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  • Exelon Patch
    / Novartis


    Active Ingredient
    Rivastigmine 4.6, 9.5, 13.3 mg/24 hours

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Patch

    30 X 5 cm - 9mg

    partial basket chart 78063 5477

    Patch

    30 X 10 cm - 18 mg

    partial basket chart 78064 5478

    Patch

    30 X 15 cm - 27 mg

    partial basket chart 50169 5571

    Related information


    Dosage

    Initial dose and dose titration to the effective dose: Treatment is started with Exelon Patch 5 once a day. After a minimum of four weeks of treatment and if well tolerated, this dose should be increased to Exelon Patch 10, the recommended effective dose, which can be continued for as long as a therapeutic benefit for the patient exists. Individual responses to rivastigmine may vary and some patients may derive additional benefit from higher doses. Subsequent increases to Exelon Patch 15 should always be based on good tolerability of the current dose and may be considered only after a minimum of four weeks of treatment at each dose level.
    Severe dementia of the Alzheimer’s type
    Initial dose and dose titration to the effective dose: Treatment is started with Exelon Patch 5 once a day. Subsequently the dose should be increased to Exelon Patch 10 and then to Exelon Patch 15 which is the demonstrated effective dose. These dose increases should always be based on good tolerability of the current dose and may be considered only after a minimum of four weeks of treatment at each dose level.
    Interruption of treatment: Treatment should be temporarily interrupted if gastrointestinal adverse effects and/or worsening of existing extrapyramidal symptoms (e.g. tremor) are observed until these adverse effects resolve. 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 Exelon Patch 5. If adverse effects persist on re-initiation of therapy, the dose should be temporarily reduced to the previous well-tolerated dose.
    Switching from capsules or oral solution: Patients treated with Exelon capsules or oral solution may be switched to Exelon patches as follows: A patient who is on a dose of < = 6 mg per day oral rivastigmine can be switched to Exelon Patch 5. A patient who is on a dose of 9 or 12 mg per day oral rivastigmine may be directly switched to Exelon Patch 10. It is recommended to apply the first patch on the day following the last oral dose.
    Special population
    Patients with body weight below 50 kg:
    Caution should be exercised in titrating these patients as they may experience more adverse reactions. Carefully titrate and monitor these patients for adverse reactions (e.g. excessive nausea or vomiting) and consider reducing the dose if such adverse reactions develop.
    Renal impairment: No dose adjustment is necessary for patients with renal impairment.
    Paediatric patients: Children and adolescents (age below 18 years): Rivastigmine is not recommended for use in children.
    Method of administration: Exelon 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. The patch should be replaced by a new one after 24 hours.
    Important administration instructions (patients and caregivers should be instructed): The previous day’s patch must be removed before applying a new one. The patch should be replaced by a new one after 24 hours. Only one patch should be worn at a time. The patch should not be applied to skin that is red, irritated or cut. It is recommended to change the application site daily to avoid potential irritation, although consecutive patches can be applied to the same general anatomic site (e.g., another spot on the upper back). 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 (e.g. excessive sunlight, saunas, solarium) for long periods of time. The patch should not be cut into pieces.
    For full details see prescribing information.


    Indications

    Exelon patch 5, Exelon patch 10: Treatment of mild to moderate dementia of the Alzheimer’s type.
    Exelon patch 15: For the treatment of dementia of the Alzheimer’s type (AD). Efficacy has been demonstrated in patients with mild, moderate and severe Alzheimer’s disease.


    Contra-Indications

    The use of Exelon is contraindicated in patients with: Known hypersensitivity to rivastigmine, to other carbamate derivatives or to the excipients of the formulation. Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine transdermal patch.


    Special Precautions

    Medication misuse and dosing errors resulting in overdose: Medication misuse and dosing errors with Exelon transdermal patch have resulted in serious adverse reactions; some cases have required hospitalization, and rarely led to death. The majority of medication misuse and dosing errors have involved not removing the old patch when putting on a new one and the use of multiple patches at one time. Patients and their caregivers must be instructed on important administration instructions for Exelon transdermal patch.
    Gastrointestinal disorders: The incidence and severity of adverse reactions generally increase with increasing doses, particularly at dose changes. If treatment is interrupted for more than three days, it should be re-initiated with Exelon Patch 5. Gastrointestinal disorders such as nausea, vomiting and diarrhea may occur when initiating treatment and/or increasing the dose. They may respond to a dose reduction. In other cases, use of Exelon patches has been discontinued. Patients who show signs or symptoms of dehydration resulting from prolonged vomiting or diarrhoea can be managed with IV fluids and dose reduction or discontinuation if recognized and treated promptly. Dehydration can be associated with serious outcomes.
    Weight loss: Patients with Alzheimer’s disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine. The patient’s weight should be monitored during therapy with Exelon patches.
    Other adverse reactions from increased cholinergic activity: As with other cholinergic substances care must be taken when prescribing Exelon patches: To patients with sick sinus syndrome or conduction defects (sino-atrial block, atrioventricular block). To patients with active gastric or duodenal ulcers or patients predisposed to these conditions because gastric acid secretions may be increased. To patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases. To patients with a history of asthma or obstructive pulmonary disease. Like other cholinomimetics, rivastigmine may exacerbate extrapyramidal symptoms. In patients with dementia associated with Parkinson’s disease who were treated with Exelon capsules, worsening of parkinsonian symptoms, particularly tremor, has been observed. Such adverse events may also occur with Exelon patches, particularly with Exelon Patch 15 which provides higher exposure (AUC) than that achieved with twice-daily administration of Exelon 6 mg capsules.
    Application site reactions and skin reactions: Skin application site reactions may occur with Exelon Patch and are usually mild or moderate in intensity. These reactions are not in themselves an indication of sensitization. However, use of rivastigmine patch may lead to allergic contact dermatitis. Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g. increasing erythema, edema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal. In these cases, treatment should be discontinued. In patients who develop application site reactions suggestive of allergic contact dermatitis to Exelon Patch and who still require rivastigmine, treatment should be switched to oral rivastigmine only after negative allergy testing and under close medical supervision. It is possible that some patients sensitized to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form. There have been isolated post-marketing reports of patients experiencing disseminated skin hypersensitivity reactions when administered rivastigmine irrespective of the route of administration (oral, transdermal). In these cases, treatment should be discontinued. Patients and caregivers should be instructed accordingly.
    Special populations
    Patients with body weight below 50: kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions. Carefully titrate and monitor these patients for adverse reactions (e.g. excessive nausea or vomiting) and consider reducing the dose if such adverse reactions develop.
    Hepatic impairment: Patients with clinically significant hepatic impairment might experience more adverse events. Particular caution should be exercised in titrating these patients above the recommended maintenance dose of Exelon Patch 10.
    Driving and using machines: Alzheimer’s disease dementia may cause gradual impairment of driving performance or compromise the ability to use machinery. Rivastigmine may induce dizziness and somnolence, mainly when initiating treatment or increasing the dose. Therefore, in patients with dementia treated with rivastigmine, the ability to continue driving or operating complex machines should be routinely evaluated by the treating physician.


    Side Effects

    The overall incidence of adverse events in patients treated with Exelon Patch 10 was lower than the rate in patients who received capsule treatment. Very common: Vomiting, nausea.
    Common: Anorexia, decreased appetite, Anxiety, depression, insomnia, Dizziness, headache, Diarrhea, dyspepsia, abdominal pain, Urinary incontinence, Application site reactions, application site erythema, application site pruritus, application site oedema, fatigue, asthenia, Weight decrease, Urinary tract infection.
    For full details see prescribing information.


    Drug interactions

    No specific interaction studies have been conducted with Exelon patches. Rivastigmine is metabolised mainly through hydrolysis by esterases. Minimal metabolism occurs via the major cytochrome P450 isoenzymes thus, no pharmacokinetic interactions are anticipated with other drugs metabolised by these enzymes. No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers. The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine. No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine. Concomitant administration of rivastigmine with commonly prescribed medications, such as antacids, antiemetics, antidiabetics, centrally acting antihypertensives, -blockers, calcium channel blockers, inotropic drugs, antianginals, non-steroidal anti-inflammatory drugs, oestrogens, analgesics, benzodiazepines and antihistamines, was not associated with an alteration in the kinetics of rivastigmine or an increased risk of clinically relevant untoward effects. In view of its pharmacodynamic effects, rivastigmine should not be given concomitantly with other cholinomimetic drugs and might interfere with the activity of anticholinergic medications. As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.


    Pregnancy and Lactation

    Pregnancy: In animal studies, rivastigmine was not teratogenic. However, the safety of Exelon in human pregnancy has not been established, and it should only be given to pregnant women if the potential benefit outweighs the potential risk for the foetus.
    Breast-feeding: It is not known if Exelon is excreted into human milk, and patients on Exelon should therefore not breast-feed.
    For full details see prescribing information.


    Overdose

    Symptoms: Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment. Where symptoms have occurred, they have included nausea, vomiting, diarrhoea, hypertension and hallucinations. Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur. Ingestion of 46 mg has occurred in one case; following conservative management the patient fully recovered within 24 hours. Overdose with Exelon patches resulting from misuse/medication errors (application of multiple patches at a time) has been reported in the post-marketing setting. The typical symptoms reported among these cases are similar to those seen with cases of overdose associated with Exelon oral formulations
    Treatment: As rivastigmine has a plasma half-life of about 3.4 hours and duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose all Exelon patches should be immediately removed and no further patch should be applied for the next 24 hours. In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered. Symptomatic treatment for other adverse events should be given as necessary. In massive overdose, atropine can be used. An initial dose of 0.03 mg/kg i.v. atropine sulfate is recommended, with subsequent doses based on clinical response. Use of scopolamine as an antidote is not recommended.
    For full details see prescribing information.


    Important notes

    Incompatibilities: To prevent interference with the adhesive properties of the patch, no cream, lotion or powder should be applied to the skin area where the Exelon transdermal patch is to be applied.
    Storage: Store below 25°C. Keep the patch in the sachet until use.


    Manufacturer
    LTS Lohmann, Germany
    Licence holder
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