What is Incruse and what is it used for - umeclidinium bromide?
Incruse is a medicine that contains the active substance umeclidinium bromide . It is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic (protracted) disease in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulty breathing. Incruse is used for maintenance treatment (regular).
How is Incruse used - umeclidinium bromide?
Incruse can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler. The inhaler delivers 65 micrograms of umeclidinium bromide, equivalent to 55 micrograms of umeclidinium for each inhalation. The recommended dose is one inhalation per day, at the same time each day. For detailed information on the correct use of the inhaler, see the instructions in the package leaflet.
How does Incruse - umeclidinium bromide work?
The active substance in Incruse, umeclidinium bromide, is a muscarinic receptor antagonist. It works by blocking certain receptors called "muscarinic receptors", which control muscle contraction. When inhaled, umeclidinium bromide induces relaxation of the airway muscles and helps to keep the airways free, allowing the patient to breathe more easily.
What benefit has Incruse - umeclidinium bromide shown during the studies?
Incruse has been examined in four main studies involving 4, 000 patients. Three studies compared Incruse with a placebo (a dummy treatment), while in another Incruse study it was compared to tiotropium (another medicine for the treatment of COPD). The main measure of effectiveness was based on changes in the forced expiratory volume (FEV1, the maximum volume of air that a person is able to exhale in one second) of the patient. The results show that Incruse, taken at a dose equivalent to 55 micrograms of umeclidinium, improved lung function for an average FEV1 value of 127 ml more than placebo after 12 weeks of treatment and 115 ml after 24 weeks of treatment. A double dose of Incruse compared to the lower dose showed only minimal improvements, which were not considered significant. In the study in which Incruse was compared to tiotropium, improvements in FEV1 over a period of 24 weeks were similar with both drugs. Studies have also shown improvement in symptoms such as difficulty breathing and wheezing.
What is the risk associated with Incruse - umeclidinium bromide?
The most common side effects of Incruse (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (colds), sinusitis, cough, urinary tract infection, and tachycardia (acceleration of heart rate). For the full list of side effects and limitations, see the package leaflet.
Why has Incruse - umeclidinium bromide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Incruse's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Incruse was effective in improving lung function and COPD symptoms. The CHMP also noted that no important critical aspects emerged in relation to the use of Incruse and that undesirable effects are manageable and are similar to those observed with other antimuscarinic bronchodilator medicinal products.
What measures are being taken to ensure the safe and effective use of Incruse - umeclidinium bromide?
A risk management plan has been developed to ensure that Incruse 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 Incruse, including the appropriate precautions to be followed by healthcare professionals and patients. Since antimuscarinic bronchodilators may have cardiac and vascular effects, the company will continue to closely monitor the cardiovascular effects of the medicine and will conduct another study in patients to identify potential risks. Further information is available in the summary of the risk management plan.
Other information on Incruse - umeclidinium bromide
On 28 April 2014, the European Commission issued a marketing authorization for Incruse, valid throughout the European Union.
For the full version of the EPAR and the summary of the Incruse risk management plan, see the website of the Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Incruse therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.
