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BETHKIS® (Tobramycin Inhalation Solution)

Concentrated on improving lung function

BETHKIS (Tobramycin Inhalation Solution) showed significant improvements in pulmonary function measures including FEV1, FVC, and FEF25-75%.1-3

Sustained improvement In FEV11,3

  • At week 20, BETHKIS demonstrated a significant improvement in FEV1 percent predicted vs placebo (P<0.001)2
  • For patients treated with BETHKIS, FEV1 remained above the baseline value throughout the study, including after each 4-week “off” cycle3
  • BETHKIS is contraindicated in patients with a known hypersensitivity to any aminoglycoside. 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

Change in FEV1 % predicted over 24 weeks (BETHKIS vs placebo)

Adapted from Chuchalin et al. Pediatr Drugs. 2007;9(suppl 1):21-31.
FEV1 = forced expiratory volume in 1 second.
The graph above demonstrates the results (primary end point) from a double-blind, multinational, multicenter, randomized, placebo-controlled clinical trial of 247 patients with cystic fibrosis and chronic P aeruginosa (Pa) infection. The study compared the efficacy and tolerability of inhaled aerosolized Bramitob® (Tobramycin Inhalation Solution) (marketed as BETHKIS® 300 mg/4 mL in the United States) with 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 BETHKIS 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 BETHKIS group and 61% in the placebo group.1-3

Significant improvements in FVC And FEF25-75%2,3

  • At week 20, patients treated with BETHKIS demonstrated significant improvements in both FVC and FEF25-75% vs placebo (P=0.022 and P=0.001, respectively)3
  • Patients treated with BETHKIS showed an 8.3% improvement in mean FVC and a 21.1% improvement in mean FEF25-75% over baseline3
  • Trial was not powered to evaluate FVC or FEF25-75% as primary outcomes3

Mean change from baseline in FVC % predicted at 20 weeks (BETHKIS vs placebo) Mean change from baseline in FEF25-75% predicted at 20 weeks (BETHKIS vs placebo)

Adapted from Chuchalin et al. Pediatr Drugs. 2007;9(suppl 1):21-31.
FVC = forced vital capacity.
FEF25-75% = forced expiratory flow at 25-75% FVC.
The charts above demonstrate the results (secondary end points) from a double-blind, multinational, multicenter, randomized, placebo-controlled clinical trial of 247 patients with cystic fibrosis and chronic Pa infection. The study compared the efficacy and tolerability of inhaled aerosolized Bramitob® (Tobramycin Inhalation Solution) (marketed as BETHKIS 300 mg/4 mL in the United States) with 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 BETHKIS group and 14.7 ± 6.6 in the placebo group). The percentage of the study population presenting with isolated Pa mucoid strains was 64% in the BETHKIS group and 61% in the placebo group.1,2

 

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. Data on file. Chiesi USA, Inc. 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.

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