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Ella (Ulipristal Acetate) - Warnings and Precautions

 
 



WARNINGS AND 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.

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; 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).

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category X. [See Contraindications (4 ).]

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 1/3 and 1/2 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. 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.

Page last updated: 2014-07-01

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