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The Efficacy and Safety of PhexxiThe Efficacy and Safety of Phexxi

Efficacy & Safety

Jump to Safety

Phexxi® is proven to prevent pregnancy without the use of hormones

Results of AMPOWER—a Phase 3, multicenter, single-arm, open-label clinical triala (N=1384)

PRIMARY ENDPOINT
86%
EFFICACY RATE
OVER 7 CYCLES1
Kaplan-Meier/time-to-event efficacy analysis over 7 cycles with typical use. 7-cycle cumulative pregnancy risk of 13.7%
SECONDARY ANALYSIS
93%
EFFICACY RATE
OVER 7 CYCLES2
Kaplan-Meier/time-to-event efficacy analysis over 7 cycles when used as directed. 7-cycle cumulative pregnancy risk of 6.7%
POST HOC ANALYSIS
99%
PREGNANCIES PREVENTED
PER ACT OF INTERCOURSE1,3
Based on 101 pregnancies (n=1182) over 24,289 acts of intercourse with typical use. Per-act-of-intercourse pregnancy risk of 0.415%
Post hoc analysis was not statistically tested in the clinical trial. Data are not in the USPI and should be interpreted with caution.

aThe effectiveness rates described above should not be compared to other contraceptive methods with different trial designs and study duration beyond 7 cycles.

Phexxi is a non-hormonal, bioadhesive gel that works by maintaining an acidic vaginal pH and decreasing sperm motility. In clinical studies, Phexxi was proven effective and safe.

Watch this video to see instructions for the correct use of Phexxi. You can also share this video with your patients so they understand how to use Phexxi.

Read about the AMPOWER Clinical Trial, a Phase 3, single-arm, open-label trial that demonstrated the safety and effectiveness of Phexxi.

Phexxi offers a non-hormonal side effect profile4

Phexxi is non-systemic, and systemic exposure is not expected to lead to safety concerns.4

The majority of adverse reactions in clinical trials (≥10%) were mild, and few led to discontinuation:

  • Vulvovaginal burning sensation (18.0%)
  • Vulvovaginal pruritus (14.5%)
  • Only 1.6% discontinued due to adverse reactions
  • Two subjects discontinued due to male partner symptoms, and less than 10% of male partners reported local discomfort

Phexxi can meet the personal needs of women

Baby icon

Breastfeeding4

Phexxi has not been studied in breastfeeding women; however, Phexxi works locally and may be an appropriate choice for breastfeeding women.

Bed with heart above it icon

Oral Sex3

In clinical studies, couples were allowed to engage in oral sex, and no side effects directly related to oral sex were reported.

Condom icon

Concomitant Use4

Phexxi may be used with latex, polyurethane, and polyisoprene condoms, as well as vaginal diaphragms. Avoid Phexxi use with vaginal rings.

The box may be black, but Phexxi does not have a black box warning. The ingredients are nontoxic, making Phexxi a suitable option for women who are contraindicated for hormonal contraception.

Phexxi non-hormonal birth control box of 12 gel applicators
How does Phexxi work?

How does Phexxi work?

 

The unique MOA of Phexxi maintains an acidic vaginal pH to reduce sperm motility.

Dosing and prescribing Phexxi.

Dosing and prescribing Phexxi.

 

What does 1 dose/1 act mean?

It’s time to get personal.

It’s time to get personal.

 

Who is right for Phexxi?
Women who are simply seeking pregnancy prevention.

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.

INDICATION

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.

References:

  1. 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. Contracept X. 2020;2:100031.
  2. Chappell BT, Culwell K, Dart C, Howard B. Perfect-use pregnancy rates with the vaginal pH regulator: efficacy results from AMPOWER [30I]. Obstet Gynecol. 2020;135:99S.
  3. Data on file. Evofem Biosciences, Inc.
  4. Phexxi® [Prescribing Information]. Evofem Biosciences, Inc.: San Diego, CA; April 2021.

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.

INDICATION

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.

References:

  1. 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. Contracept X. 2020;2:100031.
  2. Chappell BT, Culwell K, Dart C, Howard B. Perfect-use pregnancy rates with the vaginal pH regulator: efficacy results from AMPOWER [30I]. Obstet Gynecol. 2020;135:99S.
  3. Data on file. Evofem Biosciences, Inc.
  4. Phexxi® [Prescribing Information]. Evofem Biosciences, Inc.: San Diego, CA; April 2021.