INDICATION AND IMPORTANT SAFETY INFORMATION
TOBI® Podhaler® (Tobramycin Inhalation Powder) 28 mg per capsule is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.  ...More

Safety Considerations for Patients Taking TOBI® Podhaler®

In a head-to-head study, TOBI Podhaler was evaluated for safety vs TOBI® (Tobramycin Inhalation Solution, USP)1,*

Adverse reaction
(≥10%)
TOBI Podhaler, %
(n=308)
TOBI, %
(n=209)
Cough 48.4 31.1
Lung disorder 33.8 30.1
Productive cough 18.2 19.6
Dyspnea 15.6 12.4
Pyrexia 15.6 12.4
Oropharyngeal pain 14.0 10.5
Dysphonia 13.6 3.8
Hemoptysis 13.0 12.4
Headache 11.4 12.0
  • Discontinuations due to adverse events were higher in the TOBI Podhaler arm (14%) than in the TOBI arm (8%)1

*The EAGER study was a randomized, open-label, parallel-group study in 517 patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (Pa) (within 6 months of screening) aged ≥6 years with FEV1 ≥25% to ≤75% predicted. The study consisted of 3 cycles; each cycle consisted of 28 days on treatment followed by 28 days off treatment, for a total duration of 24 weeks. Patients were randomized (3:2) to receive TOBI Podhaler 112 mg BID (n=308) or TOBI 300 mg/5 mL BID (n=209).1,2

This includes adverse events of pulmonary or CF exacerbations.

Ototoxicity

  • Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory or vestibular 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 dizziness1

Nephrotoxicity

  • 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 class1

Neuromuscular disorders

  • Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected neuromuscular dysfunction. 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 function1

Bronchospasm

  • Bronchospasm can occur with inhalation of TOBI Podhaler. Bronchospasm should be treated as medically appropriate1
  • EAGER study

    • Similar rates of bronchospasm were seen in the 2 treatment groups (≈5% in each treatment group, as defined by a ≥20% decrease in FEV1% predicted postdose)1
    • None of these patients experienced concomitant cough1

Use in pregnancy

  • 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 Podhaler1

A centralized support and access program for TOBI® Podhaler® patients

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SET TREATMENT EXPECTATIONS

Inform your patients about what to expect while taking TOBI® Podhaler®

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ADMINISTRATION INFORMATION

Administration information and helpful tips for patients taking TOBI® Podhaler®

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

TOBI® Podhaler® (Tobramycin Inhalation Powder) 28 mg per capsule is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in
1 second
(FEV1) <25% or >80% predicted, or patients colonized with Burkholderia cepacia.