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SAFETY PROFILEa

The most common adverse reactions in clinical studies (≥10%) were1:

  • Vulvovaginal burning sensation (18.0%)
  • Vulvovaginal pruritus (14.5%)

The majority of adverse reactions were mild and few led to discontinuation1

  • 1.6% of patients discontinued due to adverse reactions
  • Two subjects discontinued due to male partner symptoms. 9.8% of male partners reported local discomfortb

Warnings and precautions1

  • There were few cases (0.36%) of cystitis, pyelonephritis, and other upper urinary tract infections. Of these, one case of pyelonephritis was considered serious and required hospitalization

Phexxi...

  • Should be avoided in women who have had recurrent urinary tract infections or abnormalities1
  • Should be avoided if the woman or her partner is allergic to any of the ingredients in Phexxi1
  • May be used with other contraceptives, including latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms. Avoid Phexxi use with vaginal rings1
  • Is not expected to lead to safety concerns from systemic exposure to ingredients following vaginal exposurec

aThe safety of Phexxi has been evaluated in 2 clinical trials in 2804 subjects.

bIn the AMPOWER study.

cPharmacokinetic studies have not been performed.

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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.

REFERENCE:

  1. Phexxi [Prescribing Information]. Evofem Biosciences, Inc.: San Diego, CA; May 2020.
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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.