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Home/Cystic Fibrosis & P. aeruginosa

What is cystic fibrosis?

Cystic fibrosis (CF) is an inherited, chronic disease that affects the lungs and digestive system. It affects more than 30,000 children and adults in the United States alone, with approximately 1000 new patients diagnosed each year. In CF, a faulty gene leads to the production of unusually thick, sticky mucus that changes normal processes in the lungs and digestive system.

What is P. aeruginosa?

Pseudomonas aeruginosa (Pa) is a potentially life-threatening type of bacteria that can grow in the lungs within the mucus associated with CF. Once it settles in the lungs, Pa causes a chronic lung infection that can reduce lung function.

Chronic Pa infection progressively worsens lung function as patients get older.

  • The mucoid form of Pa occurs more frequently as patients get older
  • When compared with nonmucoid Pa, the mucoid form is more difficult to treat and leads to increased morbidity and mortality

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