Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are also discussed elsewhere in the labeling: Nephrotoxicity [ see Warnings and Precautions ( 5.3 ) ] Infusion-related reactions [ see Warnings and Precautions ( 5.7 ) ] Clostridium difficile -associated diarrhea [ see Warnings and Precautions ( 5.8 ) ] 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.
Most common adverse reaction (≥10% of patients treated with VIBATIV) in the HABP/VABP trials is diarrhea;
in the cSSSI trials, the most common adverse reactions (≥10% of patients treated with VIBATIV) include: taste disturbance, nausea, vomiting, and foamy urine.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc.
at 1-877-683-6110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Complicated Skin and Skin Structure Infections 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.
5 WARNINGS AND PRECAUTIONS Decreased efficacy among patients treated for skin and skin structure infections with moderate/severe pre-existing renal impairment: Consider these data when selecting antibacterial therapy for patients with baseline CrCl ≤50 mL/min.
( 5.2 ) Coagulation test interference: Telavancin interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time.
( 5.5 , 7.1 ) Hypersensitivity reactions: Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses.
VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin.
( 5.6 , 6.2 ) Infusion-related reactions: Administer VIBATIV over at least 60 minutes to minimize infusion-related reactions.
Like all medications, Vibativ can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: