HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PERSERIS TM safely and effectively. See full prescribing information for PERSERIS.
PERSERIS (risperidone) for extended-release injectable suspension, for subcutaneous use.
Initial U.S. Approval: 1993
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
PERSERISTM is not approved for use in patients with dementia-related psychosis. (5.1)
INDICATIONS AND USAGE

PERSERIS is an atypical antipsychotic indicated for the treatment of schizophrenia in adults. (1)
DOSAGE AND ADMINISTRATION
Establish tolerability with oral risperidone. (2.1)
PERSERIS may be initiated at a dose of 90 mg or 120 mg. (2.1)
Supplementation with oral risperidone is not recommended. (2.1)
Prior to use, the product is constituted by coupling the liquid and powder syringes and passing the contents back and forth between the syringes. (2.4)
Failure to fully mix the medication could result in incorrect dosage. (2.4)
Administer monthly by subcutaneous injection in the abdomen by a healthcare professional. Do not administer by any other route. (2.4)
Do not administer more than one dose (90 mg or 120 mg total) per month. (2.1)
DOSAGE FORMS AND STRENGTHS
For extended-release injectable suspension: 90 mg and 120 mg risperidone. (3)
CONTRAINDICATIONS
Known hypersensitivity to risperidone, paliperidone, or other components of PERSERIS. (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis: Increased risk of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities. PERSERIS is not approved for use in patients with dementia-related psychosis. (5.2)
Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring. (5.3)
Tardive Dyskinesia: Discontinue treatment if clinically appropriate. (5.4)
Metabolic Changes: Monitor for hyperglycemia, dyslipidemia, and weight gain. (5.5)
Hyperprolactinemia: Prolactin elevations occur and persist during chronic administration. Long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in females and males. (5.6)
Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular disease or cerebrovascular disease, and risk of dehydration or syncope. (5.7)
Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with a history of a clinically significant low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing PERSERIS if a clinically significant decline in WBC occurs in absence of other causative factors. (5.9)
Potential for Cognitive and Motor Impairment: Use caution when operating machinery. (5.10)
Seizures: Use caution in patients with a history of seizures or with conditions that lower the seizure threshold. (5.11)
ADVERSE REACTIONS
The most common adverse reactions in clinical trials (≥ 5% and greater than twice placebo) were increased weight, sedation/somnolence, and musculoskeletal p