Potassium Bitartrate

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 the majority of subjects, and sperm motility reduction.

• PHEXX is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. PHEXX 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.ICD-10: Z30.9

Administer one ( 1 ) pre-filled single-dose applicator of PHEXX (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 PHEXX (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 PHEXX contains 90 mg of lactic acid, 50 mg of citric acid, and 20 mg of potassium bitartrate. 2.2 Timing of PHEXX Use May use PHEXX during any part of the menstrual cycle. May use PHEXX as soon as it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage. 2.3 Use of PHEXX with Other Contraceptive Methods PHEXX may be used concomitantly with hormonal contraceptives; latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms. Avoid PHEXX use with vaginal rings. 2.4 Use of PHEXX with Other Vaginal Products PHEXX may be used concomitantly with other products for vaginal infections including miconazole, metronidazole, and tioconazole.

Cystitis and Pyelonephritis: Avoid use in women with a history of recurrent UTI or urinary tract abnormalities ( 5.1 ) 5.1 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 infection (UTI). Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of PHEXX in females of reproductive potential with a history of recurrent urinary tract infection or urinary tract abnormalities.

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 PHEXX (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% Native Hawaiian or Pacific Islander, and 5% other; 32% of the study population was Hispanic. Study 1 included a one-year extension phase where 342 U.S. subjects were exposed to PHEXX for 13 cycles. Hypersensitivity Reaction Of the 2804 PHEXX-treated subjects in Studies 1 and 2, one subject reported a suspected drug hypersensitivity.

8.1 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 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. 8.2 Lactation 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. 8.4 Pediatric Use The safety and effectiveness of PHEXX have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older. The use of PHEXX before menarche is not indicated.

Metabolism

Pharmacokinetic studies in humans have not been performed. Systemic exposures of lactic acid, citric acid, and potassium bitartrate following vaginal administration of PHEXX are not expected to lead to safety concerns.

• May 22, 2020NDANDA208352Evofem Inc

1. 1Drug Ineffective5934%
2. 2Pregnancy5934%
3. 3Abortion Spontaneous1911%
4. 4Vulvovaginal Burning Sensation1810%
5. 5Pregnancy On Contraceptive148.0%
6. 6Product Administration Error148.0%
7. 7Complication Of Device Insertion63.4%
8. 8Expired Product Administered63.4%
9. 9Nausea63.4%
10. 10Vaginal Discharge63.4%
11. 11Vaginal Haemorrhage63.4%
12. 12Abdominal Pain52.9%
13. 13Burning Sensation52.9%
14. 14Ectopic Pregnancy52.9%
15. 15Vulvovaginal Pain52.9%

The 2 most recently updated of 2 ClinicalTrials.gov registrations naming Potassium Bitartrate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
  Completed · Phase 3 · Interventional · 3,389 enrolled · Evofem Inc.
  NCT01306331updated 2022-07-12
• Phase 2B/3 Double-blinded Placebo-controlled
  Completed · Phase 2 · Phase 3 · Interventional · 860 enrolled · Evofem Inc.
  NCT03107377updated 2020-08-12

Frequently asked questions

How does Potassium Bitartrate work?

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 the majority of subjects, and sperm motility reduction.

What is Potassium Bitartrate used for?

According to FDA labeling, Potassium Bitartrate carries indications including: PHEXX is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. PHEXX 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Potassium Bitartrate?

Potassium Bitartrate is classified as Acid-Base Activity, Electrolyte Activity, Cellular Activity Alteration, Increased Insulin Secretion, Organized Electrical Activity Alteration.

What are the brand names for Potassium Bitartrate?

Potassium Bitartrate is marketed under brand names including Ceo-Two, Phexx, Phexxi.