This is a summary of the European public assessment report (EPAR) for Xadago. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Xadago.
For practical information about using Xadago, patients should read the package leaflet or contact their doctor or pharmacist.
What is Xadago and what is it used for?
Xadago is a medicine used to treat Parkinson’s disease, a progressive brain disorder that causes shaking, slow movement and muscular stiffness. It is used in addition to levodopa (a medicine commonly used to treat the symptoms of Parkinson’s disease) either alone or in combination with other medicines for Parkinson’s, in patients with mid- to
Xadago contains the active substance safinamide.
How is Xadago used?
Xadago is available as tablets (50 and 100 mg) and can only be obtained with a prescription. Treatment should be started at a dose of 50 mg a day and the doctor may increase the dose up to 100 mg a day based on patient’s need.
For further information, see the package leaflet.
How does Xadago work?
In patients with Parkinson’s disease, certain cells in the brain that produce dopamine die, and as dopamine is involved in controlling movement, the patient's movement worsens over time.
The active substance in Xadago, safinamide, is a ‘monoamine
What benefits of Xadago have been shown in studies?
Xadago, as an
Xadago was also investigated as an
What are the risks associated with Xadago?
The most common side effects with Xadago (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), dyskinesia (difficulty controlling movement), somnolence (sleepiness), dizziness, headache, worsening of existing Parkinson’s disease, cataract (clouding of the lens), orthostatic hypotension (drop in blood pressure when standing up), nausea (feeling sick) and falls. For the full list of all side effects reported with Xadago, see the package leaflet.
Xadago must not be used in patients with severe liver problems, in patients treated with pethidine or other MAO inhibiting medicines, or in patients with certain conditions affecting the eyes. For the full list of restrictions, see the package leaflet.
Why is Xadago approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Xadago’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee concluded that the effect of Xadago on the daily time that patients lived without motor symptoms was of clinical relevance, also taking into account the response reported in the literature for other Parkinson’s medicines. This effect was also maintained in the
What measures are being taken to ensure the safe and effective use of Xadago?
A risk management plan has been developed to ensure that Xadago 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 Xadago, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information can be found in the summary of the risk management plan.
Other information about Xadago
The European Commission granted a marketing authorisation valid throughout the European Union for Xadago on 24 February 2015.
The full EPAR and risk management plan summary for Xadago can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Xadago, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in