Ulipristal Acetate
Generic Name: ulipristal acetate
Brand Names:
Ella
11 DESCRIPTION The ella (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate [17α-acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione], a synthetic progesterone agonist/antagonist. The inactive ingredients are lactose monohydrate, povidone K-30, croscarmellose sodium and magnesium stearate. Ulipristal acetate is a white to yellow crystalline powder which has a molecular weight of 475.6.
Overview
11 DESCRIPTION The ella (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate [17α-acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione], a synthetic progesterone agonist/antagonist. The inactive ingredients are lactose monohydrate, povidone K-30, croscarmellose sodium and magnesium stearate. Ulipristal acetate is a white to yellow crystalline powder which has a molecular weight of 475.6.
Uses
1 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 [see Dosage and Administration (2.1) ] . Ella is not intended for routine use as a contraceptive. 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
2 DOSAGE AND ADMINISTRATION Take one tablet orally as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. Take with or without food. Take at any time during the menstrual cycle. ( 2.1 ) After ella use, initiate or resume hormonal contraception no sooner than 5 days after the intake of ella and use a reliable barrier method until the next menstrual period. ( 2.2 ) If vomiting occurs within 3 hours of taking ella , consider repeating the dose. ( 2.3 ) 2.1 Recommended Dosage and Administration Take one tablet of ella orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. Take ella with or without food.
Side Effects
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 HRA Pharma America Inc., at 844-994-0329 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Interactions
7 DRUG INTERACTIONS Several in vivo drug interaction studies have shown that ella is predominantly metabolized by CYP3A4. Drugs or herbal products that induce CYP3A4 decrease the effectiveness of ella . ( 7.1 ) Initiation of progestin-containing contraceptives may impair the ability of ella to delay ovulation. ( 7.1 ) 7.1 Changes in Emergency Contraceptive Effectiveness Associated with Co-Administration of Other Products CYP3A inducers Drugs or herbal products that induce CYP3A4 decrease the plasma concentrations of ella , and may decrease its effectiveness [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ] .
Warnings
5 WARNINGS AND PRECAUTIONS Existing Pregnancy: ella is not indicated for termination of an existing pregnancy. ( 5.1) Ectopic pregnancy: Evaluate women who become pregnant or complain of lower abdominal pain after taking ella for ectopic pregnancy. ( 5.2 ) Fertility Following Use : Rapid return of fertility is likely. Subsequent acts of intercourse should be protected by a reliable barrier method of contraception until the next menstrual period. ( 5.5 ) Effect on Menstrual Cycle: ella may alter the next expected menses. If menses is delayed beyond 1 week, rule out pregnancy. ( 5.6 ) Ella does not protect against STI/HIV. ( 5.7 ) 5.1 Existing Pregnancy Ella is not indicated for termination of an existing pregnancy. 4 CONTRAINDICATIONS Ella is contraindicated for use in the case of known or suspected pregnancy [see Use in Specific Populations (8.1) ]. Known or suspected pregnancy ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Ella is contraindicated for use during an existing or suspected pregnancy. No signal of concern regarding pregnancy complications was found in postmarketing studies [see Data ]. Isolated cases of major malformations in ella- exposed pregnancies were identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent use of ella during pregnancy. Miscarriage was reported in 14% of the known pregnancy outcomes; a rate that is similar to the U.S. background rate for miscarriage. In the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Ella (ulipristal acetate) tablet, 30 mg is supplied in a PVC-PE-PVDC or PVC-PVDC-aluminum blister. The tablet is a white to off-white, round, curved tablet marked with “ ella ” on both sides.
Frequently Asked Questions
What is Ulipristal Acetate used for?▼
1 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 [see Dosage and Administration (2.1) ] . Ella is not intended for routine use as a contraceptive. 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 )
What are the side effects of Ulipristal Acetate?▼
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 HRA Pharma America Inc., at 844-994-0329 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Can I take Ulipristal Acetate during pregnancy?▼
8.1 Pregnancy Risk Summary Ella is contraindicated for use during an existing or suspected pregnancy. No signal of concern regarding pregnancy complications was found in postmarketing studies [see Data ]. Isolated cases of major malformations in ella- exposed pregnancies were identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent use of ella during pregnancy. Miscarriage was reported in 14% of the known pregnancy outcomes; a rate that is similar to the U.S. background rate for miscarriage. In the U.S.
What are the important warnings for Ulipristal Acetate?▼
5 WARNINGS AND PRECAUTIONS Existing Pregnancy: ella is not indicated for termination of an existing pregnancy. ( 5.1) Ectopic pregnancy: Evaluate women who become pregnant or complain of lower abdominal pain after taking ella for ectopic pregnancy. ( 5.2 ) Fertility Following Use : Rapid return of fertility is likely. Subsequent acts of intercourse should be protected by a reliable barrier method of contraception until the next menstrual period. ( 5.5 ) Effect on Menstrual Cycle: ella may alter the next expected menses. If menses is delayed beyond 1 week, rule out pregnancy. ( 5.6 ) Ella does not protect against STI/HIV. ( 5.7 ) 5.1 Existing Pregnancy Ella is not indicated for termination of an existing pregnancy. 4 CONTRAINDICATIONS Ella is contraindicated for use in the case of known or suspected pregnancy [see Use in Specific Populations (8.1) ]. Known or suspected pregnancy ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.