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Tobi Podhaler is a brand name for Tobramycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TOBI Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups. Consideration should be given to official guidance on the appropriate…
Verbatim from this product's EMA label. Tap a section to expand.
Posology The dose of TOBI Podhaler is the same for all patients within the approved age range, regardless of age or weight. The recommended dose is 112 mg tobramycin (4 x 28 mg capsules), administered twice daily for 28 days. TOBI Podhaler is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment.
The two doses (of 4 capsules each) should be inhaled as close as possible to 12 hours apart and not less than 6 hours apart. Missed doses 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. Duration of treatment Treatment with TOBI Podhaler should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the treatment with TOBI Podhaler.
If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered. 1. Special populations Elderly patients (≥65 years) There are insufficient data in this population to support a recommendation for or against dose adjustment.
3 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) 40 mg/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 TOBI Podhaler.
Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction. Please also refer to nephrotoxicity information in section
8. If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered. 6 Observed benefits on lung function and P. aeruginosa suppression should be assessed in the context of the patient’s tolerance of TOBI Podhaler.
Safety and efficacy have not been studied in patients with forced expiratory volume in 1 second (FEV1) <25% or >80% predicted, or patients colonised with Burkholderia cepacia. 5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed with TOBI Podhaler.
Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of TOBI Podhaler is not recommended with other medicinal products with nephrotoxic or ototoxic potential.
Concomitant use of TOBI Podhaler with diuretic compounds (such as ethacrynic acid, furosemide, urea or intravenous mannitol) is not recommended. Such compounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
4. Other medicinal products that have been reported to increase the potential toxicity of parenterally administered aminoglycosides include: - amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity); - platinum compounds (risk of increased nephrotoxicity and ototoxicity); - anticholinesterases, botulinum toxin (neuromuscular effects).
In clinical studies, patients receiving TOBI Podhaler continued to take dornase alfa, bronchodilators, inhaled corticosteroids and macrolides, no evidence of drug interactions with these medicines was identified. 6 Fertility, pregnancy and lactation Pregnancy There are no adequate data on the use of tobramycin via inhalation in pregnant women.
3). g. congenital deafness) when high systemic concentrations are achieved in a pregnant woman. e. when the benefits to the mother outweigh the risks to the foetus. Patients who use TOBI Podhaler during pregnancy, or become pregnant while taking TOBI Podhaler, should be informed of the potential hazard to the foetus.
4. Hepatic impairment No studies have been performed on patients with hepatic impairment. As tobramycin is not metabolised, 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 TOBI Podhaler in patients after organ transplantation.
No recommendation for or against dose adjustment can be made for patients after organ transplantation. Paediatric population The safety and efficacy of TOBI Podhaler in children aged under 6 years have not been established. No data are available.
Method of administration Inhalation use. 6 for detailed instructions for use). It must not be administered by any other route or using any other inhaler. 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.
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. Where patients are receiving several different inhaled medicinal products and chest physiotherapy, it is recommended that TOBI Podhaler is taken last.
1. 4 Special warnings and precautions for use 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. 8). Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory or vestibular dysfunction.
4 In patients with any evidence of auditory dysfunction, or those with a predisposing risk, it may be necessary to consider audiological assessment before initiating TOBI Podhaler therapy. 1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tobramycin in European Union.
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Breast-feeding 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 exposure.
Because of the potential for ototoxicity and nephrotoxicity in infants, a decision should be made whether to terminate breast-feeding or discontinue treatment with TOBI Podhaler, taking into account the importance of the treatment to the mother.
3). 7 Effects on ability to drive and use machines TOBI Podhaler has no or negligible influence on the ability to drive and use machines. 8 Undesirable effects Summary of the safety profile The most commonly reported adverse reactions in the main safety, active-controlled clinical study with TOBI Podhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P.
aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis. 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.
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. Tabulated summary of adverse reactions Adverse drug reactions in Table 1 are listed according to system organ classes in MedDRA.
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
The frequencies in Table 1 are based on the reporting rates from the active-controlled study. Table 1 Adverse reactions Adverse reactions Frequency category Ear and labyrinth disorders Hearing loss Common Tinnitus Common Vascular disorders Haemoptysis Very common Epistaxis Common Respiratory, thoracic and mediastinal disorders Dyspnoea Very common Dysphonia Very common Productive cough Very common Cough Very common Wheezing Common Rales Common Chest discomfort Common Nasal congestion Common Bronchospasm Common Aphonia Common Sputum discoloured Not known 8 Gastrointestinal disorders Oropharnygeal pain Very common Vomiting Common Diarrhoea Common Throat irritation Common Nausea Common Dysgeusia Common Skin and subcutaneous tissue disorders Rash Common Musculoskeletal and connective tissue disorders Musculoskeletal chest pain Common Renal and urinary disorders Acute kidney injury (AKI) Not known General disorders and administration site conditions Pyrexia Very common Malaise Not known Description of selected adverse drug reactions Cough was the most frequently reported adverse reaction in both clinical studies.
However, no association was observed in either clinical study between the incidence of bronchospasm and cough […]
In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, it may be necessary to consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies.
If a patient reports tinnitus or hearing loss during TOBI Podhaler therapy the physician should consider referring them for audiological assessment. See also “Monitoring of serum tobramycin concentrations” below. Nephrotoxicity Nephrotoxicity has been reported with the use of parenteral aminoglycosides.
8). 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.
2 and “Monitoring of serum tobramycin concentrations” below. Monitoring of serum tobramycin concentrations Patients with known or suspected auditory or renal dysfunction should be monitored for serum tobramycin concentrations. 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 concentrations greater than 12 μg/ml are associated with tobramycin toxicity and treatment should be discontinued if concentrations exceed this level. The serum concentration of tobramycin should only be monitored through validated methods.
Finger prick blood sampling is not recommended due to the risk of contamination of the sample. Bronchospasm Bronchospasm can occur with inhalation of medicinal products and has been reported with TOBI Podhaler in clinical studies. 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 was reported with use of TOBI Podhaler in clinical studies. Based on clinical trial data the 5 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 […]