Methods of treatment

Abstract

The present disclosure provides for methods of treating a patient with a CYP3A4 substrate drug contraindicated for concomitant administration with a strong CYP3A4 inhibitor, wherein the patient is treated with multiple doses of posaconazole, stops posaconazole treatment, and then is treated with the CYP3A4 substrate drug. In some embodiments, treatment with the CYP3A4 substrate drug is delayed for about 2-21 after stopping posaconazole. In some embodiments, the patient is treated with or prescribed a reduced dose of the CYP3A4 substrate drug for about 2-21 after stopping posaconazole.

1 . A method of treating a patient for a condition selected from schizophrenia or bipolar depression with lurasidone, wherein the patient is treated with posaconazole, comprising:
 (a) stopping posaconazole treatment;   (b) delaying administering a first dose of lurasidone ranging from 20 mg to 120 mg until:
 (i) at least 9 days after stopping posaconazole in step (a), and 
 (ii) said administering the first dose of lurasidone provides an AUC ranging from 105% to 216% of the normal baseline AUC of lurasidone. 
   
     
     
         2 . The method of  claim 1 , wherein the first dose of lurasidone is 20 mg. 
     
     
         3 . The method of  claim 1 , wherein the first dose of lurasidone is 40 mg. 
     
     
         4 . The method of  claim 1 , wherein the first dose of lurasidone is 60 mg. 
     
     
         5 . The method of  claim 1 , wherein the first dose of lurasidone is 80 mg. 
     
     
         6 . The method of  claim 1 , wherein the first dose of lurasidone is 120 mg. 
     
     
         7 . The method of  claim 1 , wherein the patient is not obese. 
     
     
         8 . The method of  claim 1 , wherein the patient has at least one characteristic selected from the group consisting of the following:
 i) BMI of at least about 35;   ii) waist size greater than about 42 inches;   iii) % body fat greater than about 40%;   iv) total body fat greater than about 40 kg, and;   v) medically diagnosed as obese.   
     
     
         9 . The method of  claim 1 , wherein the schizophrenia is schizophrenia in adults and adolescents (13 to 17 years); and the bipolar depression is depressive episodes associated with Bipolar I Disorder in adults, as monotherapy or as adjunctive therapy with lithium or valproate. 
     
     
         10 . The method of  claim 1 , wherein said administering in step (b) is 9-21 days after stopping posaconazole in step (a). 
     
     
         11 . The method of  claim 1 , wherein said administering in step (b) is 9 days after stopping posaconazole in step (a). 
     
     
         12 . The method of  claim 1 , wherein said administering in step (b) is 10 days after stopping posaconazole in step (a). 
     
     
         13 . The method of  claim 1 , wherein said administering in step (b) is 11 days after stopping posaconazole in step (a). 
     
     
         14 . The method of  claim 1 , wherein said administering in step (b) is 12 days after stopping posaconazole in step (a). 
     
     
         15 . The method of  claim 1 , wherein said administering in step (b) is 13 days after stopping posaconazole in step (a). 
     
     
         16 . The method of  claim 1 , wherein said administering in step (b) is 14 days after stopping posaconazole in step (a).