ANNOVERA Vaginal system (Ring) (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

TherapeuticsMD, Inc.

Λέξεις κλειδιά

50261-313

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increas es the risk of s erious cardiovas cular events from combination hormonal contraceptive (CHC) us e. This ...

1. Indications and Usage

ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use ANNOVERA has not been adequately studied in females with a BMI >29 kg/m2.

2. Dosage and Administration

2.1 How to Use ANNOVERA Instruct patients that ANNOVERA should be used as directed [see How to Start ANNOVERA (2.2)]. One ANNOVERA should be placed in the vagina. For maximum contraceptive effectiveness, ...

3. Dosage Forms and Strengths

Vaginal system: Each ANNOVERA releases an approximate average 0.15 mg/day of segesterone acetate (SA) and 0.013 mg/day of ethinyl estradiol (EE) when placed in the vagina over a period of 21 days of each ...

4. Contraindications

ANNOVERA is contraindicated in females who are known to have the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include females who are known to:Smoke, if over age ...

5. Warnings and Precautions

5.1 Thromboembolic Disorders and Other Vascular Conditions Females are at increased risk for a venous thrombotic event (VTE) when using ANNOVERA. Limited data are available in females with a BMI >29.0 ...

6. Adverse Reactions

The following adverse reactions are described elsewhere in other sections of the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)] Vascular ...

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 the rates in the clinical trials of ...

7. Drug Interactions

The sections below provide information on substances for which data on drug interactions with CHCs are available. There is little information available about the clinical effect of most drug interactions ...

8. Use in Specific Populations

8.8 Body Mass Index (BMI) / Body Weight The safety and efficacy of ANNOVERA in females with a BMI >29 kg/m2 have not been adequately evaluated because this subpopulation was excluded from the ...

8.1. Pregnancy

Risk Summary Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure ...

8.2. Lactation

Risk Summary Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur ...

8.4. Pediatric Use

Safety and efficacy of ANNOVERA have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. ...

8.5. Geriatric Use

ANNOVERA has not been studied in females who have reached menopause and is not indicated in this population.

8.6. Hepatic Impairment

No studies have been conducted to evaluate the effect of hepatic impairment on the disposition of ANNOVERA. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute ...

8.7. Renal Impairment

No studies were conducted in subjects with renal impairment; ANNOVERA is not recommended in patients with renal impairment.

10. Overdosage

There have been no reports of serious ill effects from overdose of CHCs. Overdosage may cause withdrawal bleeding in females and nausea. In case of suspected overdose, all ANNOVERA vaginal systems should ...

11. Description

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) is a toroidal-shaped (ring), nonbiodegradable, flexible, opaque white vaginal system containing two active components, a progestin, segesterone ...

12.1. Mechanism of Action

CHCs lower the risk of becoming pregnant primarily by suppressing ovulation.

12.2. Pharmacodynamics

Cardiac Electrophysiology The effect of SA on the QTc interval was evaluated in a Phase 1 randomized, placebo and positive controlled, double-blind, single-dose, three-period, crossover thorough QTc study ...

12.3. Pharmacokinetics

Absorption The pharmacokinetics (PK) of ANNOVERA were determined in 39 women who used ANNOVERA for up to 13 cycles. Following vaginal administration, SA and EE were absorbed into systemic circulation with ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In a 2-year carcinogenicity study in rats with subdermal implants releasing 40, 100, and 200 mcg segesterone acetate per day (approximately 17-86 times the daily dose of segesterone acetate ...

14. Clinical Studies

The efficacy of ANNOVERA was evaluated in two 1-year multicenter trials enrolling 2,265 females, age 18-40 years, who were healthy and sexually active with regular menstrual cycles. The trials were conducted ...

15. References

1. Dinger, J et. al., Cardiovascular risk associated with the use of an etonogestrel-containing vaginal ring. Obstetrics & Gynecology 2013; 122(4): 800-808. 2. Sidney, S. et. al., Recent combined hormonal ...

16.1. How Supplied

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) is a toroidal-shaped (ring), nonbiodegradable, flexible, opaque white vaginal system. The vaginal system body has an overall diameter ...

16.2. Storage and Handling

Prior to dispensing ANNOVERA to the user, store ANNOVERA at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect ANNOVERA from ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Cigarette Smoking Cigarette smoking increases the risk of serious cardiovascular events from ...