Phexxi

— THERAPEUTIC CATEGORIES —
  • Contraception
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Phexxi Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Lactic acid 1.8%, citric acid 1%, potassium bitartrate 0.4%; per 5g vaginal gel.

    Pharmacological Class

    Vaginal pH regulator.

    How Supplied

    Prefilled single-dose vaginal applicators—12

    How Supplied

    Phexxi vaginal gel is an off-white to tan color gel of uniform consistency containing lactic acid (1.8%), citric acid (1%), and potassium bitartrate (0.4%), supplied as individually wrapped 5 gram prefilled single-dose vaginal applicators in sealed foil pouches along with a plunger, and are available as follows:

    • Box of 12 units

    Storage

    Store in the original foil pack at room temperature 20° C to 25° C (68° F to 77° F); excursion permitted between 15° C to 30° C (59° F to 86° F).

    Manufacturer

    Evofem Biosciences, Inc.

    Generic Availability

    NO

    Mechanism of Action

    In vitro studies showed that a pH lowering effect and sperm motility reduction contribute to the activity of Phexxi in the vagina.

    Phexxi Indications

    Indications

    On-demand method of contraception.

    Limitations of Use

    Not effective for preventing pregnancy when administered after intercourse.

    Phexxi Dosage and Administration

    Adult

    Insert 1 applicatorful vaginally immediately before or up to 1hr before each act of intercourse. Must apply additional dose if more than 1 act of intercourse occurs within 1hr. 

    Children

    Premenarche: not indicated.

    Administration

    Timing of Phexxi Use

    • May use Phexxi during any part of the menstrual cycle.
    • May use Phexxi as soon as it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage.

    Use of Phexxi with Other Contraceptive Methods

    • Phexxi may be used concomitantly with hormonal contraceptives; latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms.
    • Avoid Phexxi use with vaginal rings.

    Use of Phexxi with Other Vaginal Products

    • Phexxi may be used concomitantly with other products for vaginal infections including miconazole, metronidazole, and tioconazole.

    Phexxi Contraindications

    Not Applicable

    Phexxi Boxed Warnings

    Not Applicable

    Phexxi Warnings/Precautions

    Warnings/Precautions

    History of recurrent urinary tract infection or urinary tract abnormalities: avoid use. Pregnancy.

    Warnings/Precautions

    Cystitis and Pyelonephritis

    • Among 2804 patients who received Phexxi in Studies 1 and 2, 0.36% (n=10) reported adverse reactions of cystitis, pyelonephritis, or other upper urinary tract infection. Of these, one case of pyelonephritis was considered serious and required hospitalization. 
    • Avoid Phexxi use in females of reproductive potential with a history of recurrent urinary tract infection or urinary tract abnormalities.

    Pregnancy Considerations

    There is no use for Phexxi in pregnancy; therefore, discontinue during pregnancy. There are no data with the use of Phexxi in pregnant women or animals.

    Nursing Mother Considerations

    There are no data on the presence of lactic acid, citric acid, and potassium bitartrate or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

    Pediatric Considerations

    The safety and effectiveness of Phexxi have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older. The use of Phexxi before menarche is not indicated.

    Phexxi Pharmacokinetics

    See Literature

    Phexxi Interactions

    Interactions

    Avoid contraceptive vaginal rings.

    Phexxi Adverse Reactions

    Adverse Reactions

    Vulvovaginal effects (burning sensation, pruritus, mycotic infection, discomfort, pain), urinary tract infection, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria; cystitis, pyelonephritis, hypersensitivity reaction.

    Phexxi Clinical Trials

    Clinical Trials

    The efficacy of Phexxi for the prevention of pregnancy was evaluated in a multi-center, open-label, single-arm clinical trial in the US (AMP002; NCT03243305). The study enrolled females 18–35 years of age with regular menstrual cycles (21–35 days). The median age was 27.8 years. 

    • Patients agreed to engage in at least 3 acts of heterosexual, vaginal intercourse per cycle. 
    • Patients self-administered a 5 gram dose of Phexxi intravaginally up to one hour before each episode of intercourse for up to 7 cycles.
    • The primary efficacy endpoint was the 7-cycle typical use cumulative pregnancy rate as derived by Kaplan-Meier life-table analysis. 
    • A total of 101 on-treatment pregnancies occurred in 1183 patients contributing 4769 evaluable natural cycles. 
    • The 7-cycle cumulative pregnancy rate was 13.7% (95% CI, 10.0%-17.5%), excluding cycles with back-up contraception, cycles <21 days or >35 days in length and cycles in which no intercourse was reported. 
    • The estimated Pearl Index, calculated based on data from the 7-cycle study, was 27.5 (95% CI, 22.4%-33.5%).

    Phexxi Note

    Not Applicable

    Phexxi Patient Counseling

    Patient Counseling

    Advise patients:

    • To intravaginally administer the contents of one prefilled single-dose applicator of Phexxi before each episode of vaginal intercourse and to administer an additional dose if intercourse does not occur within one hour of administration.
    • To consult their healthcare provider for severe or prolonged genital irritation.
    • To discontinue Phexxi if they develop a local hypersensitivity reaction.
    • To contact their healthcare provider if experiencing urinary tract symptoms.
    • That Phexxi does not protect against HIV infection and other sexually transmitted infections.

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