Risperidone LAI

RYKINDO

Open Risperidone LAI in the interactive console ↗

What it isDepot D2 and 5-HT2A antagonist; schizophrenia and bipolar I maintenance.

Why this oneIts release profile shortens the oral-overlap requirement at initiation compared with CONSTA’s three weeks.

What limits itIt keeps the two-week injection frequency, so the visit burden is unchanged; prolactin elevation, parkinsonism, weight gain, and orthostasis can still end use.

FDA label

Read the full label on DailyMed ↗

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	25 mg IM every 2 weeks	25–50 mg IM every 2 weeks	50 mg every 2 weeks
Bipolar I disorder, maintenance (monotherapy or adjunct to lithium/valproate)	Adult	25 mg IM every 2 weeks	25–50 mg IM every 2 weeks	50 mg every 2 weeks

Titration Do not titrate dose more frequently than every 4 weeks

Renal Titrate with oral risperidone up to at least 2 mg before initiating; reduced elimination expected in renal impairment

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

Administered every 2 weeks; overlap with 7 days of oral risperidone at initiation.

Instructions

Establish tolerability with oral risperidone before initiating
IM gluteal injection by a healthcare provider (alternate buttocks); do not give by any other route
Administer the first dose with 7 days of oral risperidone
Do not combine two different dose strengths in a single administration

Contraindications

Known hypersensitivity to risperidone, paliperidone, or any components of RYKINDO (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

headache
parkinsonism
dizziness
akathisia
fatigue
constipation
dyspepsia
sedation
weight increased
pain in extremity
dry mouth

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