Elements for a Public Summary

Transcription

1 VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Alzheimer's disease is the most common form of dementia, a general term for memory loss and other intellectual abilities serious enough to interfere with daily life. Alzheimer's disease accounts for 60 to 80 percent of dementia cases. Alzheimer's is not a normal part of aging, although the greatest known risk factor is increasing age, and the majority of people with Alzheimer's are 65 and older. But Alzheimer's is not just a disease of old age. Up to 5 percent of people with the disease have early onset Alzheimer's (also known as younger-onset), which often appears when someone is in their 40s or 50s. 1 Alzheimer s disease (AD) disproportionately affects women in both prevalence and severity; however, the biologic mechanisms underlying these sex differences are not fully understood. 2 Worldwide, nearly 44 million people are believed to be living with Alzheimer's disease or other dementias. By 2030, if breakthroughs are not discovered, we will see an increase to nearly 76 million. By 2050, rates could exceed 135 million. Every four seconds, a new case of dementia occurs somewhere in the world. 4 VI.2.2 Summary of treatment benefits Taking into account the published information on the use and dosage of rivastigmine, it can be concluded that the use of this medicinal product in the proposed indication, i.e. symptomatic treatment of mild to moderately severe Alzheimer s dementia and according to the dosage recommendations given in the SmPC is fully justified. Safety and efficacy of rivastigmine in symptomatic treatment of mild to moderately severe Alzheimer s dementia is sufficiently evident from its approved clinical use. VI.2.3 Unknowns relating to treatment benefits None. VI.2.4 Summary of safety concerns Important identified risks Gastrointestinal symptoms (Nausea, vomiting and diarrhea) Treatment should be temporarily interrupted if gastrointestinal adverse reactions are observed until these adverse reactions resolve. Gastrointestinal disorders such as nausea, vomiting and diarrhoea are dose-related, and may occur when initiating treatment and/or increasing the dose. These adverse reactions occur more commonly in women. The next most common adverse reactions are gastrointestinal in Gastrointestinal symptoms. warning and undesirable effect

2 Worsening of movement disorders (motor symptoms) associated with Parkinson s disease Inflammation of the pancreas (Pancreatitis) Cardiac dysrhythmias (arrhythmias) Worsening (Exacerbation) of Asthma and Chronic obstructive pulmonary disease (COPD) and irritations nature including nausea and vomiting. Rivastigmine may worsen or induce extrapyramidal symptoms and worsening of Parkinson s disease. Inflammation of the pancreas (Pancreatitis) is a known undesirable effect with unknown frequency. Care must be taken when using rivastigmine transdermal patches in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrioventricular block). Different Cardiac disorders are known as undesirable effects following rivastigmine treatment. Slow heart rate (Bradycardia) has been seen in cases of overdose with rivastigmine. Care must be taken when using rivastigmine transdermal patches in patients with a history of asthma or obstructive pulmonary disease. 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. Rivastigmine is contraindicated in patients with known hypersensitivity to rivastigmine, to other carbamate derivatives or to any of the excipients as well as previous history of application site reactions Worsening of movement disorders. warning in the summary of patient Inflammation of the pancreas. n undesirable effect in the Cardiac dysrhythmias. warning, undesirable effects and overdose section in the Worsening of Asthma and Chronic obstructive pulmonary disease. warning in the summary of patient and irritations. contraindication in the summary of patient The risk can be reduced by not allowing the product to be used in patients who are at risk of and irritations.

3 suggestive of allergic contact dermatitis with rivastigmine patch. Skin application site reactions may occur with rivastigmine patch and are usually mild or moderate in intensity. warning and undesirable effects Increased blood pressure (Hypertension) Gastrointestinal wounds (ulceration), bleeding (haemorrhage), and perforation Seizures There have been rare postmarketing reports of patients experiencing disseminated skin hypersensitivity reactions when administered rivastigmine irrespective of the route of administration (oral, transdermal). (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of rivastigmine transdermal patch. Rash, Pruritus, erythema, urticaria, vesicles, allergic dermatitis and disseminated cutaneous hypersensitivity reactions are listed as undesirable effects. Hypertension is a known undesirable effect of not known frequency. have included e.g. hypertension. Care must be taken when using rivastigmine transdermal patches in patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions. Gastric ulcer is a known uncommon undesirable effect. Care must be taken when using rivastigmine transdermal patches in Increased blood pressure. undesirable effect and symptom of overdose in the summary of patient Gastrointestinal wounds, bleeding and perforation. warning and undesirable effect Seizures.

4 Hallucinations Transient loss of consciousness (Syncope) and loss of consciousness Medication misuse patients predisposed to seizures as rivastigmine may induce or exacerbate seizures. Seizure is a known undesirable effect of unknown frequency. Hallucinations is a known undesirable effect of unknown frequency. have included e.g. hallucinations. Alzheimer s disease may cause gradual impairment of driving performance or compromise the ability to use machines. Furthermore, rivastigmine may induce syncope or delirium. As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines. Syncope is a known common undesirable effect. Syncope may also occur in overdose. The administration instructions given should be carefully followed. Misuse of rivastigmine transdermal patches, have resulted in serious adverse reactions; some cases have required hospitalisation, and rarely led to death. Most cases of misuse of the medicinal product have involved not removing the old patch when putting on a new one and the use of multiple patches at the same time. Overdose with rivastigmine transdermal patch resulting from misuse/dosing 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 warning and undesirable effect Hallucinations. undesirable effect and symptom of overdose in the summary of patient Syncope and loss of consciousness. warning concerning ability to drive and use machinery, undesirable effect and in the overdose section in the Medication misuse. The risk is mentioned in the dosage section, as a warning and in the overdose section in the

5 Medication errors to those seen with cases of overdose associated with rivastigmine oral formulations. have included nausea, vomiting and diarrhoea, hypertension or hallucinations. Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur. The administration instructions given should be carefully followed. Dosing errors of rivastigmine transdermal patches have resulted in serious adverse reactions; some cases have required hospitalisation, and rarely led to death. Most cases of dosing errors of the medicinal product have involved not removing the old patch when putting on a new one and the use of multiple patches at the same time. Overdose with rivastigmine transdermal patch resulting from misuse/dosing 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 rivastigmine oral formulations. have included nausea, vomiting and diarrhoea, hypertension or hallucinations. Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur. Medication errors. The risk is mentioned in the dosage section, as a warning and in the overdose section in the

6 Liver disorders Severe skin reactions (bullous reactions) Patients with clinically significant hepatic impairment might experience more adverse reactions. Hepatitis and elevated liver function tests are known undesirable effects with unknown frequency. Rivastigmine is contraindicated in patients with known hypersensitivity to rivastigmine, to other carbamate derivatives or to any of the excipients as well as previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch. Skin application site reactions may occur with rivastigmine patch and are usually mild or moderate in intensity. These reactions are not in themselves an indication of sensitisation. However, use of rivastigmine patch may lead to allergic contact dermatitis. There have been rare postmarketing reports of patients experiencing disseminated skin hypersensitivity reactions when administered rivastigmine irrespective of the route of administration (oral, transdermal). Rash, Pruritus, erythema, urticaria, vesicles, allergic dermatitis and disseminated cutaneous hypersensitivity reactions are known undesirable effects. Liver disorders. The risk is mentioned in the dosage section, as a warning and undesirable effect in the Severe skin reactions. contraindication in the summary of patient The risk can be reduced by not allowing the product to be used in patients who are at risk of Severe skin reactions. warning and undesirable effects Important potential risks Risk Myocardial infarction Cerebrovascular accident Pulmonary infections What is known (Including reason why it is considered a potential risk)

7 Risk Death What is known (Including reason why it is considered a potential risk) Missing information Risk What is known - - VI.2.5 Summary of risk minimisation measures by safety concern All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures. The Summary of the Package leaflet for Orivast can be found in the Orivast EPAR page. This medicine has no additional risk minimisation measures. VI.2.6 Planned post authorisation development plan None. VI.2.7 Summary of changes to the Risk Management Plan over time Not applicable as this is the initial risk management plan.