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FIND BALANCE WITH XACIATO

clindamycin phosphate vaginal gel 2%

XACIATO is a vaginal gel that is designed to stay in place, act at the site of infection, and provide complete treatment for bacterial vaginosis (BV).
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FIRST THINGS FIRST.

What is BV?

BV is the most common vaginal condition in women aged 15 to 44 years.

Many different kinds of bacteria and other organisms exist naturally in your vagina. When certain bacteria grow more than they should, they may create a pH imbalance that can lead to BV.

Learn More About BV

EXPERIENCING A BACTERIAL VAGINOSIS INFECTION?

XACIATO vaginal gel is a prescription medicine used to treat bacterial vaginal infections in females 12 years of age and older. It is not known if XACIATO is safe and effective in children under 12 years of age.

XACIATO provides complete treatment for bacterial vaginosis (BV) in just one dose.

Learn More About XACIATO

Why is it important to treat BV?

Sometimes BV causes noticeable symptoms, like vaginal odor and discharge. While around 1/3 of cases go away on their own, it's still important to treat BV because it can lead to more serious complications, like:
  • Increased risk of getting other sexually transmitted infections
  • Early labor and delivery in pregnancy
  • Increased persistence of HPV (human papillomavirus) which can result in precancerous lesions
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Would women use XACIATO Again?

In the clinical study for XACIATO, all participants* were asked at 2 different visits:
”How likely would you be to use this treatment again if it were available after the study and you had BV again?”

  • On visits from days 7 to 14:

    ~92%
    (176 of 192 patients)

    Said they were “Very likely” or “Likely” to use XACIATO again

    vs ~75% (76 of 102 patients) who used placebo

  • On visits from days 21 to 30:

    ~96%
    (182 of 190 patients)

    Said they were “Very likely” or “Likely” to use XACIATO again

    vs ~74% (74 of 100 patients) who used placebo

*192 women were asked this question on days 7 to 14 and 190 women were asked the same question on days 21 to 30. The data for effectiveness included 122 women who used XACIATO.

INDICATION

XACIATO vaginal gel is a prescription medicine used to treat bacterial vaginal infections in females 12 years of age and older. It is not known if XACIATO is safe and effective in children under 12 years of age.

IMPORTANT SAFETY INFORMATION

XACIATO is for intravaginal use only. Do not use in the eyes, mouth, or on your skin.

Do not use XACIATO if you are allergic to clindamycin or lincomycin.

Before using XACIATO, tell your healthcare provider about all of your medical conditions, including if you have an inflammatory bowel disease, or if you are pregnant or plan to become pregnant. It is not known if XACIATO will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with XACIATO. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

After you insert XACIATO, do not have vaginal sex or use vaginal products (such as tampons or douches) during treatment with XACIATO and for 3 days after using XACIATO. You should not use polyurethane condoms while taking XACIATO and for another 7 days after using it, since XACIATO may weaken the ability of polyurethane condoms and may not work well to prevent pregnancy or protect against Human Immunodeficiency Virus (HIV) and other sexually transmitted diseases (STDs). Latex or polyisoprene condoms should be used.

XACIATO may cause serious side effects, including diarrhea. If you have diarrhea after you use XACIATO, call your healthcare provider. One type of diarrhea is caused by a serious intestinal infection called Clostridioides difficile-associated diarrhea (CDAD), which may range from mild to colitis that can lead to death.

The most common side effects of XACIATO include yeast infection in your vagina that may require treatment with an antifungal medicine and vaginal discomfort, including itching, burning, redness, and dryness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XACIATO. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

Please read the accompanying Patient Information and Instructions for Use for XACIATO and discuss them with your healthcare provider. The physician Prescribing Information also is available.