|
——每月一次的Paliperidone Palmitate注射剂获美国FDA批准治疗精神分裂症
美国食品药物管理局(FDA)核准一种长效、每月一次的paliperidone palmitate注射剂(商品名Invega Sustenna，Ortho-McNeil-Janssen Pharmaceuticals公司之子公司Janssen公司)，用於成人精神分裂症之急性与维持治疗。
虽然多数病患可以藉由持续的、长期抗精神病治疗来控制精神分裂症症状与復发风险，有大约80%的病患在诊断后5年内復发。
復发风险增加原因之一为治疗不顺从性，服用口服抗精神病药物的病患经常有此状况。
Henry A. Nasrallah医师在公司的新闻稿中表示，药物顺从性不佳可以说是精神分裂症状控制障碍与復发风险的单一最大因素。核准每月一次的Invega Sustenn将可提供健康照护专业人士另一个治疗选择，同时，明确的持续药物顺从性监测工具也有助於精神分裂症的适当临床结果。
Nasrallah医师是Invega Sustenna临床试验的临床研究员，也是俄亥俄州辛辛那提大学医学院精神分裂症研究计画主任、精神与神经科学教授。
临床试验计画包括四个急性症状控制研究以及一个长期维持研究。四篇研究(n=1695人)显示，缓释型paliperidone注射剂对於改善精神分裂症病患之正向与负向症状量表(Positive and Negative Syndrome Scale，PANSS)整体分数显然比安慰剂更有效。
PANSS是一种多项目表单，可测量正向症状、负向症状、脱序思考、未控制的敌意/激动以及焦虑/忧鬱。
长期维持研究(n=410人)的结果发现，缓释型paliperidone注射剂显著延迟了初次復发的时间(P<.0001)，相较於安慰剂，较少病患发生復发(10% vs 34%)。接受安慰剂病患的復发率为使用缓释型paliperidone palmitate者的3.6倍。此研究因为维持效果明确而提早停止。
使用paliperidone治疗者最常(发生率≧5%，发生率为安慰剂的2倍)报告的副作用为注射部位反应、想睡/镇静、头昏眼花、静坐不能(akathisia)、以及锥体外异常(extrapyramidal disorder)。
缓释型paliperidone palmitate治疗，在第1天，起始剂量应该是234mg，1週之后为156mg，注射部位都是在三角肌。
建议的每月维持剂量维117mg；根据病患的耐受性和/或效果，有些病患可能会需要比建议剂量高或低的剂量，剂量范围在39至234mg。每月维持剂量可以注射在三角肌或臀肌。
IMPORTANT SAFETY INFORMATION FOR INVEGA SUSTENNA
INVEGA SUSTENNA(paliperidone palmitate) is used for the treatment of schizophrenia.
INVEGA SUSTENNAis not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who
were given oral antipsychotics like INVEGA SUSTENNA in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.
Neuroleptic Malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEGA
SUSTENNA and similar medicines. Call the doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.
Tardive Dyskinesia (TD) is a rare, but serious and sometimes permanent side effect reported with INVEGA SUSTENNA and similar medicines.
Call your doctor right away if you start to develop twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the total dose received.
This condition can also develop after a short period of treatment at low doses but
this is less common. There is no known treatment for TD but it may go away partially or completely if the medicine is stopped.One risk of INVEGA SUSTENNA is that it may change your heart rhythm. This effect is potentially serious. You should talk to your
doctor about any current or past heart problems. Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).
High blood sugar and diabetes have been reported with INVEGA
SUSTENNA and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment.
The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or "pass urine" more often than usual, or feeling
weak or hungry.
Weight gain has been observed with INVEGA® SUSTENNA™ and other atypical antipsychotic medications. If you notice that you are gaining weight, please notify your doctor.
Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly.
It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the medicine.
INVEGA SUSTENNA and similar medicines have been associated with decreases in the counts of white cells in circulating blood.
If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.
INVEGA SUSTENNA and similar medicines can raise the blood levels of a hormone called prolactin and blood levels of prolactin remain high with continued use. This may result in some side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.
If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.
Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.
INVEGA SUSTENNA can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA SUSTENNA, be careful driving a car, operating machines, or doing things that require you to be alert.
This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.
Some medications interact with INVEGA® SUSTENNA™ Please inform your healthcare professional of any medications or supplements that you are taking.
INVEGA SUSTENNA should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with INVEGA SUSTENNA.
Do not drink alcohol while you are taking INVEGA SUSTENNA.In a study of people taking INVEGA® SUSTENNA, common side effects in the treatment of schizophrenia were reactions at the injection site, sleepiness, dizziness, feeling of inner restlessness, and abnormal muscle movements, including tremor (shaking), shuffling,
uncontrolled involuntary movements, and abnormal movements of the eyes.
This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.
If you have any questions about INVEGA SUSTENNA or your therapy, talk with your doctor.
INVEGA SUSTENNA Rx
Generic Name and Formulations:
Paliperidone (as palmitate) 39mg, 78mg, 117mg, 156mg, 234mg; ext-rel susp for IM inj.
Company:
Janssen Pharmaceuticals, Inc.
Select therapeutic use: Psychosis
Indications for INVEGA SUSTENNA:
Treatment of schizophrenia. Treatment of schizoaffective disorder as monotherapy or as an adjunct to mood stabilizers or antidepressants.
Adult:
Establish tolerability with oral paliperidone or oral risperidone prior to initiating. Give by deep deltoid IM inj, initially 234mg on Day 1, then 156mg one week later. Maintenance: Give by deep deltoid or gluteal IM inj once monthly. Schizophrenia: 117mg; may increase or decrease in the range of 39–234mg. Schizoaffective: usual range of 78–234mg. Both max: 234mg/month. Renal impairment: CrCl ≥50–<80mL/min: initially 156mg on Day 1, then 117mg one week later, then 78mg monthly; 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 TRINZA
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)
----------------------------------------------------------
注：以下产品不同规格和不同价格，采购以咨询为准！
----------------------------------------------------------
产地国家: 美国
原产地英文商品名:
INVEGA SUSTENNA 39MG/0.25ML/vial+2 SAFETY NEEDLE PALIPERIDONE PALMITATE Pack size: 1 VIAL
原产地英文药品名:
PALIPERIDONE PALMITATE
中文参考商品译名:
INVEGA SUSTENNA 39毫克/0.25毫升/瓶+2棕榈酸帕潘立酮安全针
中文参考药品译名:
棕榈酸帕潘立酮 缓释型注射用混悬剂
生产厂家中文参考译名:
杨森制药公司
生产厂家英文名:
JOHNSON AND JOHNSON
-------------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
INVEGA SUSTENNA 234MG/1.5ML/vial+ SAFETY NEEDLE PALIPERIDONE PALMITATE Pack size: 1 VIAL
原产地英文药品名:
PALIPERIDONE PALMITATE
中文参考商品译名:
INVEGA SUSTENNA 234毫克/1.5毫升/瓶+棕榈酸帕潘立酮安全针
中文参考药品译名:
棕榈酸帕潘立酮 缓释型注射用混悬剂
生产厂家中文参考译名:
杨森制药公司
生产厂家英文名:
JOHNSON AND JOHNSON
-------------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
INVEGA SUSTENNA 117MG/0.75ML/vial+ SAFETY NEEDLE PALIPERIDONE PALMITATE Pack size: 1 VIAL
原产地英文药品名:
PALIPERIDONE PALMITATE
中文参考商品译名:
INVEGA SUSTENNA 117毫克/0.75毫升/瓶+棕榈酸帕潘立酮安全针
中文参考药品译名:
棕榈酸帕潘立酮 缓释型注射用混悬剂
生产厂家中文参考译名:
杨森制药公司
生产厂家英文名:
JOHNSON AND JOHNSON
-------------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
INVEGA SUSTENNA 78MG/0.5ML/vial+2 SAFETY NEEDLE PALIPERIDONE PALMITATE Pack size: 1 VIAL
原产地英文药品名:
PALIPERIDONE PALMITATE
中文参考商品译名:
INVEGA SUSTENNA 78毫克/0.5毫升/瓶+2棕榈酸帕潘立酮安全针
中文参考药品译名:
棕榈酸帕潘立酮 缓释型注射用混悬剂
生产厂家中文参考译名:
杨森制药公司
生产厂家英文名:
JOHNSON AND JOHNSON
-------------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
INVEGA SUSTENNA 156MG/1.0ML/vial+2 SAFETY NEEDLE PALIPERIDONE PALMITATE Pack size: 1 VIAL
原产地英文药品名:
PALIPERIDONE PALMITATE
中文参考商品译名:
INVEGA SUSTENNA 156毫克/1.0毫升/瓶+2棕榈酸帕潘立酮安全针
中文参考药品译名:
棕榈酸帕潘立酮 缓释型注射用混悬剂
生产厂家中文参考译名:
杨森制药公司
生产厂家英文名:
JOHNSON AND JOHNSON
该药品相关信息网址1:
https://www.invegasustenna.com/invegasustenna/index.html |
