ys prior to study drug administration; 45% were female and 91% were Caucasian.
The primary purpose of Study 1 was to eva luate safety. Interpretation of efficacy results in Study 1 is limited by several factors including open-label design, testing of multiple secondary endpoints, and missing values for the outcome of FEV1 % predicted. The number (%) of patients with missing values for FEV1 % predicted at Weeks 5 and 25 in the TOBI Podhaler treated group were 40 (13.0%) and 86 (27.9%) compared to 15 (7.2%) and 40 (19.1%) in the TOBI treated group. Using imputation of the missing data, the mean differences (TOBI Podhaler minus TOBI) in the percent relative change from baseline in FEV1 % predicted at Weeks 5 and 25 were -0.87 (95% CI: -3.80, 2.07) and 1.62 (95% CI: -0.90, 4.14), respectively.
15 REFERENCES
Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Ninth Edition; Approved Standard. CLSI Document M7-A9. CLSI, 950 West Valley Rd., Suite 2500, Wayne, PA 19087, 2012.
CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard – 11th ed. CLSI document M02-A11. CLSI, 2012.
CLSI. Performance Standards for Antimicrobial Susceptibility Testing; 22nd Informational Supplement. CLSI document M100-S22. CLSI, 2012
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
TOBI Podhaler contains aluminum blister-packaged 28 mg TOBI Podhaler (tobramycin inhalation powder) clear, colorless hypromellose capsules with “NVR AVCI” in blue radial imprint on one part of the capsule and the Novartis logo “” in blue radial imprint on the other part of the capsule, and Podhaler devices.
Each Podhaler device consists of the inhaler body, mouthpiece, capsule chamber and blue push button. The Podhaler device is provided in a case that protects the device during shipment, storage and its one week in-use period.
Unit Dose (blister pack), Box of 224 capsules contains: NDC 0078-0630-35
4 weekly packs, each containing:
56 capsules (7 blister cards of 8 capsules)
1 Podhaler device
1 reserve Podhaler device
16.2 Information for Patients
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Protect TOBI Podhaler from moisture.
TOBI Podhaler capsules should be used with the Podhaler device only. The Podhaler device should not be used with any other capsules.
Capsules should always be stored in the blister and each capsule should only be removed immediately before use.
Always use the new Podhaler device provided with each weekly pack.
Keep this and all drugs out of the reach of children.
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling
Information for Patients
Information on the long term efficacy and safety of TOBI Podhaler is limited. There is no information in patients with limited pulmonary reserve (FEV1 <25% predicted). Decreased susceptibility of Pseudomonas aeruginosa to tobramycin has been seen with use of TOBI Podhaler. The relationship between in vitro susceptibility test results and clinical outcome with TOBI Podhaler therapy is not clear. Occurrence of decreased susceptibility on treatment should be monitored, and treatment with an alternative therapy should be considered if clinical worsening is observed.
TOBI Podhaler may not be tolerated by all patients. Patients should be
