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BETHKIS® (Tobramycin Inhalation Solution)

A concentrated formulation proven to benefit patients

BETHKIS demonstrated benefits in pivotal clinical studies compared with placebo

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.
 

Provided improvement in lung function

FEV1
FVC and FEF25%–75%
Change in FEV1 % predicted over 24 weeks (BETHKIS vs placebo)
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)

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)
Change in FEV1 % predicted over 24 weeks (BETHKIS vs placebo)
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.
FVC = forced vital capacity.
FEF25%–75%= forced expiratory flow at 25%–75% forced vital capacity.

 
 

Reduced 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 CF 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 weeks80% difference between BETHKIS vs placebo in body weight at 24 weeks. 400% difference between BETHKIS vs placebo in BMI at 24 weeks80% 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.

Important Safety Information

Do not take BETHKIS® (Tobramycin Inhalation Solution) 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.

About BETHKIS® (Tobramycin Inhalation Solution)

BETHKIS 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.

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.
References available upon request.

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Dear [NAME],

I thought you might be interested in learning more about BETHKIS® (Tobramycin Inhalation Solution), an inhaled prescription medication for cystic fibrosis (CF) patients infected by Pseudomonas aeruginosa.

BETHKIS is an inhaled antibacterial solution prescribed to patients with CF whose lungs contain bacteria called Pseudomonas aeruginosa. BETHKIS delivers the same amount of antibiotic as other available nebulized tobramycin products (300 mg) in only 4 mL. Approximately 15 minutes to administer with PARI LC PLUS®.

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).

Scroll down for Important Safety Information.

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

Important Safety Information

Do not take BETHKIS® (Tobramycin Inhalation Solution) 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.


About BETHKIS® (Tobramycin Inhalation Solution)

BETHKIS 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.

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.
PARI LC PLUS® and Vios® are registered trademarks of PARI Respiratory Equipment, Inc.
©2018 Chiesi, Inc. All rights reserved.
Created in the USA. PP-B-0045 V2.0