What is Quinsair and what is Levofloxacin used for?
Quinsair is an antibiotic indicated for the treatment of chronic lung infections due to Pseudomonas aeruginosa bacteria in adult patients with cystic fibrosis. Cystic fibrosis is a hereditary disease in which an accumulation of thick mucus is observed in the lungs, which allows bacteria to multiply more easily, causing infections. Lung infection caused by P. aeruginosa bacteria is common in patients with cystic fibrosis. Quinsair contains the active ingredient levofloxacin. Before using Quinsair, doctors should consult the official guidelines on the correct use of antibiotics.
How is Quinsair used - Levofloxacin?
Quinsair is available as a nebulizer solution in single-dose vials called "ampoules". The medicine can only be obtained with a prescription. Quinsair is inhaled through a nebulizer called Zirela, which transforms the solution of the vial into aerosol with very fine drops. The medicine should not be inhaled with other devices. The recommended dose is one ampoule twice a day, possibly at an interval of 12 hours. After 28 days of treatment, therapy should be interrupted for 28 days before starting a new cycle. Cycles can be repeated until the doctor believes the patient benefits.
How does Quinsair - Levofloxacin work?
The active ingredient in Quinsair, levofloxacin, is an antibiotic belonging to the group of "fluoroquinolones". It works by blocking the enzymes that P. aeruginosa bacteria use to duplicate their DNA during cell multiplication. In this way it prevents the bacteria responsible for the infection from growing and multiplying. Levofloxacin is a commonly used antibiotic. Systemic formulations of levofloxacin (including tablets and infusion solutions) have been authorized in the EU since the 1990s.
What benefit has Quinsair - Levofloxacin shown during the studies?
Quinsair has been studied in two main studies involving patients with cystic fibrosis and P. aeruginosa lung infection. In the first study, involving 330 patients, Quinsair was compared with placebo (a dummy treatment), while in the second study, which involved 282 subjects, Quinsair was compared to another inhaled antibiotic (tobramycin). In both studies the patients were predominantly adults. In the first study, Quinsair was shown to be more effective than placebo in improving the forced expiratory volume (FEV1) of patients in one second, based on age, height and gender. The FEV1 is the maximum volume of air that a person is able to exhale in a second. After 28 days of treatment, patients treated with Quinsair reported an improvement of FEV1 equal to 1.73%, while in subjects treated with placebo there was an improvement in FEV1 of 0.43%. However, the study did not demonstrate greater efficacy of Quinsair than placebo in increasing the time interval preceding an exacerbation of the disease. The second study showed that Quinsair has at least an efficacy of tobramycin in improving FEV1 after 1-3 treatment cycles.
What is the risk associated with Quinsair - Levofloxacin?
The most common side effects of Quinsair are cough (seen in 54% of patients), dysgeusia (taste disturbances, 30%) and fatigue / weakness (25%). For the full list of all side effects reported with Quinsair, see the package leaflet. Quinsair should not be used in epileptic patients and in subjects with a history of tendon disorders related to the use of fluoroquinolones. The medicine should not be used in women who are pregnant or breast-feeding. For the full list of limitations, see the package leaflet.
Why has Quinsair - Levofloxacin been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Quinsair's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP is of the opinion that the modest increase in FEV1 seen with Quinsair is a signal of the medicinal product's potential to respond to the need for additional inhaled antibiotics in the treatment of P. aeruginosa infections in cystic fibrosis. As for safety, Quinsair was well tolerated, with side effects similar to those of levofloxacin administered systemically (in the whole body). Since levofloxacin represents a potential risk for cartilage, the use of the medicine is not justified in adolescents.
What measures are being taken to ensure the safe and effective use of Quinsair - Levofloxacin?
A risk management plan has been developed to ensure that Quinsair is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Quinsair, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Quinsair will conduct a study to examine the long-term safety of the medicine where it is used in clinical practice in the European Union. Further information is available in the summary of the risk management plan
More information on Quinsair - Levofloxacin
On 26 March 2015, the European Commission issued a marketing authorization for Quinsair, valid throughout the European Union. For more information about treatment with Quinsair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 04-2015.
