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Click on icon to see table/diagram/imageInitial dose: Treatment is started with 4.6 mg/24 h.
Maintenance dose: 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.
Dose escalation: 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 (see Pharmacology: Pharmacodynamics under Actions).
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.
Switching from capsules or oral solution to transdermal patches: Based on comparable exposure between oral and transdermal rivastigmine (see Pharmacology: Pharmacokinetics under Actions), patients treated with Exelon capsules or oral solution can be switched to Exelon transdermal patches as follows: A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
A patient on a dose of 6 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
A patient on a stable and well tolerated dose of 9 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches. If the oral dose of 9 mg/day has not been stable and well tolerated, a switch to 4.6 mg/24 h transdermal patches is recommended.
A patient on a dose of 12 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches.
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.
Special populations: Paediatric population: There is no relevant use of Exelon in the paediatric population in the treatment of Alzheimer's disease.
Patients with body weight below 50 kg: Particular caution should be exercised in titrating patients with body weight 50 kg above the recommended effective dose of 9.5 mg/24 h (see Precautions). They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Hepatic impairment: No dose adjustment is necessary for patients with hepatic impairment. However, due to increased exposure in these populations as observed with the oral forms, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant hepatic impairment might experience more adverse reactions. Patients with severe hepatic impairment have not been studied (see Pharmacology: Pharmacokinetics under Actions and Precautions).
Renal impairment: No dose adjustment is necessary for patients with renal impairment. However, due to increased exposure in these populations as observed with the oral forms, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal impairment might experience more adverse reactions (see Pharmacology: Pharmacokinetics under Actions and Precautions).
Method of administration: 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.
Patients and caregivers should be instructed on important administration instructions: The previous day's patch must be removed before applying a new one every day (see Overdosage).
The patch should be replaced by a new one after 24 hours. Only one patch should be worn at a time (see Overdosage).
The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
If the patch falls off, a new one should be applied for the rest of the day, then it should be replaced at the same time as usual the next day.
The patch can be used in everyday situations, including bathing and during hot weather.
The patch should not be exposed to any external heat sources (eg, excessive sunlight, saunas, solarium) for long periods of time.
The patch should not be cut into pieces.
Wash the hands with soap and water after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
