How can TOBI Podhaler treatment fit into my day?

ADMINISTERED IN 2-7 MINUTES1,*

  • Take 4 capsules for inhalation twice daily: 4 in the morning and 4 in the evening
    • The powder from all 4 capsules must be inhaled to receive the full dose
    • Inhale 2 times from each capsule in order to empty it
  • 28 days on and 28 days off

PORTABLE1,2

  • Compact and lightweight
  • No refrigeration or power source required

CLEANUP WITH MINIMAL NUMBER OF STEPS1

  • No disinfection required
  • Wipe clean with a dry cloth

*As observed in a clinical trial.

Important Dosing Considerations1

  • TOBI Podhaler capsules must not be swallowed
  • Capsules are for use with the Podhaler device only
  • Capsules are for oral inhalation only
  • Each dose of 4 capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart
  • Capsules should always be stored in the blister card; each capsule should only be removed IMMEDIATELY BEFORE USE

References: 1. TOBI Podhaler [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 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.

IMPORTANT SAFETY INFORMATION

INDICATION

TOBI® Podhaler® (Tobramycin Inhalation Powder) 28 mg per capsule is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa.

It is not known if TOBI Podhaler is safe and effective in patients under 6 years of age, in those with lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia.

IMPORTANT SAFETY INFORMATION

You should not use TOBI Podhaler if you are allergic to it or to any other aminoglycoside antibacterial.

Tell your doctor before starting treatment if you have or have had hearing, kidney, breathing, or muscle weakness problems or if you have dizziness, an organ transplant, or are pregnant or nursing.

Tell your doctor about all the drugs you take. Ask if you should take other medicines that may harm your nervous system, kidneys, or hearing; "water pills" (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or mannitol; or urea.

TOBI Podhaler can cause serious side effects, including hearing loss or ringing in the ears. Tell your doctor right away if you have hearing loss, noises in your ears such as ringing or hissing, vertigo, difficulty with balance, or dizziness.

TOBI Podhaler is in a class of drugs that may worsen kidney problems, especially in people with known or suspected kidney problems. Your health care provider may do a blood test to check how your kidneys are working while you are using TOBI Podhaler.

TOBI Podhaler is in a class of drugs that may worsen muscle weakness problems or harm an unborn baby.

TOBI Podhaler can cause severe breathing problems (bronchospasm). Tell your doctor right away if you get shortness of breath with wheezing, or coughing and chest tightness.

The most common side effects of TOBI Podhaler include cough, worsening of lung problems or cystic fibrosis, productive cough, shortness of breath, fever, sore throat, changes in your voice (hoarseness or loss of voice), coughing up blood, headache, and altered taste.

Let your doctor know if your symptoms worsen or if you have a side effect that bothers you enough to stop treatment or that does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.