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XACIATOTM

(clindamycin phosphate) vaginal gel 2%

XACIATO<sup>TM</sup>
XACIATO<sup>TM</sup>

XACIATOTM

(clindamycin phosphate) vaginal gel 2%

Patient Profiles

Consider XACIATO for your appropriate patients with BV

Hypothetical patients

Amanda

Frustrated with
recurrent BV

See profile

Keely

Embarrassed by her
new infection

See profile

Cecilia

Currently
pregnant

See profile

Amanda

Frustrated with recurrent BV

Hypothetical patient

  • Has a fourth episode of BV in the past year, with her last infection 4 months ago
  • Previously prescribed multi-day oral medications, which led to GI upset
  • Wants a treatment that is effective against recurrent BV

Why XACIATO?

Single-dose XACIATO vaginal gel was effective in patients with recurrent (>3 episodes in the previous 12 months) and new infections (≤3 episodes in the previous 12 months).

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Keely

Embarrassed by her new infection

Hypothetical patient

  • Tries to cover up her odor with perfume but still embarrassed to attend classes or join her study group
  • Has no prior history of BV and wants the infection gone
  • Prefers a simple dosing regimen
  • Is a social drinker

Why XACIATO?

Complete treatment in 1 dose, XACIATO can be taken at any time of day and is not contraindicated for use with alcohol. Patients who have been prescribed XACIATO for BV should avoid alcohol if they have other medical conditions or take other medications that may pose serious health risks if alcohol is consumed.

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Cecilia

Currently pregnant

Hypothetical patient

  • Concerned after reading about BV-related pregnancy complications online
  • Had BV in the past but not in 5 years
  • Is considering appropriate treatment options given her pregnancy

Why XACIATO?

XACIATO is not contraindicated for use in pregnant women. Although not studied in pregnant women, the low systemic absorption of XACIATO is not likely to result in significant fetal exposure to the drug.

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BV = bacterial vaginosis; GI = gastrointestinal.

Indication

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

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.

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

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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.