The first antibiotic inhaler device has been launched in the UK to treat chronic lung infections in adults and older children with cystic fibrosis (CF).
The TOBI Podhaler (pictured) from Novartis is a hand-held inhaler that delivers a new dry powder form of tobramycin to fight chronic Pseudomonas aeruginosa (Pa) lung infections, a common cause of death in people with CF.
The new device is estimated to save almost half an hour treatment time per day in people with CF over the age of 6, increasing their independence and quality of life.
CF affects 9,000 people in the UK. A life-threatening condition, it makes the lungs vulnerable to chronic infections.
Clinical studies have shown that treatment with tobramycin inhalation powder reduces treatment time by 72% compared with the nebulised drug.
Professor Stuart Elborn, Professor of Respiratory Medicine at Queen’s University, Belfast, commented: “People with CF have to endure a lengthy regimen of treatments and physiotherapy every day, so the time saved using tobramycin inhalation powder is significant.”
The new tobramycin inhalation powder has been produced using Novartis’ patented PulmoSphere technology. In trials, it was successfully inhaled in 5–6 minutes, whereas the nebuliser solution takes 20 minutes. For a twice-daily regimen, this saves approximately 28 minutes per day.
The dry powder inhaler is also less vulnerable to bacterial growth than the nebuliser, and needs no battery.
“We are proud to be launching TOBI Podhaler: a product that clearly demonstrates how we are applying innovative technology to better meet the needs of people with CF, helping them to lead independent and active lives,” said Dr Tim Cave, Medical Director of Novartis Pharmaceuticals UK.
Based in Basel, Switzerland, Novartis supplies a diversified portfolio of healthcare products including pharmaceuticals, diagnostics and drug delivery devices.
TOBI Podhaler Rx
Generic Name and Formulations:
Tobramycin 28mg/cap; dry pwd in caps for oral inhalation; with Podhaler device.

Company:
Novartis Pharmaceuticals Corp
Indications for TOBI Podhaler:
Management of cystic fibrosis patients with P. aeruginosa.

Adults and Children's Dose:
<6yrs: not recommended. For oral inhalation only. Give in alternate 28-day cycles (28 days on, 28 days off). ≥6yrs: Inhale 4 capsules twice daily, as close to every 12hrs as possible (must be at least 6hrs apart). Give last when using multiple inhalation therapies.

Pharmacological Class:
Aminoglycoside.

Warnings/Precautions:
Safety and efficacy have not been demonstrated in patients <6yrs, in those with FEV1 <25% or >80% predicted, or patients colonized with B. cepacia. Known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. Myasthenia gravis. Parkinson’s disease. Consider performing an audiogram at baseline (esp. at risk of auditory dysfunction). Monitor serum tobramycin levels in auditory or renal dysfunction patients, or if used with other aminoglycosides (or other nephrotoxic or ototoxic drugs) as needed. Discontinue if ototoxicity or nephrotoxicity occurs; may restart when serum tobramycin <2μg/mL. Monitor renal function as needed. Elderly. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:
Concomitant ethacrynic acid, furosemide, urea, mannitol: not recommended. Diuretics may increase toxicity. Avoid concomitant and/or sequential use with other neurotoxic, nephrotoxic, or ototoxic drugs.

Adverse Reactions:
Cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, headache; hearing loss, tinnitus, nephrotoxicity, bronchospasm.

How Supplied:
Caps—224 (w. Podhaler devices)