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。
Generic Name and Formulations:
Aripiprazole extended-release injectable suspension 300mg, 400mg; per vial or pre-filled syringe; lyophilized pwd for IM inj after reconstitution.
Company:
Lundbeck Inc. and Otsuka America Pharmaceutical, Inc.

Indications for ABILIFY MAINTENA:
Schizophrenia. Tourette's disorder.

Adult:
Treatment-naive: establish tolerability with oral form first. Give by IM inj into the deltoid or 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, CYP2D6 poor metabolizers, concomitant CYP2D6 inhibitors, CYP3A4 inhibitors or inducers for >14 days: see full labeling.

Children:
<18yrs: not recommended.

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. Reeva luate 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).

See Also:
ABILIFY

Aripiprazole Oral Solution

ABILIFY DISCMELT

Pharmacological Class:
Atypical antipsychotic.

Adverse Reactions:
Headache, anxiety, insomnia, constipation, nausea, vomiting, somnolence, fatigue, sedation, dizziness, restlessness, akathisia, orthostatic hypotension, blurred vision, tremor, pyrexia, salivary hypersecretion, nasopharyngitis, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.

How Supplied:
Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Discmelt—30; Prefilled Dual Chamber Syringe—1 (w. supplies); Single use vials—1 (w. supplies); Oral solution—contact supplier