ulipristal (Rx)Brand and Other Names:ella

 
 
 

Dosing & Uses

AdultPediatric

Dosing Form & Strengths

tablet

  • 30mg

Emergency Contraception

30 mg (1 tablet) PO as soon as possible (within 120 hr [5 days]) after unprotected intercourse or a known/suspected contraceptive failure

If vomiting occurs within 3 hr after the dose, consider repeating the regimen

Higher efficacy if administered within first 72 hr postcoitus

Premenarche: Not indicated

<18 year: Safety and efficacy not established

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Interactions

Interaction Checker

ulipristal and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (18-19%)

            Abdominal and upper abdominal pain (8-15%)

            Nausea (12-13%)

            Menstruation occurring ≥7 days than expected (19%)

            Dysmenorrhea (7-13%)

            1-10%

            Intermenstrual bleeding (9%)

            Fatigue (6%)

            Dizziness (5%)

            Menstruation occuring ≥7 days earlier than expected

            Postmarketing Reports

            Acne

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            Warnings

            Contraindications

            Known or suspected pregnancy

            Cautions

            Not indicated for termination of existing pregnancy

            Exclude pregnancy before prescribing

            Consider possibility of ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking ulipristal

            Not for replacement of regular contraceptive methods; for occasional use as an emergency contraceptive only

            The possibility of ectopic pregnancy should be considered in patients with abdominal pain after administration of ulipristat

            Repeated use within the same menstrual cycle not recommended

            Does not protect against sexually transmitted diseases

            Fertility following use

            • A rapid return of fertility is likely following treatment; therefore, routine contraception should be continued or initiated as soon as possible following use
            • After use of ulapristal, 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

            Effect on menses

            • After use of ulipristal, menses sometimes occur earlier or later than expected by a few days; if there is a delay in the onset of expected menses beyond 1 week, rule out pregnancy
            • 9% of women in clinical trials reported intermenstrual bleeding after use
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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: Not recommended for use by breastfeeding women

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Selective progesterone receptor modulator with antagonistic and partial agonistic effects

            When taken immediately before ovulation, postpones follicular rupture

            It is thought that the primary mechanism of action for emergency contraception is inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also occur

            Pharmacokinetics

            Protein binding: >94%

            Half-life: 32hr (ulipristal); 27 hr (monodemethylated metabolite)

            Peak serum time:1hr

            Peak Plasma Concentration: 176 ng/mL

            Metabolism: predominantly by CYP3A4 to active metabolite monodemethyl-ulipristal acetate

            AUC: 548 ng•hr/mL

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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
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