Active Ingredient: Rivastigmine
Symptomatic treatment of mild to moderately severe Alzheimer’s dementia.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 1.5 milligrams rivastigmine, 2 times daily to meals, over the duration of 2 weeks. Afterwards, oral, between 1.5 milligrams rivastigmine and 6 milligrams rivastigmine, 2 times daily to meals. The maximum allowed total dose is 6 milligrams rivastigmine daily.
1.5 mg twice a day.
The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.
If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with Parkinson’s disease are observed during treatment, these may respond to omitting one or more doses. If adverse reactions persist, the daily dose should be temporarily reduced to the previous well-tolerated dose or the treatment may be discontinued.
The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose. The recommended maximum daily dose is 6 mg twice a day. Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. Therefore, the clinical benefit of rivastigmine should be reassessed on a regular basis, especially for patients treated at doses less than 3 mg twice a day. If after 3 months of maintenance dose treatment the patient’s rate of decline in dementia symptoms is not altered favourably, the treatment should be discontinued. Discontinuation should also be considered when evidence of a therapeutic effect is no longer present. Individual response to rivastigmine cannot be predicted. However, a greater treatment effect was seen in Parkinson’s disease patients with moderate dementia. Similarly a larger effect was observed in Parkinson’s disease patients with visual hallucinations. Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
If treatment is interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily. Dose titration should then be carried out as described above.
Rivastigmine should be administered twice a day, with morning and evening meals.
For:
Transdermal, 4.6 milligrams rivastigmine, once every 24 hours, over the duration of 4 weeks. Afterwards, transdermal, 9.5 milligrams rivastigmine, once every 24 hours, over the duration of 6 months. Afterwards, transdermal, 13.3 milligrams rivastigmine, once every 24 hours. The maximum allowed total dose is 13.3 milligrams rivastigmine every 24 hours.
| Transdermal patches | Rivastigmine in vivo release rates per 24 h |
|---|---|
| Exelon 4.6 mg/24 h | 4.6 mg |
| Exelon 9.5 mg/24 h | 9.5 mg |
| Exelon 13.3 mg/24 h | 13.3 mg |
Treatment is started with 4.6 mg/24 h.
After a minimum of four weeks of treatment and if well tolerated according to the treating physician, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, the daily recommended effective dose, which should be continued for as long as the patient continues to demonstrate therapeutic benefit.
9.5 mg/24 h is the recommended daily effective dose which should be continued for as long as the patient continues to demonstrate therapeutic benefit. If well tolerated and only after a minimum of six months of treatment at 9.5 mg/24 h, the treating physician may consider increasing the dose to 13.3 mg/24 h in patients who have demonstrated a meaningful cognitive deterioration (e.g. decrease in the MMSE) and/or functional decline (based on physician judgement) while on the recommended daily effective dose of 9.5 mg/24 h. The clinical benefit of rivastigmine should be reassessed on a regular basis.
Discontinuation should also be considered when evidence of a therapeutic effect at the optimal dose is no longer present.
Treatment should be temporarily interrupted if gastrointestinal adverse reactions are observed until these adverse reactions resolve. Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days. Otherwise treatment should be re-initiated with 4.6 mg/24 h.
Based on comparable exposure between oral and transdermal rivastigmine, patients
treated with rivastigmine capsules or oral solution can be switched to rivastigmine transdermal patches as follows:
After switching to 4.6 mg/24 h transdermal patches, provided these are well tolerated after a minimum of four weeks of treatment, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, which is the recommended effective dose.
It is recommended to apply the first transdermal patch on the day following the last oral dose.
Transdermal patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, in a place which will not be rubbed by tight clothing. It is not recommended to apply the transdermal patch to the thigh or to the abdomen due to decreased bioavailability of rivastigmine observed when the transdermal patch is applied to these areas of the body.
The transdermal patch should not be applied to skin that is red, irritated or cut. Reapplication to the exact same skin location within 14 days should be avoided to minimise the potential risk of skin irritation.
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