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MICROMEDEX® Healthcare Series : Document Page 1 of 33 Case 3:09-Cv-00080-TMB Document 78-18 Filed 03/24/2010 Page 44 of 205 MICROMEDEX®Case 3:09-cv-00080-TMB Healthcare Series :Document Document 78-18 Filed 03/24/2010 Page 1 ofPa 205ge 1 of 43 DRUGDEX® Evaluations ARIPIPRAZOLE 0.0 Overview 1) Class a) This drug is a member of the following class(es): Antipsychotic 2) Dosing Information a) Adult 1) oral solution may be substituted for the tablet dosages on a mg-per-mg basis for up to a 25 mg dose; patients oral solution (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM injection, 2008) a) Bipolar disorder - Psychomotor agitation 1) initial, 9.75 mg IM (dose range 5.25 mg to 15 mg); cumulative doses up to a total of 30 mg/day may b dose required, wait at least 2 h after initial dose; for ongoing therapy, oral aripiprazole in a range of 10 m injection as soon as possible (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM b) Bipolar I disorder, Adjunctive therapy with lithium or valproate for acute manic or mixed episodes 1) initial and target dose, 15 mg ORALLY once a day; may increase to MAX dose of 30 mg ORALLY on solution, orally disintegrating tablets, IM injection, 2008) c) Bipolar I disorder, Monotherapy, manic or mixed episodes 1) initial and target dose, 15 mg ORALLY once a day; may increase up to MAX dose of 30 mg ORALLY solution, orally disintegrating tablets, IM injection, 2008) d) Major depressive disorder, Adjunctive treatment in patients also receiving antidepressants 1) initial, 2 mg to 5 mg ORALLY once daily; dose adjust in up to 5 mg/day increments at intervals of 1 we (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM injection, 2008) e) Psychomotor agitation - Schizophrenia 1) initial, 9.75 mg IM (dose range 5.25 mg to 15 mg); cumulative doses up to a total of 30 mg/day may b dose required, wait at least 2 hr after initial dose; for ongoing therapy, oral aripiprazole in a range of 10 m injection as soon as possible (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM f) Schizophrenia 1) initial, 10 to 15 mg ORALLY once daily (Prod Info ABILIFY(R) oral tablets, solution, orally disintegratin 2) maintenance, MAX daily dosage is 30 mg/day ORALLY; increase dose only after 2 weeks at each do greater with doses higher than 10 to 15 mg/day (Prod Info ABILIFY(R) oral tablets, solution, orally disinte b) Pediatric 1) safety and efficacy not established in pediatric patients with major depressive disorder or agitation associated less than 13 years of age with schizophrenia, or patients less than age 10 years with bipolar I disorder (Prod Info A disintegrating tablets, IM injection, 2008) 2) oral solution may be substituted for the tablet dosages on a mg-per-mg basis for up to a 25 mg dose; patients oral solution (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM injection, 2008) a) Bipolar I disorder, Monotherapy, manic or mixed episodes 1) 10 yr and older, oral tablets, initial, 2 mg ORALLY once a day for 2 days, then 5 mg ORALLY once a ORALLY once a day; MAX dose 30 mg ORALLY once a day, titrated in 5 mg per day increments (Prod I disintegrating tablets, IM injection, 2008) b) Schizophrenia 1) initial, oral tablets, 2 mg ORALLY once daily; increase to 5 mg after 2 days and to 10 mg (target dose mg; efficacy not greater at 30 mg/day compared to 10 mg/day (Prod Info ABILIFY(R) oral tablets, solutio 2008) 3) Contraindications a) hypersensitivity to aripiprazole or any component of the product (Prod Info ABILIFY(R) oral tablets, oral solution, IM disintegrating tablets, 2008) 4) Serious Adverse Effects a) At risk for suicide b) Cerebrovascular accident c) Death d) Diabetic ketoacidosis e) Immune hypersensitivity reaction f) Leukopenia g) Neuroleptic malignant syndrome h) Prolonged QT interval i) Seizure j) Suicidal behavior k) Tardive dyskinesia l) Transient ischemic attack 5) Clinical Applications a) FDA Approved Indications Exhibit E.1, page 1 http://www.thomsonhc.com/hcs/librarian/PFDefaultActionId/pf.PrintReady 7/1/2009 MICROMEDEX®Case 3:09-cv-00080-TMB Healthcare Series :Document Document 78-18 Filed 03/24/2010 Page 2 ofPa 205ge 2 of 43 1) Bipolar disorder - Psychomotor agitation 2) Bipolar I disorder, Adjunctive therapy with lithium or valproate for acute manic or mixed episodes 3) Bipolar I disorder, Monotherapy, manic or mixed episodes 4) Major depressive disorder, Adjunctive treatment in patients also receiving antidepressants 5) Psychomotor agitation - Schizophrenia 6) Schizophrenia 1.0 Dosing Information Drug Properties Storage and Stability Adult Dosage Pediatric Dosage 1.1 Drug Properties A) Information on specific products and dosage forms can be obtained by referring to the Tradename List (Product Ind B) Synonyms Aripiprazole C) Physicochemical Properties 1) Molecular Weight a) 448.38 (Prod Info Abilify™, 2002) 1.2 Storage and Stability A) Preparation 1) Intramuscular route a) Aripiprazole should not be injected by intravenous or subcutaneous injection. It should only be used intram muscle mass. The required volumes of solution for a dose of 5.25 milligrams (mg), 9.75 mg, and 15 mg are 0 respectively. Discard any unused portion of the injection (Prod Info ABILIFY(R) oral tablets, solution, orally di 2) Oral route a) Aripiprazole may be taken without regard to meals (Prod Info ABILIFY(R) oral tablets, solution, orally disin B) Oral route 1) Solution a) Aripiprazole oral solution should be stored at 25 degrees Celsius (77 degrees Fahrenheit) with excursions Celsius (59 and 86 degrees Fahrenheit). The oral solution should be used within 6 months after opening, but (Prod Info ABILIFY(R) oral tablets, disintegrating tablets, solution, 2006). 2) Tablet/Tablet, Disintegrating a) Aripiprazole tablets should be stored at 25 degrees Celsius (77 degrees Fahrenheit) with excursions perm to 86 degrees Fahrenheit) (Prod Info ABILIFY(R) oral tablets, disintegrating tablets, solution, 2006). 1.3 Adult Dosage Normal Dosage Dosage in Renal Failure Dosage in Hepatic Insufficiency Dosage in Geriatric Patients 1.3.1 Normal Dosage Intramuscular route Oral route 1.3.1.A Intramuscular route Exhibit E.1, page 2 http://www.thomsonhc.com/hcs/librarian/PFDefaultActionId/pf.PrintReady 7/1/2009 MICROMEDEX®Case 3:09-cv-00080-TMB Healthcare Series :Document Document 78-18 Filed 03/24/2010 Page 3 ofPa 205ge 3 of 43 Bipolar disorder - Psychomotor agitation Psychomotor agitation - Schizophrenia 1.3.1.A.1 Bipolar disorder - Psychomotor agitation a) The recommended dose to control agitation in patients with schizophrenia or bipolar mania is 9.75 mi 5.25 mg to 15 mg). No additional benefit was observed after a 15 mg dose compared to a 9.75 mg dose. day may be administered if a second dose is required. However, the efficacy of repeated doses in agitate evaluated in clinical trials. Additionally, the safety of total daily doses greater than 30 mg or injections adm have not been adequately evaluated. For ongoing therapy, oral aripiprazole in a range of 10 mg to 30 mg as soon as possible (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM injection b) Concomitant CYP3A4 Inhibitors 1) The dosage of aripiprazole should be reduced to one-half the usual dose when administered con as ketoconazole or clarithromycin. When the CYP3A4 inhibitor is discontinued, the aripiprazole dose oral tablets, solution, orally disintegrating tablets, IM injection, 2008). c) Concomitant CYP3A4 Inducers 1) The dosage of aripiprazole should be doubled when administered concurrently with a potential C dose may be further increased if needed based on clinical evaluation. When the CYP3A4 inducer is reduced to 10 to 15 mg (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM i d) Concomitant CYP2D6 Inhibitors 1) The dosage of aripiprazole should be reduced to at least one-half the usual dose when administe inhibitors, such as quinidine, fluoxetine, or paroxetine. When the CYP2D6 inhibitor is discontinued fr dose should be increased (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM 1.3.1.A.2 Psychomotor agitation - Schizophrenia a) The recommended dose to control agitation in patients with schizophrenia is 9.75 milligrams (mg) intr No additional benefit was observed after a 15 mg dose compared to a 9.75 mg dose. Cumulative doses administered if a second dose is required. However, the efficacy of repeated doses in agitated patients h clinical trials. Additionally, the safety of total daily doses greater than 30 mg or injections administered mo been adequately evaluated. For ongoing therapy, oral aripiprazole in a range of 10 mg to 30 mg/day sho possible (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM injection, 2008). b) Concomitant CYP3A4 Inhibitors 1) The dosage of aripiprazole should be reduced to one-half the usual dose when administered con as ketoconazole or clarithromycin. When the CYP3A4 inhibitor is discontinued, the aripiprazole dose oral tablets, solution, orally disintegrating tablets, IM injection, 2008). c) Concomitant CYP3A4 Inducers 1) The dosage of aripiprazole should be doubled when administered concurrently with a potential C dose may be further increased if needed based on clinical evaluation. When the CYP3A4 inducer is reduced to 10 to 15 mg (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM i d) Concomitant CYP2D6 Inhibitors 1) The dosage of aripiprazole should be reduced to at least one-half the usual dose when administe inhibitors, such as quinidine, fluoxetine, or paroxetine. When the CYP2D6 inhibitor is discontinued fr dose should be increased (Prod Info ABILIFY(R) oral tablets, solution, orally disintegrating tablets, IM 1.3.1.B Oral route Bipolar I disorder, Adjunctive therapy with lithium or valproate for acute manic or mixed episodes Bipolar I disorder, Monotherapy, manic or mixed episodes Major depressive disorder, Adjunctive treatment in patients also receiving antidepressants Schizophrenia 1.3.1.B.1 Bipolar I disorder, Adjunctive therapy with lithium or valproate for acute manic or mixed ep a) As adjunctive therapy with lithium or valproate, the recommended initial and target dose is aripiprazol Depending on clinical response, the dose may be increased to 30 mg orally once a day.
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