Approved December 15, 2009

TELAVANCIN HYDROCHLORIDE
(FDA Category 1S)

VIBATIV(TM) (Astellas Pharma US, Inc.) is a semisynthetic lipoglycopeptide antibiotic, which is bactericidal against Gram-positive microorganisms via interference with cell wall synthesis and disruption of membrane barrier function.

FDA Approval Date : 911-2009

DOSING INFORMATION: 10 mg/kg intravenous infusion over 60 minutes once daily for 7 to 14 days; renally adjusted based on creatinine clearance.

PHARMACOKINETICS: Steady state concentrations are achieved by the third daily dose. The average protein binding is approximately 90% and is not affected by renal or hepatic impairment. The primary route of elimination is renal, with 76% recovered unchanged in the urine and less than 1% recovered in feces. Clearance is not expected to be affected by CYP450 inhibitors. Hydroxylated metabolites were predominately identified, but the exact metabolic pathway is unknown. The terminal elimination halflife is approximately 8 hours.

CAUTIONS: New onset or worsening of renal impairment has occurred, and efficacy was reduced in patients with baseline moderate to severe renal impairment. Use with caution in patients with underlying conditions or receiving concomitant drugs that cause QT interval prolongation. Infusion-related reactions, including Red-man-like syndrome, have occurred. Telavancin interferes with coagulation test results such as PT, INR, aPTT, activated clotting time, and coagulation based factor Xa tests. It also interferes with urine qualitative dipstick protein assays, as well as quantitative dye methods such as those using pyrogallol red-molybdate. The most common adverse events include taste disturbance, nausea, vomiting, and foamy urine.

FDA APPROVED INDICATIONS: Telavancin is indicated for the treatment of complicated skin and skin structure infections (cSSSI) in adults caused by susceptible Gram-positive microorganisms.