Abilify Maintena KIT(Aripiprazole Extended-Release Injectable Suspension) 2013年3月1日，美国食品药品管理局FDA批准Abilify Maintena(阿立哌唑)用于治疗精神分裂症。ABILIFY MAINTENA KIT粉和溶剂组成的缓释型混悬液注射剂,400毫克;每月一次;肌内注射。 aripiprazole monohydrate (Abilify Maintena®) 400 mg powder and solvent for prolonged-release suspension for injection ABILIFY MAINTENA Rx Generic Name and Formulations: Aripiprazole extended-release injectable suspension 300mg, 400mg; per vial. Company: Lundbeck Inc. and Otsuka America Pharmaceutical, Inc. Indications for ABILIFY MAINTENA: Schizophrenia. Adult: Treatment-naive: establish tolerability with oral form first. Give by IM inj into the gluteal muscle. Initial and maintenance: 400mg once monthly (no sooner than 26 days after the previous inj); may consider reducing to 300mg once monthly if adverse reactions occur. After first Maintena dose, continue with concurrent oral aripiprazole (10mg or 20mg) or other antipsychotic for 14 consecutive days. Dose adjustments for missed dose, CYP3A4 poor metabolizers, concomitant CYP2D6 inhibitors, CYP3A4 inhibitors or inducers for >14 days: see full labeling. Children: <18yrs: not recommended. See Also: ABILIFY ORAL SOLUTION ABILIFY DISCMELT ABILIFY INJECTION ABILIFY Warnings/Precautions: Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Reevaluate periodically. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. Suicidal tendencies. Write ℞ for smallest practical amount. Labor & delivery. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended. Interactions: Avoid alcohol. Caution with other centrally-acting drugs. Potentiates antihypertensives. Levels may be reduced by CYP3A4 inducers (eg, carbamazepine). Levels may be increased by CYP3A4 inhibitors (eg, ketoconazole) or CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Caution with drugs that interfere with temperature regulation (eg, anticholinergics). Adverse Reactions: Headache, anxiety, insomnia, constipation, vomiting, somnolence, fatigue, sedation, restlessness, akathisia, orthostatic hypotension, asthenia, blurred vision, tremor, pyrexia, salivary hypersecretion, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, dyslipidemia, others. Inj: local reactions. How Supplied: Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Oral soln (w. dosing cup)—150mL; Discmelt—30; Maintena Kit—1 (w. supplies); Single use vials—1 灵北和大冢在欧洲推出长效精神分裂症药物Abilify Maintena(Aripiprazole Extended-Release Injectable Suspension) 2014年3月17日，灵北（Lundbeck）和大冢（Otsuka）3月17日宣布，在欧盟推出长效版精神分裂症药物Abilify Maintena（aripiprazole，阿立哌唑），该药为每月一次的肌内注射（IM）剂型药物，用于口服阿立哌唑稳定病情的精神分裂症（schizophrenia）成人患者的维持治疗。目前，Abilify Maintena已获FDA、欧盟、加拿大批准。 防止复发是治疗精神分裂症的关键。支持Abilify Maintena监管文件的关键性研究证明，在精神分裂症的长期治疗中，与安慰剂相比，Abilify Maintena能够降低复发的风险，而且疗效不逊色于口服阿立哌唑。 此外，Abilify Maintena具有与口服阿立哌唑类似的耐受性，同时，与安慰剂相比，Abilify Maintena在患者个人和社会功能上表现出统计学意义的显著改善，在双盲治疗阶段结束时，高达93%的患者对Abilify Maintena治疗表现出及其满意、非常满意或有点满意。 在欧洲，Abilify Maintena是唯一一种每月一次的注射剂型多巴胺D2部分激动剂，用于精神分裂症的维持治疗。 Abilify Maintena: new depot injection for schizophrenia Otsuka has launched Abilify Maintena (aripiprazole), a new injectable formulation allowing once-monthly dosing for the maintenance treatment of schizophrenia in patients already stabilised on oral aripiprazole. Abilify Maintena is presented as powder in a vial which is reconstituted to provide a 400mg prolonged-release suspension for injection. The recommended dose is 400mg by intramuscular injection into the gluteal muscle once monthly (no sooner than 26 days after the previous injection). The efficacy of aripiprazole 400mg given once monthly by intramuscular injection was compared with that of oral aripiprazole (10-30mg daily) and aripiprazole 50mg given intramuscularly once monthly in a 38-week double-blind study involving 662 patients (randomised population) with schizophrenia requiring chronic treatment with an antipsychotic. Aripiprazole 400mg injected once monthly was found to be non-inferior to oral aripiprazole and was also shown to significantly reduce the rate of relapse and to delay the time to impending relapse compared with aripiprazole 50mg injected once monthly. In another study, aripiprazole 400mg given once monthly by intramuscular injection for the maintenance treatment of schizophrenia (n=269) was shown to significantly delay time to impending relapse compared with placebo (n=134). In addition, improvements in total scores on the Clinical Global Impressions-Severity of Illness Scale and the Positive and Negative Syndrome Scale were maintained with aripiprazole monthly injection but worsened significantly with placebo.