Classes
DEA Class; Rx
Common Brand Names; ella, Logilia
- Progestins Receptor Modulators
Description
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
Indications
Contraindications
Known or suspected pregnancy
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
Safety and efficacy have not been established.
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.
Use before menarche is not indicated.
Not indicated.
How supplied
Ulipristal
tablet
- 30mg (ella, Logilia)
