ELLA- ulipristal acetate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ULIPRISTAL ACETATE (UNII: YF7V70N02B) (ULIPRISTAL - UNII:6J5J15Q2X8)

Available from:

HRA PHARMA AMERICA, INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated for use in the case of known or suspected pregnancy [see Use in Specific Populations (8.1)]. 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. general population, the estimated background risk of major birth defects and m

Product summary:

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. NDC 73302-456-01 (1 tablet unit of use package) Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP controlled room temperature.] Keep the blister in the outer carton in order to protect from light.  Keep out of reach of children .

Authorization status:

New Drug Application

Summary of Product characteristics

ELLA- ULIPRISTAL ACETATE TABLET
HRA PHARMA AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
RECENT MAJOR CHANGES
•
06/2021
•
06/2021
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
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•
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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.
DRUG INTERACTIONS
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Dosage and Administration (2.1 , 2.2, 2.3)
Warnings and Precautions (5.5)
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)
30 mg tablet (3)
Known or suspected pregnancy (4)
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 inte