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BETHKIS® (Tobramycin Inhalation Solution)

Concentrated on reducing patient burden

BETHKIS (Tobramycin Inhalation Solution) offers reduced patient burden in the form of:

  • Reduced hospitalizations1
  • Less need for IV tobramycin or other antipseudomonal antibiotics1,2
  • Significant improvements in weight gain and BMI1,2

 

Reduced hospitalizations by 50%1

50% less hospitalization for patients taking BETHKIS vs placebo

Adapted from Chuchalin et al. Pediatr Drugs. 2007;9(suppl 1):21-31.

 

  • Trial was not powered to evaluate hospitalizations or need for IV tombramycin or other antipseudomonal antibiotics as primary outcomes
  • Avoid concurrent and/or sequential use of BETHKIS with other drugs with neurotoxic or ototoxic potential

 

Reduced need for IV tobramycin or other antipseudomonal antibiotics1,2

63% reduction for IV tobramycin in patients taking BETHKIS vs placebo. 20% reduction for antipseudomonal antibiotics in patients taking BETHKIS vs placebo

Adapted from Chuchalin et al. Pediatr Drugs. 2007;9(suppl 1):21-31.

 

Significant improvements in weight gain and BMI1,2​

80% difference between BETHKIS vs placebo in body weight at 24 weeks. 400% difference between BETHKIS vs placebo in BMI at 24 weeks

Adapted from data on file and Chuchalin et al. Pediatr Drugs. 2007; 9(suppl 1):21-31.
BMI = body mass index.
These graphs demonstrate results (secondary end points) from a double-blind, multinational, multicenter, randomized, placebo-controlled clinical trial of 247 patients with cystic fibrosis and chronic Pseudomonas aeruginosa (Pa) infection. The study compared the efficacy and tolerability of inhaled aerosolized Bramitob® (marketed as BETHKIS® 300 mg/4 mL in the United States) to placebo given over a 24-week study period (three 4-week “on” cycles, each followed by a 4-week “off” cycle) in a twice-daily regimen (BETHKIS [n=161], placebo [n=86]). Study population included patients with FEV1 ≥40% and ≤80% of the predicted normal value. All patients were naïve to aerosolized tobramycin. Patient ages ranged from 6 to 45 years (mean ages [±SD] of 14.8 ± 5.7 in the treatment group and 14.7 ± 6.6 in the placebo group). The percentage of the study population presenting with Pa mucoid strains was 64% in the treatment group and 61% in the placebo group.2,3
 

  • BETHKIS-treated patients experienced greater absolute mean weight gain than placebo-treated patients1
  • Patients treated with BETHKIS experienced a significant improvement in BMI vs
    placebo (P<0.007)1
  • Trial was not powered to evaluate body weight or BMI as primary outcomes

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. 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. 2. Data on file. Chiesi USA, Inc. 3. BETHKIS [package insert]. Cary, NC: Chiesi USA, Inc.; 2014.

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