TOBI PODHALER—
Designed with your patients in mind

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Not an actual patient

Carl

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48 years | Male

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First Pa Diagnosis: Age 17

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FEV1: 55%

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BMI: 19.2

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Average# Hospitalizations
per year: 1-2

Carl's travel doesn't always allow for a power source or refrigeration of my treatments

  • Consultant for a leading food distribution company
  • Proud uncle to his niece and nephew who live two states away
  • Fiercely proactive about adhering to his treatment schedule and incorporates exercise into his daily routine
  • Frequent visits to clients and family

Whether I am traveling for work or to visit
family, I don't have the same resources for my
treatments as I do when I am at home.

photo of male high school graduate
Not an actual patient

Josh

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18 years | Male

Icon of a heart with a cross and EKG line

First Pa Diagnosis: Age 10

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FEV1: 63%

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BMI: 50th percentile

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Average# Hospitalizations
per year: ~1

Looking for ways to help decrease his treatment time

  • Youngest of 3 siblings
  • High School graduate moving away to college this year
  • Active in theatre program and will continue to pursue in college
  • Believes existing nebulized treatment time will impact his busy class and extracurricular schedule

Time saved with my treatments is
time for the things I want to do.

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Not an actual patient

Olivia

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11 years | Female

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First Pa Diagnosis: 14 months ago

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FEV1: 75%

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BMI: 35th percentile

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Average# Hospitalizations
per year: ~1

Olivia wants to save time and have flexibility with her treatments

  • Recently transitioned from elementary to middle school
  • Her mom encourages Olivia to be more independent in managing her treatments
  • Plays violin in the concert band and is active in her church's youth group
  • Unable to eradicate her Pa and will now shift to maintenance treatment
    • It is not known if TOBI PODHALER is safe and effective when used for more than 3 cycles

Decreasing treatment time is exactly what
my daughter wants to fit her active lifestyle.

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Not an actual patient

Angela

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38 years | Female

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First Pa Diagnosis: Age 15

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FEV1: 60%

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BMI: 18.1

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Average# Hospitalizations
per year: ~1

Unable to take her treatments with her during her busy day

  • Single mother to her 8 year old son Liam
  • Works as a local Wedding Coordinator
  • Difficulty fitting in all her daily treatments due to travel around town for work and Liam's school commitments and sporting events

Portability is everything for a mom
on the go and especially for one like
me who is managing their CF.

MORE + LESS –

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.

Please see full Prescribing Information