Telavancin adverse reactions: Difference between revisions
| Line 7: | Line 7: | ||
The following serious adverse reactions are discussed elsewhere in the labeling: | The following serious adverse reactions are discussed elsewhere in the labeling: | ||
*Nephrotoxicity[see Warnings and Precautions ] | *[[Nephrotoxicity]] [see Warnings and Precautions ] | ||
*Infusion-related reactions [see Warnings and Precautions] | *Infusion-related reactions [see Warnings and Precautions] | ||
*Clostridium difficile-associated diarrhea [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. | 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. | ||
Latest revision as of 23:58, 9 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Adverse Reactions
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 included 929 adult patients treated with VIBATIV at 10 mg/kg IV once daily. The mean age of patients treated with VIBATIV was 49 years (range 18-96). There was a slight male predominance (56%) in patients treated with VIBATIV, and patients were predominantly Caucasian (78%).
In the cSSSI clinical trials, <1% (8/929) patients who received VIBATIV died and <1% (8/938) patients treated with vancomycin died. Serious adverse events were reported in 7% (69/929) of patients treated with VIBATIV 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, 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-treated patients observed in the VIBATIV 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 possibly related to the drug (including those reactions known to occur with other glycopeptide antibacterial agents).[1]
| [[File:|800px|thumb]] |
References
Adapted from the FDA Package Insert.