ding risperidone. Agranulocytosis has also been reported.
Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and a history of drug-induced leukopenia/neutropenia. Patients with a history of a clinically significant low WBC or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of PERSERIS should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count < 1000/mm3) should discontinue PERSERIS and have their WBC followed until recovery.
5.10 Potential for Cognitive and Motor Impairment
In an 8-week, double-blind, placebo-controlled study, somnolence/sedation was reported by 7.0% and 7.7% of subjects treated with PERSERIS 90 mg and 120 mg, respectively.
Since risperidone has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that treatment with PERSERIS does not affect them adversely.
5.11 Seizures
Seizures have been observed during pre-marketing studies of risperidone in adult patients with schizophrenia. PERSERIS should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
5.12 Dysphagia
Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer's dementia. PERSERIS and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia [see BOXED WARNING and Warnings and Precautions (5.1)].
5.13 Priapism
Priapism has been reported during postmarketing surveillance for other risperidone products. Severe priapism may require surgical intervention.
5.14 Body Temperature Regulation
Disruption of body temperature regulation has been attributed to antipsychotic agents. Both hyperthermia and hypothermia have been reported in association with oral risperidone use. Caution is advised when prescribing PERSERIS for patients who will be exposed to temperature extremes.
6 ADVERSE REACTIONS
The following are discussed in more detail in previous sections of the labeling:
Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see BOXED WARNING and Warnings and Precautions (5.1)]
Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2)]
Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.3)]
Tardive Dyskinesia [see Warnings and Precautions (5.4)]
Metabolic Changes [see Warnings and Precautions (5.5)]
Hyperprolactinemia [see Warnings and Precautions (5.6)]
Orthostatic Hypotension [see Warnings and Precautions (5.7)]
Falls [see Warnings and Precautions (5.8)]
Leukopenia, Neutropenia and Agranulocytosis [see Warnings and Precautions (5.9)]
Potential for Cognitive and Motor Impairment [see Warnings and P |
