BOXED WARNING Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death; not approved for dementia-related psychosis.
FDA dosing
Population
Start
Target
Max
Schizophrenia
Adult
90 mg or 120 mg SC once monthly
90–120 mg once monthly
120 mg per month
Renal Titrate with oral risperidone up to at least 3 mg daily before initiating; then 90 mg once monthly based on response/tolerability
Hepatic Titrate with oral risperidone up to at least 3 mg daily before initiating; then 90 mg once monthly based on response/tolerability
One dose per month only; no loading dose.
Instructions
Establish tolerability with oral risperidone before initiating
Subcutaneous injection in the abdomen or back of the upper arm by a healthcare provider; do not give by any other route
Do not give more than one dose (90 mg or 120 mg) per month; supplemental oral risperidone not recommended
Fully mix the medication before administration
Contraindications
Known hypersensitivity to risperidone, paliperidone, or any components of PERSERIS (anaphylactic reactions and angioedema reported).
Cautions
Increased mortality in elderly patients with dementia-related psychosis (boxed; not approved for this use)
Cerebrovascular adverse events, including stroke, in elderly dementia patients
Leukopenia/neutropenia; seizures; potential for cognitive/motor impairment; dysphagia; priapism; disruption of body temperature regulation
Adverse reactions
increased weight
sedation/somnolence
musculoskeletal pain
Pregnancy Neonates exposed to antipsychotics in the third trimester are at risk for extrapyramidal and/or withdrawal symptoms after delivery. Pregnancy registry available.
Lactation Risperidone and 9-hydroxyrisperidone present in human milk (relative infant dose 2.3–4.7% of maternal); reports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms in breastfed infants.
⚠ BOXED WARNING
Increased mortality in elderly patients with dementia-related psychosis