What is Levodopa / Carbidopa / Entacapone Orion?
Levodopa / Carbidopa / Entacapone Orion is a medicine containing three active substances: levodopa, carbidopa and entacapone. It is available in a range of tablets in six formulations containing 50 to 200 mg of levodopa and 12.5 to 50 mg of carbidopa. All tablets contain 200 mg of entacapone.
This medicine is the same as Stalevo, already authorized in the European Union (EU). The company that makes Stalevo has agreed that its scientific data can be used for Levodopa / Carbidopa / Entacapone Orion ("informed consent").
What is Levodopa / Carbidopa / Entacapone Orion used for?
Levodopa / Carbidopa / Entacapone Orion is indicated for the treatment of adults with Parkinson's disease. Parkinson's disease is a progressive mental disorder that causes tremor, slowness of movement and muscle stiffness. Levodopa / Carbidopa / Entacapone Orion is used in patients receiving treatment with levodopa and a dopa decarboxylase inhibitor (two standard treatments for Parkinson's disease) that exhibit "fluctuations" towards the end of the interval time between the administration of two doses. Fluctuations occur when the effects of the drug are reduced and symptoms reappear. The fluctuations are linked to a reduction in the effects of levodopa, whereby the patient is subjected to sudden changes between the "on" state, in which he is able to move, and the "off" state, in which he has difficulty in movement. Levodopa / Carbidopa / Entacapone Orion is used when such fluctuations cannot be treated with the standard combination alone. The medicine can only be obtained with a prescription.
How is Levodopa / Carbidopa / Entacapone Orion used?
Each Levodopa / Carbidopa / Entacapone Orion tablet contains a full dose of levodopa, in six formulations, with corresponding amounts of carbidopa and entacapone which improve its effectiveness. The formulation of Levodopa / Carbidopa / Entacapone Orion that the patient must take depends on the amount of levodopa needed to control the symptoms. Further information on how to switch to Levodopa / Carbidopa / Entacapone Orion therapy and the correct dose adjustment during treatment is contained in the Summary of Product Characteristics (also part of the EPAR).
The maximum dose of Levodopa / Carbidopa / Entacapone Orion is 10 tablets per day, except for tablets containing 200 mg of levodopa and 50 mg of carbidopa, in which case the maximum dose is seven tablets per day. Levodopa / Carbidopa / Entacapone Orion tablets should be given whole and can be taken with or without food. The medicine should be used with caution in patients with mild to moderate problems with the liver or severe kidney problems. It must also not be given to patients with severe liver problems.
How does Levodopa / Carbidopa / Entacapone Orion work?
In patients with Parkinson's disease, the brain cells that produce the dopamine neurotransmitter begin to die, resulting in a decrease in the concentration of this substance in the brain. Patients therefore lose the ability to control their movements reliably. All the active ingredients present in Levodopa / Carbidopa / Entacapone Orion help restore dopamine levels in the areas of the brain responsible for controlling movement and coordination.
Levodopa turns into dopamine in the brain. Carbidopa and entacapone block some of the enzymes involved in the breakdown of levodopa in the body: carbidopa blocks the enzyme dopa decarboxylase, while entacapone blocks the catechol-O-methyltransferase (COMT) enzyme. As a result, levodopa remains active longer, helping to improve the symptoms of Parkinson's disease, such as muscle stiffness and slowness in movement. Entacapone has been authorized in the European Union (EU) as Comtess / Comtan since 1998. The use of combinations of levodopa and carbidopa is well established and dates back to the mid-1970s. Thanks to the combination of all three active ingredients in a single tablet, the number of tablets to be taken decreases and this can help patients comply with the treatment regimen.
How has Levodopa / Carbidopa / Entacapone Orion been studied?
The company used some data related to Comtess / Comtan to support the use of Levodopa / Carbidopa / Entacapone Orion and presented data from published literature on levodopa and carbidopa.
The company has also carried out "bioequivalence" studies to show that taking Levodopa / Carbidopa / Entacapone Orion produces the same concentrations of levodopa, carbidopa and entacapone in the blood compared to taking separate tablets containing entacapone and a combination of levodopa and carbidopa.
What benefit has Levodopa / Carbidopa / Entacapone Orion shown during the studies?
Studies have shown that Levodopa / Carbidopa / Entacapone Orion is bioequivalent to separate tablets.
What are the risks associated with Levodopa / Carbidopa / Entacapone Orion?
The most common side effects with Levodopa / Carbidopa / Entacapone Orion (seen in more than 1 patient in 10) are dyskinesia (involuntary movements), aggravated parkinsonism (worsening of Parkinson's disease), nausea and harmless urine discoloration. For the full list of all side effects reported with Levodopa / Carbidopa / Entacapone Orion, see the package leaflet.
Levodopa / Carbidopa / Entacapone Orion should not be used in people who may be hypersensitive (allergic) to levodopa, carbidopa, entacapone or any of the other ingredients. Levodopa / Carbidopa / Entacapone Orion should not be given to patients:
- suffering from severe liver disease;
- suffering from narrow-angle glaucoma (increased intraocular pressure);
- suffering from pheochromocytoma (a tumor of the adrenal gland);
- with a history of neuroleptic malignant syndrome (a serious nervous disorder normally caused by antipsychotic drugs) or rhabdomyolysis (rupture of muscle fibers).
Levodopa / Carbidopa / Entacapone Orion should not be used simultaneously with other medicines belonging to the group of "monoamine oxidase inhibitors" (a type of antidepressant). For more details, see the summary of product characteristics (also included with the EPAR).
Why has Levodopa / Carbidopa / Entacapone Orion been approved?
The CHMP decided that Levodopa / Carbidopa / Entacapone Orion's benefits are greater than its risks and recommended that it be given marketing authorization.
Other information on Levodopa / Carbidopa / Entacapone Orion
On 24 August 2011, the European Commission issued a marketing authorization for Levodopa / Carbidopa / Entacapone Orion, valid throughout the European Union.
For more information about treatment with Levodopa / Carbidopa / Entacapone Orion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 07-2011.
