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. 
     

Last review date: September 1, 2023

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