For US Healthcare Professionals Only

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

Formulation

Thermosetting formulation for gradual release of clindamycin1

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

Click video below to learn more about XACIATO.

aBased on an in vitro study using clindamycin HCl.1

Formulated with the goal of limiting leakage and increasing vaginal retention time2

Pathophysiology of BV

The normal vagina contains a microbiota dominated by Lactobacillus species.5

BV is characterized by a displacement of Lactobacillus and an increase in anaerobic bacteria, often as part of a biofilm.5,6

Thermosetting formulation1

As demonstrated by an in vitro study

The gel exhibits mucoadhesive properties that may help it adhere to the vaginal wall.

The gel is less viscous at lower temperatures, which may permit the gel to coat and conform to the shape of the vaginal wall during the introduction of XACIATO.

The specifically formulated gel in XACIATO thermosets at body temperature. This increase in viscosity may help XACIATO stay in place in the vagina.

Clindamycin is released from the gel over time, reaching a peak at days 2 and 3.b

bClindamycin HCl was used in this study.

BV = bacterial vaginosis; HCl = hydrochloride.

Safety Patient Considerations

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 TRI-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.

3. Joseph RJ, Ser H-L, Kuai Y-H, et al. Finding a balance in the vaginal microbiome: how do we treat and prevent the occurrence of bacterial vaginosis? Antibiotics (Basel). 2021;10(6):719. doi: 10.3390/antibiotics10060719

4. Aldunate M, Srbinovski D, Hearps AC, et al. Antimicrobial and immune modulatory effects of lactic acid and short chain fatty acids produced by vaginal microbiota associated with eubiosis and bacterial vaginosis. Front Physiol. 2015;6:164. doi: 10.3389/fphys.2015.00164

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

6. Muzny CA, Taylor CM, Swords WE, et al. An updated conceptual model on the pathogenesis of bacterial vaginosis. J Infect Dis. 2019;220(9):1399–1405.

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…