Revised: 03/2013

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FULL PRESCRIBING INFORMATION: CONTENTS*
*
Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
TOBI Podhaler is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION
DO NOT SWALLOW TOBI PODHALER CAPSULES
FOR USE WITH THE PODHALER DEVICE ONLY
FOR ORAL INHALATION ONLY
TOBI Podhaler capsules must not be swallowed as the intended effects in the lungs will not be obtained. The contents of TOBI Podhaler capsules are only for oral inhalation and should only be used with the Podhaler device.
The recommended dosage of TOBI Podhaler for both adults and pediatric patients 6 years of age and older is the inhalation of the contents of four 28 mg TOBI Podhaler capsules twice-daily for 28 days using the Podhaler device.
Refer to the Instructions For Use (IFU) for full administration information.
Dosage is not adjusted by weight. Each dose of four capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart.
TOBI Podhaler is administered twice-daily in alternating periods of 28 days. 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.
TOBI Podhaler capsules should always be stored in the blister and each capsule should only be removed IMMEDIATELY BEFORE USE.
For patients taking several different inhaled medications and/or performing chest physiotherapy, the order of therapies should follow the physician’s recommendation. It is recommended that TOBI Podhaler is taken last.
3 DOSAGE FORMS AND STRENGTHS
Inhalation powder:
28 mg: clear, colorless hypromellose capsule 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.
4 CONTRAINDICATIONS
TOBI Podhaler is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
5 WARNINGS AND PRECAUTIONS
5.1 Ototoxicity
Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory or vestibular dysfunction.

Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI Podhaler clinical studies [see Adverse Reactions (6.1)]. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Ototoxicity, manifested as both auditory (hearing loss) and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.
5.2 Nephrotoxicity
Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction.
Nephrotoxicity was not observed during TOBI Podhaler clinical studies but has been associated with aminoglycosides as a class.
5.3 Neuromusc