TOBI Podhaler is for people 6 years and older with cystic fibrosis (CF), Pseudomonas aeruginosa (Pa), and forced expiratory volume in 1 second (FEV1) 25% to 80% predicted and who do not have Burkholderia cepacia.1

In a clinical trial vs placebo, TOBI Podhaler patients experienced1

Improved lung function

Improved lung function1

Lung function is measured by forced expiratory volume in 1 second (FEV1), or the amount of air you can blow out in 1 second after taking a deep breath. After FEV1 is measured, it is expressed as a percentage of the predicted normal FEV1 value for the patient, or FEV1% predicted.1-3

  • TOBI Podhaler demonstrated 12.54% improvement in FEV1% predicted after 28 days of treatment compared with 0.09% improvement with placebo

  • In another study, TOBI Podhaler did not show significant improvements in lung function compared with placebo

Fewer respiratory-related hospitalizations 64%

Fewer respiratory-related hospitalizations1

4.4% of patients who received TOBI Podhaler required respiratory-related hospitalizations during the course of 1 treatment cycle vs 12.2% of patients who received placebo.1

Fewer patients needed IV antipseudomonal antibiotics 15%

Fewer patients needed IV antipseudomonal antibiotics1

8.7% of patients who received TOBI Podhaler used IV antipseudomonal antibiotics during the course of 1 treatment cycle vs 10.2% of patients who received placebo.1

It is not known if TOBI Podhaler is safe and effective when used for more than 3 cycles.1

Laboratory test results show reduced tobramycin activity against Pa bacteria in some patients with the use of TOBI Podhaler. The relationship between these lab results and how well TOBI Podhaler works is not clear. Let your health care provider know if your symptoms worsen.1

Established safety profile in a clinical trial vs TOBI® nebulizing solution

TOBI Podhaler was evaluated for safety in 425 patients with CF exposed to at least 1 dose of TOBI Podhaler, including 273 patients who were exposed across 3 cycles. The most common side effects of TOBI Podhaler include cough, worsening of lung problems or cystic fibrosis, productive cough, shortness of breath, fever, sore throat, changes in voice (hoarseness), coughing up blood, headache, and altered taste.1

References: 1. TOBI Podhaler [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 2. Konstan MW, Geller DE, Minić P, Brockhaus F, Zhang J, Angyalosi G. Tobramycin inhalation powder for P aeruginosa infection in cystic fibrosis: the EVOLVE trial. Pediatr Pulmonol. 2011;46(3):230-238. 3. National Institute for Occupational Safety and Health (NIOSH). NIOSH Spirometry Training Guide. Centers for Disease Control and Prevention website. https://www.cdc.gov/niosh/docs/2004-154c/pdfs/2004-154c.pdf. Accessed August 9, 2016.