice were exposed to ulipristal acetate for 26 weeks at doses of v, 45, or 130 mg/kg/day, representing exposures 100 times higher than exposures at the MRHD. There was no drug-related increase in neoplasm incidence in male or female mice.

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.

Damage Of Fertility

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

Use In Specific Populations

Pregnancy

Risk Summary

ella is contraindicated for use during an existing or suspected pregnancy. No signal of business concern regarding pregnancy complications was establish in postmarketing studies [see Data]. Isolated cases of major malformations in ella-exposed pregnancies were identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent employ of ella during pregnancy. Miscarriage was reported in fourteen% of the known pregnancy outcomes; a rate that is similar to the U.S background rate for miscarriage. In the U.S. general population, the estimated background risk of major nascence defects and miscarriage in clinically recognized pregnancies is two-four% and 15-xx%, respectively.

In animal reproduction studies, no malformations were observed during repeated administration of ulipristal acetate to pregnant rats, rabbits and monkeys at daily drug exposures i/3, 1/2, and 3 times respectively, the human exposure at a dose of 30 mg [see Data] .

Data

Human being Data

ella pregnancy exposure data was collected in the U.S. and Europe from 1999 to 2015 and analyzed postal service-marketing using data from interventional clinical trials, observational studies and pharmacovigilance reports. Known pregnancy outcomes were available for 462/784 pregnancies in which wome received ella at doses of thirty mg or greater during the conception wheel or during pregnancy. Information of pregnancies with known outcome were analyzed prospectively for 272 cases and retrospectively for 190 cases. Pregnancy outcomes included 302 elective abortions (2 for fetal anomalies including 1 with trisomy 21), 63 spontaneous abortions, and 13 ectopic pregnancies. No maternal or fetal deaths were reported. 84 pregnancies continued until nascency, with congenital anomalies reported in 5 infants, including 4 major malformations (two/4 with genetic syndromes). Although these data practise non allow estimation of the prevalence rate of built anomalies associated with inadvertent use of ella in pregnancy or conclusion of a causal relationship between reported anomalies and ella, they show that ella-exposed pregnancies were not associated with a pattern of increased risk of adverse outcomes.

Animate being Data

Ulipristal acetate was administered repeatedly to meaning rats and rabbits during the period of organogenesis. Embryofetal loss was noted in all pregnant rats and in one-half of the pregnant rabbits post-obit 12 and xiii days of dosing, at daily drug exposures i/3 and 1/2 the human exposure, respectively, based on body surface area (mg/k²). At that place were no malformations of the surviving fetuses in these studies. Agin furnishings were not observed in the offspring of meaning rats administered ulipristal acetate during the menstruum of organogenesis through lactation at drug exposures 1/24 the human exposure based on AUC. Administration of ulipristal acetate to significant monkeys for 4 days during the first trimester acquired pregnancy termination in 2/5 animals at daily drug exposures iii times the human exposure based on body surface area.

Lactation

Adventure Summary

Ulipristal acetate and its agile metabolite, monodemethyl-ulipristal acetate, are nowadays in human milk in small-scale amounts (see Data). Based on the levels of drug and active metabolite measured in breastmilk, a fully breastfed kid would receive a weight-adjusted dosage of approximately 0.viii% of ulipristal acetate and monodemethyl-ulipristal acetate on Day 1 of drug assistants and an approximate total of i% of the maternal dose over a 5-twenty-four hours period after drug administration. There is no information on the effects on the breastfed child or the furnishings on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother'south clinical need for ella and any potential adverse furnishings on the breastfed child from ella or from the underlying maternal condition

Data

The breast milk of 12 lactating women post-obit assistants of ella was nerveless in 24-hour increments to measure out the concentrations of ulipristal acetate and the active metabolite monodemethyl-ulipristal acetate in breast milk. The mean daily concentrations of ulipristal acetate in breast milk were 22.7 ng/mL [0-24 hours], ii.96 ng/mL [24-48 hours], one.56 ng/mL [48-72 hours], i.04 ng/mL [72-96 hours], and 0.69 ng/mL [96-120 hours]. The hateful daily concentrations of monodemethyl-ulipristal acetate in breast milk were four.49 ng/mL [0-24 hours], 0.62 ng/mL [24-48 hours], 0.28 ng/mL [4872 hours], 0.17 ng/mL [72-96 hours], and 0.10 ng/mL [96-120 hours]. Using these data, a fully breastfed infant would receive approximately 4.1 mcg/kg of ulipristal acetate and monodemethyl-ulipristal acetate on Day one post-obit drug administration and approximately v.2 mcg/kg over a five day menstruum post-obit drug administartion.

Females And Males Of Reproductive Potential

Contraception

ella and progestin-containing contaceptives may interact and decrease the effectivess of both products. Advise females to use a a reliable barrier method for subsequent acts of intercourse until her side by side menstrual period and to wait at least v days after taking ella to resume oral contraceptives [run across WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

Pediatric Use

Prophylactic and efficacy of ella have been established in women of reproductive age. The clinical trials of ella enrolled 41 females nether age 18, and a post-marketing observational written report evaluating effectiveness and safety of ella in adolescents enrolled 279 females nether age 18, including 76 under age xvi years. In these studies, the safety and efficacy profile observed in adolescents aged 17 and younger was similar to that in adults. Apply of ella earlier menarche is non indicated.

Geriatric Employ

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 unlike races in clinical studies.

Hepatic Impairment

No studies accept 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.

Overdosage & Contraindications

OVERDOSE

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

CONTRAINDICATIONS

ella is contraindicated for utilize in the example of known or suspected pregnancy. [Run into Utilize In Specific Populations.]

CLINICAL PHARMACOLOGY

Mechanism Of Activeness

When taken immediately earlier ovulation is to occur, ella postpones follicular rupture. The probable primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition or delay of ovulation; still, 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 homo progesterone receptor and prevents progesterone from occupying its receptor.

The pharmacodynamics of ulipristal acetate depends on the timing of administration in the menstrual wheel. Administration in the mid-follicular phase causes inhibition of folliculogenesis and reduction of estradiol concentration.

Pharmacodynamic data showed that assistants of ella to 34 women in the late follicular phase postponed follicular rupture for at to the lowest degree 5 days in all (100%) of 8 subjects who took ella before the luteinizing hormone (LH) surge and xi (79%) of 14 subjects who took ella immediately earlier ovulation (when LH has already started to rise). Withal, treatment was non constructive in postponing follicular rupture when administered on the twenty-four hour period of LH peak.

Dosing in the early luteal phase does not significantly filibuster endometrial maturation but decreases endometrial thickness by 0.6 ± ii.two mm (mean ± SD).

Hormonal Contraceptives later ella intake

When a combined oral contraceptive pill (COC) containing ethinyl estradiol 30 μg + levonorgestrel 150 μg was started the solar day afterwards ella intake during the follicular phase, ella did not interfere with the COC's ability to suppress ovarian activity, equally assessed past measurement of follicle size via transvaginal ultrasound, combined with serum progesterone and estradiol levels: ovarian activity was suppressed in 61.five% (24/39) of subjects receiving ella plus COC and 62.2% (23/37) of subjects receiving a placebo plus the COC. The incidence of ovulation was similar betwixt the group who received ella plus the COC [33.iii% (xiii/39)] and the group who received a placebo plus the COC [32.4% (12/37)]. [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

The initiation of a desogestrel 75 μg "progestin-just pill" the day after ella intake during the follicular phase was associated with a college incidence of ovulation in the half-dozen days following ella intake compared to an ella-only treatment group, and a relatively slower onset (iii to 4 days) of thickened cervical mucus compared to a group given desogestrel without prior ella intake (2 days), suggesting an effect of prior employ of ella on the ability of desogestrel to inhibit mucus permeability. [See WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Pharmacokinetics

Absorption

Following a single dose administration of ella in 20 women nether fasting atmospheric condition, 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 one hr, respectively.

Figure 1: Mean (± SD) Plasma Concentration-fourth dimension Profile of Ulipristal Acetate and Monodemethyl-ulipristal Acetate Post-obit Single Dose Administration of thirty mg Ulipristal Acetate

Table 2: Pharmacokinetic Parameter Values Post-obit Administration of ella (ulipristal acetate) Tablet 30 mg to 20 Salubrious Female Volunteers nether Fasting Conditions

	Hateful (± SD)
	C max (ng/ml)	AUCo-t (ng•hr/ml)	AUC0-∞ (ng•60 minutes/ml)	tmax (hr)*	t½ (hr)
Ulipristal acetate	176 (89)	548 (259)	556 (260)	0.9 (0.5-ii.0)	32 (half dozen.3)
Monodemethyl-ulipristal acetate	69 (26)	240 (59)	246 (59)	1.00 (0.8-2.0)	27 (six.9)
Cmax = maximum concentration AUC0-t = area under the drug concentration curve from time 0 to time of concluding determinable concentration AUC0-∞ = area nether the drug concentration curve from time 0 to infinity tmax = time to maximum concentration t½ = emptying 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% college hateful 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 safe of ella to a clinically pregnant extent; therefore, ella can be taken with or without nutrient.

Distribution

Ulipristal acetate is highly bound ( > 94%) to plasma proteins, including high density lipoprotein, alpha-50-acrid glycoprotein, and albumin.

Metabolism

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

Excretion

The concluding half-life of ulipristal acetate in plasma following a unmarried 30 mg dose is estimated to 32.4 ± 6.three hours.

Drug Interactions

CYP3A4 inducers: When a unmarried 30 mg dose of ulipristal acetate was administered post-obit assistants of the strong CYP3A4 inducer, rifampin 600 mg one time daily for 9 days, Cmax and AUC of ulipristal acetate decreased by 90% and 93% respectively. The Cmax and AUC of monodemethyl-ulipristal acetate decreased by 84% and xc% respectively [run across DRUG INTERACTIONS].

CYP3A4 inhibitors: When a unmarried 10 mg dose of ulipristal acetate was administered following assistants of the strong CYP3A4 inhibitor, ketoconazole 400 mg once daily for 7 days, Cmax and AUC of ulipristal acetate increased past 2and 5.nine-fold, respectively. While the AUC of monodemethyl-ulipristal acetate increased past 2.4-fold, Cmax of monodemethyl-ulipristal acetate decreased by 47%. There was no in vivo drug-drug interaction study between ulipristal acetate 30 mg and CYP3A4 inhibitors [see DRUG INTERACTIONS].

In vitro studies demonstrated that ella does non induce or inhibit the action of cytochrome P450 enzymes.

P-glycoprotein (P-gp) transporter : In vitro information indicate that ulipristal may be an inhibitor of P-gp at clinically relevant concentrations. When a single 60 mg dose of fexofenadine, a substrate of P-gp glycoprotein, was administered 1.5 hours after the assistants of a single 10 mg dose of ulipristal acetate, in that location was no increase in Cmax or AUC of fexofenadine.

Chest Cancer Resistance Protein (BCRP) transporter : In vitro data indicate that ulipristal acetate may exist an inhibitor of BCRP at the intestinal level.

The furnishings of ella on P-gp and BCRP transporters are unlikely to have any clinical consequences when considering ella's single dose handling regimen, although in that location was no in vivo drug interaction report between ulipristal acetate 30 mg (ella) and substrates of P-pg and BCRP transporters.

Clinical Studies

2 multicenter clinical studies evaluated the efficacy and safety of ella. An open-label written report provided the principal data to back up the efficacy and safety of ulipristal acetate for emergency contraception when taken 48 to 120 hours subsequently unprotected intercourse. A single-blind comparative report 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 main 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 (thirty mg Ulipristal Acetate)

	Open-Label Study 48 to 120 Hours * N = 1,242	Single-Bullheaded Comparative Study 0 to 72 Hours * North = 844
Expected Pregnancy Rate **	5.v	v.6
Observed Pregnancy Charge per unit **(95% confidence interval)	two.2 (ane.v, iii.2)	1.9 (1.ane, 3.1)
* Fourth dimension 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 twoscore family planning clinics in the The states. Salubrious women with a mean age of 24 years who requested emergency contraception 48 to 120 hours afterwards 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/one thousand² .

Twenty-vii pregnancies occurred in one,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.five% to an observed rate of 2.2%, when taken 48 to 120 hours after unprotected intercourse.

Single-Blind Comparative Report

This study was a multicenter, single-blind, randomized comparison of the efficacy and rubber of 30 mg ulipristal acetate (ella) to levonorgestrel (another form of emergency contraception). Subjects were enrolled at 35 sites in the U.Southward., the Great britain and Ireland, with the majority (66%) having been enrolled in the U.Due south. Good for you 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 i.v mg. The median BMI for the study subjects was 25.3 and ranged from 14.9 to 70.0 kg/1000² .

In the ella group, 16 pregnancies occurred in 844 women anile 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 charge per unit, from an expected v.6% to an observed 1.nine%, when taken inside 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 afterward UPI. Fourth dimension Trend analysis for the five 24-hr intervals from 0 to 120 hours between unprotected intercourse and treatment was conducted. In that location were no significant differences in the observed pregnancy rates across the five fourth dimension 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.five% in the absenteeism 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 one.5 mg. For levonorgestrel, when used by women with BMI > 30 kg/thousand², the observed pregnancy charge per unit was 7.4% (95% CI: 3.9, 13.four), compared to the expected pregnancy rate of 4.4% in the absence of emergency contraception taken within 72 hours afterward unprotected intercourse.

PATIENT INFORMATION

ella
("el-uh")
(ulipristal acetate) tablet

Read this Patient Information Leaflet before you take ella. At that place may be new information. This data does not take the identify of talking to your healthcare provider about your medical status or handling.

What is ella?

ella is a prescription emergency contraceptive that reduces your take a chance of becoming pregnant if your birth control fails or y'all take unprotected sexual practice.

ella should not be used as your regular birth control. It is very important that you have a reliable class of birth command that is right for you.

ella volition not protect you against HIV infection (AIDS) and other sexually transmitted diseases (STDs).

Who should non take ella?

• Practice not take ella if yous know or doubtable yous are already pregnant. ella is not for use to finish an existing pregnancy.

What should I tell my healthcare provider earlier taking ella?

See "Who should not take ella?"

Tell your healthcare provider about all the medicines you have, 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 virtually whether ella is right for you if y'all are currently using these medications. Know the medicines you lot have. Go along a list of them to show your healthcare provider and chemist when yous get a new medicine.

What should I do nearly birth control afterward I take ella?

Using ella with hormonal contraceptives such every bit nascence command pills could reduce the effectiveness of both drugs to forestall pregnancy. Afterward using ella, if you wish to apply hormonal contraception, you should do so no sooner than 5 days after the intake of ella. Be certain to utilise a reliable bulwark contraceptive method (such as a condom with spermicide) each fourth dimension you take sex until your hormonal birth control has taken effect.

If you practise not use hormonal contraception, later using ella, yous should use a reliable barrier contraceptive method (such every bit rubber with spermicide) each time you accept sex.

When is it non advisable to use ella?

• Practise not use ella as a regular nascency command method. It does not piece of work every bit well as virtually other forms of birth command when they are used consistently and correctly.
• Do not employ ella if you are already pregnant.
• Do not use ella more than than i time in the same menstrual cycle for different acts of unprotected sexual practice or nascency control failure.

How does ella work?

ella is idea 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 equally soon every bit possible within 5 days (120 hours) subsequently unprotected sex or if you had a nascency control failure.
• ella can be taken with or without food.
• Contact your healthcare provider right away if you vomit within iii 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 wheel.

How effective is ella?

If ella is taken as directed, it will reduce the chance that you will get pregnant. ella is non effective in every case. ella is simply to be used for a single episode of unprotected intercourse. Be sure to utilize a regular birth command method the adjacent time yous have sex.

ella and other emergency contraceptives may be less effective in women with a trunk mass index (BMI) > thirty kg/k².

What if I am already meaning and use ella?

ella should not be taken if you lot are already pregnant. Currentlythere is noinformation suggesting that ella would harm a developing infant. Contact your healthcare provider if you lot think y'all may be pregnant and take taken ella.

ella is not for use to finish an existing pregnancy.

What should I practice if my menstrual menstruum is delayed beyond 1 week or I have astringent lower breadbasket (abdominal) hurting?

Afterwards taking ella, your next menstrual period may begin a few days earlier or later than expected. If your menstruum is more than seven days later than expected, yous may be pregnant. You should go 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 abroad. Phone call your healthcare provider or go to the nearest emergency room correct away if you remember you may take an ectopic pregnancy.

How often tin 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 employ emergency contraception often, talk to your healthcare provider and acquire 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 hurting (dysmenorrhea)
• tiredness
• dizziness

Some women taking ella may have their next period earlier or later than expected. If your menstruum is more than than a week late, y'all should become a pregnancy examination.

Tell your healthcare provider if you accept any side effect that bothers you or that does not go away.

These are non all the possible side effects of ella. For more information, enquire your healthcare provider or chemist.

Call your healthcare provider for medical advice most side furnishings. You may report side furnishings to FDA 1800- FDA-1088.

How should I store ella?

• Store ella at 68-77°F (twenty-25°C).
• Protect ella from light. Go on ella in the blister card within the original box until yous are ready to take information technology.

Practice not use ella if the packet is torn or broken.

Continue ella and all medicines out of the reach of children.

Full general data almost the safe and effective utilize of ella:

Medicines are sometimes prescribed for purposes other than those in a Patient Information Leaflet. Do not utilise ella for a status for which it was non prescribed. Do not give ella to other people, fifty-fifty if they have the same symptoms that you have. Information technology may harm them.

In the case of an overdose, become medical help or contact a Poison Control Eye correct away at one-800-2221222. Overdose feel with ella is limited.

This Patient Information Leaflet summarizes the most important data about ella. If you would similar more than data, talk with your healthcare provider. You can enquire your pharmacist or healthcare provider for information about ella that is written for health professionals.

For more than information, go to www.ella-rx.com or you lot tin contact Afaxys Pharma LLC, Health and Safety Team 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

From

Report Issues to the Nutrient and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or phone call 1-800-FDA-1088.

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Source: https://www.rxlist.com/ella-drug.htm

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