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Phexxi

These highlights do not include all the information needed to use PHEXXI safely and effectively. See full prescribing information for PHEXXI. PHEXXI (lactic acid, citric acid, and potassium bitartrate) vaginal gel Initial U.S. Approval: 2020

Approved
Approval ID

173ff411-7227-47b0-94dc-844e1ebaf14e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 21, 2023

Manufacturers
FDA

Evofem, Inc.

DUNS: 832466119

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

lactic acid, L-, citric acid monohydrate, and potassium bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69751-100
Application NumberNDA208352
Product Classification
M
Marketing Category
C73594
G
Generic Name
lactic acid, L-, citric acid monohydrate, and potassium bitartrate
Product Specifications
Route of AdministrationVAGINAL
Effective DateJune 30, 2023
FDA Product Classification

INGREDIENTS (3)

CITRIC ACID MONOHYDRATEActive
Quantity: 50 mg in 5 g
Code: 2968PHW8QP
Classification: ACTIM
POTASSIUM BITARTRATEActive
Quantity: 20 mg in 5 g
Code: NPT6P8P3UU
Classification: ACTIB
LACTIC ACID, L-Active
Quantity: 90 mg in 5 g
Code: F9S9FFU82N
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/30/2023

PRINCIPAL DISPLAY PANEL - 12 Applicator Box

phexxi™

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

NDC 69751-100-12
PN-5011

PRINCIPAL DISPLAY PANEL - 12 Applicator Box

WARNINGS AND PRECAUTIONS SECTION

LOINC: 43685-7Updated: 6/30/2023

5 WARNINGS AND PRECAUTIONS

5.1 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.

Key Highlight
  • Cystitis and Pyelonephritis: Avoid use in women with a history of recurrent UTI or urinary tract abnormalities (5.1)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/30/2023

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Administer one pre-filled applicator of PHEXXI (5 grams) vaginally immediately before or up to one hourbefore 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.

2.2 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.

2.3 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.

2.4 Use of PHEXXI with Other Vaginal Products

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

Key Highlight
  • Administer one (1) pre-filled single-dose applicator of PHEXXI (5 grams) vaginally immediately before (or up to one hour before) each episode of vaginal intercourse (2.1)
  • May use during any part of the menstrual cycle (2.2)

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 6/30/2023

16 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:

  • NDC 69751-100-12

Box of 12 units

  • NDC 69751-100-03

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].

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 6/30/2023

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:

  • 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).

Figure A

Figure A

Important Information You Need to Know Before Using PHEXXI

  • Use 1 dose of PHEXXIwithin 1 hour before you have vaginal sex.
  • A new PHEXXI pre-filled applicator must be usedeach 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

  • Remove the pre-filled applicator and plunger rod from the foil pouch (see Figure B).

Figure B

Figure B

Important: Do not remove the pink cap until instructed in Step 4.

Insert PHEXXI Gel

Step 3: Insert the Plunger Rod

  • Gently and slowly insert the plunger rod into the pre-filled applicator. Push until you feel the tip of the plunger rod connect to the inside of the pre-filled applicator (see Figure C). *Do not push hard or continue to push after the tip of the plunger rod connects to the inside of the pre-filled applicator. This could cause the gel to go into the pink cap.
  • Use a new pre-filled applicator if the gel goes into the pink cap.

Figure C

Figure C

Step 4: Remove the Pink Cap

  • After the plunger rod is connected to the pre-filled applicator, remove the pink cap from the pre-filled applicator (see Figure D).
  • The extra space between the gel and the end of the pre-filled applicator is normal.
  • The pre-filled applicator is now ready for use.

Figure D

Figure D

Step 5: Insert the PHEXXI Pre-filled Applicator into the Vagina

  • Hold the pre-filled applicator at the grooved area closest to the plunger rod (see Figure E).
  • Gently insert the pre-filled applicator into the vagina as far as it will comfortably go while you continue to hold it by the grooved area firmly. This can be done sitting with your knees apart, lying on your back with your knees bent (see Figure F), or while standing with your feet apart or knees bent.

Figure E

Figure E

Figure F

Figure F

Step 6: Insert PHEXXI Gel

  • While the pre-filled applicator is inserted in your vagina, use your index finger to push the plunger rod down until it stops. This is to make sure you receive the entire dose of PHEXXI (see Figure G).
  • It is normal for a small amount of gel to be left in the applicator. You will still get the right dose.

Figure G

Figure G

Step 7: Remove the Used PHEXXI Pre-filled Applicator

  • Gently remove the plunger rod and pre-filled applicator from the vagina (see Figure H) and throw away (dispose of) the used pre-filled applicator.
  • PHEXXI should be usedwithin 1 hour before each time you have vaginal sex. Use a new pre-filled applicator if you do not have vaginal sex within 1 hour of inserting PHEXXI gel and you still plan to have vaginal sex.

Figure H

Figure H

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

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