Rolufta - Umeclidinium Bromide

What is Rolufta - Umeclidinium Bromide and what is it used for?

Rolufta is a medicine used in adults to relieve the symptoms of chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and alveoli of the lungs are damaged or blocked, resulting in difficulty in breathing. Rolufta is used for maintenance (regular) therapy.

Rolufta contains the active substance umeclidinium bromide.

This medicine is the same as Incruse, which is already authorized in the European Union (EU). The company that makes Incruse has agreed that its scientific data can be used for Rolufta (“informed consent”).

How is Rolufta used - Umeclidinium Bromide?

Rolufta 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, always at the same time. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.

The medicine can only be obtained with a prescription.

How does Rolufta - Umeclidinium Bromide work?

The active substance in Rolufta, umeclidinium bromide, is a muscarinic receptor antagonist. It works by blocking the action of the so-called “muscarinic receptors”, which are responsible for controlling muscle contraction. Once inhaled, umeclidinium bromide induces relaxation of the muscles of the airways and helps to keep them free, allowing the patient to breathe more easily.

What benefit has Rolufta - Umeclidinium Bromide shown during the studies?

Rolufta has been studied in four main studies involving over 4,000 patients. Three studies compared Rolufta with placebo (a dummy treatment), while in another study Rolufta was compared with tiotropium (another COPD medicine). The main measure of effectiveness was based on changes in the patients' forced expiratory volume (FEV1, the maximum volume of air a person is able to breathe out in one second). The results showed that Rolufta, at one dose equivalent to 55 micrograms of umeclidinium, improved lung function by a mean FEV1 greater than 127 ml compared to placebo after 12 weeks of treatment and by 115 ml after 24 weeks of treatment. Administration of a double dose of Rolufta only resulted in improvements compared to the lowest dose, which were not considered significant. In the study where Rolufta was compared with tiotropium, improvements in FEV1 over 24 weeks was similar for both drugs.

The studies also showed improvement in symptoms such as wheezing (difficulty breathing) and wheezing.

What are the risks associated with Rolufta - Umeclidinium Bromide?

The most common side effects with Rolufta (seen in 1 to 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (cold), sinusitis, cough, urinary tract infection and tachycardia ( increased heart rate).

For the full list of side effects and limitations reported with Rolufta, see the package leaflet.

Why has Rolufta - Umeclidinium Bromide been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rolufta's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Rolufta had been shown to be effective in improve lung function and COPD symptoms The CHMP also noted that Rolufta had no relevant safety concerns and that side effects were manageable and similar to those of other antimuscarinic bronchodilator medicines.

What measures are being taken to ensure the safe and effective use of Rolufta - Umeclidinium Bromide?

As antimuscarinic bronchodilator medicines can have cardiac and vascular effects, the company that markets Rolufta will continue to closely monitor the medicine's cardiovascular effects and will carry out another study in patients to identify any potential risks.

The recommendations and precautions to be observed by healthcare professionals and patients for Rolufta to be used safely and effectively have also been included in the summary of product characteristics and package leaflet.

More information about Rolufta - Umeclidinium Bromide

For the complete version of Rolufta's EPAR, please consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Rolufta therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.

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