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 instructed to consider alternative therapy if they are unable to tolerate TOBI Podhaler. Patients should be advised to complete a full 28-day course of TOBI Podhaler, even if they are feeling better. After 28 days of therapy, patients should stop TOBI Podhaler therapy for the next 28 days, and then resume therapy for the next 28 day on and 28 day off cycle.

It is important for patients to understand how to correctly administer TOBI Podhaler capsules using the Podhaler device. It is recommended that caregivers and patients be adequately trained in the proper use of the TOBI Podhaler prior to use. [See Instructions for Use at the end of the Patient Information leaflet.] Caregivers should provide assistance to children using TOBI Podhaler (including preparing the dose for inhalation) particularly for those aged 10 years or younger, and should continue to supervise them until they are able to use the Podhaler device properly without help.

For patients taking several different inhaled medications and/or performing chest physiotherapy, advise the patient regarding the order they should take the therapies. It is recommended that TOBI Podhaler be taken last.

17.1 Ototoxicity
Inform patients that ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI Podhaler clinical studies. Physicians should consider an audiogram at baseline, particularly for patients at increased risk of auditory dysfunction. If a patient reports tinnitus or hearing loss during TOBI Podhaler therapy, the physician should refer that patient for audiological assessment.

Patients should be reminded that vestibular toxicity may manifest as vertigo, ataxia, or dizziness.

17.2 Bronchospasm
Inform patients that bronchospasm can occur