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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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