What is Uptravi - Selexipag and what is it used for?
Uptravi is a medicine used to treat adults with pulmonary arterial hypertension (PAH, excessively high blood pressure in the arteries of the lungs). It can be used in combination with other medicines called endothelin receptor antagonists (ERA) or phosphodiesterase type 5 inhibitors (PDE-5) or on its own in patients for whom these medicines are not suitable. Uptravi is used in patients with PAH class II or III. The "class" reflects the severity of the disease: "class II" involves a slight limitation of physical activity, while "class III" involves a marked limitation of physical activity.
Uptravi contains the active ingredient selexipag.
How is Uptravi used - Selexipag?
Uptravi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of PAH.
Uptravi is available as tablets (200, 400, 600, 800, 1, 000, 1, 200, 1, 400 and 1, 600 micrograms). Treatment should start with a dose of 200 micrograms twice a day, with an interval between doses of about 12 hours. As long as it is tolerated, the dose is increased weekly, up to a maximum dose of 1, 600 micrograms twice a day, which is then used to continue the therapy. Patients can better tolerate the treatment if they take the tablets with meals and if they take an increased dose for the first time in the evening instead of in the morning. If the patient cannot tolerate an increased dose, the doctor may need to reduce it.
If treatment with Uptravi is stopped, the dose should be reduced gradually.
Patients with severely impaired liver function should not take Uptravi. Patients with moderately impaired liver function should start treatment at a dose of 200 micrograms once a day. If tolerated, this dose can be increased weekly. For more information, see the package leaflet.
How does Uptravi - Selexipag work?
PAH is a debilitating disease in which a severe narrowing of the blood vessels in the lungs occurs. This leads to high blood pressure in the blood-carrying vessels from the heart to the lungs and a reduction in the amount of oxygen that passes into the blood inside the lungs, making physical activity more difficult.
The active substance in Uptravi, selexipag, is a "prostacyclin receptor agonist", meaning that it functions similarly to prostacyclin. This is a natural substance that regulates blood pressure by binding to receptors in the muscles of the blood vessel walls, causing relaxation and enlargement of the vessels. Also Uptravi, by binding to the receptors of the prostacyclin, causes the enlargement of the blood vessels and therefore reduces the pressure inside them, improving the symptoms of the disease.
What benefit has Uptravi - Selexipag shown during the studies?
The benefits of Uptravi for PAH have been highlighted in a main study involving 1, 156 patients with PAH. Patients were given Uptravi or a placebo (a dummy treatment) for about 70 weeks. Patients had not been treated previously, or received other medicines for the treatment of PAH (ERA or PDE-5 inhibitors). The main parameter for assessing efficacy was the number of patients who worsened their disease or died during treatment or shortly after the end of treatment. Overall, 24.4% of patients treated with Uptravi (140 out of 574) died or showed signs of worsening the disease, compared with 36.4% of placebo-treated patients (212 out of 582).
What is the risk associated with Uptravi - Selexipag?
The most common side effects of Uptravi (which may affect more than 1 in 10 people) are headache, diarrhea, nausea and vomiting, pain in the jaw, myalgia (muscle pain), pain in the limbs, arthralgia (joint pain) and redness . These effects are mild or moderate and are more frequent when the dose of Uptravi is increased.
Uptravi should not be used in patients who have had a heart attack in the last 6 months, suffer from severe coronary heart disease (heart disease caused by the obstruction of blood vessels to the heart muscle) or unstable angina (a severe type of pain chest). Uptravi should not be used in patients who have severe arrhythmias (heart rate instability) or heart valve defects. In patients with other heart problems, Uptravi should only be used under close medical supervision. Furthermore, Uptravi should not be used in patients who have had a stroke within the last 3 months.
For the full list of restrictions and side effects reported with Uptravi, see the package leaflet.
Why has Uptravi - Selexipag been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Uptravi's benefits are greater than its risks and recommended that it be approved for use in the EU. For patients with PAH, the treatment options currently available are very limited; there is therefore an important unmet medical need. Uptravi was shown to be more effective than placebo in preventing a worsening of PAH, used alone or in combination with an ERA and / or a PDE-5 inhibitor. Compared to other medicines of the same class, which are administered in a vein, Uptravi has the advantage of being taken orally (by mouth). Regarding safety, the side effects of Uptravi are considered acceptable. The CHMP noted a slight apparent increase in the mortality rate in patients taking Uptravi compared to placebo, but considered it due to the case or the way the study was designed; therefore he considered that he had no influence on the benefits or risks of the medicine.
What measures are being taken to ensure the safe and effective use of Uptravi - Selexipag?
A risk management plan has been developed to ensure that Uptravi 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 Uptravi, including the appropriate precautions to be followed by healthcare professionals and patients.
Furthermore, any healthcare professional must register with the company that markets Uptravi before they can prescribe this medicine. The company will provide information materials to healthcare professionals who will prescribe and dispense the medicine, to help them prescribe the medicine correctly and to avoid treatment errors. These materials also include a guide and a diary to be delivered to patients, which explain how the dose should be increased and help patients keep track of the number of tablets they take. The diary contains boxes that allow patients to note the number and concentration of tablets they take each day.
More information about Uptravi - Selexipag
For the full EPAR of Uptravi, consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Uptravi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
