Manage your treatment schedule with the PODMANAGER App

Treatment tracking allows you to record when you have taken a dose, completed a treatment, or
finished an activity
Educational resources for TOBI PODHALER and access to patient support programs
Real-time air quality alerts based on your location
Customizable reminders for your medications or activities help you adhere to your CF regimen

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
Do not swallow TOBI PODHALER capsules. TOBI PODHALER capsules are used only with
the Podhaler device and inhaled through your mouth (oral inhalation). Never place a
capsule in the mouthpiece of the Podhaler device.
You should not use TOBI PODHALER if you are allergic to it or to any other aminoglycoside
antibacterial medicines.

Tell your doctor before starting treatment all of your medical conditions, including if you have
or have had hearing problems, dizziness, kidney problems, muscle weakness, breathing
problems such as wheezing, coughing or chest tightness, if you had an organ transplant, are
pregnant or nursing or plan to become pregnant or nurse.

TOBI PODHALER contains a medicine that can harm your unborn baby. It is not known if it
passes into breast milk. Check your baby for watery stools, bloody stools, thrush or diaper rash if
you breast feed.

Tell your doctor about all the medicines you take including over-the-counter medicines,
vitamins, and herbal supplements. If you are using TOBI PODHALER, discuss 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 intravenous mannitol; urea.

TOBI PODHALER can cause serious side effects, including:
Severe breathing problems (bronchospasm). Tell your doctor right away if you get shortness
of breath with wheezing or coughing and chest tightness while using TOBI PODHALER.

Hearing loss or ringing in the ears (ototoxicity). Tell your doctor right away if you have
hearing loss, noises in your ears such as ringing or hissing, vertigo, difficulty with balance,
dizziness, or your mother has had hearing problems after taking an aminoglycoside. Tell your
doctor if you have been told you have certain gene variants (a change in the gene) related to
hearing abnormalities inherited from your mother.
Worsening kidney problems (nephrotoxicity). TOBI PODHALER is in a class of medicines
that may cause worsening kidney problems, especially in people with known or suspected kidney
problems. Your healthcare provider may do a blood test to check how your kidneys are working
while you are using TOBI PODHALER.
Worsening muscle weakness. TOBI PODHALER is in a class of medicines that can cause
worsening muscle weakness in people who already have problems with muscle weakness
(myasthenia gravis or Parkinson's disease).

TOBI PODHALER is in a class of medicines which may cause harm to an unborn baby.
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), coughing up blood, and headache.

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.

Please see Full Prescribing Information and Patient Information at bit.ly/TobiFullPI

© 2023 Viatris Inc. All Rights Reserved. TOBI-2020-0239 V6