Version May 2024
Emergency contraception: Oral: 30 mg as soon as possible, but within 120 hours (5 days) of unprotected intercourse or contraceptive failure.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, dosage adjustment may not be necessary since renal elimination of ulipristal is minimal (Ref).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
For use in patients of reproductive potential; not indicated for use post menopause.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Endocrine & metabolic: Suppressed menstruation (>7 days later than expected: 19%)
Gastrointestinal: Abdominal pain (8% to 15%, including upper abdominal pain), nausea (12% to 13%)
Genitourinary: Dysmenorrhea (7% to 13%)
Nervous system: Headache (18% to 19%)
1% to 10%:
Endocrine & metabolic: Intermenstrual bleeding (9%)
Genitourinary: Early menses (>7 days earlier than expected: 7%)
Nervous system: Dizziness (5%), fatigue (6%)
Postmarketing:
Dermatologic: Acne vulgaris, pruritus, skin rash, urticaria
Hypersensitivity: Angioedema, hypersensitivity reaction
Pregnancy (known or suspected).
Canadian labeling: Additional contraindications (not in US labeling):Hypersensitivity to ulipristal or any component of the formulation.
Concerns related to adverse effects:
• Bleeding irregularities: Menstrual bleeding patterns may be altered (cycle length may be delayed or shortened by a few days) but returns to normal in subsequent cycles. Intermenstrual bleeding (spotting) has also been observed. The possibility of pregnancy should be considered if menstruation is delayed for >7 days of the expected menstrual period.
Other warnings/precautions:
• Appropriate use: Repeated use within the same menstrual cycle is not recommended.
• HIV infection protection: Does not protect against HIV infection or other sexually transmitted diseases.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as acetate:
Ella: 30 mg
No
Tablets (Ella Oral)
30 mg (per each): $46.50
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as acetate:
Ella: 30 mg
Oral: Administer with or without food at any time during menstrual cycle. If vomiting occurs within 3 hours of administration, consider repeating dose.
Hazardous agent (NIOSH 2016 [group 3]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.
Emergency contraception: Prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Ulipristal is not intended for routine use as a contraceptive in patients who may become pregnant.
Ulipristal may be confused with ursodiol
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Ulipristal. Risk X: Avoid combination
CYP3A4 Inducers (Strong): May decrease the serum concentration of Ulipristal. Risk X: Avoid combination
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Ulipristal. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Ulipristal. Risk C: Monitor therapy
Felbamate: May decrease the serum concentration of Ulipristal. Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Griseofulvin: May decrease the serum concentration of Ulipristal. Risk X: Avoid combination
OXcarbazepine: May decrease the serum concentration of Ulipristal. Risk X: Avoid combination
Progestins: Ulipristal may diminish the therapeutic effect of Progestins. Progestins may diminish the therapeutic effect of Ulipristal. Risk X: Avoid combination
Topiramate: May decrease the serum concentration of Ulipristal. Risk X: Avoid combination
When used for emergency contraception, exclude pregnancy prior to therapy; ulipristal is not indicated for terminating an existing pregnancy. A history of ectopic pregnancy is not a contraindication to use in emergency contraception. Patients who use ulipristal due to hormonal contraceptive failure should also refer to individual hormonal contraceptives prescribing information for additional directions.
A rapid return of fertility is expected following use for emergency contraception; routine contraceptive measures should be initiated or continued following use to ensure ongoing prevention of pregnancy. Barrier contraception is recommended immediately following emergency contraception and throughout the same menstrual cycle; efficacy of hormonal contraceptives may be decreased. The manufacturer recommends waiting ≥5 days after taking ulipristal before resuming oral contraceptives. The CDC notes any contraceptive method may be started immediately after taking ulipristal; however, a barrier method should also be used for 14 days following the dose (or until menses occurs, whichever occurs first) (CDC [Curtis 2016a]).
Ulipristal can be used for emergency contraception in patients receiving gender-affirming testosterone therapy after evaluating patient preferences and medical conditions (Bonnington 2020; Krempasky 2020).
Isolated cases of major malformations have been reported following inadvertent use during pregnancy; however, data are not sufficient to determine a causal relationship and no pattern of adverse outcomes has been identified.
Use is contraindicated during a known or suspected pregnancy.
The possibility of ectopic pregnancy should be considered in patients if pregnancy occurs after treatment or in patients with lower abdominal pain after administration of ulipristal.
Ulipristal and its active metabolite monodemethyl-ulipristal are present in breast milk.
Ulipristal 30 mg was administered as a single dose to 12 lactating women. The mean concentrations in breast milk over the first 24 hours were 22.7 ng/mL (ulipristal) and 4.49 ng/mL (monodemethyl-ulipristal). From 96 to 120 hours after the dose, concentrations decreased to 0.69 ng/mL (ulipristal) and 0.10 ng/mL (monodemethyl-ulipristal). Based on these data, the manufacturer calculated the relative infant dose (RID) of ulipristal and the active metabolite to be ~0.8% using the mean milk concentrations obtained on day 1 of administration and compared to a weight-adjusted maternal dose of 30 mg. In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. The CDC Contraception guidelines note ulipristal may be used for emergency contraception in patients who are breastfeeding; however, breast milk should be discarded for 24 hours after the dose (CDC [Curtis 2016b]).
Evaluate for pregnancy or ectopic pregnancy if expected menses is delayed for ≥1 week following emergency contraception, or if lower abdominal pain (3 to 5 weeks after administration) or persistent irregular bleeding develops. A pregnancy test is recommended if withdrawal bleeding does not occur within 3 weeks following use as an emergency contraceptive (CDC [Curtis 2016a]).
Prevents progestin from binding to the progesterone receptor. Ulipristal postpones follicular rupture when administered prior to ovulation, thereby inhibiting or delaying ovulation. May also alter the normal endometrium, impairing implantation.
Absorption: Rapid.
Protein binding: Ulipristal: >94% to plasma proteins including albumin, alpha1-acid glycoprotein, and high-density lipoprotein.
Metabolism: Hepatic via CYP3A4; forms monodemethylated metabolite (active) and inactive metabolites.
Half-life elimination: Ulipristal: ~32 to 38 hours; Monodemethylated metabolite: ~27 hours.
Time to peak, serum: 1 hour (ulipristal and monodemethylated metabolite).
Race/ethnicity: Exposure in South Asian patients may exceed that in White and Black patients. However, no difference in efficacy and safety was observed.
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