TOBI PODHALER safety considerations for patients
In a head-to-head study, TOBI PODHALER was evaluated for safety vs TOBI® (Tobramycin Inhalation Solution, USP)1,*
Adverse reactions (≥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
†This includes adverse events of pulmonary or CF exacerbations.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 In a double-blind, phase-III trial patients aged 6 to 21 years with CF, Pa and FEV1 ≥25% and ≤80% predicted at screening were randomized 1:1 to receive TOBI PODHALER (n=46) [4 times 28 mg capsules twice-daily] or placebo (n=49). Of the 79 patients included in the prespecified interim analysis, 18 were excluded due to a failure to meet spirometry quality review criteria, which resulted in a total of 61 patients included in the primary analysis. Cough was the most commonly reported adverse event during the first cycle of treatment and occurred more frequently in placebo-treated patients (26.5%) than patients treated with TOBI PODHALER (13%). In a 24-week, randomized, open-label trial patients aged ≥6 years with CF, Pa and FEV1 ≥25% and ≤80% predicted within 6 months of screening were randomized 3:2 to receive TOBI PODHALER (n=308) [four capsules/112 mg tobramycin twice-daily] or TOBI solution (n=209) [300 mg/5 mL tobramycin twice-daily]. Cough was the most frequently reported adverse event and was more common in the TOBI PODHALER arm (48% TOBI PODHALER versus 31% TOBI solution). Discontinuations due to adverse events were 14% for TOBI PODHALER versus 8% for TOBI solution. EAGER, Establish a new gold standard efficacy and safety with tobramycin in cystic fibrosis.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
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
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