What is Rivastigmine Hexal?
Rivastigmine Hexal is a medicine that contains the active substance rivastigmine. It is available as capsules (yellow: 1.5 mg; orange: 3 mg; red: 4.5 mg; red and orange: 6 mg) and oral solution (2 mg / ml).
This medicine is the same as Exelon capsules and oral solution, which is already authorized in the European Union (EU). The company that makes Exelon has agreed that its scientific data will be used for Rivastigmine Hexal ("informed consent").
What is Rivastigmine Hexal used for?
Rivastigmine Hexal is used to treat patients with mild to moderately severe Alzheimer's dementia, a progressive brain disease that gradually affects memory, intellectual ability and behavior. Rivastigmine Hexal is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
The medicine can only be obtained with a prescription.
How is Rivastigmine Hexal used?
Treatment with Rivastigmine Hexal should be started and supervised by a doctor experienced in the diagnosis and treatment of Alzheimer's disease or dementia associated with Parkinson's disease. Therapy should only be started if a person regularly attending to the patient is available, who regularly controls the patient's intake of Rivastigmine Hexal. Treatment should continue until the medicine has a beneficial effect, but the dose can be reduced or the therapy stopped if the patient experiences side effects.
Rivastigmine Hexal should be given twice a day, for breakfast and dinner. The capsules must be swallowed whole. The initial dose is 1.5 mg twice a day. If this dose is well tolerated, it can be increased, in 1.5 mg increments at intervals of not less than two weeks, to a regular dose of 3-6 mg twice a day. To get the maximum benefit it is recommended to use the highest tolerated dosage, without exceeding 6 mg twice a day.
How does Rivastigmine Hexal work?
Alzheimer's dementia or dementia due to Parkinson's disease, some nerve cells die in the brain resulting in lowering the levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other). Rivastigmine works by blocking enzymes that degrade acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivastigmine Hexal promotes an increase in acetylcholine levels in the brain, which helps to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
How has Rivastigmine Hexal been studied?
Rivastigmine Hexal has been studied in three main studies involving 2 126 patients with mild to moderately severe Alzheimer's dementia. Rivastigmine Hexal has also been studied in 541 patients with dementia due to Parkinson's disease. All studies had a duration of six months and compared the effects of Rivastigmine Hexal with those of placebo (a dummy treatment). The main indicators of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of different areas including general functioning, cognitive symptoms, behavior and capacity to carry out daily activities).
A further study conducted on 27 patients showed that Rivastigmine Hexal capsules and oral solution produce similar levels of active ingredient in the blood.
What benefit has Rivastigmine Hexal shown during the studies?
Rivastigmine Hexal was more effective than placebo at controlling symptoms. In the three studies of Rivastigmine Hexal conducted on patients with dementia of the Alzheimer type, in patients taking doses of Rivastigmine Hexal between 6 and 9 mg a day there was an average increase in cognitive symptoms of 0.2 points compared to basal levels of 22, 9 points at the beginning of the study, in which a lower score indicates a better performance. This was compared with an increase of 2.6 points compared to 22.5 in placebo-treated patients. Regarding the overall score, in the patients taking Rivastigmine Hexal there was a 4.1 point increase in symptoms compared to 4.4 in the patients treated with placebo.
Patients with dementia due to Parkinson's disease taking Rivastigmine Hexal capsules showed an improvement in cognitive symptoms of 2.1 points compared to a worsening of 0.7 points recorded in those taking placebo, starting from a baseline of about 24 points . Furthermore, the global symptom score improved more in patients treated with Rivastigmine Hexal.
What are the risks associated with Rivastigmine Hexal?
The types of side effects seen with Rivastigmine Hexal depend on the type of dementia being treated. In general, the most frequent side effects (seen in more than 1 patient in 10) are nausea and vomiting, particularly in the phase in which the dose of Rivastigmine Hexal is increased. For the full list of all side effects reported with Rivastigmine Hexal, see the Package Leaflet.
Rivastigmine Hexal should not be used in people who may be hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other substances. It must not be used in patients with severe liver problems.
Why has Rivastigmine Hexal been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Rivastigmine Hexal has a modest efficacy in the treatment of Alzheimer's-type dementia symptoms, although it actually shows considerable benefit in some patients. The committee initially concluded that, in the treatment of dementia due to Parkinson's disease, the benefits of Rivastigmine Hexal do not outweigh its risks. However, following a review of this opinion, the Committee concluded that the modest efficacy of the medicinal product could have beneficial effects in some patients.
Therefore, the Committee decided that the benefits associated with Rivastigmine Hexal outweigh its risks for the treatment of mild to moderately severe Alzheimer's dementia and mild to moderately severe dementia in patients with idiopathic Parkinson's disease. The committee recommended that Rivastigmine Hexal be given marketing authorization.
More information on Rivastigmine Hexal
On 11 December 2009, the European Commission issued a marketing authorization valid throughout the European Union for Rivastigmine Hexal to Hexal AG. The marketing authorization is valid for five years and can be renewed after this period.
For the full EPAR version of Rivastigmine Hexal, click here.
Last update of this summary: 10-2009.
