|Manufacturer:||Novartis Pharmaceuticals Corporation|
TOBI® is administered by inhalation over an approximately 15-minute period, using a hand-held PARI LC PLUS™ Reusable Nebulizer with a DeVilbiss® Pulmo-Aide® compressor.
TOBI® should not be diluted or mixed with dornase alfa (PULMOZYME®, Genentech) in the nebulizer.During clinical studies, patients on multiple therapies were instructed to take them first, followed by TOBI®.
TOBI® is indicated for the management of cystic fibrosis patients with P. aeruginosa.Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia (see CLINICAL STUDIES).
-- An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.
TOBI® is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
-- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.
Caution should be exercised when prescribing TOBI® to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction.
Patients receiving concomitant parenteral aminoglycoside therapy should be monitored as clinically appropriate.Aminoglycosides can cause fetal harm when administered to a pregnant woman.
Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero.
Patients who use TOBI® during pregnancy, or become pregnant while taking TOBI® should be apprised of the potential hazard to the fetus.
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