Diabetes mellitus and hyperglycaemia-related adverse events Weight gain Seizures Somnolence Priapism Cerebrovascular accident Venous thromboembolism Leukopenia Agranulocytosis Thrombocytopenia Rhabdomyolysis Elevated plasma concentrations in patients with renal disease Injection site reactions (injectable formulations only) Hypersensitivity reactions (injectable formulations only) Important potential risks Carcinogenicity (pituitary adenomas, endocrine pancreas tumours, breast cancer) Overall increased mortality in elderly patients with dementia Cerebrovascular adverse events in elderly patients with dementia Cognitive and motor impairment Body temperature dysregulation Suicidality Depression in patients with affective disorders (INVEGA only) Increased sensitivity to antipsychotics in patients with Parkinson's disease or Dementia with Lewy bodies Gastrointestinal obstruction (in patients with pre-existing severe gastrointestinal narrowing [pathologic or iatrogenic] or in patients with dysphagia or significant difficulty in swallowing tablets) (INVEGA only) Decreased bone mineral density/osteoporosis Use in haemodialysis patients Missing information Exposure during pregnancy Exposure via breastfeeding Pharmacovigilance plan The sponsor is proposing routine pharmacovigilance activities for all specified safety concerns.
Diabetes mellitus and hyperglycaemia-related adverse events Weight gain Seizures Somnolence Priapism Cerebrovascular accident Venous thromboembolism Leukopenia Agranulocytosis Thrombocytopenia Rhabdomyolysis Elevated plasma concentrations in patients with renal disease Injection site reactions (injectable formulations only) Hypersensitivity reactions (injectable formulations only) Important potential risks Carcinogenicity (pituitary adenomas, endocrine pancreas tumours, breast cancer) Overall increased mortality in elderly patients with dementia Cerebrovascular adverse events in elderly patients with dementia Cognitive and motor impairment Body temperature dysregulation Suicidality Depression in patients with affective disorders (INVEGA only) Increased sensitivity to antipsychotics in patients with Parkinson's disease or Dementia with Lewy bodies Gastrointestinal obstruction (in patients with pre-existing severe gastrointestinal narrowing [pathologic or iatrogenic] or in patients with dysphagia or significant difficulty in swallowing tablets) (INVEGA only) Decreased bone mineral density/osteoporosis Missing information Use in haemodialysis patients Exposure during pregnancy Exposure via breastfeeding Pharmacovigilance plan The sponsor is proposing routine pharmacovigilance activities for all specified safety concerns.
auspar-paliperidone-palmitate-171013.docx