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aripiprazole (Abilify)

Indications: 1) schizophrenia 2) bipolar disorder, mania [3] 3) depression, including major depression [4] {FDA-approved} - add-on treatment of depression in the elderly [13] 4) autism in children 5) psychosis & agitation in the elderly [10,11] Dosage: - 2-30 PO mg QD, AM dosing [11] - usual dose 10-30 mg/day [3] - depression, start 2-5 mg/day, titrate up to 15 mg/day Tabs: 2,5,10,15,20, 30 mg Injection: for IM injection [11] Pharmacokinetics: - antidepressant effects in 1-6 weeks [4] - metabolized by CYP2D6 & CYP3A4 - 1/2life is ~75 hours & 94 hours for aripiprazole & dehydro-aripiprazole, respectively [16] - for CYP2D6 poor metabolizers, the mean elimination 1/2life for aripiprazole is ~146 hours [16] - activity is presumably primarily due to the parent drug, aripiprazole, & to a lesser extent, to its major metabolite, dehydro-aripiprazole Adverse effects: 1) common: - headache, weakness, nausea, vomiting, constipation, anxiety, insomnia, dizziness, drowsiness, restlessness, rash [2] 2) does NOT prolong QT interval 3) may cause less weight gain than other atypical antipsychotics 4) may increase risk of diabetes mellitus [2] 5) esophageal dysmotility 6) impaired judgement, motor skills 7) neuroleptic malignant syndrome (rare) 8) tardive dyskinesia 9) little or no increase in risk for diabetes, dysplidemia, weight gain - can exacerbate hyperglycemia in patients with diabetes mellitus 10) weight gain, in adolescents 4.4 kg after 11 weeks of therapy [8] - metabolic syndrome 11) elderly a) mild hypotension [11] b) mild sedation [11] c) increased risk of stroke in elderly ? d) increased risk of parkinsonism (case of 58 yo woman) NEJM [16] 12) impulse control disorder - pathologic gambling, binge eating, compulsive shopping, & impulsive sexual behavior [14] 13) black box warning [11] a) increased risk of hyperglycemia b) increased risk of cerebrovascular events c) increased risk of mortality in patients with dementia * change aripiprazole to lamotrigine (NEJM) [16] Mechanism of action: 1) "dopamine system stabilizer" 2) partial dopamine D2 receptor agonist 3) partial serotonin receptor 5-HT1A & 5-HT2A agonist [16] Notes: - generic FDA-approced April 2015 - aripiprazole wth an ingestible sensor embedded (Abilify MyCite) digitally records whether & when the medication is taken FDA-approved Nov 2017 [15] - ingestible sensor transmits a message to a patch worn by the patient - the patch then sends the information to a mobile device [15] - not been shown to improve patient compliance

Interactions

drug interactions drug adverse effects (more general classes) monitor with atypical antipsychotic agents

Specific

aripiprazole parenteral; aripiprazole lauroxil (Aristada)

General

atypical antipsychotic agent; second generation antipsychotic piperazine

Database Correlations

PUBCHEM cid=60795

References

  1. Prescriber's Letter 9(12):69 2002
  2. Prescriber's Letter 10(11):62 2003
  3. Prescriber's Letter 12(9): 2005 Role of atypical antipsychotics in treating patients with Schizophrenia: Are they better than older agents? Detail-Document#: 211107 (subscription needed) http://www.prescribersletter.com
  4. Prescriber's Letter 15(1): 2008 Treatment-Resistant Depression Detail-Document#: 240103 (subscription needed) http://www.prescribersletter.com
  5. http://www.fda.gov/cder/consumerinfo/druginfo/abilify.htm
  6. http://www.abilify.com
  7. Department of Veterans Affairs, VA National Formulary - restricted to psychiatry
  8. Correll CU et al Cardiometabolic Risk of Second-Generation Antipsychotic Medications During First-Time Use in Children and Adolescents JAMA. 2009;302(16):1765-1773 PMID: 19861668 http://jama.ama-assn.org/cgi/content/short/302/16/1765 - Varley CK & McClellan J Implications of Marked Weight Gain Associated With Atypical Antipsychotic Medications in Children and Adolescents JAMA. 2009;302(16):1811-1812 PMID: 19861677 http://jama.ama-assn.org/cgi/content/short/302/16/1811
  9. Prescriber's Letter 17(1): 2010 Atypical Antipsychotics in Kids Detail-Document#: 260102 (subscription needed) http://www.prescribersletter.com
  10. Deprecated Reference
  11. Geriatric Review Syllabus, 8th edition (GRS8) Durso SC and Sullivan GN (eds) American Geriatrics Society, 2013
  12. FDA News Release. April 28, 2015 FDA approves first generic Abilify to treat mental illnesses. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444862.htm
  13. Lenze EJ et al Efficacy, safety, and tolerability of augmentation pharmacotherapy with aripiprazole for treatment-resistant depression in late life: a randomised, double-blind, placebo- controlled trial. Lancet. Published Online: 27 September 2015 PMID: 26423182 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2900308-6/abstract - Thomas A, O'Brien JT Management of late-life depression: a major leap forward. Lancet. Published Online: 27 September 2015 PMID: 26423179 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2900304-9/abstract
  14. FDA Safety Watch. May 3, 2016 Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm498823.htm
  15. Brooks M FDA Clears Drug With Ingestible Digital Tracker. Medscape - Nov 14, 2017. https://www.medscape.com/viewarticle/888586
  16. NEJM Knowledge+ Neurology
  17. HIGHLIGHTS OF PRESCRIBING INFORMATION ABILIFY (aripiprazole) Tablets https://www.otsuka-us.com/sites/g/files/qhldwo3916/files/media/static/Abilify-PI.pdf