Roteas

Roteas is available as tablets and can only be obtained with a prescription. The usual dose is 60 mg once a day but doses may be adjusted for kidney function, low body weight or in those who are also taking certain medicines (known as P-gp inhibitors) that can interfere with the removal of edoxaban from the body. Dose adjustments may also need to be made in patients who are switched between Roteas and other anticoagulant medicines. Treatment is continued while the benefit outweighs the risk of bleeding, which depends on the condition being treated and any existing risk factors. For more information about using Roteas, see the package leaflet or contact your doctor or pharmacist.

The active substance in Roteas, edoxaban, is a ‘factor Xa inhibitor’. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is essential for blood clotting. By blocking factor Xa, the medicine reduces the levels of thrombin in the blood, which helps treat clots and reduce the risk of them forming in the arteries and veins and leading to DVT, pulmonary embolism, stroke or other organ damage.

Roteas has been shown to be as effective as the standard anticoagulant warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation. The effects were studied in one main study, which involved over 21,000 patients for an average of 2.5 years. The main measure of effectiveness was the rate of stroke or systemic embolism among the patients each year. A first systemic embolism or stroke occurred in around 1.2% of those given standard doses of Roteas and 1.5% of those given warfarin respectively. When another recommended definition of the type of stroke was used, embolism or stroke due to blood clots was seen in 0.9% of patients given Roteas  and 1% of those given warfarin. There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal.

In the treatment and prevention of blood clots in patients with DVT or pulmonary embolism, Roteas was also found to be as effective as warfarin, in a study involving over 8,200 patients. The main measure of effectiveness was the number of patients who had another episode of DVT or pulmonary embolism during the study period. Further episodes were seen in 130 of 4,118 patients given edoxaban (3.2%) and in 146 of 4,122 given warfarin (3.5%).

The most common side effects with Roteas (which may affect up to 1 in 10 people) are  nose bleeds (epistaxis), blood in the urine (haematuria) and anaemia (low levels of red blood cells). Bleeding can occur at any site and can be severe or even fatal. For the full list of side effects of Roteas, see the package leaflet.

Roteas must not be used in patients who are actively bleeding, have liver diseases that affect blood clotting, have severe uncontrolled high blood pressure or who have a condition putting them at significant risk of major bleeding. It must also not be used in pregnant or breastfeeding women or together with another anticoagulant. For the full list of restrictions, see the package leaflet.

The European Medicines Agency decided that Roteas’s benefits are greater than its risks and it can be authorised for use in the EU. The medicine has been shown to be at least as effective as warfarin in reducing stroke rates in patients with atrial fibrillation and in preventing further episodes of DVT or pulmonary embolism.

With respect to safety, overall the risk of serious bleeding such as bleeding into the brain was reduced compared with warfarin, although there may be less difference where warfarin treatment is well managed. Although there was greater a risk of bleeding from the mucosa (tissues lining body cavities such as the nose, gut and vagina), the Agency considered that the risk could be managed with appropriate measures.

The company that markets Roteas will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Roteas have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Roteas are continuously monitored. Side effects reported with Roteas are carefully evaluated and any necessary action taken to protect patients.

Roteas received a marketing authorisation valid throughout the EU on 20 April 2017.