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BETHKIS® (Tobramycin Inhalation Solution)

Concentrated on microbiologic outcomes

Decrease in density of isolated Pseudomonas aeruginosa (Pa) strains in sputum1

Mean change from baseline
Following first “on-drug” cycle Following third “on-drug” cycle
–1.67 log10 cfu/g –1.73 log10 cfu/g
  • BETHKIS® (Tobramycin Inhalation Solution) significantly reduced the density (Pa) in expectorated sputum following completion of the first and third cycles (P<0.001)1
  • Bronchospasm can occur with inhalation of BETHKIS. Bronchospasm and wheezing should be treated as medically appropriate

Improvement in Pa-related microbiologic outcomes after 3 cycles2

Time Categorical
result
BETHKIS Placebo

Week 20
(end of 3rd “on” cycle)

N  156  79
Negative culture (No.,%)  52 (33.3%)  13 (16.5%)
Persistence (No.,%)  69 (44.2%)  41 (51.9%)
Superinfection (No.,%)  25 (16.0%)  21 (26.6%)
Reinfection (No.,%)  7 (4.5%)  2 (2.5%)
NA (No.,%)  3 (1.9%)  2 (2.5%)

Adapted from Chuchalin et al. Pediatr Drugs. 2007;9(suppl 1):21-31.
Superinfection = addition of a pathogen not previously detected and persistence of Pa.2
Reinfection = reappearance of Pa after the third cycle when Pa is not present after first cycle.2
NA = not available/not accessible.
The table above demonstrates 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® 300 mg/4 mL (Tobramycin Inhalation Solution) (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 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

  • Despite a high incidence of Pa mucoid strains isolated (64% of patients), 33.3% of patients demonstrated an absence of Pa in cultures following their third “on-drug” cycle of treatment1
  • Trial was not powered to evaluate density of isolated Pa strains in sputum or improvements in microbiologic outcomes 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. Data on file. Chiesi USA, Inc. 2. 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. 3. BETHKIS [package insert]. Cary, NC: Chiesi USA, Inc.; 2014.

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