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RISPERIDONE INJ,SUSP,SA

Clinical Criteria Summary

Document 661

Continuity of Care

  • Veteran is transitioning care from the Department of Defense to VHA
  • Additional Inclusion Criteria (Select ONE):
  • Medication is safe and clinically appropriate as determined by a VA prescriber using shared decision making
  • Medication is indicated for tapering the dose or slowly discontinuing therapy as determined by a VA prescriber using shared decision making

Non-Continuity of Care Exclusion Criteria

  • Patient has never taken the long-acting injectable (LAI) antipsychotic ordered in any formulation (e.g., oral)
  • Patient has a hypersensitivity to the antipsychotic ordered (consider risperidone and paliperidone cross-sensitive)

Non-Continuity of Care Inclusion Criteria

  • All of the following must be met:
  • Diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
  • Initial prescriber is a VA Mental Health provider
  • Patient has taken and tolerated the antipsychotic ordered prior to receiving it as a LAI for an adequate length of time (consider risperidone and paliperidone cross-tolerant)
  • Patient will be transitioned from oral medication to the LAI per guideline/manufacturer recommendations
  • One of the following must be met:
  • Patient has relapsed or been hospitalized for the intended indication or complications of the intended indication because of nonadherence when treated with oral antipsychotics
  • Patient’s care environment is such that a LAI is a more reliable route of administration (e.g., homeless, lack of medication supervision, or the medication cannot be stored safely)

Document 542

Indication & Patient Population

  • Indicated for the treatment of schizophrenia in adults.
  • Appropriate for patients with a schizophrenia diagnosis greater than one year and one or more relapse episodes in the last 24 months, or those who responded to an antipsychotic (other than clozapine) in the past year.
  • Patients must be on stable oral risperidone doses between 2 mg/day and 5 mg/day; candidates with stable doses lower than 2 mg/day or higher than 5 mg/day are not appropriate.

Dosing & Administration Criteria

  • Administered as a subcutaneous extended-release injectable suspension.
  • Dosing interval is either once monthly or every two months.
  • Initiate therapy the day after the last dose of oral risperidone.
  • Neither a loading dose nor supplemental oral risperidone doses are recommended when switching from oral to injectable therapy.
  • Oral-to-injectable conversion: 2 mg/day oral = 50 mg SC q1m or 100 mg SC q2m; 3 mg/day = 75 mg/150 mg; 4 mg/day = 100 mg/200 mg; 5 mg/day = 125 mg/250 mg.

Safety, Warnings & Monitoring Requirements

  • Contraindicated in elderly patients with dementia-related psychosis due to increased mortality and cerebrovascular adverse reactions (including stroke).
  • Monitor for neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes (hyperglycemia, diabetes mellitus, dyslipidemia, weight gain), hyperprolactinemia, orthostatic hypotension, syncope, falls, leukopenia/neutropenia/agranulocytosis, cognitive and motor impairment, seizures, dysphagia, priapism, and body temperature regulation issues.
  • Pregnancy: Not studied in pregnancy; neonates exposed during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery.
  • Lactation: Present in human breast milk (2.3–4.7% relative infant dose); monitor breastfed infants for sedation, failure to thrive, jitteriness, and EPS.

Formulation & Storage Specifications

  • Supplied as single-dose prefilled syringes (50, 75, 100, 125, 150, 200, and 250 mg) that do not require reconstitution.
  • Requires refrigeration.
  • Must be protected from light.
  • Discard if the package is opened; must remain in an unopened package until administration.
  • Staff education is required for proper storage and administration.

Source Documents