近日，美国FDA批准ARISTADA（aripiprazole lauroxil）作为长效注射用非典型抗精神病药物的启动方案，用于治疗成人精神分裂症患者。本品可在第一天为患者开始任何剂量的ARISTADA。
批准日期：2018年7月3日  公司：ALKERMES INC
ARISTADA（月桂酰阿立哌唑[aripiprazole lauroxil]）缓释注射悬浮液，肌肉注射使用
美国首次批准：2015年
警告：死亡率增加老年痴呆相关精神病见完整的黑框警告完整的处方信息。
老年痴呆患者的相关精神病用抗精神病药物治疗是在死亡的风险增加。
ARISTADA未被批准用于治疗老年痴呆症相关的精神病治疗。
适应症和用法
ARISTADA是精神分裂症的治疗中所表示的非典型抗精神病药。
用法用量
通过注射在三角肌肌肉注射给药（441毫克剂量只）或医疗专业人士臀（441毫克，662毫克或882毫克）的肌肉。
对于患者天真的阿立哌唑，建立耐受口服阿立哌唑，然后与ARISTADA开始治疗。
ARISTADA可在441毫克剂量开始，662毫克或882毫克的施用每月或882毫克的剂量每6周。
与第一ARISTADA注射的同时，实施治疗用口服阿立哌唑，连续21天。
可能需要错过剂量给药方案进行调整。
所需的1）已知的CYP2D6弱代谢和2）进行拍摄CYP3A4抑制剂，CYP2D6抑制剂或CYP3A4诱导为2周以上患者调整剂量。
剂型和规格
对于延长释放可注射悬浮液：441毫克，662毫克或882毫克单次使用的预先填充的注射器
禁忌
已知过敏阿立哌唑
警告和注意事项
脑血管不良反应的老年痴呆相关精神病：增加脑血管的不良反应发生率（如中风，短暂性脑缺血发作，包括死亡）。
抗精神病药物恶性症候群：与管理立即停止，并密切监测。
迟发性运动障碍：如临床适宜以停止。
代谢的变化：监测高血糖，血脂异常，和体重增加。
体位性低血压：监控心脏速率和血压和警告患者具有已知的心血管或脑血管疾病，和脱水或晕厥的风险。
白细胞减少症，中性粒细胞减少，粒细胞缺乏症和：执行在患者全血计数与临床显著低白细胞（WBC）计数的历史。考虑停药，如果临床显著下降，白细胞在没有其他致病因素（5.7）的。
癫痫发作：患者谨慎使用有惊厥史或与降低癫痫发作阈值的条件。
潜在的认知和运动功能障碍：操作机械设备时要小心。
不良反应
最常观察到的不良反应与ARISTADA（发生率≥5％和至少两次，对于安慰剂）是静坐不能。
特殊人群中使用
怀孕：可在妊娠的第三孕期暴露的女性新生儿引起锥体外系和/或戒断症状。
包装供应
ARISTADA缓释注射悬浮液是在441毫克的优势，可以在1.6毫升，662毫克，2.4毫升，和882毫克320毫升。
所述试剂盒包含含有ARISTADA无菌水性悬浮液和安全针5毫升的预填充注射器。
ARISTADA 441MG SYG 1.6ML ARIPIPRAZOLE LAUROXIL ALKERMES INC  65757040103 
ARISTADA 662MG SYG 2.4ML ARIPIPRAZOLE LAUROXIL ALKERMES INC  65757040203 
ARISTADA INITIO 675MG ER SYG 2.4ML  ARIPIPRAZOLE LAUROXILSUBMICR. ALKERMES INC  65757050003
ARISTADA 882MG SYG 3.2ML ARIPIPRAZOLE LAUROXIL ALKERMES INC   65757040303 
ARISTADA 1064MG SYG 3.9ML ARIPIPRAZOLE LAUROXIL  ALKERMES INC  65757040403
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ARISTADA(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.