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Ulipristal

Ella

30MG tabletVereinigte StaatenIm HandelZugelassen am 13. Aug. 2010

Inhalt auf Englisch

Anwendungsgebiete

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) ] . E lla 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 )

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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 )

Warnhinweise und Vorsichtsmaßnahmen

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 )

5.1Existing Pregnancy

Ella is not indicated for termination of an existing pregnancy.

5.2Ectopic Pregnancy

A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking ella . A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking ella .

Zwei Arzneimittel in einer Frage?

Nenn zwei oder mehr Arzneimittel und Osler führt einen Wechselwirkungscheck durch. Eine schwere Wechselwirkung steht ganz oben in der Antwort.

Osler entdecken

Ulipristal

Ella

30MG tabletVereinigte StaatenIm HandelZugelassen am 13. Aug. 2010

Inhalt auf Englisch

Im Register öffnenFrag Osler dazu

Anwendungsgebiete

Ella is not intended for routine use as a contraceptive. ( 1 )

Gegenanzeigen

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 )

Warnhinweise und Vorsichtsmaßnahmen

( 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 )

5.1Existing Pregnancy

Ella is not indicated for termination of an existing pregnancy.

5.2Ectopic Pregnancy

Zwei Arzneimittel in einer Frage?

Nenn zwei oder mehr Arzneimittel und Osler führt einen Wechselwirkungscheck durch. Eine schwere Wechselwirkung steht ganz oben in der Antwort.

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Wechselwirkungen

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 )

7.1Changes 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) ] . Avoid co-administration of ella and drugs or herbal products such as: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John's Wort topiramate Hormonal contraceptives Progestin-containing contraceptives may impair the ability of ella to delay ovulation.

After using ella , if a woman wishes to initiate or resume hormonal contraception, she can do so, no sooner than 5 days after the intake of ella and she should use a reliable barrier method until the next menstrual period. If a woman used ella due to a known or suspected failure of her hormonal contraception refer to the hormonal contraceptive’s prescribing information for instructions on what to do [see Dosage and Administration (2.2) , Warnings and Precautions (5.5) and Clinical Pharmacology (12.2) ] .

7.2Increase in Plasma Concentrations

of ella Associated with Co-Administered Drugs CYP3A4 inhibitors such as itraconazole or ketoconazole increase plasma concentrations of ella [see Pharmacokinetics (12.3) ] .

7.3Effects

of ella on Co-Administered Drugs Hormonal contraceptives: ella may impact the effect of the progestin component of hormonal contraceptives. Therefore, if a woman wishes to use hormonal contraception after using ella , she should use a reliable barrier method for subsequent acts of intercourse until her next menstrual period [see Dosage and Administration (2.2) , Warnings and Precautions (5.5) and Clinical Pharmacology (12.2) ] .

Schwangerschaft und Stillzeit

8.1Pregnancy 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 miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. In animal reproduction studies, no malformations were observed during repeated administration of ulipristal acetate to pregnant rats, rabbits and monkeys at daily drug exposures ⅓, ½, and 3 times respectively, the human exposure at a dose of 30 mg [ see Data ] .

Data Human Data Ella pregnancy exposure data was collected in the U.S. and Europe from 1999 to 2015 and analyzed post-marketing using data from interventional clinical trials, observational studies and pharmacovigilance reports. Known pregnancy outcomes were available for 462/784 pregnancies in which women received ella at doses of 30 mg or greater during the conception cycle or during pregnancy. Data of pregnancies with known outcome were analyzed prospectively for 272 cases and retrospectively for 190 cases.

Pregnancy outcomes included 302 elective abortions (2 for fetal anomalies including 1 with trisomy 21), 63 spontaneous abortions, and 13 ectopic pregnancies. No maternal or fetal deaths were reported. 84 pregnancies continued until birth, with congenital anomalies reported in 5 infants, including 4 major malformations (2/4 with genetic syndromes). Although these data do not allow estimation of the prevalence rate of congenital anomalies associated with inadvertent use of ella in pregnancy or determination of a causal relationship between reported anomalies and ella , they show that ella -exposed pregnancies were not associated with a pattern of increased risk of adverse outcomes.

Animal Data Ulipristal acetate was administered repeatedly to pregnant rats and rabbits during the period of organogenesis. Embryofetal loss was noted in all pregnant rats and in half of the pregnant rabbits following 12 and 13 days of dosing, at daily drug exposures 1/3 and 1/2 the human exposure, respectively, based on body surface area (mg/m 2 ). There were no malformations of the surviving fetuses in these studies.

Adverse effects were not observed in the offspring of pregnant rats administered ulipristal acetate during the period of organogenesis through lactation at drug exposures 1/24 the human exposure based on AUC. Administration of ulipristal acetate to pregnant monkeys for 4 days during the first trimester caused pregnancy termination in 2/5 animals at daily drug exposures 3 times the human exposure based on body surface area.

Nebenwirkungen

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.

6.1Clinical 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. Ella was studied in an open-label multicenter trial (Open-Label Study) and in a comparative, randomized, single-blind, multicenter trial (Single-Blind Comparative Study).

In these studies, a total of 2,637 (1,533 + 1,104) women in the 30 mg ulipristal acetate groups were included in the safety analysis. The mean age of women who received ulipristal acetate was 24.5 years and the mean body mass index (BMI) was 25.3. The racial demographics of those enrolled were 67% Caucasian, 20% Black or African American, 2% Asian, and 12% other. The most common adverse reactions (≥ 10%) in the clinical trials for women receiving ella were headache (18% overall), nausea (12% overall) and abdominal and upper abdominal pain (12% overall).

Table 1 lists those adverse reactions that were reported in ≥ 5% of subjects in the clinical studies ( 14 ). Table 1: Adverse Reactions in ≥ 5% of Women (%) Receiving a Single Dose of ella (30 mg Ulipristal Acetate) Most Common Adverse Reactions Open-Label Study Single-Blind Comparative Study N = 1,533 N = 1,104 Headache 18 19 Nausea 12 13 Abdominal and upper abdominal pain 15 8 Dysmenorrhea 7 13 Fatigue 6 6 Dizziness 5 5

6.2Postmarketing 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 reactions have been identified during post-approval use of ella : Skin and Subcutaneous Tissue Disorders: Acne Hypersensitivity reactions, including rash, urticaria, pruritis, and angioedema Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Ella

Anwendungsgebiete

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

5.1Existing Pregnancy

5.2Ectopic Pregnancy

Zwei Arzneimittel in einer Frage?

Ella

Anwendungsgebiete

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

5.1Existing Pregnancy

5.2Ectopic Pregnancy

Zwei Arzneimittel in einer Frage?

5.3Repeated Use

5.5Fertility Following Use

5.6Effect on Menstrual Cycle

5.7Sexually Transmitted Infections/HIV

Wechselwirkungen

7.1Changes in Emergency Contraceptive Effectiveness Associated with Co-Administration of Other Products

7.2Increase in Plasma Concentrations

7.3Effects

Schwangerschaft und Stillzeit

8.1Pregnancy Risk Summary

Nebenwirkungen

6.1Clinical Trials Experience

6.2Postmarketing Experience Adolescents:

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