INDICATION: TOBI® PODHALER® (Tobramycin Inhalation Powder) 28 mg per capsule and TOBI® (Tobramycin Inhalation Solution) are prescription inhaled medications for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. It is not known if TOBI PODHALER or TOBI are 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

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.

You should not use TOBI PODHALER or TOBI if you are allergic to tobramycin, any of the ingredients, or to any other aminoglycoside antibacterial medicines.

Before using TOBI PODHALER or TOBI, tell your healthcare provider about all of your medical conditions, including if you have or have had hearing problems; dizziness; kidney problems; muscle weakness; breathing problems such as wheezing, coughing, or chest tightness; if you have had an organ transplant; are pregnant or nursing or plan to become pregnant or nurse; or if you are receiving aminoglycoside therapy by injection or through a vein. Also, tell your healthcare provider if your mother has had hearing problems after taking an aminoglycoside or if you have been told you have certain gene variants related to hearing abnormalities inherited from your mother.

TOBI PODHALER and TOBI contain a medicine that can harm your unborn baby. It is not known if it passes into breast milk. Check your baby for watery stools, bloody stools, thrush, or diaper rash if you breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using TOBI Podhaler or TOBI with certain other medicines can cause serious side effects. If you are using TOBI PODHALER or TOBI, discuss 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 intravenous mannitol; or urea.

TOBI PODHALER and TOBI can cause serious side effects, including:

  • Severe breathing problems (bronchospasm). Tell your healthcare provider right away if you get shortness of breath with wheezing or coughing and chest tightness while using TOBI PODHALER or TOBI.
  • Hearing loss or ringing in the ears (ototoxicity). Tell your healthcare provider right away if you have hearing loss, noises in your ears such as ringing or hissing, vertigo, difficulty with balance, or dizziness.
  • Worsening kidney problems (nephrotoxicity). TOBI PODHALER and TOBI are in a class of medicines that may cause worsening kidney problems, especially in people with known or suspected kidney problems. Your healthcare provider may do a blood test to check how your kidneys are working while you are using TOBI PODHALER or TOBI.
  • Worsening muscle weakness. TOBI PODHALER and TOBI are in a class of medicines that can cause worsening muscle weakness in people who already have problems with muscle weakness (myasthenia gravis or Parkinson's disease).

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), coughing up blood, and headache.

The most common side effects of TOBI include increased cough, coughing up blood, voice changes, sore throat, decreased lung function, loss or change in taste, increased sputum, trouble breathing, and rash.

Let your healthcare provider 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.

Please see Full Prescribing Information and Patient Information for TOBI PODHALER.
Please see Full Prescribing Information and Patient Information for TOBI Solution.