Phexxi (Lactic Acid, L-, Citric Acid Monohydrate, And Potassium Bitartrate)

PHEXXI is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

• 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 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.
  )
• May use during any part of the menstrual cycle (
  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.
  )

Vaginal 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 single-dose (5 grams) vaginal applicator

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.

• Cystitis and Pyelonephritis: Avoid use in women with a history of recurrent UTI or urinary tract abnormalities (
  5.1 Cystitis and Pyelonephritis

  Among 2804 subjects who received PHEXXI 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 PHEXXI 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

  5.1 Cystitis and Pyelonephritis

  Among 2804 subjects who received PHEXXI 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 PHEXXI in females of reproductive potential with a history of recurrent urinary tract infection or urinary tract abnormalities

  .

  ]