TOBI®: PROVEN TO REDUCE THE NEED FOR IV
ANTIPSEUDOMONAL ANTIBIOTICS1

TOBI demonstrated a significant reduction in the need for IV
antipseudomonal antibiotics1


In pivotal studies, TOBI patients required IV antipseudomonal antibiotics an average of 9.6 days over 24 weeks compared to an average of 14.1 days for those patients taking placebo.1

37% fewer days receiving IV antipseudomonal antibiotics

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 20.1,2

  • Patients treated with TOBI were 36% less likely to require IV antipseudomonal antibiotics than placebo (95% CI, 17%-51%)1
  • During the same 6-month studies, TOBI treatment reduced the proportion of patients requiring IV antipseudomonal antibiotics by 25%1
  • Of those patients, 40% of TOBI patients required IV antipseudomonal antibiotics compared with 53% of placebo patients1

*Average number of days receiving IV antipseudomonal antibiotics.

 



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

References:

  • 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.
  • TOBI [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2009.