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Answers to commonly asked questions about TOBI.
 

It's important to have all the facts about taking TOBI® (Tobramycin Inhalation Solution, USP)   .
The questions and answers below are some of those most frequently asked by patients. For additional answers, please contact Novartis at 1-888-NOW-NOVA (1-888-669-6682) or
talk to your doctor.

What kind of air compressor     and nebulizer     should be used when taking TOBI?

The PARI LC® PLUS Reusable Nebulizer     and DeVilbiss® Pulmo-Aide®
air compressor     should be used when taking TOBI. This was the
equipment approved by the FDA for use with TOBI.
   
Can TOBI be mixed with other inhaled medications?

No. TOBI should not be diluted or mixed in the nebulizer with any other medications, including dornase alfa. TOBI should not be diluted with water or saline.
   
How should TOBI be stored?

Patients should store TOBI ampules     in a refrigerator. When there's no refrigerator available, or when transporting TOBI, store the foil pouches (opened or unopened) for up to 28 days at room temperature.
   
Is TOBI still OK to use if it changes color?

TOBI is clear and slightly yellow. Over time, TOBI's color goes from light yellow to a darker yellow. This is normal as the drug ages, or with changes with temperature or exposure to light. Do not expose TOBI to intense light. When TOBI is exposed to intense light, it will change color from light to dark yellow at a faster rate. It may even become brown with longer exposure. Make sure to store it as recommended.
   
How should TOBI be incorporated into a treatment routine?

Some patients are on several therapies at once. If taking a bronchodilator, dornase alfa, inhaled steroids, and TOBI, try following this order: bronchodilator first, followed by chest physiotherapy, then other inhaled drugs, and finally TOBI. Ask your Healthcare Professional what is the best treatment regimen for you.
   
What's the difference between TOBI and compounded IV solutions of tobramycin used for inhalation?

TOBI is the only tobramycin     solution approved by the Food and Drug Administration (FDA) for inhalation     in patients with cystic fibrosis and Pseudomonas aeruginosa     infection. TOBI is free from preservatives   . Compounded IV solutions of tobramycin not approved for inhalation by the FDA may not be free from preservatives.
   
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Please see full Prescribing Information.

Please see Patient Prescribing Information.

Information for Patients and Caregivers
Indication
TOBI® (Tobramycin Inhalation Solution, USP) is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. TOBI has not been studied in patients under 6 years of age, in those with a lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia. Ask your doctor if TOBI is right for you.

IMPORTANT SAFETY INFORMATION
If you are allergic to antibiotics in the same family as TOBI (ie, aminoglycosides), you should not take TOBI. Tell your doctor before starting treatment if you have any history of hearing, kidney, balance, or muscle problems.

Patients taking TOBI may have temporary side effects like coughing or difficulty breathing. Some people taking TOBI experienced ringing in the ears, hearing loss, or changes in voice (hoarseness)   . Ringing in the ears may be a warning sign for hearing loss. If you have ringing in the ears, changes in hearing, or dizziness, you should tell your doctor.

In studies, kidney damage was not seen in patients taking TOBI. However, antibiotics in the same family as TOBI have been linked to kidney damage.

If you are pregnant, plan to become pregnant, or if you are breast-feeding, talk with your doctor before taking TOBI.

Some drugs may interact with TOBI. Discuss all medications you are taking with your doctor.

Patients with cystic fibrosis can have many symptoms. Some of these may be related to your medications. You should tell your doctor if you have new or worsening symptoms.

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.

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