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TOBI is a brand name for Tobramycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TOBI is indicated in cystic fibrosis (CF) patients aged 6 years and older for long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Verbatim from this product's MHRA label. Tap a section to expand.
TOBI is supplied for use via inhalation and is not for parenteral use. Posology The recommended dose for adults and children is one ampoule twice daily for 28 days. The dose interval should be as close as possible to 12 hours and not less than 6 hours.
After 28 days of therapy, patients should stop TOBI therapy for the next 28 days. A cycle of 28 days of active therapy and 28 days of rest from treatment should be maintained. Dosage is not adjusted for weight. All patients should receive one ampoule of TOBI (300 mg of tobramycin) twice daily.
Controlled clinical studies, conducted for a period of 6 months using the following TOBI dosage regimen, have shown that improvement in lung function was maintained above baseline during the 28 day rest periods. TOBI Dosing Regimen in Controlled Clinical Studies Cycle 1 Cycle 2 Cycle 3 28 Days 28 Days 28 Days 28 Days 28 Days 28 Days TOBI 300 mg twice daily plus standard care standard care TOBI 300 mg twice daily plus standard care standard care TOBI 300 mg twice daily plus standard care standard care Safety and efficacy for long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa have been assessed in controlled and open label studies for up to 96 weeks (12 cycles), but have not been studied in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonised with Burkholderia cepacia.
Therapy should be initiated by a physician experienced in the management of cystic fibrosis. Treatment with TOBI should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the inclusion of TOBI in their treatment regimen.
If clinical deterioration of pulmonary status is evident, additional anti-pseudomonal therapy should be considered. Clinical studies have shown that a microbiological report indicating in vitro drug resistance does not necessarily preclude a clinical benefit for the patient.
Special populations Elderly (≥ 65 years) There are insufficient data in this population to support a recommendation for or against dose adjustment. Patients with renal impairment There are no data in this population to support a recommendation for or against dose adjustment with TOBI.
2. 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 TOBI in patients after organ transplantation.
Summary of the safety profile Two parallel, 24-week, randomised, double-blind, placebo-controlled clinical studies were conducted with TOBI in 520 cystic fibrosis patients ranging in age from 6 to 63 years. The most commonly (≥ 10%) reported adverse events in the placebo-controlled studies with TOBI were cough, pharyngitis, productive cough, asthenia, rhinitis, dyspnoea, pyrexia, lung disorder, headache, chest pain, sputum discoloured, haemoptysis, anorexia, pulmonary function test decreased, asthma, vomiting, abdominal pain, dysphonia, nausea, and weight loss.
Most events were reported at similar or higher frequencies in patients receiving placebo. 8% TOBI vs. 1% TOBI vs. 0% placebo) respectively. These episodes of tinnitus were transient and resolved without discontinuation of TOBI therapy, and were not associated with permanent loss of hearing on audiogram testing.
4 Ototoxicity). Tabulated summary of adverse reactions In the 24-week placebo-controlled studies and their open-label extensions on active treatment, a total of 313, 264 and 120 patients completed treatment with TOBI for 48, 72 and 96 weeks respectively.
Table 1 provides the incidence of treatment-emergent adverse drug reactions, according to the following criteria: reported with an incidence of ≥ 2% for patients receiving TOBI, occurring at a higher rate in the TOBI arm, and assessed as drug- related in ≥ 1% of patients.
Adverse drug reactions from clinical trials 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, <1/10); uncommon (≥1/1,000to <1/100) rare (≥1/10,000, <1/1,000) very rare (<1/10,000).
General Warnings For information on pregnancy and lactation see section
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Paediatric population The safety and efficacy of TOBI in children aged less than 6 years have not yet been established. 1 but no recommendation on a posology can be made. Method of administration The contents of one ampoule should be emptied into the nebuliser and administered by inhalation over approximately a 15-minute period using a hand-held PARI LC PLUS reusable nebuliser with a suitable compressor.
Suitable compressors are those which, when attached to a PARI LC Plus nebuliser, deliver a flow rate of 4-6 L/min and/or a back pressure of 110-217 kPa. The manufacturers’ instructions for the care and use of the nebuliser and compressor should be followed.
TOBI is inhaled whilst the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebuliser. Nose clips may help the patient breathe through the mouth. The patient should continue their standard regimen of chest physiotherapy.
The use of appropriate bronchodilators should continue as thought clinically necessary. Where patients are receiving several different respiratory therapies it is recommended that they are taken in the following order: bronchodilator, chest physiotherapy, other inhaled medicinal products, and finally TOBI.
Maximum tolerated daily dose The maximum tolerated daily dose of TOBI has not been established.
Table 1 Adverse reactions in clinical trials Adverse reactions Frequency category Infections and infestations Laryngitis Common Ear and labyrinth disorders Tinnitus Common Respiratory, thoracic, and mediastinal disorders Lung disorder Very common Rhinitis Very common Dysphonia Very common Sputum discoloured Very common Musculoskeletal and connective tissue disorders Myalgia Common General disorders and administration site conditions Malaise Common Investigations Pulmonary function test decreased Very common As the duration of exposure to TOBI increased over the two open-label extension studies, the incidence of productive cough and pulmonary function test decreased appeared to increase; however, the incidence of dysphonia appeared to decline.
Overall, the incidence of adverse events related to the following MedDRA System Organ Class (SOC) decreased with increasing exposure to TOBI: Respiratory, thoracic, and mediastinal disorders, Gastrointestinal disorders, and General disorders and administration site conditions.
Adverse reactions derived from spontaneous reports Spontaneously reported adverse reactions, presented below, are reported voluntarily and it is not always possible to reliably establish frequency or a causal relationship to drug exposure.
4). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.