What is Azilect?
Azilect is a medicine that contains the active substance rasagiline, available in the form of white round tablets (1 mg).
What is Azilect used for?
Azilect is indicated for the treatment of Parkinson's disease. Parkinson's disease is a progressive mental disorder that causes tremor, slow movement, and muscle stiffness. Azilect can be used as monotherapy (alone) or as a combination therapy with levodopa (another drug used in the treatment of Parkinson's disease) in patients with end-of-dose "fluctuations" in the time interval between different doses of drugs. Levodopa doses The fluctuations are related to a reduction in the effects of levodopa, during which the patient undergoes sudden changes between the "on" state, in which he is able to move, and the "off" state, ie immobility. Azilect can only be obtained with a prescription.
How is Azilect used?
The standard dose of Azilect is one tablet once a day, to be taken with or without food.
How does Azilect work?
The active substance in Azilect, rasagiline, is a 'monoamine oxidase-B' inhibitor. It blocks the enzyme monoamine oxidase type B, which is responsible for the breakdown of the neurotransmitter dopamine in the brain. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. In patients with Parkinson's disease, the cells that produce dopamine begin to die, resulting in a decrease in the amount of this neurotransmitter in the brain. Patients therefore lose the ability to reliably control their movements. By increasing dopamine concentrations in the areas of the brain responsible for movement and coordination, Azilect improves signs and Parkinson's disease symptoms such as stiffness and slowness of movement.
How has Azilect been studied?
Azilect has been studied in three main studies involving a total of 1 563 patients with Parkinson's disease. In the first study, the effects of two different doses of Azilect taken alone were compared with those of placebo (a dummy treatment) in 404 patients with early disease. The main measure of effectiveness was the change in symptoms over 26 weeks, as measured by a standard rating scale (Unified Parkinson's Disease Rating Scale, UPDRS).
The other two studies involved a total of 1 159 patients with more advanced disease, where Azilect was added in conjunction with the patient's ongoing therapy including levodopa. The drug was compared with placebo or with entacapone (another medicine used in the treatment of Parkinson's disease). The studies lasted 26 and 18 weeks, respectively. The main measure of effectiveness was the time spent in the 'off' state during the day, as reported in the patient diaries.
What benefit has Azilect shown during the studies?
In all studies, Azilect was more effective than placebo. In the study where Azilect was used on its own, patients who took 1 mg of the medicine once daily reported, on average, a decrease in UPDRS score of 0.13 points over the 26-week study compared to starting value of 24.69. This result should be compared with the increase of 4.07 points recorded among the subjects treated with placebo, whose starting value was 24.54. A reduction in the UPDRS score indicates an improvement in symptoms, while an increase indicates worsening. . When used in combination with levodopa, 1 mg of Azilect reduced the "off" time more than placebo. In both studies, patients taking Azilect as add-on therapy reported, on average, approximately one "hour into less in the "off" state than in placebo-treated subjects. A similar reduction in the time spent in the "off" state was observed in subjects treated with entacapone.
What is the risk associated with Azilect?
The most common side effect with Azilect (seen in more than 1 in 10 patients) is headache. For the full list of side effects reported with Azilect, see the package leaflet. Azilect must not be used in people who may be hypersensitive (allergic) to rasagiline or any of the other ingredients. Azilect should not be used with other monoamine oxidase inhibitors such as non-prescription herbal medicines or herbal preparations such as St. John's wort. Azilect should not be used with pethidine (a pain reliever). At least 14 days should elapse between stopping treatment with Azilect and initiation of treatment with another monoamine oxidase inhibitor or with pethidine. Azilect should also not be given to patients with severe liver problems. It is not recommended in patients with moderate liver problems. Patients with mild liver problems. liver problems should take Azilect with caution and stop treatment if liver problems get worse.
Why has Azilect been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Azilect's benefits are greater than its risks for the treatment of Parkinson's disease both as monotherapy (without levodopa) and as combination therapy (with levodopa) in patients with fluctuations. end of dose. The committee therefore recommended the granting of a marketing authorization for Azilect.
Other information about Azilect:
On 21 February 2005, the European Commission granted Teva Pharma GmbH a "Marketing Authorization" for Azilect, valid throughout the European Union. The "Marketing Authorization" was renewed on 21 February 2010.
For the complete version of the Azilect EPAR click here.
Last update of this summary: 02-2010.
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