^ Pharmacodynamics
Pharmacodynamic studies in humans have not been performed.
^ Patient Counseling Information
Advise the patient to read the Patient Information and FDA-approved patient labeling (Instructions for Use). Advise the patient:
^ Description
PHEXXI (lactic acid, citric acid, and potassium bitartrate) is a vaginal gel.
PHEXXI is an off-white to tan in color gel of uniform consistency, containing three active ingredients: lactic acid, citric acid, and potassium bitartrate.
The structural formula for lactic acid is:
Lactic acid is designated chemically as 2-hydroxypropanoic acid with an empirical formula of C3H6O3 and a molecular weight of 90.08 g/mol.
The structural formula for citric acid is:
Citric acid is designated chemically as 2-hydroxypropane-1,2,3-tricarboxylic acid with an empirical formula of C6H8O7 and a molecular weight of 192.124 g/mol.
The structural formula for potassium bitartrate is:
Potassium bitartrate is designated chemically as potassium; (2R, 3R)-2,3,4-trihydroxy-4-oxobutanoate with an empirical formula of KC4H5O6 and a molecular weight of 188.177 g/mol.
Each 5 gram dose is provided in a pre-filled single-dose applicator containing lactic acid USP (1.8% w/w), citric acid USP (1% w/w), and potassium bitartrate USP (0.4% w/w). Inactive ingredients present in the gel are: glycerin, alginic acid, xanthan gum, sodium hydroxide, benzoic acid, and purified water.
^ Cystitis And Pyelonephritis
Among 2804 subjects who received PHEXXI 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 PHEXXI in females of reproductive potential with a history of recurrent urinary tract infection or urinary tract abnormalities.
^ 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 PHEXXI (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 PHEXXI for 13 cycles.
^ Clinical Studies
The efficacy of PHEXXI for the prevention of pregnancy was evaluated in a multi-center, open-label, single-arm clinical trial in the United States (AMP002; NCT03243305). The study enrolled females of reproductive potential 18 to 35 years of age with regular menstrual cycles (21 to 35 days). The median age was 27.8 years. The racial distribution was 70.6% White, 23.7% Black or African American, 2.5% Asian, 0.4% American Indian or Alaska Native, 0.2% Native Hawaiian or Pacific Islander, and 2.7% other. Subjects agreed to engage in at least 3 acts of heterosexual, vaginal intercourse per cycle. Subjects 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 subjects 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%).
^Principal Display Panel - Applicator Box
phexxi™
(lactic acid, citric acid, andpotassium bitartrate) Vaginal Gel1.8%, 1%, 0.4%
NDC 69751-100-12PN-5011
2
^6 Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling:
^ 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.
^3 Dosage Forms And Strengths
Vaginal gel: 18 mg of lactic acid, 10 mg of citric acid, and 4 mg of potassium bitartrate in each gram (1.8%, 1%, and 0.4%, respectively) of off-white to tan color gel supplied in a pre-filled single-dose (5 grams) vaginal applicator
^ Pharmacokinetics
Pharmacokinetic studies in humans have not been performed. Systemic exposures of lactic acid, citric acid, and potassium bitartrate following vaginal administration of PHEXXI are not expected to lead to safety concerns.
In vitro studies with commonly used vaginal preparations (miconazole, metronidazole, tioconazole, and a product for maintaining normal vaginal pH) showed no significant effect on the pH or buffering capacity of PHEXXI.
^ Pediatric Use
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.
^1 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.
^ Use Of Phexxi With Other Vaginal Products
PHEXXI may be used concomitantly with other products for vaginal infections including miconazole, metronidazole, and tioconazole.
^ Recommended Dosage
Administer one pre-filled applicator of PHEXXI (5 grams) vaginally immediately before or up to one hour before each act of vaginal intercourse. If more than one act of vaginal intercourse occurs within one hour, an additional dose must be applied. Five grams of PHEXXI contains 90 mg of lactic acid, 50 mg of citric acid, and 20 mg of potassium bitartrate.
^ Mechanism Of Action
In in vitro studies, Phexxi produced a normal vaginal pH range (pH 3.5 – 4.5) in the presence of semen. In clinical studies, post-coital testing demonstrated pH < 5 in the majority of subjects, and sperm motility reduction.
^ How Supplied/storage And Handling
PHEXXI (lactic acid, citric acid, and potassium bitartrate) 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 pre-filled single-dose vaginal applicators in sealed foil pouches along with a plunger, and are available as follows:
^Instructions For Use
PHEXXI® (FEX ee) (lactic acid, citric acid, and potassium bitartrate) vaginal gel
For Vaginal Use Only
These Instructions for Use contain information on how to use PHEXXI vaginal gel. Make sure that you read, understand, and follow the Instructions for Use before using PHEXXI and each time you get a refill. There may be new information.
Contents:
Important Information You Need to Know Before Using PHEXXI
Prepare to Use PHEXXI
Keep the pre-filled applicator and plunger rod in the foil pouch until you are ready to use PHEXXI.
Step 1: Wash Your Hands
Step 2: Remove the Pre-filled Applicator and Plunger Rod from the Foil Pouch
Important: Do not remove the pink cap until instructed in Step 4.
Insert PHEXXI Gel
Step 3: Insert the Plunger Rod
Step 4: Remove the Pink Cap
Step 5: Insert the PHEXXI Pre-filled Applicator into the Vagina
Step 6: Insert PHEXXI Gel
Step 7: Remove the Used PHEXXI Pre-filled Applicator
Disposing of PHEXXI
Step 8: Throw Away (Dispose of) the Used PHEXXI Pre-filled Applicator
Storing PHEXXI
Keep PHEXXI and all medicines out of the reach of children.
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
For more information, including full prescribing information and information on patient safety, go to www.phexxi.com or call 1-833-EVFMBIO.
Manufactured for Evofem, Inc., a wholly owned subsidiary of Evofem Biosciences, Inc. ©2023 Evofem, Inc. All rights reserved.
Issued: June 2023