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  • Tobi Podhaler 28 mg
    / Novartis


    Active Ingredient
    Tobramycin 28 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Hard Capsules

    224 X 28 mg

    partial basket chart 26220 20720

    Dosage

    This drug  is for oral administration only and must not be administered by any other route.
    The dose of Tobramycin is the same for all patients (adults and children aged 6 years or older) regardless of age or weight. The recommended dosage is four capsules (4 × 28 mg = 112 mg Tobramycin) administered twice daily (BID) for 28 days. TOBI Podhaler is taken in alternating cycles of 28 days on drug followed by 28 days off drug. Each dose of four capsules should be inhaled as close as possible to 12 hours apart and not less than six hours apart. In case of missed dose with at least 6 hours until the next dose, the patient should take the dose as soon as possible. Otherwise, the patient should wait for the next dose and not inhale more capsules to make up for the missed dose. Treatment with Tobramycin should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the treatment with Tobramycin taking into account that long-term safety data are not available for Tobramycin. If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 (Forced Expiratory Volume in 1 second) <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
    Dosing in special populations
    Elderly patients (≥ 65 years): There are insufficient data in this population to support a recommendation for or against dose adjustment. Renal function in elderly patients should be taken into account while using Tobramycin.
    Patients with renal impairment: Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to Tobramycin. Patients with serum creatinine 2 mg/dL or more and blood urea nitrogen (BUN) 40mg/dL or more have not been included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment with this drug. Caution should be exercised when prescribing this drug to patients with known or suspected renal dysfunction. Please also refer to section 6 Warnings and precautions – nephrotoxicity.
    Patients with hepatic impairment: No studies have been performed on patients with hepatic impairment. As Tobramycin is not metabolized, an effect of hepatic impairment on the exposure to Tobramycin is not expected.
    Patients after organ transplantation: Adequate data do not exist for the use of this drug in patients after organ transplantation.
    Pediatric patients aged less than 6 years: The safety and efficacy of this drug in children aged under 6 years have not been established.
    Method of administration: TOBI Podhaler is administered only by the oral inhalation route and only using the Podhaler device. It must not be administered by any other route or using any other inhaler. TOBI Podhaler capsules must not be swallowed. Each TOBI Podhaler capsule should be inhaled with two breath-hold manoeuvres and checked to ensure it is empty. Caregivers should provide assistance to children starting TOBI Podhaler treatment, particularly those aged 10 years or younger, and should continue to supervise them until they are able to use the Podhaler device properly without help. Where patients are receiving several different inhaled medications and performing chest physiotherapy, it is recommended that TOBI Podhaler is taken last.


    Indications

    Suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.


    Contra-Indications

    Known hypersensitivity to the active substance and any aminoglycoside, or to any of the excipients.


    Special Precautions

    Ototoxicity: Ototoxicity, manifested as both auditory toxicity (hearing loss) and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia, or dizziness. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Hearing loss and tinnitus were reported by patients in the TOBI Podhaler clinical trials. Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory or vestibular dysfunction. Physicians should consider an audiogram for patients who show any evidence of auditory dysfunction, or who are at increased risk for auditory dysfunction. If a patient reports tinnitus or hearing loss during TOBI Podhaler therapy, the physician should refer them for audiological assessment.
    Nephrotoxicity: Nephrotoxicity has been reported with the use of parenteral aminoglycosides. Nephrotoxicity was not observed during TOBI Podhaler clinical studies. Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction. Baseline renal function should be assessed. Urea and creatinine levels should be reassessed after every 6 complete cycles of TOBI Podhaler therapy. Laboratory tests should be performed for monitoring renal function as clinically appropriate.
    Laboratory tests and monitoring – serum concentrations: Serum tobramycin concentrations should be monitored in patients with known or suspected auditory or renal dysfunction. If oto- or nephrotoxicity occurs in a patient receiving TOBI Podhaler, tobramycin therapy should be discontinued until serum concentration falls below 2 μg/mL. Serum tobramycin concentrations are approximately1 to 2 μg/mL one hour after TOBI Podhaler administration. Serum concentrations greater than 12 μg/ml are associated with tobramycin toxicity and treatment should be discontinued if concentrations exceed this level. Serum concentrations of tobramycin should be monitored in patients receiving concomitant parenteral aminoglycoside therapy (or other medications that can affect renal excretion). These patients should be monitored as clinically appropriate. The serum concentration of tobramycin should only be monitored through venipuncture and not finger prick blood sampling. Contamination of the skin of the fingers with tobramycin may lead to falsely increased measurements of serum levels of the drug. This contamination cannot be completely avoided by hand washing before testing.
    Bronchospasm: Bronchospasm can occur with inhalation of medicinal products and has been reported with TOBI  Podhaler during clinical trials. Bronchospasm should be treated as medically appropriate. The first dose of TOBI Podhaler should be given under supervision, after using a bronchodilator if this is part of the current regimen for the patient. FEV1 should be measured before and after inhalation of TOBI Podhaler. If there is evidence of therapy-induced bronchospasm, the physician should carefully evaluate whether the benefits of continued use of TOBI Podhaler outweigh the risks to the patient. If an allergic response is suspected, TOBI Podhaler should be discontinued.
    Cough: Cough can occur with the use of inhaled medicinal products and was reported with use of TOBI Podhaler in clinical studies. Based on clinical trial data the inhalation powder TOBI Podhaler was associated with a higher reported rate of cough compared with tobramycin nebuliser solution (TOBI). Cough was not related to bronchospasm. Children below the age of 13 years may be more likely to cough when treated with TOBI Podhaler compared with older subjects. If there is evidence of continued therapy-induced cough with TOBI Podhaler, the physician should consider whether an approved tobramycin nebuliser solution should be used as an alternative treatment. Should cough remain unchanged, other antibiotics should be considered.
    Haemoptysis: Haemoptysis is a complication in cystic fibrosis and is more frequent in adults. Patients with haemoptysis (>60 ml) were excluded from the clinical studies so no data exist on the use of TOBI Podhaler in these patients. This should be taken into account before prescribing TOBI Podhaler, considering the inhalation powder TOBI Podhaler was associated with a higher rate of cough. The use of TOBI Podhaler in patients with clinically significant haemoptysis should be undertaken or continued only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
    Other precautions: Patients receiving concomitant parenteral aminoglycoside therapy (or any medication affecting renal excretion, such as diuretics) should be monitored as clinically appropriate taking into account the risk of cumulative toxicity. This includes monitoring of serum concentrations of tobramycin. In patients with a predisposing risk due to previous prolonged, systemic aminoglycoside therapy it may be necessary to consider renal and audiological assessment before initiating TOBI Podhaler therapy. Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected neuromuscular disorders such as myasthenia gravis or Parkinson’s disease. Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy. In clinical studies, some patients on TOBI Podhaler therapy showed an increase in aminoglycoside minimum inhibitory concentrations (MIC) for P. aeruginosa isolates tested. MIC increases observed were in large part reversible during off treatment periods. There is a theoretical risk that patients being treated with TOBI Podhaler may develop P. aeruginosa isolates resistant to intravenous tobramycin over time. Development of resistance during inhaled tobramycin therapy could limit treatment options during acute exacerbations; this should be monitored.
    For full details see prescribing information.


    Side Effects

    The most commonly reported adverse reactions in the main safety, active-controlled clinical study with TOBI Podhaler versus tobramycin nebuliser solution (TOBI) in cystic fibrosis patients with P. aeruginosa infection were cough, lung disorder, productive cough, pyrexia, dyspnoea, oropharyngeal pain and dysphonia. In the placebo-controlled study with TOBI Podhaler, the adverse reactions for which reported frequency was higher with TOBI Podhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia. Long-term safety data are not available for TOBI Podhaler. The vast majority of adverse reactions reported with TOBI Podhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods.
    For full details see prescribing information.


    Drug interactions

    No clinical drug interaction studies have been performed with this drug. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue, should not be administered concomitantly with ethacrynic acid, furosemide, urea, or mannitol.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: There is a limited amount of data on the use of inhaled Tobramycin in pregnant patients. Treatment with TOBI Podhaler during pregnancy should be undertaken only if the expected benefits to the mother outweigh the potential risks to the fetus or baby.
    Lactation: Tobramycin is excreted in human breast milk after systemic administration. The amount of Tobramycin excreted in human breast milk after administration by inhalation is not known, though it is estimated to be very low considering the low systemic exposureBecause of the potential for ototoxicity and nephrotoxicity in infants, a decision should be made whether to terminate nursing or discontinue treatment with TOBI Podhaler, taking into account the importance of the drug to the mother.
    For full details see prescribing information.


    Overdose

    Adverse reactions specifically associated with overdose of Tobramycin have not been identified. The maximum tolerated daily dose of this drug  has not been established. Tobramycin serum concentrations may be helpful in monitoring overdose. Acute toxicity should be treated with immediate withdrawal of this drug , and baseline tests of renal function should be undertaken. In the event of accidental oral ingestion of this drug , systemic toxicity is unlikely as Tobramycin is poorly absorbed. Hemodialysis may be helpful in removing Tobramycin from the body.


    Important notes

    Incompatibilities: The Podhaler device is the only inhaler to be used with TOBI Podhaler capsules; this inhaler must not be used for any drug product other than TOBI Podhaler.
    Storage: Store below 30°C; Store in the original package to protect from moisture. Store the inhaler in its tightly closed case when not in use.


    Manufacturer
    Novartis Pharma Stein AG Switzerland
    Licence holder
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