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FAQs

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What is Phexxi (lactic acid, citric acid, and potassium bitartrate) vaginal gel?

Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. Phexxi is not effective for the prevention of pregnancy when administered after intercourse.

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How is Phexxi dosed?

One pre-filled applicator of Phexxi should be administered immediately before or up to 1 hour before each act of vaginal intercourse. If more than 1 act of vaginal intercourse occurs within 1 hour, an additional dose must be applied.1

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How was the clinical trial for Phexxi designed?

The AMPOWER Clinical Trial was a Phase 3, single-arm, open-label trial for women who were at risk of pregnancy, to demonstrate the safety and effectiveness of Phexxi over 7 cycles. Subjects were required to complete a daily eDiary to record coital information, study drug-use information, use of concomitant medications, including other vaginal products and other contraceptives, menses, and sign and symptom data for the subject or as reported to her by her partner.2

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Can patients use this with other forms of birth control?

Yes, Phexxi may be used with other contraceptives, including latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms. Avoid Phexxi use with vaginal rings.1

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How soon can HCPs prescribe Phexxi?

Phexxi was approved by the FDA on 05/22/2020 and and will be available for prescription in September.

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Are there any contraindications for Phexxi?

No, there are no contraindications for Phexxi. However, Phexxi should be avoided in women who have had recurrent urinary tract infections or abnormalities, or are using a vaginal ring. Phexxi should also be avoided if the woman or her partner is allergic to any of the ingredients in Phexxi.

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What does "beyond hormones" mean?

Your patients may be characterized as beyond hormones if they:

  • Cannot use hormonal contraception due to comorbidities or other risk factors
  • Have concerns about exposure to hormonal contraception
  • Are embracing a natural lifestyle across all aspects of their lives
  • Have had side effects from hormonal birth control
  • Have given up on available birth control methods
  • Are currently using hormonal birth control, but don’t find it to be the best option for their bodies and lives
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What are the warnings and precautions for Phexxi?

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 history of recurrent urinary tract infection or urinary tract abnormalities.

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What are the most common adverse reactions associated with Phexxi?

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.1

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Will there be patient counseling resources for Phexxi?

Yes, the Phexxi Patient Brochure, Instructions for Use flashcard, the Phexxi Concierge Experience, Phexxi Patient Information, and Phexxi.com are all resources you can use with your patients.

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Will Phexxi be covered?

Phexxi has preferred access on most insurance plans. Additionally, patient co-pay support is also available for your eligible patients who need it.

If you have additional questions related to medical information, please reach out to Evofem Medical Information at medicalinformation@evofem.com.

 

*Includes preferred terms (PT) vulvovaginal mycotic infection and vulvovaginal candidiasis.

Includes PTs urinary tract infection, streptococcal urinary tract infection, Escherichia urinary tract infection, and urinary tract infection bacterial.

Does not include PTs cystitis, kidney infection, and pyelonephritis.

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 history of recurrent urinary tract infection or urinary tract abnormalities.

ADVERSE REACTIONS

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.

Patients should be counseled on the following:

  • To contact and consult with their healthcare provider for severe or prolonged genital irritation or 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 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 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.

REFERENCES:

  1. Phexxi [Prescribing Information]. Evofem Biosciences, Inc.: San Diego, CA; May 2020.
  2. Thomas MA, Chappell BT, Maximos B, Culwell KR, Dart C, Howard B. A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial. Contraception: X. 2020;2:1-6.
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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 history of recurrent urinary tract infection or urinary tract abnormalities.