TM Owner Viatris Specialty LLC (formerly Mylan)
TOBI 300mg/5mL Inhalation Solution
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Indications & Clinical Uses
- TOBI 300 mg/5 mL tobramycin inhalation solution is an aminoglycoside antibiotic given by nebuliser to treat lung infection with the bacterium Pseudomonas aeruginosa in people with cystic fibrosis aged 6 years and older.
- It is not the same product as tobramycin eye drops (Tobrex) or the dry-powder capsules Tobi Podhaler, which use a different device and dosing schedule for the same antibiotic - the three must never be substituted for one another.
- One 300 mg ampule is inhaled twice daily, about 12 hours apart and never less than 6 hours apart, in repeating cycles of 28 days on treatment followed by 28 days off.
- TOBI is self-administered at home using a PARI LC PLUS nebuliser with a compatible compressor, and is manufactured and distributed by Viatris (formerly marketed under Mylan).
Side Effects
- TOBI does not carry a boxed warning.
- Very common effects, in more than 1 in 10 people, include increased cough, sore throat, increased sputum, breathlessness, coughing up blood-streaked sputum, voice changes and reduced lung function test results.
- Aminoglycosides such as tobramycin can rarely cause hearing loss or ringing in the ears (ototoxicity) and kidney problems (nephrotoxicity), even when inhaled, so report any hearing changes, ringing in the ears, dizziness or reduced urine output promptly.
- Wheezing or tightness in the chest can occur during or shortly after a dose (bronchospasm); if this happens, a fast-acting inhaler should be used beforehand on future doses.
- Tell your care team about any new muscle weakness, since aminoglycosides can rarely worsen conditions affecting the nerves and muscles.
Precautions & Warnings
- Do not use TOBI if you are allergic to tobramycin or any other aminoglycoside antibiotic.
- Hearing tests and kidney function checks are recommended periodically, especially if you have existing hearing or kidney problems, take other medicines that can harm the ears or kidneys, or carry certain mitochondrial gene variants that increase the risk of sudden hearing loss with aminoglycosides.
- Only use TOBI with the specific PARI LC PLUS nebuliser and compressor combination named on the label, since other devices change the dose delivered to the lungs.
- If you have asthma or your airways react to inhaled medicines, a bronchodilator may be used before each TOBI dose to prevent wheezing.
- Tell your healthcare provider if you are pregnant, since aminoglycosides can affect an unborn baby, although absorption from inhalation into the bloodstream is low.
Avoid Interactions
- Tell your healthcare provider about all your medicines before starting TOBI.
- Avoid using TOBI together with other drugs that can damage the ears, kidneys or nerve-muscle function, including intravenous aminoglycosides, amphotericin B, cisplatin, and certain diuretics such as furosemide, ethacrynic acid, urea or intravenous mannitol, as combining them raises the risk of hearing loss and kidney injury.
- If you use inhaled bronchodilators, these are typically given a few minutes before TOBI to reduce the chance of wheezing.
- TOBI ampules should not be mixed with other nebuliser medicines in the same chamber.
- Report any other prescribed antibiotics, especially other aminoglycosides, to avoid unintentional double dosing of the same drug class.
References
Frequently Asked Questions
TOBI is tobramycin inhalation solution, an antibiotic used in people with cystic fibrosis aged 6 and older to treat lung infection with Pseudomonas aeruginosa bacteria. It is inhaled through a nebuliser and is a different product from Tobrex eye drops or Tobi Podhaler capsules.
Inhale one 300 mg TOBI ampule twice daily, about 12 hours apart, using a PARI LC PLUS nebuliser with its matching compressor. Treatment runs in cycles: 28 days on TOBI, then 28 days off, repeated as your care team advises.
Common TOBI side effects include increased cough, sore throat, more sputum, breathlessness and voice changes. Less often it can affect hearing or kidney function; report ringing in the ears, hearing changes, dizziness or reduced urine output to your care team.
Avoid other ear- or kidney-harming drugs alongside TOBI, such as intravenous aminoglycosides, amphotericin B, cisplatin, or diuretics like furosemide. Use only the specified PARI LC PLUS nebuliser and compressor, since other devices change how much medicine reaches your lungs.
Take the missed TOBI dose as soon as you remember, unless it is close to your next dose, in which case skip it and continue as scheduled. Do not take two doses within 6 hours of each other, and keep to the 28-day on/off treatment cycle.
Store TOBI ampules in the refrigerator at 2°C to 8°C. If refrigeration is not available, they may be kept at room temperature, up to 25°C, for a maximum of 28 days. Protect ampules from light and check they are clear before use.
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