Ulipristal acetate is indicated for:

• Treatment of moderate to severe symptoms of uterine fibroids in premenopausal women who are eligible for surgery
• Emergency contraception within 120 hours (5 days) of unprotected intercourse or a contraceptive failure

Uterine Fibroids

Contraception

Prevention of Pregnancy

For the treatment of uterine fibroids:

• The recommended dose is 5 mg once daily for up to 3 months. Treatment can be repeated for up to two treatment courses.
• Treatment should be initiated during the first week of the menstrual cycle.

For emergency contraception:

• One tablet ( 30 mg) taken orally as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.
• The tablet can be taken with or without food.

The most common adverse reactions (≥ 5%) reported in clinical trials for ulipristal acetate are:

• Headache
• Abdominal pain
• Nausea
• Dysmenorrhea
• Fatigue

Headache

Abdominal Pain

Nausea

Dysmenorrhea

• Ulipristal acetate is not intended for use during an existing pregnancy.
• It is important to rule out pregnancy before initiating treatment for uterine fibroids or emergency contraception.
• Ulipristal acetate may delay the onset of the next menstrual period. Women who do not menstruate within 21 days after taking ulipristal acetate should be evaluated for pregnancy.
• Patients with a history of hepatic impairment should be monitored closely as there is limited data on the use of ulipristal acetate in this population.
• Ulipristal acetate may interact with hormonal contraceptives and may decrease their effectiveness.
• Ulipristal acetate may cause a decrease in bone mineral density. It is not recommended for long-term use or for women with a history of osteoporosis.