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The following serious adverse reactions are discussed elsewhere in the labeling:
- Nephrotoxicity [see WARNINGS AND PRECAUTIONS]
- Infusion-related reactions [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]
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.
Clinical Trials Experience
The two Phase 3 cSSSI clinical trials (Trial 1 and Trial 2) for VIBATIV (telavancin for injection) included 929 adult patients treated with VIBATIV (telavancin for injection) at 10 mg/kg IV once daily. The mean age of patients treated with VIBATIV (telavancin for injection) was 49 years (range 18-96). There was a slight male predominance (56%) in patients treated with VIBATIV (telavancin for injection) , and patients were predominantly Caucasian (78%).
In the cSSSI clinical trials, < 1% (8/929) patients who received VIBATIV (telavancin for injection) died and < 1% (8/938) patients treated with vancomycin died. Serious adverse events were reported in 7% (69/929) of patients treated with VIBATIV (telavancin for injection) and most commonly included renal, respiratory, or cardiac events. Serious adverse events were reported in 5% (43/938) of vancomycin-treated patients, and most commonly included cardiac, respiratory, or infectious events. Treatment discontinuations due to adverse events occurred in 8% (72/929) of patients treated with VIBATIV (telavancin for injection) , the most common events being nausea and rash (~1% each). Treatment discontinuations due to adverse events occurred in 6% (53/938) of vancomycin-treated patients, the most common events being rash and pruritus (~1% each).
The most common adverse reactions occurring in 10% of VIBATIV (telavancin for injection) -treated patients observed in the VIBATIV (telavancin for injection) Phase 3 cSSSI trials were taste disturbance, nausea, vomiting, and foamy urine.
Table 4 displays the incidence of treatment-emergent adverse drug reactions reported in > 2% of patients treated with VIBATIV (telavancin for injection) possibly related to the drug (including those reactions known to occur with other glycopeptide antibacterial agents).
Table 4: Incidence of Treatment-emergent Adverse Drug Reactions
Reported in ≥ 2% of VIBATIV (telavancin for injection) or Vancomycin Patients Treated in Trial 1 and
|Body as a Whole|
|Metabolic and Nutritional|
|Skin and Appendages|
|Infusion site pain||4%||4%|
|Infusion site erythema||3%||3%|
|1Described as a metallic or soapy taste.|
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Drug-Laboratory Test Interactions
Effects of Telavancin on Coagulation Test Parameters
Telavancin binds to the artificial phospholipid surfaces added to common anticoagulation tests, thereby interfering with the ability of the coagulation complexes to assemble on the surface of the phospholipids and promote clotting in vitro. These effects appear to depend on the type of reagents used in commercially available assays. Thus, when measured shortly after completion of an infusion of VIBATIV (telavancin for injection) , increases in the PT, INR, aPTT, and ACT have been observed. These effects dissipate over time, as plasma concentrations of telavancin decrease.
Urine Protein Tests
Telavancin interferes with urine qualitative dipstick protein assays, as well as quantitative dye methods (e.g., pyrogallol red-molybdate). However, microalbumin assays are not affected and can be used to monitor urinary protein excretion during VIBATIV (telavancin for injection) treatment.
Last reviewed on RxList: 9/17/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Vibativ Information
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