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VIBATIV

Last Updated: January 21, 2010

Manufacturer:

Astellas Pharma US, Inc.

Pharmacological Class:

Antibiotic (lipoglycopeptide)

Active Ingredient(s):

Telavancin (as HCl) 250mg, 750mg; per vial; pwd for IV infusion after reconstitution and dilution; preservative-free.

Indication(s):

Complicated skin and skin structure infections due to susceptible gram (+) bacteria.

Pharmacology:

Telavancin is a synthetic derivative of vancomycin that exerts its antibacterial effect by inhibiting bacterial cell wall synthesis and disrupting the functioning of the cell membrane. It has been shown to be effective against most isolates of Staphylococcus aureus (including methicillin-resistant strains, or MRSA), Streptococcus pyogenes, S. agalactiae, S. anginosus group, E. faecalis (vancomycin-susceptible strains only).

The use of telavancin should be avoided in patients who are pregnant, unless the benefits to the patient outweighs the potential risks to the fetus (eg, skeletal malformations).

Clinical Trials:

Telavancin (10mg/kg daily) was compared to vancomycin (1g every 12 hrs) in two randomized, multinational, double-blind studies in adults with clinically documented complicated skin and skin structure infections with MRSA suspected or confirmed as the primary pathogen. Patients could receive concomitant aztreonam or metronidazole for suspected gram (–) or anaerobic infections, respectively. The all-treated efficacy (ATe) population included all patients who received any amount of study drug and were evaluated for efficacy; the clinically evaluable (CE) population included those patients in the ATe group with sufficient adherence to protocol.

Of 1794 ATe patients, 1410 were clinically evaluable. The primary efficacy endpoint for each trial was the clinical cure rate at a followup visit in the ATe and CE populations. The clinical cure rates for the ATe populations in Trial 1 and Trial 2 were 72.5% and 74.7%, respectively, for telavancin, compared with 71.6% and 74.0% for vancomycin. The clinical cure rates for telavancin in the CE populations for the two trials were 84.3% and 83.9%, respectively, compared with 82.8% and 87.7% for vancomycin. The clinical cure rate for MRSA for telavancin was 87.0% compared to 85.9% for vancomycin.

Legal Classification:

Adults:

≥18yrs: Give by IV infusion over 60 minutes. Treat for 7–14 days. Normal renal function: 10mg/kg every 24hrs. Renal impairment: CrCl 30–50mL/min: 7.5mg/kg every 24 hrs; CrCl 10 – <30mL/min: 10mg/kg every 48hrs; CrCl<10mL/min or dialysis: not recommended.

Children:

<18yrs: not recommended.

Precaution(s):

Obtain (–) pregnancy test before treatment for women of childbearing potential; use appropriate effective contraception during treatment. Baseline CrCl≤50mL/min. Monitor renal function. Diabetes. CHF. Hypertension. Long QT syndrome, uncompensated heart failure, severe left ventricular hypertrophy: not recommended. Pregnancy (Cat.C): not recommended, may cause fetal harm. Nursing mothers.

Interaction(s):

Caution with other drugs that can cause QT prolongation. Increased risk of renal toxicity with NSAIDs, ACE inhibitors, loop diuretics). May interfere with coagulation tests (eg, PT/INR, aPPT, activated clotting time, coagulation-based factor Xa tests) and some urine protein tests.

Adverse Reaction(s):

Dysgeusia, GI upset, foamy urine; nephrotoxicity (reevaluate if occurs), infusion reactions ("red man syndrome"), superinfection (eg, antibiotic-associated colitis), QT prolongation.