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ARISTADA INITIO KIT 675mg/2.4ml(月桂酰阿立哌唑缓释注射悬浮液)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 675毫克/2.4毫升/支 1支/盒 
包装规格 675毫克/2.4毫升/支 1支/盒 
计价单位: 盒 
生产厂家中文参考译名:
ALKERMES INC
生产厂家英文名:
ALKERMES INC
该药品相关信息网址1:
https://www.aristada.com/caregiver-information
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
ARISTADA INITIO 675MG ER SYG 2.4ML
原产地英文药品名:
ARIPIPRAZOLE LAUROXIL SUBMICR
中文参考商品译名:
ARISTADA缓释注射悬浮液 675毫克/2.4毫升/支 1支/盒
中文参考药品译名:
月桂酰阿立哌唑
曾用名:
简介:

 

近日,美国FDA批准ARISTADA INITIO(aripiprazole lauroxil)作为长效注射用非典型抗精神病药物ARISTADA®(aripiprazole lauroxil)的启动方案,用于治疗成人精神分裂症患者。
ARISTADA INITIO可用于任何剂量的ARISTADA,为患者和医生提供了多种灵活的剂量选择。第一次ARISTADA®给药可以在ARISTADA INITIO™给药后的同一天进行,或在给药后10天内进行。
批准日期:2018年7月3日 公司:ALKERMES INC
ARISTADA INITIO(月桂酰阿立哌唑[aripiprazole lauroxil])缓释注射用悬浮液,肌肉注射用
美国最初批准:2015年
警告:
老年痴呆症相关心理病患者的死亡率增加,请参阅完整的警告信息的完整预定信息。
用抗精神病药治疗的老年痴呆相关精神病患者死亡风险增加。
ARISTADA INITIO未被批准用于治疗痴呆相关精神病患者。
作用机制
阿立哌唑月桂酰是阿立哌唑的前药。 在肌内注射后,阿立哌唑月桂酰可能通过酶介导的水解转化为N-羟甲基阿立哌唑,然后将其水解成阿立哌唑。 阿立哌唑在精神分裂症中的作用机制尚不清楚。 然而,功效可以通过多巴胺D2和5-羟色胺5-HT1A受体的部分激动剂活性和5-HT2A受体的拮抗剂活性的组合来介导。
适应症和用法
ARISTADA INITIO与口服阿立哌唑联用,用于治疗成人精神分裂症时引发ARISTADA®。
剂量和给药
与第一次ARISTADA注射一起给予一次675mg注射ARISTADA INITIO和一次30mg剂量的口服阿立哌唑。
ARISTADA INITIO仅用作单剂量,不用于重复给药。
通过医疗保健专业人员在三角肌或臀肌中肌肉注射来管理ARISTADA INITIO。
对于初次接受阿立哌唑治疗的患者,在开始使用ARISTADA INITIO治疗前建立口服阿立哌唑的耐受性。
有关详细的准备和管理说明,请参阅剂量和管理。
避免在已知的CYP2D6弱代谢者中使用。
避免使用强CYP2D6或CYP 3A4抑制剂和强CYP3A4诱导剂。
ARISTADA INITIO与ARISTADA不可互换。
剂量形式和强度
缓释可注射悬浮液:675mg单剂量预填充注射器。
禁忌症
已知对阿立哌唑的超敏反应
警告和注意事项
老年痴呆相关精神病患者的脑血管不良反应:脑血管不良反应发生率增加(例如中风,短暂性脑缺血发作,包括死亡)。
给药和药物治疗错误的可能性:ARISTADA INITIO和ARISTADA之间可能发生替代和分配错误。不要用ARISTADA INITIO代替ARISTADA。
神经阻滞性恶性综合症:立即停药并密切监测。
迟发性运动障碍:如果临床适当,则停用。
代谢变化:监测高血糖,血脂异常和体重增加。
病理性赌博和其他强迫行为:考虑停止。
直立性低血压:监测心率和血压,并警告患有已知心血管或脑血管疾病的患者,以及脱水或晕厥的风险。
白细胞减少症,中性粒细胞减少症和粒细胞缺乏症:对有临床显着低白细胞(WBC)计数史的患者进行全血细胞计数。如果在没有其他致病因素的情况下WBC临床显着下降,则考虑停药。
癫痫发作:对有癫痫发作史或癫痫发作阈值降低的患者慎用。
认知和运动损伤的可能性:操作机器时要小心。
不良反应
最常见的不良反应(发生率≥5%,至少是安慰剂的两倍)是静坐不能。
要报告疑似不良反应,请致电1-866-274-7823联系Alkermes,Inc。或致电1-800-FDA-1088联系FDA或
WWW.FDA.GOV/MEDWATCH
用于特定人群
怀孕:在妊娠晚期暴露的女性中,可能会导致新生儿出现锥体外系和/或戒断症状。
包装提供/存储和处理
提供
ARISTADA INITIO延长释放注射用悬浮液的强度为675毫克,2.4毫升。 该试剂盒包含一个5 mL预装注射器,含有ARISTADA INITIO,为无菌白色至灰白色水性缓释注射悬浮液,带有安全针。
675mg强度试剂盒(NDC 65757-500-03;灰色标签)含有三个安全针; 1英寸(25毫米)21规格,1½英寸(38毫米)20规格和2英寸(50毫米)20规格针头。
存储
储存在室温20°C至25°C(68°F至77°F),允许偏差在15°C至30°C之间(59°F至86°F之间)。 不要冻结。
完整说明书附件:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403
ARISTADA(aripiprazole lauroxil)/ARISTADA INITIO® (aripiprazole lauroxil)
ARISTADA(aripiprazole lauroxil) extended-release injectable suspension is a long-acting atypical antipsychotic that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. ARISTADA is available in four dose strengths with once-monthly dosing (441 mg, 662 mg, 882 mg), a six-week dosing option (882mg) and a two-month dosing option (1064 mg).
ARISTADA INITIO® (aripiprazole lauroxil), in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. ARISTADA INITIO is an extended-release injectable suspension available in a 675 mg single-dose pre-filled syringe. ARISTADA INITIO is only to be used as a single dose and is not for repeated dosing. ARISTADA and ARISTADA INITIO are not interchangeable due to differing pharmacokinetic profiles.
For more information, visit www.aristada.com.
INDICATION and IMPORTANT SAFETY INFORMATION for ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use
INDICATION
ARISTADA INITIO is a prescription medicine given as a one-time injection and is used in combination with oral aripiprazole to start ARISTADA treatment, or re-start ARISTADA treatment after a missed dose, when ARISTADA is used for the treatment of schizophrenia in adults.
ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia in adults.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at increased risk of death when treated with antipsychotic medicines including ARISTADA INITIO and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or ARISTADA if you are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects including:
Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
high fever
stiff muscles
confusion
sweating
changes in pulse, heart rate, and blood pressure
Uncontrolled body movements (tardive dyskinesia). ARISTADA INITIO and ARISTADA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
Problems with your metabolism such as:
High blood sugar (hyperglycemia). Increases in blood sugar can happen in some people who receive ARISTADA INITIO and/or ARISTADA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA.
Call your healthcare provider if you have any of these symptoms of high blood sugar:
feel very thirsty
need to urinate more than usual
feel very hungry
feel weak or tired
feel sick to your stomach
feel confused, or your breath smells fruity
Increased fat levels (cholesterol and triglycerides) in your blood
Weight gain. You and your healthcare provider should check your weight regularly.
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having unusual strong urges, talk to your healthcare provider.
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or dizzy when standing which may make you at risk for falls and related injuries
Low white blood cell count
Seizures (convulsions)
Problems controlling your body temperature. Avoid becoming too hot or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
Difficulty swallowing
The most common side effects of ARISTADA INITIO and ARISTADA include restlessness or feeling like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and ARISTADA. You should tell your healthcare provider about any side effects you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA INITIO and ARISTADA affect you. ARISTADA INITIO and ARISTADA may affect your judgment, thinking or motor skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider about all of your medical conditions, including if you:
have not taken Abilify®, Abilify Maintena®, or any aripiprazole product before
have or had heart problems or a stroke
have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you receive ARISTADA INITIO and/or ARISTADA or during your treatment with ARISTADA
have or had low or high blood pressure
have or had seizures (convulsions)
have or had a low white blood cell count
have problems that may affect you receiving an injection in your buttocks or your arm
are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO and/or ARISTADA will harm your unborn baby. If you become pregnant while taking ARISTADA INITIO and/or ARISTADA, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388, or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
are breastfeeding or plan to breastfeed. ARISTADA INITIO and/or ARISTADA can pass into your breast milk. It is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ARISTADA INITIO and/or ARISTADA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO and ARISTADA and other medicines may affect each other causing possible serious side effects. Do not start or stop any medicines after you receive ARISTADA INITIO and ARISTADA without talking to your healthcare provider first. 

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