For US Healthcare Professionals Only

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

Overview

Complete treatment in a single dose

1 applicatorful administered once intravaginally as a single dose at any time of day.

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Thermosetting formulation for gradual release of clindamycin1

XACIATO vaginal gel increases viscosity at body temperature and gradually releases clindamycin over time.a

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aBased on an in vitro study using clindamycin HCl.1

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Clear efficacy at Day 21–30 and Day 7–14

Superior Clinical Cureb vs placebo at Day 21–30, with significant results as early as Day 7–14.

Treatment difference:

  • Day 21–30: 34.9%; 95% CI: 19.0, 50.8; P<0.001
  • Day 7–14: 52.5%; 95% CI: 38.0, 67.0; P<0.001

Robust efficacy in both new and recurrent BV

Significantly higher Clinical Cure at Day 21–30 vs placebo in both subsets of patients with ≤3 episodes or >3 episodes (recurrent) of BV in the past 12 months.

Treatment difference2:

  • ≤3 episodes of BV in the past 12 months: 32.2%; 95% CI: 13.9, 50.4; P=0.001 (XACIATO: N=101, placebo: N=46)
  • Recurrent BV: 46.9%; 95% CI: 10.1, 83.7; P=0.01 (XACIATO: N=20, placebo: N=13)

bClinical 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.

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Eligible patients pay as little as $25c

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cTerms and Conditions

BV = bacterial vaginosis; HCl = hydrochloride; KOH = potassium hydroxide.

Dosing

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. Mondal P, Alur HH, Johnston TP. Evaluation of TRl-726 as a drug delivery matrix. Drug Dev Ind Pharm. 2011;37(8):995–1001.

2. 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.

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…