July 29, 2015
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Ella

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Ella




Warnings
Precautions

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.

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 anytime during pregnancy. Enroll your patient by completing the forms available at www.ellipse2.com where voluntary reports from health care providers or consumers are received.

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.

CYP3A4 Inducers

A CYP3A4 inducer, rifampin, decreases the plasma concentration of ella significantly. ella should not be administered with CYP3A4 inducers [see DRUG INTERACTIONS and Pharmacokinetics].

Fertility Following Use

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

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.

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

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.
  • 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.

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 (3 mg/kg/day). Despite the increase, this incidence of adrenal cortical adenomas in females may not be relevant to clinical use.

Tg.rasH2 transgenic mice were exposed to ulipristal acetate for 26 weeks at doses of 5, 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.

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]

Pregnancy Exposure Study

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. Enroll your patient by completing the forms available at www.ellipse2.com where voluntary reports from healthcare providers or consumers are received.

Risk Summary

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

Data

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 1/3 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

The breast milk of 12 lactating women following administration of ella was collected in 24-hour increments to measure the concentrations of ulipristal acetate and monodemethyl-ulipristal acetate in breast milk. The mean daily concentrations of ulipristal acetate in breast milk were 22.7 ng/mL [0-24 hours], 2.96 ng/mL [24-48 hours], 1.56 ng/mL [48-72 hours], 1.04 ng/mL [72-96 hours], and 0.69 ng/mL [96-120 hours]. The mean daily concentrations of monodemethyl-ulipristal acetate in breast milk were 4.49 ng/mL [0-24 hours], 0.62 ng/mL [24-48 hours], 0.28 ng/mL [48-72 hours], 0.17 ng/mL [72-96 hours], and 0.10 ng/mL [96-120 hours].

The effect of this exposure on newborns/infants has not been studied; therefore, risk to the breast-fed child cannot be excluded. Therefore, use of ella by breastfeeding women is not recommended.

Pediatric Use

Safety and efficacy of ella have been established in women of reproductive age. The clinical trials of ella enrolled 41 females under age 18, and a post-marketing observational study evaluating effectiveness and safety of ella in adolescents enrolled 279 females under age 18, including 76 under age 16 years. In these studies, the safety and efficacy profile observed in adolescents aged 17 and younger was similar to that in adults. 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: 3/30/2015
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions

Report Problems to the Food and Drug Administration

 

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


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