ulipristal


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ulipristal

(u-li-priss-tal) ,

Ella

(trade name)

Classification

Therapeutic: contraceptive hormones
Pharmacologic: progesterone agonists antagonists
Pregnancy Category: X

Indications

Prevention of pregnancy following unprotected intercourse or known/suspected contraceptive failure; not intended for routine use.

Action

Binds to progesterone receptors.
Delays follicular rupture, thereby inhibiting/delaying ovulation. Changes in endometrial environment may also contribute to action.

Therapeutic effects

Prevention of pregnancy.

Pharmacokinetics

Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Protein Binding: >94%.
Metabolism and Excretion: Mostly metabolized by CYP3A4 enzyme system; one metabolite (monodemethyl-ulispristal) pharmacologically active.
Half-life: Ulipristal—32 hr; monodemethyl-ulispristal—27 hr.

Time/action profile

ROUTEONSETPEAK†DURATION
POunknownUlipristal—0.9 hr; monodemethyl-ulispristal—1 hrunknown
†Blood level.

Contraindications/Precautions

Contraindicated in: Pregnancy or termination of existing pregnancy; Lactation: Not recommended during breastfeeding.
Use Cautiously in: Repeated use; regular contraception should be continued/instituted and additional method should be used during current cycle.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • dizziness
  • fatigue

Gastrointestinal

  • abdominal pain (most frequent)
  • nausea (most frequent)

Genitourinary

  • altered menstrual cycle
  • dysmenorrhea

Interactions

Drug-Drug interaction

Effectiveness may be ↓ by CYP3A4 inducers, including barbiturates, bosentan, carbamazepine, oxcarbazepine, phenytoin, topiramate, felbamate, rifampin.Effects may be ↑ CYP3A4 inhibitor including itraconazole and ketoconazole.May ↑ levels of P-glycoprotein substrates, including dabigatran and digoxin Efficacy of hormonal contraceptives may be ↓ during current cycle.Effectiveness may be ↓ by St. John's wort.

Route/Dosage

Oral (Adults) One tablet as soon as possible within 120 hours (5 days) after unprotected intercourse or known/suspected contraceptive failure. If vomiting occurs within 3 hr dose may be repeated.

Availability

Tablet: 30 mg

Nursing implications

Nursing assessment

  • Exclude the possibility of pregnancy on the basis or history and/or physical exam or a pregnancy test before administering ulipristal.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Oral: Administer 1 tablet as soon as possible within 120 hrs (5 days) after unprotected intercourse or a known or suspected contraceptive failure. May be taken without regard to food. If vomiting occurs within 3 hrs of dose, may repeat. May be taken at any time during the menstrual cycle.
    • Ulipristal may be less effective in women with a body mass index >30 kg/m2.

Patient/Family Teaching

  • Instruct patient to take ulipristal as directed. Advise patient that they should not take ulipristal if they know or suspect they are pregnant; ulipristal is not for use to end an existing pregnancy. Advise patient to contact health care professional if they vomit within 3 hrs after taking ulipristal.
  • Inform patient that ulipristal may reduce the effectiveness of hormonal contraceptives. Advise patient to use a non-hormonal contraceptive during that menstrual cycle.
  • Advise patient to notify health care professional and consider the possibility of pregnancy of their period is delayed by more than 1 wk beyond the expected date after taking ulipristal.
  • Inform patient that ulipristal is not to be used as a routine form of contraception or to be used repeatedly within the same menstrual cycle.
  • Advise patient that ulipristal does not protect against HIV infection and other sexually transmitted infections.
  • Advise patient to notify health care professional if severe lower abdominal pain occurs 3–5 wks after taking ulipristal to be evaluated for an ectopic pregnancy.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise female patients to avoid breastfeeding if taking ulipristal.

Evaluation/Desired Outcomes

  • Prevention of pregnancy.
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References in periodicals archive ?
The US FDA's PDUFA target action date has been extended to August 2018 to provide time for a full review of the ulipristal acetate file, said the company.
Research published in 2011 sparked vigorous debate--and some regulatory changes--when it reported that levonorgestrel EC pills may be ineffective for women who weigh at least 154 pounds, and that ulipristal acetate EC pills may be ineffective for women who weigh 194 pounds or more.
Pellicer, "Successful pregnancy after treatment with ulipristal acetate for uterine fibroids," Case Reports in Obstetrics and Gynecology, vol.
The second-generation antiprogestin ulipristal acetate (30 mg in a single dose) has been studied for use as emergency contraception and has been found to be highly effective and well-tolerated.
Commenting on the newly formed association between the two organizations, Erin Gainer, CEO of HRA Pharma, said, We are looking forward to this collaborative relationship that we anticipate to prove successful in improving women's access to ulipristal acetate emergency contraception in the USA.
37) The FDA-approved contraceptive methods include intrauterine devices, diaphragms, oral contraceptive pills, and so-called emergency contraceptives, such as Plan B and ulipristal (or "Ella"), which are known as the morning-after pill and the week-after pill, respectively.
There are three FDA-approved emergency contraception pills in the United States: Plan B One-Step and Next Choice, all of which contain the progestin levonorgestrel, and ulipristal acetate tablets, sold under the brand name "ella.
25) The FDA also approved ulipristal acetate-based EC (ella), which requires a prescription for all of its users and is effective up to 120 hours after unprotected sex.
Two randomised clinical trials have found that ulipristal acetate (UPA), currently licensed for emergency contraceptive use up to five days (120 hours) after intercourse in Europe and the US, (1) is effective in treatment of heavy menstrual bleeding due to uterine fibroids.
The HHS regulation in question will require all employers that provide employee health insurance to include, at no cost to employees, voluntary sterilization and contraceptive services--including ulipristal acetate, more commonly referred to as "ella," which can prevent implantation of a fertilized ovum as well as fertilization and is therefore regarded by the Catholic church as not just a contraceptive but an abortifacient.
This edition has 200 new monographs, new and updated interactions advice, and the addition of drugs like febuxostat, ivabradine, lacosamide, pitavastatin, retigabine (ezogabine), rufinamide, and ulipristal.
Today, however, a second antiprogestin, ulipristal has been marketed (as an emergency contraceptive) and work has resumed on possible applications of antiprogestins in the treatment of a number of proliferative disorders of the female reproductive tract.