Generic Name and Formulations:
Paliperidone (as palmitate) 273mg, 410mg, 546mg, 819mg; ext-rel susp for IM inj.
Janssen Pharmaceuticals, Inc.
Treatment of schizophrenia after adequately treated with Invega Sustenna (1-month paliperidone palmitate ext-rel inj susp) for ≥4 months.
Establish tolerability with Invega Sustenna prior to initiating. Give by deep deltoid or gluteal IM inj when next Invega Sustenna dose is scheduled using 3.5-fold higher dose equivalent (see full labeling). Maintenance: give once every 3 months; may adjust dose every 3 months in increments of 273–819mg based on tolerability and/or efficacy. Renal impairment: CrCl ≥50–<80mL/min: adjust dose and stabilize patient using Invega Sustenna, then transition to Invega Trinza; CrCl<50mL/min: not recommended. Missed doses or switching from other antipsychotics: see full labeling.
<18yrs: not established.
Elderly (not for dementia-related psychosis): increased risk of death. Avoid in congenital long QT syndrome, cardiac arrhythmias. Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Diabetes risk factors (obtain baseline fasting blood sugar). Cardio- or cerebrovascular disease; risks may be increased due to metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Monitor for signs/symptoms of infection; discontinue if severe neutropenia (ANC <1000mm3) occurs. Predisposition to hypotension; monitor. Perform fall risk assessments when initiating and recurrently on long-term therapy. Parkinson's disease. Dementia with Lewy bodies. History of seizures. Patients at risk for aspiration pneumonia. Renal impairment. Severe hepatic impairment. Exposure to extreme temperatures. Suicidal patients. Reevaluate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: not recommended.
Avoid drugs that prolong QT interval (eg, Class 1A and Class III antiarrhythmics, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin). Avoid concomitant strong CYP3A4 and/or P-gp inducers (eg, carbamazepine, rifampin, St. John's Wort); if coadmin necessary, consider oral paliperidone ext-rel tabs. Caution with other CNS drugs, alcohol, drugs that may cause orthostatic hypotension (monitor). May antagonize levodopa, other dopamine agonists. Additive effects with concomitant risperidone or oral paliperidone for long-term use; caution.
Inj site reactions, somnolence/sedation, dizziness, akathisia, extrapyramidal disorder; may cause NMS, tardive dyskinesia, QT prolongation, metabolic changes, orthostatic hypotension, syncope, hyperprolactinemia, priapism.
Kit—1 (prefilled syringe + needles)
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