Label: PHEXX- lactic acid, l-, citric acid monohydrate, and potassium bitartrate gel
- NDC Code(s): 69751-101-01, 69751-101-12
- Packager: Evofem, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 23, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PHEXX® safely and effectively. See full prescribing information for PHEXX. PHEXX (lactic acid, citric acid, and potassium ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEPHEXX is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. Limitations of Use - PHEXX is not effective for the ...
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2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage - Administer one pre-filled applicator of PHEXX (5 grams) vaginally immediately before or up to one hour before each act of vaginal intercourse. If more than one act of ...
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3 DOSAGE FORMS AND STRENGTHSVaginal 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 ...
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5 WARNINGS AND PRECAUTIONS5.1 Cystitis and Pyelonephritis - Among 2804 subjects who received PHEXX in Studies 1 and 2, 0.36% (n=10) reported adverse reactions of cystitis, pyelonephritis, or other upper urinary tract ...
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6 ADVERSE REACTIONSThe following clinically significant adverse reactions are described elsewhere in the labeling: Cystitis and Pyelonephritis [see Warnings and Precautions (5.1)] 6.1 Clinical Trials ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - There is no use for PHEXX in pregnancy; therefore, discontinue PHEXX during pregnancy. There are no data with the use of PHEXX in pregnant women or animals. In ...
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11 DESCRIPTIONPHEXX (lactic acid, citric acid, and potassium bitartrate) is a vaginal gel. PHEXX is an off-white to tan in color gel of uniform consistency, containing three active ingredients: lactic acid ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - In in vitro studies, PHEXX 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Long-term carcinogenicity studies have not been performed with PHEXX. Mutagenesis - Mutagenic studies have not ...
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14 CLINICAL STUDIESThe efficacy of PHEXX 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGPHEXX (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 ...
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17 PATIENT COUNSELING INFORMATIONAdvise 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 ...
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SPL UNCLASSIFIED SECTIONManufactured for Evofem, Inc., a wholly owned subsidiary of Evofem Biosciences, Inc. San Diego, CA 92130 - ©2024 Evofem, Inc. All rights reserved. U.S. Patents 6,706,276 and 10,568,855
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PATIENT PACKAGE INSERTPATIENT INFORMATION - PHEXX® (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 ...
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INSTRUCTIONS FOR USEPHEXX® (FEX) (lactic acid, citric acid, and potassium bitartrate) vaginal gel - For Vaginal Use Only - These Instructions for Use contain information on how to use PHEXX vaginal gel. Make sure ...
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PRINCIPAL DISPLAY PANEL - 12 Applicator Boxphexx® (lactic acid, citric acid, and - potassium bitartrate) Vaginal Gel - 1.8%, 1%, 0.4% NDC 69751-101-12 - PN-XXXX RXX
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INGREDIENTS AND APPEARANCEProduct Information