17.3 Risks Associated with Aminoglycosides
Inform patients of adverse reactions associated with aminoglycosides such as nephrotoxicity and neuromuscular disorders.

17.4 Laboratory Tests
Inform patients of the need to monitor hearing, serum concentrations of tobramycin, or renal function as necessary during treatment with TOBI Podhaler.

17.5 Pregnancy
Inform patients that aminoglycosides can cause fetal harm when administered to a pregnant woman. Advise them to inform their doctor if they are pregnant, become pregnant, or plan to become pregnant.

17.6 Cough
Inform patients that cough was reported with the use of TOBI Podhaler in clinical trials. If coughing that may be experienced with TOBI Podhaler becomes bothersome or cannot be tolerated, advise patients that tobramycin inhalation solution or alternative therapeutic options may be considered.

T2013-20
March 2013

Patient Information

TOBI (TOH-bee) Podhaler (POD-hay-ler)

(tobramycin inhalation powder)

For Oral Inhalation

Important information: Do not swallow TOBI Podhaler capsules. TOBI Podhaler capsules are used only with the Podhaler device and inhaled through your mouth (oral inhalation). Never place a capsule in the mouthpiece of the Podhaler device.

Read this Patient Information before you start using TOBI Podhaler and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is TOBI Podhaler?

TOBI Podhaler is a prescription medicine used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. TOBI Podhaler contains an antibacterial medicine called tobramycin (an aminoglycoside).

It is not known if TOBI Podhaler is safe and effective:

in children under 6 years of age
in people who have an FEV1 less than 25% predicted
in people who are colonized with a bacterium called Burkholderia cepacia
when used for more than 3 cycles
Who should not use TOBI Podhaler?

Do not use TOBI Podhaler if you are allergic to tobramycin, any of the ingredients in TOBI Podhaler, or to any other aminoglycoside antibacterial.

What should I tell my healthcare provider before using TOBI Podhaler?

Before you use TOBI Podhaler, tell your healthcare provider if you:

have or have had hearing problems (including noises in your ears such as ringing or hissing)
have dizziness
have or have had kidney problems
have or have had problems with muscle weakness such as myasthenia gravis or Parkinson’s disease
have or have had breathing problems such as wheezing, coughing, or chest tightness
have had an organ transplant
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed. It is not known if TOBI Podhaler passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using TOBI Podhaler with certain other medicines can cause serious side effects.

If you are using TOBI Podhaler, you should discuss with your healthcare provider if you should take:

other medicines that may harm your nervous system, kidneys, or hearing
“water pills” (diuretics) suc