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BETHKIS® (Tobramycin Inhalation Solution)

Concentrated on safety and tolerability

High rates of compliance across clinical trials

Mean treatment compliance across BETHKIS® (Tobramycin Inhalation Solution) clinical trials
(≥75% of ampules administered)
Phase 2 Trial 98.0%
Phase 3 Trial 98.5%*

*Adjusted mean.

  • Average treatment compliance with BETHKIS across clinical trials was more than 98%

Selected treatment-emergent adverse reactions occurring in ≥2% of BETHKIS patients

Adverse reactions BETHKIS (n=190) Placebo (n=115)
Forced expiratory volume decreased 59 (31%) 33 (29%)
Rales 36 (19%) 18 (16%)
Red blood cell sedimentation rate increased 16 (8%) 6 (5%)
Dysphonia 11 (6%) 2 (2%)
Wheezing 10 (5%) 4 (4%)
Epistaxis 6 (3%) 0
Pharyngolaryngeal pain 5 (3%) 2 (2%)
Bronchitis 5 (3%) 1 (1%)
Tonsillitis 4 (2%) 0
Diarrhea 3 (2%) 1 (1%)
Eosinophilia 3 (2%) 0
Immunoglobulins increased 3 (2%) 0

The data described in the table above reflect exposure to BETHKIS in 2 placebo-controlled studies in 305 cystic fibrosis patients. Patients receiving BETHKIS ranged in age from 6 to 31 years. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

  • In clinical trials, results of assessments for ototoxicity were similar between BETHKIS and placebo, with no reports of tinnitus (ringing in ears)
  • Nephrotoxicity was not seen during clinical studies, with serum creatinine levels similar between BETHKIS and placebo groups
In clinical trials
  • Therapy was generally well tolerated with a low incidence of voice alteration and bronchospasm
  • Bronchospasm was rarely reported and incidence of wheezing was similar to placebo
  • The most commonly reported adverse events (>2%) for patients treated with BETHKIS included: decreased FEV (forced expiratory volume), abnormal lung sounds (rales), red blood cell inflammation (sedimentation rate increased), and difficulty speaking (dysphonia)

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.
References available upon request.

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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