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BETHKIS® (Tobramycin Inhalation Solution)

A concentrated formulation proven to benefit patients

The concentrated formulation of BETHKIS® (Tobramycin Inhalation Solution) delivers the same amount of antibiotic as other available nebulized tobramycin products (300 mg) in only 4 mL.

  • Benefits demonstrated in pivotal clinical studies vs placebo
  • Offers administration time of approximately 15 minutes
  • Tobramycin in a solution designed to be like the liquid in your airways
  • Before you take BETHKIS, tell your healthcare provider if you have or have had hearing problems (ringing or other noises in your ears), dizziness, kidney problems, muscle weakness such as myasthenia gravis or Parkinson’s disease, breathing problems such as wheezing, coughing, or chest tightness, or have had an organ transplant

Concentrated on improving lung function

FEV1
FVC and FEF25%–75%
Significant improvement in lung function (FEV1) in just 4 weeks
  • Lasting improvement over 24 weeks
  • BETHKIS can cause serious side effects including hearing loss or ringing in the ears (ototoxicity), worsening kidney problems (nephrotoxicity), worsening muscle weakness, harm to an unborn baby, and/or severe breathing problems (bronchospasm)

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

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

Significant improvements in other breathing measures (FVC and FEF25%–75%)
Mean change from baseline in FVC % predicted at 20 weeks. 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.

FEV1= forced expiratory volume in 1 second.

FVC = forced vital capacity.

FEF25%–75%= forced expiratory flow at 25%–75% forced vital capacity.

Concentrated on reducing patient burden

Less burdens
Improved nutrition
Reduced need for IV antibiotics and hospitalizations

In clinical studies, patients taking BETHKIS:

  • Needed less IV tobramycin and other antipseudomonal antibiotics (vs placebo)
  • Had 50% fewer hospitalizations (vs placebo)
63% reduction in the need for IV tobramycin for patients taking BETHKIS vs placebo. 20% reduction in the need for antipseudomonal antibiotics for patients taking BETHKIS vs placebo50% less hospitalization for patients taking BETHKIS vs placebo

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

Improved nutritional status

In clinical studies, patients taking BETHKIS showed:

  • Significant improvement in weight gain
  • Significant improvement in body mass index (BMI)
    • Weight gain and BMI are important markers of health status in cystic fibrosis patients

  • If you are taking BETHKIS, you should discuss with your healthcare provider if you should take other medicines that may harm your nervous system, kidneys, or hearing, or “water pills” (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), mannitol, or urea
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.

About BETHKIS® (Tobramycin Inhalation Solution)

BETHKIS® (Tobramycin Inhalation Solution) is a prescription medicine for people with cystic fibrosis (CF) who have lung infection with Pseudomonas aeruginosa bacteria. BETHKIS solution contains tobramycin, an aminoglycoside antibiotic.

It is not known if BETHKIS is safe and effective in children under 6 years of age, in people who have decreased lung volume (FEV1 less than 40% predicted), in people who have lung infection with Burkholderia cepacia bacteria, or when BETHKIS is used for more than 3 on/off cycles.

Important Safety Information

Do not take BETHKIS if you are allergic to tobramycin, or any of the ingredients in BETHKIS, or to any other aminoglycoside antibiotic.

Before you take BETHKIS, tell your health care provider if you have or have had hearing problems (ringing or other noises in your ears), dizziness, kidney problems, muscle weakness such as myasthenia gravis or Parkinson’s disease, breathing problems such as wheezing, coughing or chest tightness, or have had an organ transplant. Before you take BETHKIS, tell your health care provider if you are pregnant, plan to become pregnant, are breastfeeding or plan to breastfeed. It is not known if tobramycin in BETHKIS will pass into breast milk.

Tell your health care provider about all the medicines you take. Taking BETHKIS with certain other medications can cause serious side effects. If you are taking BETHKIS, you should discuss with your healthcare provider if you should take other medicines that may harm your nervous system, kidneys or hearing, or “water pills” (diuretics) such as Edecrin® (ethacrynic acid), Lasix® (furosemide), mannitol, or urea.

BETHKIS can cause serious side effects including hearing loss or ringing in the ears (ototoxicity), worsening kidney problems (nephrotoxicity), worsening muscle weakness, harm to an unborn baby, and/or severe breathing problems (bronchospasm). Tell your healthcare provider right away if you have hearing loss or hear noises in your ears (such as ringing or hissing), develop vertigo, dizziness, difficulty with balance, shortness of breath with wheezing, or coughing and chest tightness. Your healthcare provider may do a blood test and urine test to check how your kidneys are working while you are taking BETHKIS.

The most common side effects of BETHKIS include worsening of lung problems (decreased FEV), noisy breathing (rales), abnormal red blood cell sedimentation rate (determined by a blood test), and changes in your voice (hoarseness). Tell your health care provider about any side effect that bothers you or that does not go away.

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 Patient Information within the accompanying full Prescribing Information.

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Dear [NAME],

I thought you may be interested in learning more about a condition called cystic fibrosis (CF) with Pseudomonas aeruginosa bacteria and a treatment that can help— BETHKIS® (Tobramycin Inhalation Solution).

What makes BETHKIS different is its concentrated formulation. BETHKIS delivers the same amount of antibiotic as other available nebulized tobramycin products (300 mg) in only 4 mL. The approximate administration time is 15 minutes.

The most common side effects of BETHKIS include worsening of lung problems, noisy breathing, abnormal red blood cell sedimentation rate (determined by a blood test), and changes in your voice (hoarseness).

You can learn more about this treatment at www.bethkis.com.

About BETHKIS® (Tobramycin Inhalation Solution)

BETHKIS® (Tobramycin Inhalation Solution) is a prescription medicine for people with cystic fibrosis (CF) who have lung infection with Pseudomonas aeruginosa bacteria. BETHKIS solution contains tobramycin, an aminoglycoside antibiotic.

It is not known if BETHKIS is safe and effective in children under 6 years of age, in people who have decreased lung volume (FEV1 less than 40% predicted), in people who have lung infection with Burkholderia cepacia bacteria, or when BETHKIS is used for more than 3 on/off cycles.


Important Safety Information

Do not take BETHKIS if you are allergic to tobramycin, or any of the ingredients in BETHKIS, or to any other aminoglycoside antibiotic.

Before you take BETHKIS, tell your health care provider if you have or have had hearing problems (ringing or other noises in your ears), dizziness, kidney problems, muscle weakness such as myasthenia gravis or Parkinson’s disease, breathing problems such as wheezing, coughing or chest tightness, or have had an organ transplant. Before you take BETHKIS, tell your health care provider if you are pregnant, plan to become pregnant, are breastfeeding or plan to breastfeed. It is not known if tobramycin in BETHKIS will pass into breast milk.

Tell your health care provider about all the medicines you take. Taking BETHKIS with certain other medications can cause serious side effects. If you are taking BETHKIS, you should discuss with your healthcare provider if you should take other medicines that may harm your nervous system, kidneys or hearing, or “water pills” (diuretics) such as Edecrin® (ethacrynic acid), Lasix® (furosemide), mannitol, or urea.

BETHKIS can cause serious side effects including hearing loss or ringing in the ears (ototoxicity), worsening kidney problems (nephrotoxicity), worsening muscle weakness, harm to an unborn baby, and/or severe breathing problems (bronchospasm). Tell your healthcare provider right away if you have hearing loss or hear noises in your ears (such as ringing or hissing), develop vertigo, dizziness, difficulty with balance, shortness of breath with wheezing, or coughing and chest tightness. Your healthcare provider may do a blood test and urine test to check how your kidneys are working while you are taking BETHKIS.

The most common side effects of BETHKIS include worsening of lung problems (decreased FEV), noisy breathing (rales), abnormal red blood cell sedimentation rate (determined by a blood test), and changes in your voice (hoarseness). Tell your health care provider about any side effect that bothers you or that does not go away.

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 Patient Information within the accompanying full Prescribing Information.

This website is intended for United States residents only.

BETHKIS® is a registered trademark of Chiesi Farmaceutici, S.p.A.
©2015 Chiesi USA, Inc. All rights reserved.
Created in the USA. B-Q315-08