ELLA Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

HRA Pharma America, Inc.

Λέξεις κλειδιά

73302-456

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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. Ella is not intended ...

2. Dosage and Administration

Instruct patients to take one tablet 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 ...

3. Dosage Forms and Strengths

The ella tablet is supplied as a white to off-white, round, curved tablet containing 30 mg of ulipristal acetate and is marked ella on both sides.

4. Contraindications

Ella is contraindicated for use in the case of known or suspected pregnancy [See Use in Specific Populations (8.1)].

5. Warnings and Precautions

5.1 Existing Pregnancy Ella is not indicated for termination of an existing pregnancy. 5.2 Ectopic Pregnancy A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive ...

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 ...

6.2. Postmarketing Experience

Adolescents: the safety profile observed in adolescents aged 17 and younger in studies and post-marketing is similar to the safety profile in adults [see Pediatric Use (8.4)]. The following adverse ...

7. Drug Interactions

Several in vivo drug interaction studies have shown that ella is predominantly metabolized by CYP3A4. 7.1 Changes in Emergency Contraceptive Effectiveness Associated with Co-Administration of ...

8. Use in Specific Populations

8.6 Race While no formal studies have evaluated the effect of race, a cross-study comparison of two pharmacokinetic studies indicated that exposure in South Asians may exceed that in Caucasians and African ...

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 ...

8.2. Lactation

Risk Summary Ulipristal acetate and its active metabolite, monodemethyl-ulipristal acetate, are present in human milk in small amounts (see Data). Based on the levels of drug and active metabolite ...

8.3. Females and Males of Reproductive Potential

Contraception Ella and progestin-containing contraceptives' may interact and decrease the effectiveness of both products. Advise females to use a a reliable barrier method for subsequent acts of intercourse ...

8.4. Pediatric Use

Safety and efficacy of ella have been established in women of reproductive age. The clinical trials of ella enrolled 41 females under age 18, and a post-marketing observational study evaluating effectiveness ...

8.5. Geriatric Use

This product is not intended for use in postmenopausal women.

8.7. Hepatic Impairment

No studies have been conducted to evaluate the effect of hepatic disease on the disposition of ella.

8.8. Renal Impairment

No studies have been conducted to evaluate the effect of renal disease on the disposition of ella.

10. Overdosage

Experience with ulipristal acetate overdose is limited. In a clinical study, single doses equivalent to up to 4 times ella were administered to a limited number of subjects without any adverse reactions. ...

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], ...

12.1. Mechanism of Action

When taken immediately before ovulation is to occur, ella postpones follicular rupture. The likely primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition ...

12.2. Pharmacodynamics

Ulipristal acetate is a selective progesterone receptor modulator with antagonistic and partial agonistic effects (a progesterone agonist/antagonist) at the progesterone receptor. It binds the human progesterone ...

12.3. Pharmacokinetics

Absorption Following a single dose administration of ella in 20 women under fasting conditions, maximum plasma concentrations of ulipristal acetate and the active metabolite, monodemethyl-ulipristal acetate, ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity Carcinogenicity potential was evaluated in rats and mice. Sprague Dawley rats were exposed to ulipristal acetate daily for 99-100 weeks at doses of 1, 3, or 10 mg/kg/day, representing exposures ...

14. Clinical Studies

Two multicenter clinical studies evaluated the efficacy and safety of ella. An open-label study provided the primary data to support the efficacy and safety of ulipristal acetate for emergency contraception ...

16.1. How Supplied

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 ...

16.2. Storage and Handling

Store at 20-25°C (68-77°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.

17. Patient Counseling Information

[See FDA- Approved Patient Labeling] Information for Patients: Instruct patients to take ella as soon as possible and not more than 120 hours after unprotected intercourse or a known or ...