Overview
11 DESCRIPTION VIBATIV contains telavancin hydrochloride ( Figure 1 ), a lipoglycopeptide antibacterial that is a synthetic derivative of vancomycin. The chemical name of telavancin hydrochloride is vancomycin, N3''-[2(decylamino-)ethyl]-29[[(phosphonomethyl)-amino]-methyl]-hydrochloride.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Telavancin is an antibacterial drug [ see Clinical Pharmacology ( 12.4 ) ]. 12.2 Pharmacodynamics The antimicrobial activity of telavancin appears to best correlate with the ratio of area under the concentration-time curve to minimum inhibitory concentration (AUC/MIC) for S taphylococcus aureus based on animal models of infection. Exposure-response analyses of the clinical trials support the dose of 10 mg/kg every 24 hours. Cardiac Electrophysiology The effect of telavancin on cardiac repolarization was assessed in a randomized, double-blind, multiple-dose, positive-controlled, and placebo-controlled, parallel study (n=160). Healthy subjects received VIBATIV 7.
Indications
- 1 INDICATIONS AND USAGE VIBATIV is a lipoglycopeptide antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria: Complicated skin and skin structure infections (cSSSI) ( 1.1 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus . VIBATIV should be reserved for use when alternative treatments are not suitable. ( 1.
Common Doses
- 10 mg
- 7.5 mg
- 10 mL
- 50 mL
Dosage
2 DOSAGE AND ADMINISTRATION Complicated skin and skin structure infections (cSSSI): 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 14 days ( 2.1 ) Dosage adjustment in patients with renal impairment. ( 2.3 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP): 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 21 days ( 2.2 ) Dosage adjustment in patients with renal impairment. ( 2.3 ) a Calculate using the Cockcroft-Gault formula and ideal body weight (IBW). Use actual body weight if 50 10 mg/kg every 24 hours 30-50 7.
Black Box Warning
WARNING: INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, POTENTIAL ADVERSE DEVELOPMENTAL OUTCOMES Patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) should be considered only when the anticipated benefit to the patient outweighs...
Contraindications
- 4 CONTRAINDICATIONS Intravenous Unfractionated Heparin Sodium ( 4.1 , 5.5 , 7.1 ) Known hypersensitivity to VIBATIV ( 4.2 , 5.6 , 6.2 ) 4.1 Intravenous Unfractionated Heparin Sodium Use of intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration because the activated partial thromboplastin time (aPTT) test results are expected to be artificially prolonged for 0 to 18 hours after VIBATIV administration [ see Warnings and Precautions ( 5.5 ) and Drug Interactions ( 7.1 ) ]. 4.
Side Effects
- 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.
Interactions
- 7 DRUG INTERACTIONS 7.1 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, increases in the PT, INR, aPTT, and ACT have been observed.