Phexxi® (lactic acid, citric acid, and potassium bitartrate)

Vaginal Gel 1.8%, 1%, 0.4% by Evofem Biosciences.



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Indications & Usage

    INDICATIONS AND USAGE

    Phexxi is a combination of lactic acid, citric acid, and potassium bitartrate 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.

    This information does not include all that is needed to use Phexxi® safely and effectively. See full prescribing information for Phexxi for more information.


    Please see full Prescribing Information for Phexxi®.

 

Dosage & Administration

DOSAGE AND ADMINISTRATION

·    Administer one (1) pre-filled single-dose applicator of Phexxi (5 grams) vaginally immediately before (or up to one hour before) each      episode of vaginal intercourse

·    May use during any part of the menstrual cycle

 

This information does not include all that is needed to use Phexxi® safely and effectively. See full prescribing information for Phexxi for more information.


Please see full Prescribing Information for Phexxi®.

Warnings & Precautions


WARNINGS AND PRECAUTIONS


  ·   Cystitis and Pyelonephritis: Avoid use in women with a history of recurrent UTI or urinary tract abnormalities

 

This information does not include all that is needed to use Phexxi® safely and effectively. See full prescribing information for Phexxi for more information.


Please see full Prescribing Information for Phexxi®.

Adverse Reactions

ADVERSE REACTIONS

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. 

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. 

This information does not include all that is needed to use Phexxi® safely and effectively. See full prescribing information for Phexxi for more information.


Please see full Prescribing Information for Phexxi®.



Phexxi is a registered trademark of Evofem Biosciences, Inc.  Other trademarks are the property of their respective owner(s).

© 2021 Evofem Biosciences, Inc.   EVFM-US-001658




Please see full Prescribing Information for Phexxi®.

Please scroll below for Important Safety Information

 


IMPORTANT SAFETY INFORMATION

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.

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.

ADVERSE REACTIONS

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®.