PHEXXI- lactic acid, l-, citric acid monohydrate, and potassium bitartrate gel

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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)

Disponible depuis:

Evofem, Inc.

Mode d'administration:

VAGINAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

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 ].

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

PHEXXI- LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM
BITARTRATE GEL
EVOFEM, INC.
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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