Risperidone LAI

UZEDY

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What it isLong-acting subcutaneous D2 and 5-HT2A antagonist; schizophrenia and bipolar I maintenance.

Why this oneRapid release from the first injection — no loading, no oral overlap — with the option to stretch to a two-month interval.

What limits itOnce injected, adverse effects cannot be quickly reversed. Prolactin elevation, EPS, weight gain, and injection-site nodules matter.

FDA label

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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	SC per oral-equivalent (2 mg oral → 50 mg monthly / 100 mg q2 months; up to 5 mg oral → 125 mg monthly / 250 mg q2 months)	once monthly or once every 2 months
Bipolar I disorder, maintenance (monotherapy or adjunct to lithium/valproate)	Adult	SC per oral-equivalent (2 mg → 50 mg; 3 mg → 75 mg; 4 mg → 100 mg) once monthly	once monthly

Renal Titrate with oral risperidone up to at least 2 mg daily before initiating (not studied in renal impairment)

Hepatic Titrate with oral risperidone up to at least 2 mg daily before initiating

Available as once-monthly or (schizophrenia) once-every-2-months subcutaneous dosing.

Instructions

Establish tolerability with oral risperidone before initiating
Subcutaneous injection in the abdomen or upper arm by a healthcare professional; do not give by any other route
Neither a loading dose nor supplemental oral risperidone is recommended when switching from oral therapy
When switching from a q2-week IM risperidone LAI, start UZEDY once monthly at least 5 weeks after the last IM dose

Contraindications

Known hypersensitivity to risperidone, paliperidone, or any components of UZEDY (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
Neuroleptic malignant syndrome
Tardive dyskinesia
Metabolic changes (hyperglycemia/diabetes, dyslipidemia, weight gain)
Hyperprolactinemia
Orthostatic hypotension and syncope
Falls
Leukopenia/neutropenia; seizures; potential for cognitive/motor impairment; dysphagia; priapism; disruption of body temperature regulation

Adverse reactions

parkinsonism
akathisia
dystonia
tremor
sedation
dizziness
anxiety
blurred vision
nausea
vomiting
dyspepsia
injection site reactions

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