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PROVEN EFFECTIVE IN PREGNANCY PREVENTION

In AMPOWER: a Phase 3 clinical studya

WHEN USED AS DIRECTED

Kaplan-Meier/time-to-event efficacy analysis over 7 cycles of use1

page-efficacy-graph-1

Post-hoc analysis

page-efficacy-graph-1

When used as directed, or per protocol, there were 49 pregnancies (n=1182) over 26,099 acts of intercourse.2

WITH TYPICAL USE

Kaplan-Meier/time-to-event efficacy analysis over 7 cycles of use (primary endpoint)3

page-efficacy-graph-2

Post-hoc analysis

page-efficacy-graph-2

With typical use, there were 101 pregnancies (n=1182) over 24,289 acts of intercourse.2,4

aMulticenter, single-arm, open-label trial (N=1384).

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

cSecondary analysis.

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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 a 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. 9.8% of male partners reported local discomfort.

Patients should be counseled on the following:

  • To contact and consult with their healthcare provider for severe or prolonged genital irritation or if 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 avoid Phexxi use with vaginal rings.

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 (lactic acid, citric acid, and potassium bitartrate) vaginal gel 1.8%, 1%, 0.4% 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.
Expand ISI

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 a history of recurrent urinary tract infection or urinary tract abnormalities.