TOBI Podhaler Safety Profile

Patients treated with TOBI Podhaler may experience side effects

Most common side effects

  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%
Altered taste 3.9% 0.5%

*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, headache, and altered taste.

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.



*This Savings Card can be used to reduce the amount of your out-of-pocket expenses Tobi® Podhaler® up to a maximum of $14,000 per calendar year while this program remains in effect, with no monthly limit. No other purchase is necessary. Valid prescription with Prescriber ID# is required. Mylan Specialty L.P. reserves the right to amend or end this program at any time without notice.

Eligibility Requirements: This Savings Card can be redeemed only by patients or patient guardians who are 18 years of age or older and who are residents of the United States and its territories. Patients must have commercial insurance. This program is not valid for uninsured patients (but may be used by commercially insured patients without coverage Tobi® Podhaler®) and patients who are covered by any state or federally funded healthcare program, including but not limited to any state pharmaceutical assistance program, Medicare (Part D or otherwise), Medicaid, Medigap, VA or DOD, or TriCare (regardless of whether Tobi® Podhaler® is covered by such government program); not valid if the patient is Medicare eligible and enrolled in an employer-sponsored health plan or prescription benefit program for retirees; and not valid if the patient’s insurance plan is paying the entire cost of this prescription. This program is void outside the US and its territories or where prohibited by law, taxed, or restricted. Absent a change in Massachusetts law, this program will no longer be valid for Massachusetts residents as of January 1, 2020.

This Savings Card is not health insurance. This Savings Card is not transferable, and the amount of the savings cannot exceed the patient’s out-of-pocket expenses. This program cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. This Savings Card is not redeemable for cash.

NOTICE: Data related to your use of this Savings Card may be collected, analyzed and shared with Mylan Specialty L.P. for market research and other purposes related to assessing coupon programs. Data shared with Mylan Specialty L.P. will be aggregated and de-identified, meaning it will be combined with data related to other savings card redemptions and will not identify you.

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 healthcare 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.