Method of providing aripiprazole to patients having impaired cyp2d6 or cyp3a4 enzyme function

Abstract

The disclosed embodiments relate to methods of initiating aripiprazole treatment in a patient who is a CYP2D6 poor metabolizer or a CYP3A4 poor metabolizer, or both.

1 - 20 . (canceled) 
     
     
         21 . A method of dosing a patient with schizophrenia or bipolar disorder comprising:
 adjusting a starting dose of a long-acting aripiprazole formulation in view of the patient's impaired CYP2D6, CYP3A4, or CYP2D6 and CYP3A4 enzyme function; and   administering intramuscularly the starting dose of aripiprazole to the patient.   
     
     
         22 . The method according to  claim 21 , further comprising co-administering to the patient an oral anti-psychotic after the starting dose of aripiprazole. 
     
     
         23 . The method according to  claim 21 , wherein the starting dose of aripiprazole is 300 mg expressed as an equivalent weight of aripiprazole and the patient's impaired enzyme function is a CYP2D6 poor metabolizer or a CYP3A4 poor metabolizer. 
     
     
         24 . The method according to  claim 21 , wherein the starting dose of aripiprazole is 200 mg expressed as an equivalent weight of aripiprazole and the patient's impaired enzyme function is a CYP2D6 poor metabolizer or a CYP3A4 poor metabolizer and the patient is concomitantly administered a strong CYP2D6 or CYP3A4 inhibitor. 
     
     
         25 . The method according to  claim 21 , wherein the starting dose of aripiprazole is 300 mg or 200 mg expressed as an equivalent weight of aripiprazole and the patient's impaired enzyme function is a CYP2D6 or a CYP3A4 extensive metabolizer and the patient is concomitantly administered a strong CYP2D6 or CYP3A4 inhibitor. 
     
     
         26 . The method according to  claim 21 , wherein the starting dose of aripiprazole is 200 mg or 160 mg, expressed as an equivalent weight of aripiprazole and the patient's impaired enzyme function is a CYP2D6 or a CYP3A4 extensive metabolizer and the patient is concomitantly administered both a strong CYP2D6 and a strong CYP3A4 inhibitor. 
     
     
         27 . A method of treating schizophrenia or bipolar mania in a patient in need thereof comprising:
 administering, intramuscularly, a long-acting aripiprazole formulation to the patient,   wherein the patient has impaired CYP2D6, CYP3A4, or CYP2D6 and CYP3A4 enzyme function, and   wherein the formulation is in a suspension form, and the formulation comprises a starting dose of aripiprazole, a solvent for injection, and a vehicle for aripiprazole.   
     
     
         28 . The method according to  claim 27 , wherein the vehicle for aripiprazole comprises one or more of at least one suspending agent, at least one bulking agent, at least one buffer, and at least one pH adjusting agent. 
     
     
         29 . A method of maintaining therapeutic levels of aripiprazole in a patient with impaired CYP2D6, CYP3A4, or CYP2D6 and CYP3A4 enzyme function, comprising:
 adjusting a starting dose of a long-acting aripiprazole formulation in view of the patient's impaired enzyme function; and   administering, intramuscularly, the aripiprazole formulation to the patient,   wherein the formulation is in a suspension form, and the formulation comprises the starting dose of aripiprazole, a solvent for injection, and a vehicle for aripiprazole, and   wherein the aripiprazole formulation systemically releases therapeutic plasma levels of aripiprazole over a period of about one month to the patient.   
     
     
         30 . The method according to  claim 29 , wherein the patient is schizophrenic, aripiprazole naïve, or both schizophrenic and aripiprazole naïve. 
     
     
         31 . The method according to  claim 29 , further comprising co-administering an oral antipsychotic after administration of the aripiprazole formulation. 
     
     
         32 . A method of minimizing extrapyramidal side effects in a patient with schizophrenia or bipolar mania comprising:
 adjusting a starting dose of a long-acting aripiprazole formulation in view of the patient's impaired CYP2D6, CYP3A4, or CYP2D6 and CYP3A4 enzyme function; and   administering, intramuscularly, the aripiprazole formulation to the patient,   wherein the formulation is in a suspension form, and the formulation comprises the starting dose of aripiprazole, a solvent for injection, and a vehicle for aripiprazole, and   wherein the aripiprazole formulation systemically releases therapeutic plasma levels of aripiprazole over a period of about one month to the patient.   
     
     
         33 . The method according to  claim 32 , wherein the extrapyramidal side effect is tardive dyskinesia.