TM Owner Viatris
Tobi Podhaler 28mg Capsule
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Indications & Clinical Uses
- Tobi Podhaler 28 mg capsules contain tobramycin inhalation powder, an aminoglycoside antibiotic, used to manage cystic fibrosis lung infection caused by Pseudomonas aeruginosa in patients aged 6 years and older.
- The capsules are never swallowed: each capsule is pierced and inhaled through the purpose-built Podhaler device, which delivers a dry powder directly to the lungs.
- This is a different formulation from the nebulised liquid TOBI (Sr 3410, 300 mg/5 mL ampules) and from tobramycin eye drops or ointment (Tobrex); the three are not interchangeable.
- Safety and efficacy have not been established in patients with an FEV1 below 25% or above 80% predicted, or those colonised with Burkholderia cepacia.
- Tobi Podhaler is self-administered at home and is manufactured and distributed by Viatris.
Side Effects
- Tobi Podhaler does not carry a boxed warning.
- The most common effects include cough, lung disorder symptoms, productive cough, breathlessness, fever, throat pain, voice changes, coughing up blood-streaked sputum and headache.
- Bronchospasm (sudden wheeze or chest tightness) can occur during or shortly after inhalation and needs prompt treatment.
- As with other aminoglycosides, hearing loss or tinnitus (ringing in the ears) and kidney problems have been reported, even though the drug is inhaled rather than injected, so report hearing changes, dizziness or reduced urine output.
- Aminoglycosides can rarely worsen muscle weakness in people with nerve-muscle conditions.
- Contact your care team promptly for sudden breathlessness, wheeze, chest tightness, or new hearing symptoms after a dose.
Precautions & Warnings
- Do not use Tobi Podhaler if you are allergic to tobramycin or any other aminoglycoside antibiotic.
- Caution is needed, with hearing and kidney monitoring, in patients with known or suspected hearing or balance problems, kidney impairment, or neuromuscular disorders such as myasthenia gravis.
- Test your lung function (FEV1) before starting, since the medicine's safety has not been established outside the 25-80% predicted range.
- Capsules must only be used with the Podhaler inhaler device provided and must never be swallowed; keep capsules in the blister until immediately before use and use each dose right after opening the blister.
- If wheeze or chest tightness occurs, your care team may have you use a bronchodilator before future doses.
- Discuss pregnancy plans with your healthcare provider before starting treatment.
Avoid Interactions
- Tell your healthcare provider about every medicine you take, including inhaled treatments.
- Avoid combining Tobi Podhaler with other drugs that can harm hearing, kidneys or nerve-muscle function, such as intravenous aminoglycosides, amphotericin B, cisplatin, and diuretics including furosemide, ethacrynic acid, urea or intravenous mannitol, since combining these raises the risk of ototoxicity and nephrotoxicity.
- If you use an inhaled bronchodilator, it is usually taken shortly before Tobi Podhaler to reduce the chance of bronchospasm; use your bronchodilator, mucolytic (such as dornase alfa) and chest physiotherapy in the order your care team recommends.
- Do not take other tobramycin-containing products at the same time to avoid unintentional double dosing.
References
Frequently Asked Questions
Tobi Podhaler is tobramycin inhalation powder, used in people with cystic fibrosis aged 6 and older to treat lung infection with Pseudomonas aeruginosa. It is inhaled as a dry powder through its own device, not swallowed, and differs from the nebulised liquid TOBI.
Inhale four 28 mg Tobi Podhaler capsules, one after another, twice daily using the Podhaler device provided; never swallow the capsules. Treatment runs in 28-day cycles: 28 days on, then 28 days off, as your care team directs.
Common effects include cough, breathlessness, throat pain, fever, voice changes and headache. Wheeze or chest tightness can occur during inhalation. Less often it affects hearing or kidney function; report ringing in the ears, dizziness or reduced urine output promptly.
Avoid other ear- or kidney-harming drugs alongside Tobi Podhaler, including intravenous aminoglycosides, amphotericin B, cisplatin, or diuretics such as furosemide. Never swallow the capsules, and only use them with the Podhaler device supplied with your prescription.
Take the missed Tobi Podhaler dose as soon as you remember, unless your next dose is due soon, in which case skip it and continue your normal twice-daily schedule. Do not take a double dose, and keep to the 28-day on/off treatment cycle.
Store Tobi Podhaler capsules at room temperature, 25°C, with excursions permitted between 15°C and 30°C, in a dry place away from moisture. Keep each capsule in its blister until you are ready to use it, and inhale the dose right after opening.
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