The following clinically significant adverse reactions are described elsewhere in the labeling:
- Clostridioides difficile-Associated Diarrhea (CDAD) [see WARNINGS AND PRECAUTIONS]
- Use with Polyurethane Condoms [see WARNINGS AND PRECAUTIONS]
- Vaginal Candida Infections [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the placebo-controlled trial (Trial 1), 202 patients with bacterial vaginosis were treated with a single dose of XACIATO, and 103 patients were treated with a single dose of placebo gel. The median age of the patients in the trial was 35 years (range 15-59 years). The population was 56% Black or African American and 41% White. Persons of Hispanic or Latino ethnicity made up 25% of the population. A history of prior bacterial vaginosis was noted in 89% of the population.
Most Common Adverse Reactions
Adverse reactions were reported by 76/202 (38%) of patients who received XACIATO and 28/103 (27%) of patients who received placebo in Trial 1. Table 1 displays the most common adverse reactions (occurring in >2% of patients and at a higher rate in the XACIATO group than in the placebo group) in Trial 1.
Table 1: Adverse Reactions Occurring in >2% of Patients Receiving XACIATO in Trial 1
N=202 n (%)
N=103 n (%)
|Vulvovaginal candidiasis||35 (17)||4 (4)|
|Vulvovaginal discomfort*||13 (6)||5 (5)|
|*Vulvovaginal discomfort includes the terms vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal erythema, vulvovaginal dryness, and vulvovaginal discomfort.|
Other Clindamycin Formulations
XACIATO affords low peak serum levels and systemic exposure of clindamycin compared to an oral or intravenous dose of clindamycin [see CLINICAL PHARMACOLOGY]. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available.
The following additional adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin:
Gastrointestinal: Abdominal pain, esophagitis, nausea, Clostridioides difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS].
Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of these reports.
Hypersensitivity Reactions: Maculopapular rash, vesiculobullous rash, and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. Cases of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported.
Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.
Musculoskeletal: Cases of polyarthritis have been reported.
Renal: Acute kidney injury.
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.
Read the entire FDA prescribing information for Xaciato (Clindamycin Phosphate Vaginal Gel)