TOBI Podhaler Safety Profile

Patients treated with TOBI Podhaler may experience side effects

Most common side effects in a clinical trial evaluating the safety of TOBI Podhaler vs TOBI® nebulizer solution

  TOBI Podhaler (n=308) TOBI (n=209)
Cough 48.4% 31.1%
Worsening of lung problems or CF 33.8% 30.1%
Productive cough 18.2% 19.6%
Shortness of breath 15.6% 12.4%
Fever 15.6% 12.4%
Sore throat 14.0% 10.5%
Voice alteration* 13.6% 3.8%
Coughing up blood 13.0% 12.4%
Headache 11.4% 12.0%

*Majority of voice alterations recorded as hoarseness.

  • In a clinical study, stopping of treatment due to side effects was 14% for TOBI Podhaler vs 8% for TOBI 300 mg/5 mL

TOBI Podhaler can cause serious side effects, including

  • Hearing loss or ringing in the ears (ototoxicity): Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears, such as ringing or hissing. Tell your healthcare provider if you develop vertigo, difficulty with balance, or dizziness
  • Worsening kidney problems (nephrotoxicity): TOBI Podhaler is in a class of drugs 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 taking TOBI Podhaler
  • Worsening muscle weakness: TOBI Podhaler is in a class of drugs that can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis or Parkinson's disease)
  • Severe breathing problems (bronchospasm): Tell your healthcare provider right away if you get any of these symptoms of bronchospasm while you are taking TOBI Podhaler
    Shortness of breath with wheezing
    Coughing and chest tightness
  • Fetal harm: TOBI Podhaler is in a class of drugs that may cause harm to an unborn baby

Most common side effects

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

What should you know about cough when starting TOBI Podhaler?

Cough is a common symptom of CF.

Cough may develop while using TOBI Podhaler, especially during the first week of treatment.

In a clinical trial evaluating the safety of TOBI Podhaler vs TOBI® nebulizer solution

Patients using TOBI Podhaler, the dry-powder inhalation, experienced cough more frequently than patients using TOBI nebulizer solution (48% vs 31%).

After the first week of treatment, the time to first cough was similar for patients using TOBI Podhaler and TOBI nebulizer solution.

Five percent of patients using TOBI Podhaler discontinued due to cough compared with 1% of patients using TOBI nebulizer solution.

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

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, or dizziness.

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.