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BETHKIS® (Tobramycin Inhalation Solution) delivers 300 mg of nebulized tobramycin efficacy in only 4 mL1,2

BETHKIS is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. BETHKIS provides the following clinical benefits:

  • 20% less volume than generic tobramycin2
  • Approximate 15-minute administration time1
  • Osmolarity similar to that of airway surface liquid in patients with cystic fibrosis3,4
BETHKIS provides improved lung function
BETHKIS demonstrated
proven efficacy1,3-5

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Favorable safety and
tolerability profile1,5

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Important Safety Information

BETHKIS® (Tobramycin Inhalation Solution) is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Bronchospasm can occur with inhalation of BETHKIS. Bronchospasm and wheezing should be treated as medically appropriate.

Caution should be exercised when prescribing BETHKIS to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. Audiograms, serum concentration, and renal function should be monitored as appropriate.

Avoid concurrent and/or sequential use of BETHKIS with other drugs with neurotoxic or ototoxic potential.

BETHKIS should not be administered concurrently with ethacrynic acid, furosemide, urea, or mannitol.

Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.

Fetal harm can occur when aminoglycosides are administered to a pregnant woman. Apprise women of the potential hazard to the fetus.

Common adverse reactions (more than 5%) occurring more frequently in BETHKIS patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia.

Indication

BETHKIS 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 six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please see Full Prescribing Information.

 

This website is intended for United States residents only.

References: 1. BETHKIS [package insert]. Cary, NC: Chiesi, Inc.; 2017. 2. TOBI [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2015. 3. Chuchalin A, Csiszér E, Gyurkovics K, et al. A formulation of aerosolized tobramycin (Bramitob®) in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa infection: a double-blind, placebo-controlled, multicenter study. Pediatr Drugs. 2007;9(suppl 1):21-31. 4. Poli G, Acerbi D, Pennini R, et al. Clinical pharmacology study of Bramitob, a tobramycin solution for nebulization, in comparison with Tobi®. Pediatr Drugs. 2007;9(suppl 1):3-9. 5. Lenoir G, Antypkin YG, Miano A, et al. Efficacy, safety, and local pharmacokinetics of highly concentrated nebulized tobramycin in patients with cystic fibrosis colonized with Pseudomonas aeruginosa. Pediatr Drugs. 2007;9(suppl 1):11-20.

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