TOBI^® is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

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

Caution should be exercised when prescribing TOBI to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant parenteral aminoglycoside therapy should be monitored as clinically appropriate.

Voice alteration (13% vs 7%) and tinnitus (3% vs 0%) were the only adverse experiences reported by significantly more TOBI-treated patients than placebo patients in controlled clinical studies. Ototoxicity, as measured by complaints of hearing loss or by audiometric evaluations, did not occur with TOBI therapy during clinical studies. However, in postmarketing experience, patients receiving TOBI have reported hearing loss. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides.

Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. An audiogram should be considered for patients who show any evidence of, or are at increased risk for, auditory dysfunction.

Nephrotoxicity was not seen during TOBI clinical studies but has been associated with aminoglycosides as a class. If nephrotoxicity occurs, TOBI therapy should be discontinued until serum tobramycin concentrations fall to <2 μg/mL. Serum concentrations of tobramycin in patients with renal dysfunction or those treated with concomitant parenteral tobramycin should be monitored at the physician's discretion.

TOBI should be used cautiously in patients with muscular disorders, such as myasthenia gravis or Parkinson's disease.

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

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Patients who use TOBI during pregnancy, or become pregnant while taking TOBI, should be apprised of the potential hazard to the fetus. It is not known if TOBI is excreted in human breast milk; a decision should be made whether to terminate nursing or discontinue TOBI.

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