Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cystitis and Pyelonephritis [ see Warnings and Precautions (5.1) ] Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free phone 1-833-EVFMBIO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of PHEXX (pre-filled applicator with 5-gram dose) has been evaluated in two clinical trials (Study 1 and Study 2) in 2804 subjects (over 19,000 cycles of exposure).
The racial/ethnic distribution was 66% White, 27% Black or African American, 2% Asian, 1% American Indian or Alaska Native, 0.3% Native Hawaiian or Pacific Islander, and 5% other;
32% of the study population was Hispanic.
Study 1 included a one-year extension phase where 342 U.S.
subjects were exposed to PHEXX for 13 cycles.
Hypersensitivity Reaction Of the 2804 PHEXX-treated subjects in Studies 1 and 2, one subject reported a suspected drug hypersensitivity.
Avoid PHEXX use in females of reproductive potential with suspected hypersensitivity to the ingredients in PHEXX.
5 WARNINGS AND PRECAUTIONS Cystitis and Pyelonephritis: Avoid use in women with a history of recurrent UTI or urinary tract abnormalities ( 5.1 ) 5.1 Cystitis and Pyelonephritis Among 2804 subjects who received PHEXX in Studies 1 and 2, 0.36% (n=10) reported adverse reactions of cystitis, pyelonephritis, or other upper urinary tract infection (UTI).
Of these, one case of pyelonephritis was considered serious and required hospitalization.
Avoid use of PHEXX in females of reproductive potential with a history of recurrent urinary tract infection or urinary tract abnormalities.
Like all medications, Phexx can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: