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 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

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

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

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.

IMPORTANT SAFETY INFORMATION

INDICATION

TOBI® Podhaler® (Tobramycin Inhalation Powder) 28 mg per capsule is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa.

It is not known if TOBI Podhaler is safe and effective in patients under 6 years of age, in those with lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia.

IMPORTANT SAFETY INFORMATION

You should not use TOBI Podhaler if you are allergic to it or to any other aminoglycoside antibacterial.

Tell your doctor before starting treatment if you have or have had hearing, kidney, breathing, or muscle weakness problems or if you have dizziness, an organ transplant, or are pregnant or nursing.

Tell your doctor about all the drugs you take. Ask if you should take other medicines that may harm your nervous system, kidneys, or hearing; "water pills" (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or mannitol; or urea.

TOBI Podhaler can cause serious side effects, including hearing loss or ringing in the ears. Tell your doctor right away if you have hearing loss, noises in your ears such as ringing or hissing, vertigo, difficulty with balance, or dizziness.

TOBI Podhaler is in a class of drugs that may worsen kidney problems, especially in people with known or suspected kidney problems. Your health care provider may do a blood test to check how your kidneys are working while you are using TOBI Podhaler.

TOBI Podhaler is in a class of drugs that may worsen muscle weakness problems or harm an unborn baby.

TOBI Podhaler can cause severe breathing problems (bronchospasm). Tell your doctor right away if you get shortness of breath with wheezing, or coughing and chest tightness.

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 your voice (hoarseness or loss of voice), coughing up blood, headache, and altered taste.

Let your doctor know if your symptoms worsen or if you have a side effect that bothers you enough to stop treatment or that does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.