PHEXXI is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

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

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Cystitis and Pyelonephritis [see Warnings and Precautions (5.1)]

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.

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%).

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:

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., 12636 High Bluff Drive, Suite 400, San Diego, CA 92130
©2023 Evofem, Inc. All rights reserved.
U.S. Patents 6,706,276 and 10,568,855

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:

• 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.

Storing PHEXXI

• 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.
©2023 Evofem, Inc. All rights reserved.

Issued: June 2023

phexxi™

(lactic acid, citric acid, and
potassium bitartrate) Vaginal Gel
1.8%, 1%, 0.4%

NDC 69751-100-12
PN-5011