What is Corbilta and what is it used for - levodopa, carbidopa, entacapone?
Corbilta is a medicine containing three active substances: levodopa, carbidopa and entacapone . It is indicated for the treatment of adult patients with Parkinson's disease, a progressive mental disorder that causes tremor, slowness of movement and muscle stiffness. Corbilta is used in patients treated with a combination of levodopa and a dopa decarboxylase inhibitor (two standard treatments for Parkinson's disease) that present "fluctuations" towards the end of the time interval between the administration of two doses. Fluctuations occur when the effects of treatment run out and the symptoms recur. They are linked to a reduction in the effects of levodopa, and the patient suddenly goes from "on" phases, in which he is able to move, in "off" phases, in which he has difficulty in movement. Corbilta is used in cases where it is not possible to treat such fluctuations with the standard combination only. 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 Corbilta ("informed consent").
How is Corbilta used - levodopa, carbidopa, entacapone?
Corbilta is available in a range of tablets in seven dosages, containing 50 to 200 mg of levodopa and 12.5 to 50 mg of carbidopa. All tablets contain 200 mg of entacapone. The dosage of Corbilta that the patient must take depends on the amount of levodopa needed to control the symptoms. For all instructions on how to switch to Corbilta therapy and adjust the dose during treatment, see the summary of product characteristics (included with EPAR).
The maximum daily dose of Corbilta is 10 tablets, except for tablets containing 175 mg of levodopa and 43.75 mg of carbidopa and for tablets containing 200 mg of levodopa and 50 mg of carbidopa, in which case the maximum dose daily is eight and seven tablets respectively. The medicine can only be obtained with a prescription.
How does Corbilta work - levodopa, carbidopa, entacapone?
In patients with Parkinson's disease, the brain cells that produce the dopamine neurotransmitter begin to die and the amount of dopamine in the brain decreases. Patients therefore lose the ability to control their movements reliably. All the active ingredients of Corbilta help to restore dopamine levels in the areas of the brain responsible for controlling movement and coordination. Levodopa turns into dopamine in the brain. Both carbidopa and entacapone block some of the enzymes involved in the degradation of levodopa in the body: carbidopa blocks the enzyme dopa decarboxylase, while entacapone blocks the enzyme catechol-O-methyltransferase (COMT). As a result, levodopa remains active longer, which helps to improve 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 since the mid-1970s is well established. Thanks to the combination of all three active ingredients in a single tablet, the number of tablets to be taken is lower and this helps patients to stick to the therapeutic regimen
What benefit has Corbilta shown - levodopa, carbidopa, entacapone during the studies?
The company used some of the data referring to Comtess / Comtan (entacapone) to support the use of Corbilta and presented data taken from the published literature concerning the combination of levodopa and carbidopa. The company has also carried out "bioequivalence" studies to show that taking Corbilta produces the same levels of levodopa, carbidopa and entacapone in the blood obtained by taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
What is the risk associated with Corbilta - levodopa, carbidopa, entacapone?
The most common side effects of Corbilta (which may affect more than 1 in 10 people) are dyskinesia (involuntary movements), aggravated parkinsonism (worsening of Parkinson's disease), nausea and harmless urine discoloration. Serious side effects reported much more rarely include gastrointestinal haemorrhage (bleeding in the intestine) and angioedema (swelling under the skin of the face or limbs). For the full list of all side effects reported with Corbilta, see the package leaflet. Corbilta should not be given to patients with:
- severely reduced liver function;
- narrow-angle glaucoma (increased intraocular pressure);
- pheochromocytoma (a tumor of the adrenal gland);
- a history of malignant neuroleptic syndrome (a dangerous nervous system disorder normally caused by antipsychotic drugs) or rhabdomyolysis (rupture of muscle fibers).
Corbilta should not be used together with other medicines belonging to the group of "monoamine oxidase inhibitors" (a type of antidepressant). For more details, see the summary of product characteristics (included with EPAR). For the full list of limitations, see the package leaflet.
Why has Corbilta been approved - levodopa, carbidopa, entacapone?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Corbilta's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Corbilta - levodopa, carbidopa, entacapone?
A risk management plan has been developed to ensure that Corbilta 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 Corbilta, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information on Corbilta - levodopa, carbidopa, entacapone
On 13 November 2013, the European Commission issued a marketing authorization for Corbilta, valid throughout the European Union. For more information on Corbilta therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 10-2014.
