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

Safety

Demonstrated safety profile from a phase 3 clinical study

Vulvovaginal candidiasis and vulvovaginal discomfort were the only adverse reactions reported in >2% of patients and at a higher rate in the XACIATO group than in the placebo group.

aVulvovaginal discomfort includes the terms vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal erythema, vulvovaginal dryness, and vulvovaginal discomfort.

38% of patients treated with XACIATO reported adverse reactions compared with 27% of patients treated with placebo.

Clinical Efficacy Formulation

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.

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…