Duaklir Genuair - aclidinium bromide, formoterol fumarate dihydrate

What is Duaklir Genuair - aclidinium bromide, formoterol fumarate dihydrate and what is it used for?

Duaklir Genuair is a medicine used for the relief of symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs in the lungs are damaged or blocked, causing difficulty in breathing. Duaklir Genuair is used for maintenance (regular) treatment. Duaklir Genuair contains two ingredients. active ingredients: aclidinium bromide and formoterol fumarate dihydrate.

How is Duaklir Genuair used - aclidinium bromide, formoterol fumarate dihydrate?

Duaklir Genuair is available as an inhalation powder, contained in a portable inhaler device. The inhaler delivers 340 micrograms of aclidinium and 12 micrograms of formoterol fumarate dihydrate for each inhalation. The recommended dose of Duaklir Genuair is one inhalation twice a day. For detailed information on the correct use of the inhaler, see the instructions in the package leaflet. Duaklir Genuair can only be obtained with a prescription.

How does Duaklir Genuair - aclidinium bromide, formoterol fumarate dihydrate work?

The two active substances contained in Duaklir Genuair, aclidinium bromide and formoterol fumarate dihydrate, work by keeping the airways open and allowing the patient to breathe more easily. Aclidinium bromide is a long-acting muscarinic antagonist. This means that it dilates the airways, blocking certain receptors in the muscle cells of the lungs, called muscarinic receptors (also known as cholinergics), which control the contraction of muscles. When aclidinium bromide is inhaled, causing the muscles in the airways to relax, helping to keep them open and allowing the patient to breathe more easily. Formoterol is a long-acting beta-2 agonist. It works by attaching to receptors known as beta-2 receptors, which are found in the muscles of the airways. Upon binding with these receptors, it causes the muscles to relax, keeping the airways open and helping the patient to breathe. Long-acting muscarinic antagonists and long-acting beta-2 agonists are commonly used in combination in the management of COPD. Aclidinium bromide has been authorized in the EU under the names Bretaris Genuair and Eklira Genuair since July 2012; formoterol has been on the market in the EU since the 1990s.

What benefit has Duaklir Genuair - aclidinium bromide, formoterol fumarate dihydrate shown during the studies?

Duaklir Genuair has been studied in two main studies involving over 3,400 patients with COPD, in which it was compared with aclidinium alone, formoterol alone and placebo (a dummy treatment). The main measure of effectiveness was based on changes in patients' forced expiratory volume (FEV1, the maximum volume of air a person can breathe out in one second) after six months. The results showed that, after six months of treatment, the "FEV1 increase (measured one" hour after inhalation) was 293 milliliters (ml) greater with Duaklir Genuair, compared with placebo, and 118 ml greater with Duaklir Genuair, compared to treatment with aclidinium alone. However, the improvement over formoterol alone was minor and not considered clinically significant: FEV1 measured in the morning before inhalation was 68 ml higher with Duaklir Genuair than with formoterol alone. It has also been shown. that Duaklir Genuair increases the percentage of patients who have an improvement in breathlessness, compared to placebo.

What is the risk associated with Duaklir Genuair - aclidinium bromide, formoterol fumarate dihydrate?

The side effects of Duaklir Genuair are similar to those reported with the individual components. The most common side effects (seen in approximately 7 out of 100 patients) are nasopharyngitis (inflammation of the nose and throat) and headache. For the full list of side effects reported with Duaklir Genuair and their limitations, see the package leaflet.

Why has Duaklir Genuair - aclidinium bromide, formoterol fumarate dihydrate been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duaklir Genuair's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that Duaklir Genuair has been shown to significantly improve lung function in COPD patients compared to placebo, although the improvement observed when comparing Duaklir Genuair to one of the components alone, formoterol, was small.

Regarding safety, the number of side effects reported with Duaklir Genuair was low and did not raise substantial concern. Furthermore, the safety profile of the two components is well known and there is no evidence that the combination is less safe than the individual components.

What measures are being taken to ensure the safe and effective use of Duaklir Genuair - aclidinium bromide, formoterol fumarate dihydrate?

A risk management plan has been developed to ensure that Duaklir Genuair is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Duaklir Genuair, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, as long-acting muscarinic antagonists may have an effect on the heart and blood vessels, the company that markets Duaklir Genuair will provide the results of studies to further evaluate the medicine's cardiovascular safety. Further information is available in the summary of the risk management plan.

Other information about Duaklir Genuair - aclidinium bromide, formoterol fumarate dihydrate

On 19 November 2014, the European Commission granted a "Marketing Authorization" for Duaklir Genuair, valid throughout the European Union. For more information on Duaklir Genuair therapy, please read the package leaflet (included with the EPAR) or consult the doctor or pharmacist. Last update of this summary: 11-2014.


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