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 intercourse.