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 with history of recurrent urinary
tract infection or urinary tract abnormalities.
Most common adverse reactions were vulvovaginal burning sensation, pruritus, mycotic
infection, genital discomfort (including male partners); urinary tract infection, bacterial vaginosis, vaginal
discharge, and dysuria. Patients should consult their healthcare provider for severe or prolonged genital
irritation or urinary tract symptoms.
Advise the patient:
- To discontinue Phexxi if they develop a local hypersensitivity reaction.
- That Phexxi does not protect against HIV infection or other sexually transmitted infections.
- 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.
Please see full Prescribing Information for Phexxi.
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