Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N), CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), POTASSIUM BITARTRATE (UNII: NPT6P8P3UU) (TARTARIC ACID - UNII:W4888I119H)
Evofem, Inc.
VAGINAL
PRESCRIPTION DRUG
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)]. Risk Summary 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. Risk Summary 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
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: 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 ].
New Drug Application
PHEXXI- LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE GEL EVOFEM, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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 INDICATIONS AND USAGE PHEXXI is a combination of lactic acid, citric acid, and potassium bitartrate indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. (1) Limitations of Use: PHEXXI is not effective for the prevention of pregnancy when administered after intercourse. DOSAGE AND ADMINISTRATION 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) DOSAGE FORMS AND STRENGTHS Each pre-filled single-dose vaginal applicator delivers 5 grams of gel containing lactic acid (1.8%), citric acid (1%), and potassium bitartrate (0.4%). (3) WARNINGS AND PRECAUTIONS Cystitis and Pyelonephritis: Avoid use in women with a history of recurrent UTI or urinary tract abnormalities (5.1) ADVERSE REACTIONS Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT EVOFEM AT TOLL-FREE PHONE 1-833- EVFMBIO OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 6/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 2.2 Timing of PHEXXI Use 2.3 Use of PHEXXI with Other Contraceptive Methods 2.4 Use of PHEXXI with Oth Izlasiet visu dokumentu