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Ulipristal

    Brands

    DEA Class; Rx

    Common Brand Names; ella, Logilia

    • Progestins Receptor Modulators

    Oral progesterone agonist/antagonist; available by prescription only
    1-dose emergency contraceptive that may be given up to 5 days following unprotected intercourse or suspected routine contraceptive failure
    Contraindicated during pregnancy; does not terminate existing pregnancy

    Indicated for postcoital contraception after unprotected intercourse or a known or suspected contraceptive failure.
    For the treatment of uterine leiomyomata (uterine fibroids).

    Known or suspected pregnancy

    • Headache (18-19%)
    • Abdominal and upper abdominal pain (8-15%)
    • Nausea (12-13%)
    • Menstruation occurring ≥7 days than expected (19%)
    • Dysmenorrhea (7-13%)
    • Intermenstrual bleeding (9%)
    • Fatigue (6%)
    • Dizziness (5%)
    • Menstruation occuring ≥7 days earlier than expected
    • Acne

    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

    Contraindicated for use during an existing or suspected pregnancy; no signal of concern regarding pregnancy complications was found in postmarketing studies; isolated cases of major malformations in ella-exposed pregnancies were identified; however, data are not sufficient to determine risk for birth defects with inadvertent use of therapy during pregnancy

    The drug and its active metabolite, monodemethyl-ulipristal acetate, are present in human milk in small amounts; based on levels of drug and active metabolite measured in breastmilk, a fully breastfed child would receive a weight-adjusted dosage of approximately 0.8% of ulipristal acetate and monodemethyl-ulipristal acetate on Day 1 of drug administration and an approximate total of 1% of maternal dose over a 5-day period after drug administration; there is no information on effects on breastfed child or on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

    Adults

    30 mg PO single dose for emergency postcoital contraception. If the patient vomits within 3 hours of first dose, a second 30 mg dose may be given; limit use to 1 course of treatment during any given menstrual cycle.

    Geriatric

    Safety and efficacy have not been established.

    Adolescents

    30 mg PO single dose for emergency postcoital contraception. If the patient vomits within 3 hours of first dose, a second 30 mg dose may be given; limit use to 1 course of treatment during any given menstrual cycle.

    Children

    Use before menarche is not indicated.

    Infants

    Not indicated.

    Ulipristal

    tablet

    • 30mg (ella, Logilia)