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Analysis Shows Novartis Drug TOBI® Associated With Reduced Mortality in Cystic Fibrosis Patients With Common Lung Infection
Date:10/21/2010

countries including the US and EU.

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 six years of age, in those with a lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia.

IMPORTANT SAFETY INFORMATION

If patients are allergic to antibiotics in the same family as TOBI (i.e., aminoglycosides), they should not take TOBI. They should tell their doctor before starting treatment if they 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 patients have ringing in the ears, changes in hearing, or dizziness, they should tell their 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 patients are pregnant, plan to become pregnant, or if they are breast-feeding, they should talk with their doctor before taking TOBI.

Some drugs may interact with TOBI. Patients should discuss all medications they are taking with your doctor.

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

Patients 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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SOURCE Novartis Pharmaceuticals Corporation
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