PARENTERAL TOBRAMYCIN SUSCEPTIBILITY
BREAKPOINTS DON'T APPLY TO TOBI1

Even CF patients with Pa considered resistant* to tobramycin showed a clinical response to TOBI2

TOBI susceptibility breakpoints

Results from 2 identical, randomized, multicenter, double-blind, placebo-controlled trials. Patients were treated with 300 mg of aerosolized tobramycin (n=258) or placebo (n=262) twice daily in 3 cycles, with each cycle consisting of 28 days during which the drug was administered and 28 days during which the drug was not administered. The primary efficacy end point was change in FEV1 at week 20.1,3

The relationship between in vitro susceptibility test results and clinical outcome with TOBI therapy is not clear.1

*Using parenteral breakpoint value of a minimum inhibitory concentration (MIC) ≥16 µg/mL.2

 



Important Safety Information full Prescribing Information www.fda.gov/medwatch

References:

  • TOBI [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2009.
  • LiPuma JJ. Microbiological and immunologic considerations with aerosolized drug delivery. Chest. 2001;120(suppl 3):118S-123S.
  • Ramsey BW, Pepe MS, Quan JM, et al. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. N Engl J Med. 1999;340:23-30.