What is Tobi Podhaler - Tobramicina?
Tobi Podhaler is a medicine containing the active substance tobramycin. It is available as capsules (28 mg) containing a dry powder to be inhaled using a portable device.
What is Tobi Podhaler - Tobramicina used for?
Tobi Podhaler is indicated for the suppressive therapy of chronic lung infection due to bacteria called Pseudomonas aeruginosa in adults and in children from six years of age with cystic fibrosis. Cystic fibrosis is an inherited disease that affects lung cells and intestinal and pancreatic glands that secrete fluids such as mucus and digestive juices. The accumulation of mucus in the lungs allows the bacteria to develop more easily and causes infections, lung damage and respiratory problems. Lung infection caused by P. aeruginosa bacteria is common in patients with cystic fibrosis.
Because the number of patients with cystic fibrosis and P. aeruginosa pulmonary infection is low, the disease is considered "rare" and Tobi Podhaler was designated an "orphan medicine" (a medicine used in rare diseases) on 17 March 2003.
The medicine can only be obtained with a prescription.
How is Tobi Podhaler - Tobramicina used?
Tobi Podhaler is inhaled via a portable device called Podhaler. The capsules should only be inserted into the Podhaler inhaler and should never be swallowed. The recommended dose is four capsules twice a day (possibly 12 hours apart) for four weeks, followed by four weeks without treatment. Treatment should be repeated with a four-week cycle followed by a four-week interruption until the doctor believes that the patient benefits. If the lung infection gets worse, the doctor should consider replacing the treatment with Tobi Podhaler or adding a therapy. For more information on how to use Tobi Podhaler, see the instructions on the information sheet.
How does Tobi Podhaler - Tobramicina work?
The active substance of Tobi Podhaler, tobramycin, is an antibiotic belonging to the group of "aminoglycosides". It works by blocking the production of proteins that P. aeruginosa needs to build its cell walls. This causes damage to the bacteria and ultimately causes their elimination.
Tobramycin is a known antibiotic used in the treatment of pulmonary infections in patients with cystic fibrosis, available as a solution for use with a nebulizer (a device that turns a solution into an aerosol that the patient can inhale). The aim of Tobi Podhaler is to increase the ease of taking tobramycin for patients.
How has Tobi Podhaler - Tobramicina been studied?
The applicant presented data on experimental models with Tobi Podhaler and a nebuliser solution containing Tobramin called tobramycin. He also presented data from the scientific literature.
Tobi Podhaler has been studied in two main studies involving patients with cystic fibrosis and P. aeruginosa lung infection. In the first study, which involved 102 patients aged between six and 21, Tobi Podhaler was compared with placebo (a dummy treatment), while in the second study, which involved 553 mostly adult subjects, Tobi Podhaler was compared with Tobi. The studies lasted 24 weeks (three treatment cycles). The main measure of effectiveness was the change in FEV 1 at the end of the 1st treatment cycle in the first study and at the end of the 3rd treatment cycle in the second study. The VEMS indicates the maximum volume of air that a person can exhale in a second.
What benefit has Tobi Podhaler - Tobramycin shown during the studies?
Tobi Podhaler was more effective than placebo in treating P. aeruginosa infection in patients with cystic fibrosis. After four weeks of treatment, patients treated with Tobi Podhaler showed a 13.2% improvement in FEV1, while those treated with placebo showed a reduction in FEV1 of 0.6%. When patients in the placebo group received Tobi Podhaler in the second and third courses of therapy, a similar improvement in FEV1 was noted. The effect of Tobi Podhaler was similar to that of Tobi after three treatment cycles.
What is the risk associated with Tobi Podhaler - Tobramicina?
The most common side effects of Tobi Podhaler (seen in more than 1 patient in 10) are haemoptysis (emission of blood following a cough), dyspnoea (difficulty breathing), dysphonia (hoarseness), cough and productive cough (fat), oropharyngeal pain (affecting the oral cavity and throat) and pyrexia (fever). For the full list of all side effects reported with Tobi Podhaler, see the Package Leaflet.
Tobi Podhaler should not be used in people who may be hypersensitive (allergic) to tobramycin, to any aminoglycosidic or to any of the other ingredients.
Why has Tobi Podhaler - Tobramicina been approved?
The CHMP decided that Tobi Podhaler's benefits are greater than its risks, as the drug was effective in treating pulmonary infection in patients with cystic fibrosis and in view of its greater ease of use for patients, and therefore recommended the granting of the marketing authorization for the medicinal product.
What measures are being taken to ensure the safe use of Tobi Podhaler - Tobramicina?
The company that makes Fampyra will carry out a long-term study on the efficacy and safety of the medicine. The study will examine the effects of Fampyra on other aspects of walking, in addition to speed, and will seek new ways to identify patients responding to Fampyra early, to allow timely intervention on treatment management.
More information on Tobi Podhaler - Tobramicina
On 20 July 2011, the European Commission granted Tobit Podhaler a marketing authorization valid throughout the European Union to Novartis Europharm Limited. The marketing authorization is valid for five years, after which it can be renewed.
. For more information about treatment with Tobi Podhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2010.
