INDICATION AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

TOBI Podhaler is contraindicated in patients with known hypersensitivity to any aminoglycoside.

Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction.

Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI Podhaler clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia, or dizziness.

Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction. Nephrotoxicity was not observed during TOBI Podhaler clinical studies, but has been associated with aminoglycosides as a class.

TOBI Podhaler should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.

Bronchospasm can occur with inhalation of TOBI Podhaler. Bronchospasm should be treated as medically appropriate.

Physicians should consider a baseline audiogram, particularly for patients who are at increased risk for auditory dysfunction. Serum concentrations of tobramycin should be monitored at the physician’s discretion in patients with known or suspected auditory or renal dysfunction, or in patients treated with a concomitant parenteral aminoglycoside. If ototoxicity or nephrotoxicity occurs, tobramycin therapy should be discontinued until serum concentrations fall below 2 μg/mL.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Patients who use TOBI Podhaler during pregnancy, or who become pregnant while taking TOBI Podhaler, should be apprised of the potential hazard to the fetus. The amount of tobramycin excreted in human breast milk is unknown; a decision should be made whether to discontinue nursing or TOBI Podhaler.

Concurrent and/or sequential use of TOBI Podhaler with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI Podhaler should not be administered concomitantly with ethacrynic acid, furosemide, urea, or mannitol.

In a clinical trial, the most commonly observed adverse events with TOBI Podhaler vs TOBI, occurring at a frequency of at least 15% in either group, were cough (48.4%, 31.1%), lung disorder (33.8%, 30.1%), productive cough (18.2%, 19.6%), dyspnea (15.6%, 12.4%), and pyrexia (15.6%, 12.4%).

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