XACIATO
Generic: CLINDAMYCIN PHOSPHATE
Basic Information
Manufacturer
Organon LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
VAGINAL
FDA Set ID
0423007f-28fa-4159-bf58-9174626d2347
Indications & 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 )] .
( 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 )] .
Adverse Reactions
6 ADVERSE REACTIONS 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 discomfort.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 Adverse Reaction XACIATO N=202 n (%) Placebo N=103 n (%) Vulvovaginal candidiasis 35 (17) 4 (4) Vulvovaginal discomfort Vulvovaginal discomfort includes the terms vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal erythema, vulvovaginal dryness, and vulvovaginal discomfort.
13 (6) 5 (5) 6.2 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 ( 12.3 )] .
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 ( 5.1 )] .
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.
Immune: Drug reaction with eosinophilia with systemic symptoms (DRESS) cases have been reported.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 Adverse Reaction XACIATO N=202 n (%) Placebo N=103 n (%) Vulvovaginal candidiasis 35 (17) 4 (4) Vulvovaginal discomfort Vulvovaginal discomfort includes the terms vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal erythema, vulvovaginal dryness, and vulvovaginal discomfort.
13 (6) 5 (5) 6.2 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 ( 12.3 )] .
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 ( 5.1 )] .
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.
Immune: Drug reaction with eosinophilia with systemic symptoms (DRESS) cases have been reported.