XACIATO (clindamycin phosphate)

XACIATO (clindamycin phosphate)

Self-Administration – topical

Diagnosis considered for coverage:

• Bacterial Vaginosis: Indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older.  

Coverage Criteria:

For diagnosis of Bacterial Vaginosis:

• Dose does not exceed one applicatorful (8 g) once as a single dose; AND
• Patient is 12 years age or older; AND
• Diagnosis of bacterial vaginosis; AND
• Trial and failure of a minimum 5-day supply within the past 180 days, contraindication, or intolerance to generic metronidazole 0.75% vaginal gel; AND
• Trial and failure of a minimum 3-day supply within the past 180 days, contraindication, or intolerance to generic clindamycin 2% vaginal cream

Coverage Duration: 

• Limited to a single dose (1 fill of a 8-gram tube)

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dosage and administration
  • Administer once applicatorful (5 g of gel containing 100 mg of clindamycin) once intravaginally as a single dose at any time of the day
  • Xaciato gel is for 1 time (single-use) only
  • Not for ophthalmic, dermal, or oral use
• Contraindications:
  • History of hypersensitivity to clindamycin or lincomycin 
• Drug Interactions:
  • Neuromuscular blocking agents – use caution in patients receiving such agents

Policy Updates:

• 08/15/2023 – New policy approved by P&T. 

References:

1. Xaciato Prescribing Information. Daré Bioscience, Inc. San Diego, CA. December 2021.