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 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 inflammatory bowel disease, including ulcerative colitis and Crohn’s 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. The amount of XACIATO which passes into your breast milk is low and is not expected to harm your baby. Talk with your healthcare provider about the best way to feed your baby while using XACIATO.
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 during treatment with XACIATO and for 7 days after using XACIATO. XACIATO may weaken polyurethane condoms and they may not work well for preventing pregnancy or protecting 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. One type of diarrhea is caused by an infection in your intestines called Clostridioides difficile-associated diarrhea (CDAD), which may range in severity from mild diarrhea to colitis that can lead to death. If you have diarrhea after you use XACIATO, call your healthcare provider.
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 www.fda.gov/medwatch 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.