PALIPERIDONE INJ,SUSP,SA
Clinical Criteria Summary
Document 523
Transitioning Veteran
- Veteran is transitioning care from the Department of Defense to VHA, and a VA prescriber has determined continuing the medication is safe and clinically appropriate (if met, remainder of criteria does not apply)
- Exclusion Criteria (Patient should NOT receive LAI if any criterion is met)
- Has never taken the ordered long-acting injectable antipsychotic in any formulation (e.g., oral), except prior exposure to risperidone is an acceptable substitute for paliperidone
- Hypersensitivity to the ordered antipsychotic (risperidone and paliperidone are cross-sensitive)
- Moderate to severe renal impairment (Creatinine Clearance < 50ml/min)
- Receiving a strong CYP3A4 and/or P-gp inducer during a dosing interval
- Inclusion Criteria (All must be met)
- Diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
- Prescriber is a VA Mental Health Provider
- Patient has taken and tolerated the ordered antipsychotic prior to receiving it as a LAI for an adequate length of time (risperidone and paliperidone are cross-tolerant)
- Patient will be transitioned from monthly or every 3 month paliperidone extended release suspension to the long-acting injectable per guidelines/manufacturer recommendations
- Inclusion Criteria (Patient must meet ONE of the following)
- Relapsed or been hospitalized for the intended indication or complications of the intended indication because of nonadherence when treated with oral antipsychotics
- Care environment is such that a LAI is a more reliable route of administration (e.g., homeless, lack of medication supervision, or medication cannot be stored safely)
Document 524
Transitioning Veteran
- Veteran is transitioning care from the Department of Defense to VHA
- VA prescriber has determined that continuing the medication is safe and clinically appropriate after assessment and consultation
Exclusion Criteria
- Patient has never taken the ordered long-acting injectable antipsychotic in any formulation (e.g., oral), with prior exposure to risperidone being an acceptable substitute for paliperidone
- Hypersensitivity to the ordered antipsychotic (risperidone and paliperidone are cross-sensitive)
- Moderate to severe renal impairment (creatinine clearance < 50 ml/min)
Inclusion Criteria (All Required)
- Diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
- Prescriber is a VA/VA Community Care Mental Health Provider
- Patient has taken and tolerated the ordered antipsychotic prior to receiving it as a LAI for an adequate length of time (risperidone and paliperidone are cross-tolerant)
- Patient will be transitioned from oral medication to the long-acting injectable per guidelines/manufacturer recommendations
Inclusion Criteria (One Required)
- Relapse or hospitalization for the intended indication or complications due to nonadherence when treated with oral antipsychotics
- Care environment makes a LAI a more reliable route of administration (e.g., homeless, lack of medication supervision, or medication cannot be stored safely)
Document 525
Transitioning Veteran
- Veteran is transitioning care from the Department of Defense to VHA.
- A VA prescriber has determined, after assessing and consulting with the Veteran, that continuing the medication is safe and clinically appropriate.
- If met, the remainder of the criteria for use is not applicable.
- Exclusion Criteria (Patient should NOT receive a long-acting injectable antipsychotic if any are met)
- Patient has never taken the ordered long-acting injectable antipsychotic in any formulation (e.g., oral), with prior exposure to risperidone being an acceptable substitute for paliperidone.
- Patient has a hypersensitivity to the ordered antipsychotic (risperidone and paliperidone are considered cross-sensitive).
- For Paliperidone (Invega Trinza): Patient has moderate to severe renal impairment (creatinine clearance < 50 ml/min).
- Inclusion Criteria (ALL must be met)
- Diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder.
- Prescriber is a VA Mental Health Provider.
- Patient has taken and tolerated the ordered antipsychotic prior to receiving it as a long-acting injectable for an adequate length of time (risperidone and paliperidone are considered cross-tolerant).
- Patient will be transitioned from 1-month paliperidone extended-release suspension to the long-acting injectable per guidelines/manufacturer recommendations.
- Inclusion Criteria (ONE must be met)
- Patient has relapsed or been hospitalized for the intended indication or complications of the intended indication due to nonadherence when treated with oral antipsychotics.
- Patient’s care environment is such that a long-acting injectable is a more reliable route of administration (e.g., homeless, lack of medication supervision, or medication cannot be stored safely).