XACIATO

Clindamycin phosphate is a water-soluble ester prodrug of clindamycin. Biologically inactive clindamycin phosphate is converted to active clindamycin. Following a single intravaginal dose of 100 mg of XACIATO administered to 21 healthy female subjects, the arithmetic mean (range) peak plasma concentration was 69.2 ng/mL (3.8 to 236 ng/mL). The median (range) t max occurred at 6 hours (4 to 96 hours). The mean C max of clindamycin for XACIATO was approximately 0.5% of that observed after the IV i...

The efficacy of XACIATO as a treatment of bacterial vaginosis (BV) in females 12 years of age and older was demonstrated in a randomized, double-blind, placebo-controlled clinical study (

Trial 1NCT04370548). A single dose of XACIATO (clindamycin phosphate vaginal gel, 2%) was compared to a single dose of placebo vaginal gel (hydroxyethylcellulose [HEC] Universal Placebo Gel) for the treatment of BV. Patients were evaluated at 3 timepoints: a Day 1 Screening/Randomization visit, a Day 7 to 14 Interim Assessment visit, and a Day 21 to 30 Test of Cure visit. The total study duration was up to a...

The following clinically significant adverse reactions are described elsewhere in the labeling: Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.1 )] Use with Polyurethane Condoms [see Warnings and Precautions ( 5.2 )] Vaginal Candida Infections [see Warnings and Precautions ( 5.3 )] 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 ...

History of hypersensitivity to clindamycin or lincomycin. ( 4.1 ) 4.1 Hypersensitivity XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. [see Adverse Reactions ( 6.2 )] .

Clostridioides difficile -Associated Diarrhea: Discontinue and evaluate if diarrhea occurs. ( 5.1 ) Use with Polyurethane Condoms: 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 ( 5.2 ) 5.1 Clostridioides difficile -As...

7 DRUG INTERACTIONS 7.1 Neuromuscular Blocking Agents Systemic clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.