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BETHKIS® (Tobramycin Inhalation Solution)

Concentrated formulation for efficient nebulization

BETHKIS (4mL) has 20% less volume than Tobi (5mL)

300 mg of tobramycin in only 4 mL1,2

BETHKIS® (Tobramycin Inhalation Solution) is a concentrated solution delivering 300 mg of nebulized tobramycin in only 4 mL.1 The solution offers osmolarity similar to that of airway surface liquid in patients with cystic fibrosis.3,4

Efficient nebulization

  • Approximate 15-minute administration time1

Benefits demonstrated in pivotal clinical studies vs placebo

  • Proven efficacy
    • Significant improvements in lung function, decrease in density of Pseudomonas aeruginosa in sputum, and reduced patient burden1,3-5
  • Favorable safety profile
    • Adverse event rates similar to placebo1
    • 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
  • Local tolerability
    • Generally well tolerated with a low incidence of voice alteration and bronchospasm1,6
    • Incidence of wheezing similar to placebo1,6
  • High compliance
    • Mean treatment compliance ≥98% across clinical trials3,6
Comparing formulations of available nebulized tobramycin inhalation solutions
BETHKIS®
(Tobramycin Inhalation Solution)1,4,7
Tobi®
(Tobramycin Inhalation Solution)2,4,8
Indication 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 FEV1 <40% or >80% predicted, or patients colonized with Burkholderia cepacia.
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 FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
Volume 4 mL 5 mL
Dosage 300 mg 300 mg
Concentration 75 mg/mL 60 mg/mL
Tonicity adjusting agent NaCl (0.45%) NaCl (0.225%)
Osmolarity Isotonic: 280–350 mOsm/L Hypotonic: 165–190 mOsm/L
Antioxidant excipients None None
Preservatives None None
pH 5.0 6.0
Nebulizer PARI LC PLUS® Reusable Nebulizer with a PARI Vios® air compressor PARI LC PLUS® Reusable Nebulizer with a DeVilbiss® Pulmo-Aide® air compressor
Molecular weight 467.52 467.52
Fine particle fraction (% of total dose) using PARI LC PLUS 33.15% 35.92%
MMAD using PARI LC PLUS 4.18 µm 4.18 µm
Dosing schedule Twice daily in alternating 28-day cycles (on/off) Twice daily in alternating 28-day cycles (on/off)
Storage Under refrigeration at 36°–45°F
(2°–8°C). May be stored at room temperature for up to 28 days.
Under refrigeration at 36°–45°F
(2°–8°C). May be stored at room temperature for up to 28 days.

Indication

BETHKIS® (Tobramycin Inhalation Solution) 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.

Important Safety Information

BETHKIS 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.

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 USA, Inc.; 2014. 2. TOBI [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2009. 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. Data on file. Chiesi USA, Inc. 6. 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. 7. Malvolti C, Garzia R, inventors; Chiesi Farmaceutici S.p.A., assignee. Optimised formulation of tobramycin for aerosolization. US patent application US2011/0212912A1, September 1, 2011. 8. Smith AL, Ramsey BW, Montgomery AB, inventors; Pathogenesis Corporation, assignee. Aminoglycoside formulation for aerosolization. US patent application 5,508,269. April 16, 1996.

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