XACIATO™ for the treatment of Bacterial vaginosis – 12/5/23

Learn more about XACIATO

MAKE A BOLD MOVE AGAINST BV WITH A SINGLE DOSE

Bacterial vaginosis (BV) can be embarrassing for patients. XACIATOTM (clindamycin phosphate) vaginal gel 2%, a single-dose treatment for BV in females 12 years of age and older, is available in pharmacies.
BV affects as many as 21 million women in the United States. Many current treatments need to be used for multiple days. XACIATO treats BV in a single dose.

• A single intravaginal dose at any time of day.

• Thermosetting formulation for gradual release of clindamycin.1

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

• 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.2
Treatment difference: ≤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).2
XACIATO is a clear, colorless, viscous gel in an 8-g tube. The carton contains an 8-g tube of vaginal gel and one single-dose, user-filled disposable vaginal applicator.
Make a bold move against BV with single-dose XACIATO 2% vaginal gel.
aBased on an in vitro study using clindamycin HCl.1

XACIATO (clindamycin phosphate) vaginal gel 2%

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.
Selected Safety Information continued below.

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COMPANY: Organon
PRODUCT TRADE NAME: XACIATO
GENERIC NAME: clindamycin phosphate
PRODUCT DESCRIPTION: Vaginal gel: 2% clindamycin (present as clindamycin phosphate) as a clear, colorless, viscous gel in an 8-g tube

HOW SUPPLIED PACKAGING NDC WAC

XACIATO™ (clindamycin
phosphate) vaginal gel 2%
Supplied in a carton containing one
8-gram tube of vaginal gel and one
vaginal applicator
78206-189-01 $150.00

NDC, National Drug Code; WAC, wholesale acquisition cost.
STORAGE REQUIREMENTS: Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)
PRESCRIPTION LEGEND: Yes
NARCOTIC: No
Selected Safety Information (continued)

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.
Before prescribing XACIATO, please read the accompanying Prescribing Information. The Patient Information and Instructions for Use also are available.
REFERENCES:
1. Mondal P, Alur HH, Johnson 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.

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