HIGHLIGHTS OF PRESCRIBING INFORMATION
ella (ulipristal acetate) 30 mg tablet
Revised: August 2010
These highlights do not include all the information needed to use ella safely and effectively. See full prescribing information for ella.

ella (ulipristal acetate) tablet
Initial U.S. Approval: 2010
INDICATIONS AND USAGE
ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive. (1)
DOSAGE AND ADMINISTRATION
One tablet taken orally as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. (2)
The tablet can be taken with or without food. (2)
DOSAGE FORMS AND STRENGTHS
30 mg tablet  (3)
CONTRAINDICATIONS
Known or suspected pregnancy (4)
WARNINGS AND PRECAUTIONS
ella is not indicated for termination of an existing pregnancy. Exclude pregnancy before administering. (5.1)  
Ectopic pregnancy: Women who become pregnant or complain of lower abdominal pain after taking ella should be eva luated for ectopic pregnancy. (5.2)
Effect on menstrual cycle: ella may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out. (5.5)
ella does not protect against STI/HIV. (5.6)
ADVERSE REACTIONS
The most common adverse reactions (≥ 5%) in the clinical trials were headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%) and dizziness (5%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Watson Laboratories, Inc. at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of ella. (7)
USE IN SPECIFIC POPULATIONS
Nursing mothers: ella is not recommended for use by breastfeeding women. (8.3)
ella is not intended for use in premenarcheal (8.4) or postmenopausal women. (8.5)
See 17 for PATIENT COUNSELING INFORMATION 

Revised: 08/2010
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 

1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Existing Pregnancy
5.2 Ectopic Pregnancy
5.3 Repeated Use
5.4 Fertility Following Use
5.5 Effect on Menstrual Cycle
5.6 Sexually Transmitted Infections/HIV
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Changes in Emergency Contraceptive Effectiveness Associated with Co-Administration of Other Products
7.2 Increase in Plasma Concentrations of ella Associated with Co-Administered Drugs
7.3 Effects of ella on Co-Administered Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Race
8.7 Hepatic Impairment
8.8 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY