XACIATO

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE XACIATO is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. ( 1.1 ) 1.1 Bacterial Vaginosis XACIATO ® is indicated for the treatment of bacterial vaginosis in females 12 years and older [see Use in Specific Populations ( 8.1 ) and Clinical Studies ( 14 )] . Dosage and administration 2 DOSAGE AND ADMINISTRATION The recommended dosage of XACIATO is one applicatorful (5 g of vaginal gel containing 100 mg of clindamycin) administered once intravaginally as a single dose at any time of the day [see Clinical Studies ( 14 )] . Place the used tube with any remaining gel and used applicator in the container box and deposit in a trash container after use [see Instructions for Use ] . XACIATO is not for ophthalmic, dermal, or oral use. Administer one applicatorful (5 g of gel containing 100 mg of clindamycin) once intravaginally as a single dose at any time of the day. ( 2 ) Not for ophthalmic, dermal, or oral use. ( 2 ) Warnings and cautions 5 WARNINGS AND PRECAUTIONS 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 -Associated Diarrhea (CDAD) 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. Treatment with antibacterial agents alters the normal flora of the colon which can lead to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Patients with inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, have a higher risk of developing CDAD. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated [see Adverse Reactions ( 6.2 )] . 5.2 Use with Polyurethane Condoms XACIATO is not compatible with and may weaken polyurethane condoms; therefore, their use is 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 [see Use in Specific Populations ( 8.3 )] . 5.3 Vaginal Candida Infections XACIATO may result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis which may require antifungal treatment [see Adverse Reactions ( 6.1 )] . Drug interactions 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. Pregnancy 8.1 Pregnancy Risk Summary Other clindamycin vaginal products have been used to treat pregnant women during the second and third trimester. 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 [see Clinical Pharmacology ( 12.3 )] . Available data from published observational studies, based on first trimester exposure to oral and IV clindamycin, did not identify consistent increases in the rate of major birth defects. Available data from published observational studies and randomized controlled trials, based on second and third trimester exposure to oral and IV clindamycin, did not identify an increased risk of miscarriage or other adverse maternal or fetal outcomes. Most of the reported exposures to clindamycin occurred during the second and third trimesters of the pregnancy. In animal reproduction studies, no adverse developmental outcomes were observed when XACIATO was vaginally administered to pregna