英文药名：INVEGA TRINZA (paliperidone palmitate extended-release injectable suspension)

中文药名：棕榈酸帕利哌酮缓释注射悬浮液

生产厂家：杨森制药公司
药品介绍
近日，强生（JNJ）研发的长效版非典型抗精神病药物Invega Trinza（棕榈酸帕潘立酮缓释注射剂，每3个月肌内注射一次）获得美国FDA批准。
该药每3个月注射一次，一年只需注射4次，用于精神分裂症成人患者的治疗。Invega Trinza通过FDA的优先审查程序批准，是全球首个也是唯一一个一年用药仅4次的精神分裂症治疗药物。

INVEGA TRINZA® (paliperidone palmitate) is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been treated with INVEGA SUSTENNA® (paliperidone palmitate) for at least 4 months
INVEGA TRINZA Rx
Generic Name and Formulations:
Paliperidone (as palmitate) 273mg, 410mg, 546mg, 819mg; ext-rel susp for IM inj.
Company:
Janssen Pharmaceuticals, Inc.
Select therapeutic use: Psychosis
Indications for INVEGA TRINZA:
Treatment of schizophrenia after adequately treated with Invega Sustenna (1-month paliperidone palmitate ext-rel inj susp) for ≥4 months.
Adult:
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.
Children:
<18yrs: not established.
Contraindications:
Risperidone hypersensitivity.
Warnings/Precautions:
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. Orthostatic hypotension. Parkinson's disease. Dementia with Lewy bodies. History of seizures. Patients at risk for aspiration pneumonia. Renal insufficiency. Severe hepatic impairment. Exposure to extreme temperatures. May have antiemetic effect. 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.
Interactions:
Avoid drugs that prolong QT interval (eg, Class 1A and Class III antiarrhythmics, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin). Caution with other CNS drugs, alcohol, drugs that may cause orthostatic hypotension. May antagonize levodopa, other dopamine agonists. Additive effects with concomitant risperidone or oral paliperidone for long-term use; caution. Concomitant strong CYP3A4 and/or P-gp inducers (eg, carbamazepine, rifampin, St. John's Wort): may need to increase Sustenna dose and decrease when inducers discontinued; avoid inducers with Trinza; if coadmin necessary, consider oral paliperidone ext-rel tabs.
See Also:
INVEGA SUSTENNA
Pharmacological Class:
Atypical antipsychotic (benzisoxazole deriv.).
Adverse Reactions:
Inj site reactions, somnolence/sedation, dizziness, akathesia, extrapyramidal disorder; may cause NMS, tardive dyskinesia, QT prolongation, metabolic changes, orthostatic hypotension, syncope, hyperprolactinemia, priapism.
Generic Availability:
NO
How Supplied:
Kit—1 (prefilled syringe + needles)
完整处方资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c39e65d7-fa44-4e4c-8b12-a654d3ed0eae