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.
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™.