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

Patient Considerations

Patients would use XACIATO again1

As part of a questionnaire administered during the pivotal study, patients in the ITT population (N=290) were asked “How likely would you be to use this treatment again if it were available after the study and you had BV again?”

of patients were “very likely” or “likely” to use XACIATO again for BV when asked about their experience (n=182/190), vs 74% of those treated with the placebo gel (n=74/100)

Test of Cure visit (Day 21–30)

Data were collected at both the Interim Assessment visit (Day 7–14) and the Test of Cure visit (Day 21–30), but only data for the Test of Cure visit (Day 21–30) are shown.

A single-dose treatment for BV in females 12 years and older

XACIATO is contraindicated in patients with a history of hypersensitivity to clindamycin or lincomycin

Patient Counseling Information

Vaginal intercourse and use with vaginal products

Patients should not engage in vaginal intercourse or use other vaginal products, such as tampons or douches, during treatment with XACIATO and for 3 days after using XACIATO.

Use with polyurethane condoms

XACIATO is not compatible with and may weaken polyurethane condoms, so their use is not recommended during or for 7 days following treatment with XACIATO.

XACIATO is compatible with latex condoms, which are the most common type of condom.2

XACIATO is also compatible with polyisoprene condoms.

Vaginal Candida infections

Vaginal yeast infections can occur following use of XACIATO and may require treatment with an antifungal drug.

BV = bacterial vaginosis; ITT = intent-to-treat.

Formulation Patient Profiles

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. Acceptability of single-dose clindamycin gel for bacterial vaginosis: a randomized controlled trial. Clin Ther. 2023;2918(23):00130–00133. doi: 10.1016/j.clinthera.2023.04.001

2. Amory JK. Male contraception. Fertil Steril. 2016;106(6):1303–1309.

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…