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XACIATO<sup>®</sup> XACIATO<sup>®</sup>

Clinical Efficacy

Help lift the burden of BV with powerful efficacy

Superior Clinical Curea vs placebo at Day 21–30

BV resolved as early as 7–14 days after treatment

Superior Clinical Curea vs placebo

Effective in patients with new and recurrent BV

Superior Clinical Curea vs placebo at Day 21–30

aClinical Cure = resolution of the abnormal vaginal discharge associated with BV, a negative 10% KOH whiff test, and clue cells <20% of the total epithelial cells in the saline wet mount.

bBacteriological Cure = Nugent score <4.

cTherapeutic Cure = presence of both a Clinical Cure (resolution of the abnormal vaginal discharge associated with BV, a negative 10% KOH whiff test, and clue cells <20% of the total epithelial cells in the saline wet mount) and Bacteriological Cure. Data are for mITT population.

BV = bacterial vaginosis; KOH = potassium hydroxide; mITT = modified Intent-to-Treat.

Dosing Safety

Indication and Selected Safety Information

Indication

XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years and older.

Selected Safety Information

  • XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin.
  • Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.
  • Polyurethane condoms are not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used.
  • XACIATO may result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis, which may require antifungal treatment.
  • The most common adverse reactions reported in >2% of patients and at a higher rate in the XACIATO group than in the placebo group were vulvovaginal candidiasis and vulvovaginal discomfort.
  • XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug.
  • There are no data on the effect of clindamycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

Please read the accompanying Prescribing Information. The Patient Information and Instructions for Use also are available.

1. Mauck C, Hillier SL, Gendreau J, et al. Single-dose, bioadhesive clindamycin 2% gel for bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2022;139(6):1092–1102.

2. Bacterial vaginosis (BV) statistics. Centers for Disease Control and Prevention. Updated February 10, 2020. Accessed February 7, 2023. https://www.cdc.gov/std/bv/stats.htm

3. Sha BE, Chen HY, Wang QJ, Zariffard MR, Cohen MH, Spear GT. Utility of Amsel criteria, Nugent score, and quantitative PCR for Gardnerella vaginalis, Mycoplasma hominis, and Lactobacillus spp. for diagnosis of bacterial vaginosis in human immunodeficiency virus-infected women. J Clin Microbiol. 2005;43(9):607-4612.

4. Amabebe E, Anumba DOC. The vaginal microenvironment: the physiologic role of Lactobacilli. Front Med (Lausanne). 2018;5:181. doi: 10.3389/fmed.2018.00181

Indication

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Indication:

XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years and older.

Selected Safety Information +

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Selected Safety Information:

XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued…