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CLINICALLY PROVEN CONTRACEPTIVE PROTECTION

Phexxi met the FDA-prescribed primary endpoint for pregnancy prevention over 7 cycles of usea

  • Over 32,000 acts of intercourse reported during the study1

The 7-cycle cumulative pregnancy rate (primary efficacy outcome) was 13.7% (95% CI: 10.0%, 17.5%),2 which corresponds toa:

A secondary efficacy analysis, the 7-cycle cumulative pregnancy rate for perfect use, resulted in a pregnancy rate of 6.7% (95% CI: 4.61%, 8.73%),3 which corresponds toa:

aThe effectiveness rates described above should not be compared to other contraceptive methods with different trial designs and study duration beyond 7 cycles.

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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

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.

ADVERSE REACTIONS

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.

Patients should be counseled on the following:

  • To contact and consult with their healthcare provider for severe or prolonged genital irritation or experiencing urinary tract symptoms.
  • To discontinue Phexxi if they develop a local hypersensitivity reaction.
  • That Phexxi does not protect against HIV infection or other sexually transmitted infections.

To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free phone 1-833-EVFMBIO or you may contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS AND USAGE

Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

LIMITATIONS OF USE

Phexxi is not effective for the prevention of pregnancy when administered after intercourse.

Please see full Prescribing Information for Phexxi.

REFERENCES:

  1. Thomas MA, Chappell BT, Maximos B, Culwell KR, Dart C, Howard B. A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial. Contraception: X. 2020;2:1-6.
  2. Phexxi [Prescribing Information]. Evofem Biosciences, Inc.: San Diego, CA; May 2020.
  3. Chappell BT, Culwell K, Dart C, Howard B. Perfect-use pregnancy rates with the vaginal pH regulator: efficacy results from AMPOWER [30I]. Obstet Gynecol. 2020;135:99S.
  4. Reproductive health: contraception. Centers for Disease Control and Prevention. Updated April 22, 2020. Accessed July 28, 2020. https://www.cdc.gov/reproductivehealth/contraception/index.htm.
  5. Mansour D. International survey to assess women’s attitudes regarding choice of daily versus nondaily female hormonal contraception. Int J Womens Health. 2014;6:367-375.
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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

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.