Phexxi™ is indicated for the prevention of pregnancy in females of reproductive potential for use as an
One pre-filled applicator of Phexxi™ should be administered immediately before or up to 1 hour before each act of vaginal intercourse. If more than 1 act of vaginal intercourse occurs within 1 hour, an additional dose must be applied.1
The AMPOWER Clinical Trial was a Phase 3, single-arm, open-label trial for women who were at risk of pregnancy, to demonstrate the safety and effectiveness of Phexxi™ over 7 cycles. Subjects were required to complete a daily eDiary to record coital information, study drug-use information, use of concomitant medications, including other vaginal products and other contraceptives, menses, and sign and symptom data for the subject or as reported to her by her partner.2
Yes, Phexxi™ may be used with other contraceptives, including latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms. Avoid Phexxi™ use with vaginal rings.1
Phexxi™ was approved by the FDA on 05/22/2020 and and will be available for prescription in September.
No, there are no contraindications for Phexxi™. However, Phexxi™ should be avoided in women who have had recurrent urinary tract infections or abnormalities, or are using a vaginal ring. Phexxi™ should also be avoided if the woman or her partner is allergic to any of the ingredients in Phexxi™.
Your patients may be characterized as beyond hormones if they:
- Cannot use hormonal contraception due to comorbidities or other risk factors
- Have concerns about exposure to hormonal contraception
- Are embracing a natural lifestyle across all aspects of their lives
- Have had side effects from hormonal birth control
- Have given up on available birth control methods
- Are currently using hormonal birth control, but don’t find it to be the best option for their bodies and lives
Few cases (0.36%) of adverse reactions of cystitis, pyelonephritis and other upper urinary tract infection (UTI) have been reported in Phexxi™ clinical studies. Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of Phexxi™ in females of reproductive potential with history of recurrent urinary tract infection or urinary tract abnormalities.
Most common adverse reactions were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection,* urinary tract infection,†‡ vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain. 9.8% of male partners reported local discomfort.1
Phexxi™ has preferred access on most insurance plans. Additionally, patient co-pay support is also available for your eligible patients who need it.
If you have additional questions related to medical information, please reach out to Evofem Medical Information at email@example.com.
*Includes preferred terms (PT) vulvovaginal mycotic infection and vulvovaginal candidiasis.
†Includes PTs urinary tract infection, streptococcal urinary tract infection, Escherichia urinary tract infection, and urinary tract infection bacterial.
‡Does not include PTs cystitis, kidney infection, and pyelonephritis.