PulmoSphere Technology

Key
Clinical Data

Inspiratory Flow Profiles for Dispersion of PulmoSphere^® Particles¹

In a clinical study, patients with moderate to severe disease
(6 years and older) were able to receive medication via the Podhaler device²

Older patients with significant disease progression and associated decreases in forced expiratory volume in 1 second (FEV₁), and younger patients (aged >6 years) with inhaled volumes <1 L, were able to generate the inspiratory flow rates and volumes required to receive their medication when following the Instructions for Use; however, no pediatric patients aged 6 to 10 years with FEV₁ <40% predicted were evaluated.²

Inspiratory flow profiles of 96 patients with CF with varying degrees of lung disease from a simulated inhaler study^1,3,*,†

*This study explored inspiratory variables of 96 patients with CF aged ≥6 years with varying degrees of lung disease while inhaling through mouthpieces with resistance that simulated dry-powder inhaler devices. Enrolled patients were aged 6 to 53 years with FEV₁ 19% to 126% predicted. TOBI^® Podhaler^® is indicated for patients with an FEV₁ 25% to 80% predicted.^1-3

^†A flow rate of 40 L/min represents a flow rate more than 2 standard deviations below the mean peak inspiratory flow rates measured for pediatric patients in the study.⁴

References

1. TOBI Podhaler [Prescribing Information, 2020]

2. Geller DE, Weers J, Heuerding S. Development of an inhaled dry-powder formulation of tobramycin using PulmoSphere™ Technology. J Aerosol Med Pulm Drug Deliv. 2011;24(4):175-182.

3. Danforth P. Miller, Trixie Tan, Thomas E. Tarara, John Nakamura, Richard J. Malcolmson, and Jeﬀry G. Weers. Physical Characterization of Tobramycin Inhalation Powder: I. Rational Design of a Stable Engineered-Particle Formulation for Delivery to the Lungs. Mol. Pharmaceutics 2015, 12, 2582−2593.

4. Tiddens HA, Geller DE, Challoner P, et al. Effect of dry powder inhaler resistance on the inspiratory flow rates and volumes of cystic fibrosis patients of six years and older. J Aerosol Med. 2006;19(4):456-465.

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.

IMPORTANT SAFETY INFORMATION

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

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

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.

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. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal. A decision should be made whether to discontinue nursing or TOBI Podhaler. TOBI may cause intestinal flora alteration. Advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis.

Patients receiving concomitant TOBI and parenteral aminoglycoside therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class. Serum tobramycin levels should be monitored.

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 occurring at a frequency of at least 10%, were cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, and headache.

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TOBI-2020-0225 V4

Please see full Prescribing Information, including Patient Product Information.

Inspiratory Flow Profiles for Dispersion of PulmoSphere^® Particles¹

In a clinical study, patients with moderate to severe disease
(6 years and older) were able to receive medication via the Podhaler device²

References

SET TREATMENT EXPECTATIONS

ADMINISTRATION INFORMATION

Share

You are leaving Tobi Podhaler website

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

Inspiratory Flow Profiles for Dispersion of PulmoSphere® Particles1

In a clinical study, patients with moderate to severe disease (6 years and older) were able to receive medication via the Podhaler device2

References

SET TREATMENT EXPECTATIONS

ADMINISTRATION INFORMATION

Share

You are leaving Tobi Podhaler website

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

Inspiratory Flow Profiles for Dispersion of PulmoSphere^® Particles¹

In a clinical study, patients with moderate to severe disease
(6 years and older) were able to receive medication via the Podhaler device²