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 ?
have formed a commercial partnership to supply ulipristal acetate (UPA), a selective progesterone receptor modulator, to the U.S.
Ulipristal will be available in the fourth quarter of this year, according to Laboratoire HRA Pharma, the French manufacturer of the drug.
Among those who received treatment within 72 hours of unprotected intercourse, 15 pregnancies occurred in the ulipristal acetate group and 22 in the levonorgestrel group.
The found that in the efficacy-evaluable population, 1 696 women received emergency contraception within 72 h of sexual intercourse (ulipristal acetate, N=844; levonorgestrel, N=852).
Pharmacy access to ulipristal acetate in major cities throughout the United States.
A total of 58% of patients who took 10 mg ulipristal acetate per day had no bleeding except spotting during the last 35 days of treatment, compared with 2% of the placebo group (P less than .0001), James Simon, MD, said at the annual meeting of the American Society for Reproductive Medicine.
M2 PHARMA-November 22, 2016-Allergan plc wins additional approval in Canada for FIBRISTAL (ulipristal acetate, 5 mg) for the treatment of uterine fibroids in adult women
M2 EQUITYBITES-November 22, 2016-Allergan plc wins additional approval in Canada for FIBRISTAL (ulipristal acetate, 5 mg) for the treatment of uterine fibroids in adult women
And, since 2010, another Emergency Contraceptive pill containing ulipristal acetate (sold as ella[R]) has been available by prescription in the U.S.
The introduction of ulipristal acetate (UPA), a selective progesterone receptor modulator (SPRM), has opened new avenues for the control of uterine myomatosis.