Drug Guide
Ulipristal Acetate
Classification
Therapeutic: Hormonal Contraceptive; Emergency Contraceptive; Uterine Fibroid Treatment
Pharmacological: Selective Progesterone Receptor Modulator (SPRM)
FDA Approved Indications
- Emergency contraception within 5 days of unprotected intercourse or contraceptive failure
- Treatment of symptomatic uterine fibroids in women of reproductive age
Mechanism of Action
Ulipristal acetate modulates progesterone receptors, inhibiting or delaying ovulation, altering the endometrial lining, and preventing implantation.
Dosage and Administration
Adult: Ella: 30 mg orally as a single dose; Logilia: administered as prescribed for uterine fibroid treatment (usually 5 mg daily for 3 months)
Pediatric: Not approved for pediatric use
Geriatric: Limited data; use with caution and consider individual patient factors
Renal Impairment: Adjustments not specified; use with caution
Hepatic Impairment: Use caution; no specific dose adjustment recommended
Pharmacokinetics
Absorption: Rapidly absorbed after oral administration
Distribution: Wide distribution; plasma protein binding approximately 98%
Metabolism: Primarily hepatic via CYP3A4 enzyme
Excretion: Metabolites excreted mainly in feces and urine
Half Life: Approximately 13 hours
Contraindications
- Hypersensitivity to ulipristal acetate or excipients
- Use of hormonal contraception or other hormonal therapy concurrently for emergency contraception
Precautions
- Pregnancy (category X), breastfeeding, hepatic impairment, use with CYP3A4 inhibitors or inducers, liver disease
Adverse Reactions - Common
- Nausea (20-25%)
- Headache (15-20%)
- Abdominal pain (10-15%)
Adverse Reactions - Serious
- Liver injury, including hepatitis, cholestasis (Rare)
- Hypersensitivity reactions (Rare)
Drug-Drug Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) increase plasma levels; CYP3A4 inducers (e.g., rifampin, carbamazepine) decrease efficacy
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Assess for pregnancy, previous contraceptive use, hepatic function, and medication history
Diagnoses:
- Risk of ineffective contraception
- Potential for adverse hepatic effects
Implementation: Administer as prescribed, counsel on use and side effects, monitor liver function during uterine fibroid treatment
Evaluation: Assess effectiveness of contraception or fibroid symptom control, monitor for adverse effects
Patient/Family Teaching
- Take as directed, preferably as a single dose for emergency contraception
- Report severe abdominal pain, jaundice, or allergic reactions
- Inform healthcare provider of all medications, especially CYP3A4 inhibitors/inducers
Special Considerations
Black Box Warnings:
- Serious liver injury has been reported; use only when pregnancy is excluded and for approved indications
Genetic Factors: Limited data; consider pharmacogenomics in research settings
Lab Test Interference: May affect liver function tests
Overdose Management
Signs/Symptoms: Nausea, vomiting, abdominal pain
Treatment: Supportive care; no specific antidote—monitor hepatic function; manage symptoms accordingly
Storage and Handling
Storage: Store at room temperature, away from moisture and heat
Stability: Stable under recommended storage conditions for the duration of the shelf life