Package insert / prescribing information
Generic name: lactic acid, citric acid, and potassium bitartrate
Drug class: Miscellaneous vaginal agents
Medically reviewed by Drugs.com. Last updated on Feb 1, 2022.
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Indications and Usage for Phexxi Gel
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 [see Dosage and Administration (2.1)].
Phexxi Gel Dosage and Administration
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.
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.
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
Warnings and Precautions
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.
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Cystitis and Pyelonephritis [see Warnings and Precautions (5.1)]
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.
Of the 2804 PHEXXI-treated subjects in Studies 1 and 2, one subject reported a suspected drug hypersensitivity. Avoid PHEXXI use in females of reproductive potential with suspected hypersensitivity to the ingredients in PHEXXI.
The most common adverse reactions (≥10%) in the U.S. population in Studies 1 and 2 (n = 2480) were: vulvovaginal burning sensation (18.0%) and vulvovaginal pruritus (14.5%). The majority of these adverse reactions were mild and few led to discontinuation. Table 1 summarizes the most common adverse reactions (≥2%) reported by subjects using PHEXXI in the U.S.
|Vulvovaginal Burning Sensation||18.0|
|Vulvovaginal Mycotic Infection*||9.1|
|Urinary Tract Infection† ‡||9.0|
Among subjects who used PHEXXI in Studies 1 and 2, 1.6% discontinued from the clinical trials due to an adverse reaction. The most common adverse reactions leading to study discontinuation were vulvovaginal burning sensation (0.7%); and vulvovaginal pruritus and vulvovaginal discomfort (0.1% each).
Adverse Reactions in Male Partners
Among male partners of subjects who used PHEXXI for contraception in Study 2, 9.8% (131 of 1330) reported symptoms of local discomfort (burning, itching, pain, and "other"). Of these local discomfort symptoms, 74.7% were mild, 21.4% were moderate, and 3.9% were severe. Two subjects discontinued participation in the study due to male partner symptoms.
USE IN SPECIFIC POPULATIONS
There is no use for PHEXXI in pregnancy; therefore, discontinue PHEXXI during pregnancy. There are no data with the use of PHEXXI in pregnant women or animals. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
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.
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 Gel 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.
Phexxi Gel - Clinical Pharmacology
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.
Pharmacodynamic studies in humans have not been performed.
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies have not been performed with PHEXXI.
Mutagenic studies have not been performed with PHEXXI.
Impairment of Fertility
Reproductive studies have not been performed with PHEXXI. Upon discontinuation of PHEXXI, pregnancy may occur.
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%).
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:
||Box of 12 units|
||Sample box of 3 units|
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) [see USP Controlled Room Temperature].
Patient Counseling Information
Advise the patient to read the Patient Information and FDA-approved patient labeling (Instructions for Use). Advise the patient:
- To intravaginally administer the contents of one pre-filled 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 [see Dosage and Administration (2.1)].
- To consult their healthcare provider for severe or prolonged genital irritation [see Adverse Reactions (6.1)].
- To discontinue PHEXXI if they develop a local hypersensitivity reaction [see Adverse Reactions (6.1)].
- To contact their healthcare provider if experiencing urinary tract symptoms [see Warnings and Precautions (5.1)].
- That PHEXXI does not protect against HIV infection and other sexually transmitted infections.
Manufactured for Evofem, Inc., a wholly owned subsidiary of Evofem Biosciences, Inc., 12400 High Bluff Drive, Suite 600, San Diego, CA 92130
©2022 Evofem, Inc. All rights reserved.
U.S. Patents 6,706,276 and 10,568,855
|PATIENT INFORMATION PHEXXI® (FEX ee)
(lactic acid, citric acid, and potassium bitartrate) vaginal gel
For Vaginal Use Only
|This Patient Information has been approved by the U.S. Food and Drug Administration||Issued: April 2021|
|What is PHEXXI?
|How well does PHEXXI work?|
|Your chance of getting pregnant depends on how well you follow the directions for using PHEXXI. The better you follow the directions, the less chance you have of getting pregnant. It is very important that you follow the directions carefully each time you have vaginal sex.|
|PHEXXI does not protect against HIV infection or other sexually transmitted infections (STIs).|
|Before using PHEXXI, tell your healthcare provider about all of your medical conditions, including if you:
|Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.|
|Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.|
|How should I use PHEXXI?
|What are the possible side effects of PHEXXI?|
|PHEXXI may cause serious side effects, including:
|The most common side effects of PHEXXI include:|
|These are not all the possible side effects of PHEXXI.|
|Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|How should I store PHEXXI?
|Keep PHEXXI and all medicines out of the reach of children.|
|General information about the safe and effective use of PHEXXI.|
|Medicines are sometimes used for purposes other than those listed in a Patient Information leaflet. Do not use PHEXXI for a condition for which it was not prescribed. Do not give PHEXXI to other people, even if they have the same symptoms that you have. It may harm them.|
|You can ask your healthcare provider or pharmacist for information about PHEXXI that is written for health professionals.|
|What are the ingredients in PHEXXI?|
|Active ingredients: lactic acid, citric acid, and potassium bitartrate|
|Inactive ingredients: glycerin, alginic acid, xanthan gum, sodium hydroxide, benzoic acid, and purified water|
|For more information, go to www.phexxi.com or call 1-833-EVFMBIO.|
|Manufactured for Evofem, Inc., a wholly owned subsidiary of Evofem Biosciences, Inc.|
|©2021 Evofem, Inc. All rights reserved. Unless otherwise indicated, all trademarks used herein are the property of Evofem Biosciences, Inc.|
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.
- Each box contains either 3 or 12 foil pouches.
- Each foil pouch contains a pre-filled applicator and plunger rod (see Figure A).
- Each pre-filled applicator contains 1 dose of PHEXXI for 1-time use (single use).
Important Information You Need to Know Before Using PHEXXI
- Use 1 dose of PHEXXI within 1 hour before you have vaginal sex.
- A new PHEXXI pre-filled applicator must be used each time you have vaginal sex. If you have vaginal sex more than 1 time within 1 hour, a new PHEXXI pre-filled applicator must be used.
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
- Wash your hands with soap and water before opening the foil pouch.
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
- Used PHEXXI pre-filled applicators and caps should be disposed of in the trash. The cap may be a potential choking hazard.
- Store PHEXXI at room temperature between 68°F to 77°F (20°C to 25°C).
- Store PHEXXI in the original foil pouch.
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.
©2021 Evofem, Inc. All rights reserved.
Issued: April 2021
PRINCIPAL DISPLAY PANEL - 12 Applicator Box
(lactic acid, citric acid, and
potassium bitartrate) Vaginal Gel
1.8%, 1%, 0.4%
lactic acid, l-, citric acid monohydrate, and potassium bitartrate gel
|Labeler - Evofem, Inc. (832466119)|
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