What is Xoterna Breezhaler and what is it used for - indacaterol and glycopyrronium?
Xoterna Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms). It is used as a (regular) maintenance treatment to alleviate the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic disease in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulties in inhaling and exhaling air from the lungs.
How is Xoterna Breezhaler used - indacaterol and glycopyrronium?
Xoterna Breezhaler is available as capsules containing an inhalation powder that can only be obtained with a prescription. The recommended dose is one inhalation once a day of the powder contained in each individual capsule. It must be taken at the same time every day using the Xoterno Breezhaler device. The contents of the capsules must not be inhaled using another device. In patients with severely reduced kidney function, Xoterna Breezhaler should only be used after careful risk / benefit assessment.
How does Xoterna Breezhaler work - indacaterol and glycopyrronium?
The active ingredients of Xoterna Breezhaler, indacaterol and glycopyrronium, act differently to enlarge the airways and improve breathing in COPD. Indacaterol is a long-lasting beta-2 agonist. It works by adhering to beta-2 receptors located in the muscles of numerous organs including the pulmonary airways. When indacaterol is inhaled, it reaches the receptors in the airways by activating them. This causes the muscles of the airways to relax. Glycopyrronium is a muscarinic receptor antagonist. It works by blocking certain receptors called muscarinic receptors, which control muscle contraction. When glycopyrronium is inhaled, this causes the muscles to relax. The associated action of the two active ingredients helps to keep the airways open allowing the patient to breathe more easily. Muscarinic receptor antagonists and long-term beta-2 adrenergic agonists are usually associated in the management of COPD.
What benefit has Xoterna Breezhaler - indacaterol and glycopyrronium shown during the studies?
Xoterna Breezhaler has been studied in two main studies involving a total of 2, 667 patients with COPD. While one study compared the effects of Xoterna Breezhaler with those of a placebo (a dummy treatment) or indacaterol or glycopyrronium in monotherapy, the other study compared Xoterna Breezhaler with fluticasone plus salmeterol, a standard treatment for COPD. In both studies, the main measure of effectiveness was the Xoterna Breezhaler-induced improvement in the forced expiratory volume of patients (FEV1, ie the maximum air volume that a person can exhale in one second) after 26 weeks of treatment. The first study found that treatment with Xoterna Breezhaler was more effective than placebo and increased FEV1 on average by over 200 ml. Xoterna Breezhaler also increased FEV1 by 70 ml more than indacaterol monotherapy and 90 ml of glycopyrronium monotherapy. In the second study, the average increase in FEV1 was 140 ml higher with Xoterna Breezhaler than with fluticasone and salmeterol. A third study examined the effects of Xoterna Breezhaler on the rate of exacerbations (attacks) that affected patients over 64 weeks of treatment compared to treatment with glycopyrronium or tiotropium (other treatments for COPD). The reduction in the rate of exacerbations was 10-12% higher with Xoterna Breezhaler compared to tiotropium and glycopyrronium.
What is the risk associated with Xoterna Breezhaler - indacaterol and glycopyrronium?
The most common side effects with Xoterna Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds). For the full list of all side effects reported with Xoterna Breezhaler, see the package leaflet.
Why has Xoterna Breezhaler - indacaterol and glycopyrronium - been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xoterna Breezhaler's benefits are greater than its risks and recommended that it be approved for use in the EU. The effects of Xoterna Breezhaler in relieving COPD symptoms have been clinically significant. However, the CHMP considered that the effects in reducing the rate of exacerbations were too small to recommend their use for this reduction. Regarding safety, Xoterna Breezhaler is comparable to indacatenol and glycopyrronium used as monotherapy. The side effects observed in the studies were generally benign and considered manageable.
What measures are being taken to ensure the safe and effective use of Xoterna Breezhaler - indacaterol and glycopyrronium?
A risk management plan has been developed to ensure that Xoterna Breezhaler 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 Xoterna Breezhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information on Xoterna Breezhaler - indacaterol and glycopyrronium
On 19 September 2013, the European Commission issued a marketing authorization for Xoterna Breezhaler, valid throughout the European Union. For more information about treatment with Xoterna Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 09-2013.
