Phexxi 50 mg/5g
lactic acid, L-, citric acid monohydrate, and potassium bitartrate · GEL · Evofem, Inc.
Phexxi is a gel containing lactic acid, l-, citric acid monohydrate, and potassium bitartrate at 50 mg/5g, taken vaginal. Manufactured by Evofem, Inc..
Key Facts
- Brand Name
- Phexxi
- Generic Name
- lactic acid, L-, citric acid monohydrate, and potassium bitartrate
- NDC Code (Product)
69751-100- Manufacturer
- Evofem, Inc.
- Strength
- 50 mg/5g
- Dosage Form
- GEL
- Route
- VAGINAL
- Marketing Status
- Application #
- NDA208352
- Marketing Start
- 08/01/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PHEXXI is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. 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. Limitations of Use PHEXXI is not effective for the prevention of pregnancy when administered after intercourse [see Dosage and Administration (2.1) ].
Dosage & Administration
2 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 ) 2.1 Recommended Dosage Administer one pre-filled applicator of PHEXXI (5 grams) vaginally immediately before or up to one hour before 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, metroni…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cystitis and Pyelonephritis [see Warnings and Precautions (5.1) ] 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PHEXXI (pre-filled applicator with 5-gram dose) has been evaluated in two clinical trials (Study 1 and Study 2) in 2804 subjects (over 19,000 cycles of exposure) . The racial/ethnic distribution was 66% White, 27% Black or African American, 2% Asian, 1% American Indian or Alaska Native, 0.3% N…
Frequently Asked Questions
What is Phexxi used for?
Phexxi contains lactic acid, L-, citric acid monohydrate, and potassium bitartrate. It is a gel taken vaginal. Consult your doctor for specific uses.
Is Phexxi a controlled substance?
Phexxi is not classified as a controlled substance by the DEA.
What is the generic name for Phexxi?
The generic name for Phexxi is lactic acid, L-, citric acid monohydrate, and potassium bitartrate. There are 1 other brand versions of lactic acid, L-, citric acid monohydrate, and potassium bitartrate.
What is the NDC code for Phexxi 50 mg/5g?
The NDC (National Drug Code) for Phexxi 50 mg/5g is 69751-100, listed by Evofem, Inc..