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Saturday, January 5, 2019

USFDA approved Annovera (segesterone acetate andethinylestradiolvaginal system)

General Information

 Annovera contains two active components, a progestin - segesterone acetate, and an estrogen - ethinyl estradiol. Both components work together to suppress ovulation. Annovera is specifically indicated for use by females of reproductive potential to prevent pregnancy. Annovera is supplied as a vaginal ring for intravaginal administration. One Annovera is inserted in the vagina. The vaginal system must remain in place continuously for 3 weeks (21 days) followed by a 1-week (7-day) vaginal system-free interval. One vaginal system provides contraception for thirteen 28-day cycles (1year). Please see drug label for specific insertion directions.

 Clinical Results
 FDA Approval
 The FDA approval of Annovera was based on two 1-year multicenter trials enrolling 2,265 females, age 18–40 years, who were healthy and sexually active with regular menstrual cycles. Based on pooled data from the two trials, 2,111 females ≤35 years of age completed 17,427 evaluable 28-day cycles (cycles in which no back-up contraception was used).The pooled pregnancy rate, evaluated by the Pearl Index (PI),was 2.98 per 100 woman-years of Annovera use. Return to fertility was assessed in 290 of the subjects in the two trials who either desired pregnancy or switched to a non-hormonal method after the trials, and all 290 subjects reported a return to fertility during the 6-month follow-up period (defined as a return of menses or pregnancy).

 Side Effects
Adverse effects associated with the use of Annovera may include, but are not limited to, the following:
 vulvovaginal mycotic infection/candidiasis 
abdominal pain lower/upper dysmenorrhea vaginal discharge
 urinary tract infection
 breast tenderness/pain/discomfort
 bleeding irregularities including metrorrhagia diarrhea
 genital pruritus
 The Annovera label comes with the following Black Box

Females over 35 years old who smoke should not use Annovera. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use. Mechanism of Action Annovera (segesterone acetateand ethinyl estradiolvaginal system) is a ring-shaped, nonbiodegradable, flexible, opaque white vaginal system containing two active components: a progestin - segesterone acetate, and an estrogen - ethinyl estradiol. When placed in the vagina, each Annovera releases an approximate average 0.15mg/day of segesterone acetate and 0.013mg/day of ethinyl estradiol over the21 days in-use period of each cycle for up to 13 cycles (total of 273 days). Each cycle is 28 days, with 21 days in and 7 days out. The two components work together to suppress ovulation.

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