For your appropriate adult patients living with schizophrenia or for maintenance monotherapy treatment of bipolar I disorder

Extend support to two months with dual-indicated ABILIFY ASIMTUFII® (aripiprazole)


ABILIFY ASIMTUFII provides the stability*† you know from ABILIFY MAINTENA® (aripiprazole) for adult patients who are stable on an oral antipsychotic or on ABILIFY MAINTENA.

For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ABILIFY ASIMTUFII. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. For more information, see Dosing & Administration in prescribing information.

Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.


The efficacy of ABILIFY ASIMTUFII is based on the adequate and well-controlled studies of ABILIFY MAINTENA in the treatment of schizophrenia and maintenance monotherapy treatment of bipolar I disorder in adults.


The long-term efficacy of ABILIFY MAINTENA was established in two pivotal trials

  • A 52-week randomized study (N=403) of adults living with schizophrenia1
  • A 52-week randomized withdrawal study (N=266) of adults living with bipolar I disorder2

The aripiprazole concentrations of ABILIFY ASIMTUFII were explored in a pharmacokinetic bridging study, which was a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter study (N=266) in patients living with schizophrenia or bipolar I disorder3

Primary objectives included3:

  • To establish the similarity of aripiprazole plasma concentrations and exposure following ABILIFY ASIMTUFII and ABILIFY MAINTENA administration
  • To establish the safety and tolerability of multiple-dose administrations of ABILIFY ASIMTUFII

Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with oral aripiprazole.

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Pharmacokinetic bridging study


The plasma aripiprazole concentrations of ABILIFY ASIMTUFII were evaluated in an open-label, multiple-dose, randomized, parallel-arm pharmacokinetic bridging study

*In a 52-week randomized study (N=403; P<0.0001), ABILIFY MAINTENA has been proven to delay time to relapse in adults living with schizophrenia.1

In a 52-week multiphase study (N=266; P<0.0001), ABILIFY MAINTENA has been proven as a maintenance treatment to delay time to recurrence of any mood disorder in adults living with bipolar I disorder.2

In a 32-week, open-label study (N=266), ABILIFY ASIMTUFII provided comparable concentrations, and thus comparable efficacy, to ABILIFY MAINTENA.3