What is Pseudomonas aeruginosa (Pa)?

Pa is a very common bacterium that can cause damage to the lungs in patients with cystic fibrosis (CF).1-4

Pa infects the lungs of nearly everyone with CF at some time during their life1

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

In general, the chance of having Pa in the lungs increases with age in patients with CF4

Reproduced with permission from the Cystic Fibrosis Foundation.4

What are the effects of Pseudomonas aeruginosa?

Pa can cause lung function to worsen in patients with CF, and is a leading cause of chronic lung infection in patients with CF3

Over time, with Pa in your lungs, you may2,3

  • Develop a cough that doesn't go away
  • Have more mucus in your lungs
  • Feel tightness in your chest
  • Have a hard time catching your breath

If Pa infection is not properly managed, it can continue to damage the lungs and make breathing even more difficult1

Inhaled antibiotics are commonly prescribed by doctors to treat chronic lung infection in patients with CF and Pa. It is important that inhaled antibiotics be taken as prescribed.2,4,5

References: 1. TOBI Podhaler [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 2. Mogayzel PJ Jr, Naureckas ET, Robinson KA, et al; and Cystic Fibrosis Foundation Pulmonary Clinical Practice Guidelines Committee. Cystic Fibrosis Foundation pulmonary guideline: pharmacologic approaches to prevention and eradication of initial Pseudomonas aeruginosa infection. Ann Am Thorac Soc. 2014;11(10):1640-1650. 3. Lyczak JB, Cannon CL, Pier GB. Lung infections associated with cystic fibrosis. Clin Microbiol Rev. 2002;15(2):194-222. 4. Patient Registry: Annual Data Report 2014. Bethesda, MD: Cystic Fibrosis Foundation; 2015. 5. Antibiotics. Cystic Fibrosis Foundation website. https://www.cff.org/Living-with-CF/Treatments-and-Therapies/Inhaled-Medications/Antibiotics/. Accessed July 19, 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.