Phexxi

Last updated on RxList: 1/22/2021
Phexxi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Phexxi?

Phexxi (lactic acid, citric acid, and potassium bitartrate) is a combination of lactic acid, citric acid, and potassium bitartrate used to prevent pregnancy in females of reproductive potential for use as an on-demand method of contraception.

What Are Side Effects of Phexxi?

Side effects of Phexxi include:

Dosage for Phexxi

The dose of Phexxi is one (1) pre-filled single-dose applicator (5 grams) vaginally immediately before (or up to one hour before) each episode of vaginal intercourse. If more than one act of vaginal intercourse occurs within one hour, an additional dose must be applied.

Phexxi In Children

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 under the age of 17 as for users 17 years and older. The use of Phexxi before menarche is not indicated.

What Drugs, Substances, or Supplements Interact with Phexxi?

Phexxi may interact with other medicines.

Tell your doctor all medications and supplements you use.

Phexxi During Pregnancy and Breastfeeding

There is no use for Phexxi in pregnancy; therefore, discontinue Phexxi during pregnancy. It is unknown if Phexxi passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Phexxi (lactic acid, citric acid, and potassium bitartrate) Vaginal Gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Which of the following are methods for contraception? See Answer
Phexxi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Phexxi may cause a bladder or kidney infection. Call your doctor at once if you have:

  • pain or burning when you urinate;
  • urine that looks cloudy; or
  • pain in your flank, side, or lower back.

Stop using Phexxi if it causes severe irritation in or around your vagina.

Common side effects may include:

  • a bladder infection;
  • vaginal burning, itching, or discomfort;
  • vaginal itching or discharge; or
  • bacterial or fungal infection in the vagina.

If you need to use any vaginal medication to treat a vaginal infection, you may keep using Phexxi.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Phexxi (Lactic Acid, Ctric Acid, and Potassium Bitartrate Vaginal Gel)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Phexxi Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Cystitis and Pyelonephritis [see WARNINGS AND PRECAUTIONS]

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% 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 PHEXXI for 13 cycles.

Hypersensitivity Reaction

Of the 2804 PHEXXI-treated subjects in Studies 1 and 2, one subject reported a suspected drug hypersensitivity. Avoid PHEXXI use in females of reproductive potential with suspected hypersensitivity to the ingredients in PHEXXI.

The most common adverse reactions (≥10%) in the U.S. population in Studies 1 and 2 (n = 2480) were: vulvovaginal burning sensation (18.0%) and vulvovaginal pruritis (14.5%). The majority of these adverse reactions were mild and few led to discontinuation. Table 1 summarizes the most common adverse reactions (≥2%) reported by subjects using PHEXXI in the U.S.

Table 1. Adverse Reactions that Occurred in ≥ 2% of Subjects Who Used PHEXXI to Prevent Pregnancy (Studies 1 and 2 – U.S. population only)

Adverse ReactionPHEXXI
(N=2480)
(%)
Vulvovaginal Burning Sensation18.0
Vulvovaginal Pruritus14.5
Vulvovaginal Mycotic Infection*9.1
Urinary Tract Infection,9.0
Vulvovaginal Discomfort9.0
Bacterial Vaginosis8.4
Vaginal Discharge5.5
Genital Discomfort4.1
Dysuria3.1
Vulvovaginal pain2.1
* Includes preferred terms (PT) vulvovaginal mycotic infection and vulvovaginal candidiasis.
Includes PTs urinary tract infection, streptococcal urinary tract infection, Escherichia urinary tract infection, and urinary tract infection bacterial.
Does not include PTs cystitis, kidney infection, and pyelonephritis [see WARNINGS AND PRECAUTIONS ].

Among subjects who used PHEXXI in Studies 1 and 2, 1.6% discontinued from the clinical trials due to an adverse reaction. The most common adverse reactions leading to study discontinuation were vulvovaginal burning sensation (0.7%); and vulvovaginal pruritus and vulvovaginal discomfort (0.1% each).

Adverse Reactions In Male Partners

Among male partners of subjects who used PHEXXI for contraception in Study 2, 9.8% (131 of 1330) reported symptoms of local discomfort (burning, itching, pain, and “other”). Of these local discomfort symptoms, 74.7% were mild, 21.4% were moderate, and 3.9% were severe. Two subjects discontinued participation in the study due to male partner symptoms.

Read the entire FDA prescribing information for Phexxi (Lactic Acid, Ctric Acid, and Potassium Bitartrate Vaginal Gel)

© Phexxi Patient Information is supplied by Cerner Multum, Inc. and Phexxi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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