u-li-PRISS-tal

Therapeutic Classification: contraceptive hormones (emergency)

Pharmacologic Classification:

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

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

• Prevention of pregnancy.

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Protein Binding: >94%.

Metabolism/Excretion: Mostly metabolized by CYP3A4 enzyme system; one metabolite (monodemethyl-ulispristal) pharmacologically active.

Half-life: Ulipristal—32 hr; monodemethyl-ulispristal—27 hr.

†Blood level.

Contraindicated in:

• OB: 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.

GI: abdominal pain, nausea.

GU: altered menstrual cycle, dysmenorrhea.

Neuro: headache, dizziness, fatigue.

Drug-Drug:

• Effectiveness may be ↓ by CYP3A4 inducers, including barbiturates, bosentan, carbamazepine, oxcarbazepine, phenytoin, topiramate, felbamate, rifampin; avoid concomitant use.
• 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.

Drug-Natural Products:

• Effectiveness may be ↓ by St. John's wort.

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

• Tablet: 5 mg; 30 mg;

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

• PO: 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.

• Instruct patient to take ulipristal as directed. Advise patient that they should not take ulipristal if they know or suspect they are pregnant or if breastfeeding; 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. Instruct patient to read Patient Information pamphlet before taking ulipristal.
• Ulipristal may delay next expected menses. Advise patient to notify health care professional and consider the possibility of pregnancy if 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.
• Rep: Inform patient that ulipristal may reduce the effectiveness of hormonal contraceptives. Advise patient to use a non-hormonal contraceptive until the next menstrual period. Advise patient to wait at least 5 days after taking ulipristal to resume taking hormonal contraceptive. Advise female patients to avoid breastfeeding if taking ulipristal.

• Prevention of pregnancy.

Ella, Logilia

Fibristal

NDC Code^*

• 50090- A-S Medication Solutions
  • 50090-2835- Ella
    • 50090-2835-0- 1 BLISTER PACK in 1 CARTON (50090-2835-0) > 1 TABLET in 1 BLISTER PACK

• 50102- Afaxys Pharma LLC
  • 50102-911- Ella
    • 50102-911-01- 1 BLISTER PACK in 1 CARTON (50102-911-01) > 1 TABLET in 1 BLISTER PACK

• 53002- RPK Pharmaceuticals, Inc.
  • 53002-1630- Ella
    • 53002-1630-1- 1 TABLET in 1 DOSE PACK (53002-1630-1)