APPLYING ANTIPSYCHOTIC PHARMACOKINETICS TO BEST DOSING PRACTICES: DEPOT MEDICATIONS
|
|
- Silvester Moody
- 5 years ago
- Views:
Transcription
1 APPLYING ANTIPSYCHOTIC PHARMACOKINETICS TO BEST DOSING PRACTICES: DEPOT MEDICATIONS
2 Objectives Review the kinetic parameters of depot antipsychotics Review loading strategies for those depot medications which can be loaded Describe how knowledge of plasma antipsychotic data can inform appropriate use of depot medications
3 The Value of Antipsychotic Plasma Levels
4 Concepts a. Plasma levels and not dose are the best predictors of antipsychotic response P450 genetics of patients are usually unknown Some patients are nonadherent Many patients receive concurrent medications that are P450 or PGP inhibitors or inducers b. Clinical studies provide one source of plasma level/response relationships c. For newer antipsychotics, PET scans provide data on plasma level thresholds to achieve 80% D 2 blockade
5 D 2 Antagonist: Receptor Occupancy Sweet Spot: 60%-80% Kapur S and Seeman P. Does fast dissociation from the dopamine D2 receptor explain the action of atypical antipsychotics? - A New Hypothesis. Am J Psych 2001;158(3):
6 D 2 Partial Antagonist: Receptor Occupancy Sweet Spot: 85%-100% Mamo D, et al. Differential Effects of Aripiprazole on D2, 5-HT2, and 5-HT1A Receptor Occupancy in Patients With Schizophrenia: A Triple Tracer PET Study. Am J Psych 2007;164(9):
7 Response and Tolerability Threshold Levels Data From Clinical Studies Data From Imaging Studies Response Threshold (ng/ml) Tolerability threshold (ng/ml) Level associated with 60% D 2 occupancy Level associated with 80% D 2 occupancy Haloperidol Fluphenazine ???? Risperidone + 9-OH Risperidone???? ~ 17 ng/ml Olanzapine ~ 20 ng/ml Clozapine 350? ???? Meyer JM. A rational approach to employing high plasma levels of antipsychotics for violence associated with schizophrenia: case vignettes. CNS Spectrums 2014;19(5):
8 Levels and Adherence Clinicians grossly underestimate medication nonadherence. Using 70% as the threshold for medication adherence, 57% of chronic schizophrenia patients are nonadherent using MEMS cap technology, patient self-report is 5%, and physician estimate 7%. 1 Many patients characterized as treatment resistant have subtherapeutic plasma levels. 2 "The purpose of the present study was to determine the extent of subtherapeutic antipsychotic plasma levels in a group of patients clinically identified as treatment-resistant. Antipsychotic plasma levels were measured in 36 patients identified as having treatmentresistant schizophrenia by their treating clinicians. Sixteen (44%) patients showed either undetectable (19%) or subtherapeutic levels (25%), and 20 (56%) patients had levels in the therapeutic range." 1. Byerly M, et al. Psychiatric Services 2007;58: McCutcheon R., et al. Journal of Psychopharmacology 2015;29(8)
9 Oral Dose-Plasma Level Relationships Meyer JM, et al. Psychopharmacology of Persistent Violence and Aggression. Psych Clin N Am 2016;39(4): Aripiprazole Clozapine Haloperidol Concentration (ng/ml) = 12 x oral dose (mg/d) Aripiprazole/Dehydroaripiprazole Ratio: 4.4 (range ) Aripiprazole Dehydroaripiprazole 10 mg/d -> 126 ± 78 ng/ml 35 ± 4 ng/ml 20 mg/d -> 230 ± 193 ng/ml 46 ± 37 ng/ml 30 mg/d -> 400 ± 236 ng/ml 83 ± 18 ng/ml 40 year old male, 80 kg, clozapine/norclozapine ratio of 1.32 Concentration (ng/ml) = 1.08 x oral dose (mg/d) Concentration (ng/ml) = 0.67 x oral dose (mg/d) 325 mg -> 350 ng/ml (nonsmokers) 525 mg -> 350 ng/ml (smokers) (nonsmokers) (smokers) 40 year old female, 70 kg, clozapine/norclozapine ratio of 1.32 Concentration (ng/ml) = 1.32 x oral dose (mg/d) Concentration (ng/ml) = 0.80 x oral dose (mg/d) 265 mg -> 350 ng/ml (nonsmokers) 435 mg -> 350 ng/ml (smokers) Concentration (ng/ml) = 0.78 x oral dose (mg/d) 2 mg/d -> 1.57 ± 1.42 ng/ml 10 mg/d -> 7.79 ± 4.79 ng/ml (nonsmokers) (smokers)
10 Oral Dose-Plasma Level Relationships Fluphenazine Concentration (ng/ml) = 0.08 x oral dose (mg/d) Concentration (ng/ml) = 0.04 x oral dose (mg/d) (nonsmokers) (smokers) 22.9 mg -> 1.83 ± 0.94 ng/ml (nonsmokers) 20.4 mg -> 0.89 ± 0.43 ng/ml (smokers) Olanzapine Concentration (ng/ml) = 2.00 x oral dose (mg/d) Concentration (ng/ml) = 1.43 x oral dose (mg/d) 10 mg -> 20 ng/ml (nonsmokers) 14 mg -> 20 ng/ml (smokers) (nonsmokers) (smokers) Meyer JM, et al. Psychopharmacology of Persistent Violence and Aggression. Psych Clin N Am 2016;39(4): Risperidone + 9-OH Risperidone (active moiety) Active Moiety Concentration (ng/ml) = 7.00 x oral dose (mg/d) Risp/9-OH Risp Ratio: 0.2 (range ) 2 mg/d -> C/D Ratio = mg/d -> C/D Ratio = mg/d -> C/D Ratio = mg/d -> C/D Ratio = 6.95
11 Preparation Diluent Loaded Fluphenazine Decanoate Haloperidol Decanoate Aripiprazole Monohydrate Aripiprazole Lauroxil Preparations and Basic Kinetics Oral Supplementation Dosage T max (days) Steady State T 1/2 (days) Sesame Oil Yes mg/2 weeks Sesame Oil Yes mg/4 weeks Water No 14 days mg/4 weeks Water No 21 days mg/4 weeks 882 mg/6 weeks 1064 mg/2 months Olanzapine Pamoate Water Yes mg/2 weeks OR mg/4 weeks 7 30 Paliperidone Palmitate Paliperidone Palmitate 3-month Risperidone Microspheres Water Yes mg/4 weeks Water No mg/12 weeks (deltoid) (gluteal) Water No 21 days mg/2 weeks
12 Haloperidol and Fluphenazine Decanoate
13 US FDA Approval: 01/14/1986 Haloperidol Decanoate
14 Oral Haloperidol Concentration/Dose Relationships Mean Plasma Level (ng/ml) SD 2 mg mg mg mg mg Kapur S, et al. The relationship between D2 receptor occupancy and plasma levels on low dose oral haloperidol: a PET study. Psychopharmacology 1997;131: Van Putten T, et al. Neuroleptic Plasma Levels. Schiz Bulletin 1991;17(2): Wei FC, et al. A practical loading dose method for converting schizophrenic patients from oral to depot haloperidol therapy. The Journal of Clinical Psychiatry. 1996;57:
15 D 2 Occupancy vs. Plasma Haloperidol Level D 2 Receptor Occupancy nmol/l ng/ml Regenthal R, et al. Haloperidol serum concentrations and D2 dopamine receptor occupancy during low-dose treatment with haloperidol decanoate. Int Clin Psychopharmacol 1997;12(5):
16 Global Improvement at the End of a Fixed Dose Haloperidol Study (n = 68) Plasma Level Range Mean Plasma Level (ng/ml) ± SD Very much improved or much improved on the CGI scale % Improved < 2 ng/ml 1.3 ± out of 11 9% 2-5 ng/ml 3.2 ± out of 14 43% 5-12 ng/ml 8.2 ± out of 30 73% > 12 ng/ml 15.2 ± out of 13 39% Midha KK, et al. Impact of clinical pharmacokinetics on neuroleptic therapy in patients with schizophrenia. J Psychiatr Neurosci 1994;19(4):
17 Probability of Adverse Effects by Plasma Haloperidol Level Midha KK, et al. Impact of clinical pharmacokinetics on neuroleptic therapy in patients with schizophrenia. J Psychiatr Neurosci 1994;19(4):
18 Typical Depots Basic Kinetics Drug Vehicle Dosage T max (days) T 1/2 (days) Single Dose T 1/2 (days) Multiple Dose Fluphenazine decanoate Sesame Oil mg/ 2-6 weeks Haloperidol decanoate Sesame Oil mg/ 4 weeks 3-9? 21 Davis JM, et al. Depot antipsychotic drugs: place in therapy. Drugs 1994;47(5):
19 Haloperidol Dec 100 mg: Single Dose Kinetics Chang W-H, et al. Disposition of haloperidol and reduced haloperidol plasma levels after single dose haloperidol decanoate administration. Human Psychopharmacol 1995;10(1):47-51.
20 Haloperidol Decanoate: Conversion from Oral Studies using 10, 20, or 30 times the oral daily dose have been performed 20 times the oral daily dose FOR MONTHLY MAINTENANCE provided optimum plasma concentrations DURING THE EARLY PHASE OF TREATMENT Oral haloperidol bioavailability is 65% (range 60-70%) Example: pt on 10 mg/day x 30 days x 65% = 195 mg/month ~ 20 x oral daily dose Over time, may be able to decrease the maintenance dose once steady state is reached based on plasma level monitoring Jann et al. Clinical pharmacokinetics of the depot antipsychotics. Clin Pharmacokinetics 1985;10:
21 100 mg Loading Study: 100 mg weekly x 4, 100 mg at weeks 6, 8, then 100 mg every 4 weeks starting wk 12 Weekly 100 mg IM x 4 Dose decreased to 100 mg IM monthly Oral Stopped, 1 st Weekly 100 mg Injection Given Jann MW, Wei FC, Lin HN, et al. Haloperidol and reduced haloperidol plasma concentrations after a loading dose regimen with haloperidol decanoate. Prog Neuropsychopharmacol Biol Psychiatry. 1996;20:73-86.
22 Haloperidol Dec Loading Study: Implications mg loaded weekly for 4 wks provides coverage equal to 10 mg/d; however, need oral coverage of 5 mg during the first 1-2 weeks to maintain levels comparable to 10 mg/d before the first injection Depending on patient acuity, one could opt to skip supplemental medication during the first week, or, if agitated/violent, give 5 mg/d PO or IM for 7 days after the first depot injection 2. If the patient requires 10 mg oral/d, the maintenance dose of 200 mg/4 wks should start 2 weeks after the 3rd weekly loading injection of 100 mg to achieve comparable plasma levels Jann MW, Wei FC, Lin HN, et al. Haloperidol and reduced haloperidol plasma concentrations after a loading dose regimen with haloperidol decanoate. Prog Neuropsychopharmacol Biol Psychiatry. 1996;20:73-86.
23 Haloperidol Dec Loading Study: Example A pt with schizophrenia refuses oral medications and is violent. He is loaded with haloperidol decanoate 200 mg IM weekly over 3 weeks with excellent response and no adverse effects. Question 1: What is the maintenance dose for this patient? Answer: Based on the long-term data from the Jann 1996 study, the maintenance dose is 2x the weekly loading dose. For this pt, it will be 400 mg. Since injections of > 3 cc (300 mg) are not tolerated, the monthly dose will be given as 200 mg IM every 2 weeks. Question 2: When is the maintenance dose started? Answer: Based on the kinetic data from the Jann 1996 study, the maintenance dose should start 2 weeks after the last loading injection. Jann MW, Wei FC, Lin HN, et al. Haloperidol and reduced haloperidol plasma concentrations after a loading dose regimen with haloperidol decanoate. Prog Neuropsychopharmacol Biol Psychiatry. 1996;20:73-86.
24 US FDA Approval: 06/20/1972 Fluphenazine Decanoate
25 Typical Depots Basic Kinetics Drug Vehicle Dosage T max (days) T 1/2 (days) Single Dose T 1/2 (days) Multiple Dose Fluphenazine decanoate Sesame Oil mg/ 2-6 weeks Haloperidol decanoate Sesame Oil mg/ 4 weeks 3-9? 21 Davis JM, et al. Depot antipsychotic drugs: place in therapy. Drugs 1994;47(5):
26 Fluphenazine Levels and D 2 Occupancy Plasma Fluphenazine Level Striatal Occupancy 2.23 ng/ml 1 89% 4.4 ng/ml 2 92% R, 100% L 5.2 ng/ml 2 100% R, 97% L 6.13 ng/ml 1 91% 7.88 ng/ml 1 92% ng/ml 1 96% ng/ml 1 97% 1. Nyberg S et al. D(2) and 5-HT(2) receptor occupancy in high-dose neuroleptic-treated patients. IJNP 1998;1: Coppens HJ et al. High central D2-dopamine receptor occupancy as assessed with positron emission tomography in medicated but therapy-resistant schizophrenic patients. Biol Psychiatry 1991;29:
27 Probability Curves of Response and Disabling Side Effects by Plasma Fluphenazine Level Improvement Disabling side effects Response Threshold Van Putten T. Impact of clinical pharmacokinetics on neuroleptic therapy in patients with schizophrenia. J Psychiatr Neurosci 1994;19(4):
28 Fluphenazine Decanoate: Single-Dose Pharmacokinetics Ereshefsky L, Saklad SR, Jann MW. Future of depot neuroleptic therapy: pharmacokinetic and pharmacodynamic approaches. J Clin Psychiatry 1984;45 (suppl):50-58.
29 Loading Fluphenazine Decanoate: Levels on 50 mg/week Jann et al. Clinical pharmacokinetics of the depot antipsychotics. Clin Pharmacokinetics 1985;10:
30 Fluphenazine Decanoate: Chronic Dosing (25 mg/2 wks) Marder SR. Plasma levels of fluphenazine in patients receiving fluphenazine decanoate. Relationship to clinical response. Br J Psych 1991;158:
31 Risperidone Microspheres and Paliperidone Palmitate
32 General Comments on Consta, Sustenna, Trinza Similar pharmacology for risperidone and 9-OH risperidone but very different kinetics between Consta and Sustenna Recommend that patient have a test dose of risperidone (for either Consta or Sustenna) or paliperidone (for Sustenna) if never received at any time previously Trinza (3-month injection of paliperidone palmitate) is only for those on Sustenna for at least 4 months
33 Active Moiety Plasma Levels After Single 25 mg LAI Risperidone Dose Long T Max > 3-4 weeks of oral coverage Risperidone + 9-OH Risperidone (ng/ml) mg dose, N = 14. Data on file, Janssen Pharmaceutica Products, L.P. Time (wk)
34 Paliperidone Palmitate Aqueous-based suspension of nanomolecular size crystals O O N Paliperidone palmitate N N O N O Due to its extremely low water solubility, paliperidone palmitate slowly dissolves at the injection site and is enzymatically hydrolyzed to paliperidone Kinetics determined by particle size: Smaller Particles (monthly) Half-life: days F T Max 13 days Larger Particles (3-month) Half-life: days (deltoid) T Max days days (gluteal) INVEGA SUSTENNA and TRINZA [Prescribing Information]. Titusville, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
35 Paliperidone Concentrations: Sustenna Loading 40 Median Paliperidone Plasma Conc (ng/ml) mg Deltoid injections* 156 mg mg Estimated exposure window for 6-12 mg paliperidone ER Day *Initiation doses must be administered in the deltoid muscle for those coming from oral or who are on no active medication. Deltoid absorption is 28% greater than for gluteal injection. INVEGA SUSTENNA [PI]. Titusville, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
36 Initial Sustenna Dosing Initiation dosing: from oral Maintenance doses q 4 wks Day 1 1 week later 1 month later 1 month later 234 mg Deltoid 156 mg Deltoid mg Delt or Glut mg Delt or Glut ± 2 days Flexible dosing window ± 1 week Flexible dosing window ± 1 week Flexible dosing window Initiation dosing from depot: When switching patients from long-acting injectable antipsychotics, give Sustenna in place of the next scheduled depot injection and then at monthly intervals. Dose is based on prior drug requirements. The one-week initiation dosing regimen is not required. Injection volumes are dose proportional: ml, ml, 117 mg ml, 78 mg ml, 39 mg ml INVEGA SUSTENNA [Prescribing Information]. Titusville, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
37 Trinza Dose Equivalence Stable Monthly Sustenna Dose Trinza Dose 78 mg 273 mg 117 mg 410 mg 156 mg 546 mg 234 mg 819 mg Injection of Trinza is given in lieu of next routine Sustenna dose Routine 3-month doses can be given ± 2 weeks from 3-month time INVEGA TRINZA [Prescribing Information]. Titusville, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
38 D 2 Occupancy vs. Plasma Moiety Level (Risperidone + 9-OH Risperidone) 50 mg Consta Remington G, et al. A PET study evaluating dopamine D2 receptor occupancy for long-acting injectable risperidone. Am J Psychiatry 2006;163:
39 Active Moiety Plasma Levels From High Dose Consta (Risperidone + 9-OH Risperidone) Dose 12 Wk Study 1 52 Wk Study 2 26 Wk Study 3 25 mg 18.7 ± ± mg 35.5 ± ± ± mg 44.7 ± ± mg ± Kane JM, et al. Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic. Am J Psychiatry 2003;160: Fleischhacker WW, et al. Treatment of schizophrenia with long-acting injectable risperidone: a 12-month open-label trial of the first long-acting second-generation antipsychotic. J Clin Psychiatry 2003;64: Meltzer HY, et al. A six month randomized controlled trial of long acting injectable risperidone 50 and 100mg in treatment resistant schizophrenia. Schizophr Res 2014;154: doi: /j.schres
40 D 2 Occupancy vs. Plasma 9-OH Risperidone Level 234 mg Sustenna Arakawa R, Ito H, Takano A, et al. Dose-finding study of paliperidone ER based on striatal and extrastriatal dopamine D2 receptor occupancy in patients with schizophrenia. Psychopharmacology 2008;197: Epub 2007 Dec 6.
41 Active Moiety Plasma Levels From Sustenna (9-OH Risperidone) Dose Days (N) Mean ± SD Median 25 th Percentile 75 th Percentile 39 mg 92 (n=78) 10.2 ± mg 92 (n=84) 21.0 ± mg 92 (n=88) 28.4 ± Pandina GJ, Lindenmayer JP, Lull J, et al. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol 2010;30: doi: /JCP.0b013e3181dd03.
42 Aripiprazole Monohydrate (Maintena)
43 Aripiprazole Monohydrate Approved in February 2013 Lyophilized powder of aripiprazole monohydrate crystals with mean particle size of 1 10 μm (primarily 2 4 μm) The particles are poorly soluble, resulting in slow and prolonged dissolution and absorption. Administered in aqueous suspension Oral coverage required for 14 days Dosage adjustments for 2D6 and 3A4 inhibitors Cannot be used with potent 3A4 inducers Meyer JM. CNS Spectrums 2013.
44 Aripiprazole Oral Dose and Plasma Levels Mean Plasma Level By Dose (ng/ml) Aripip Dehydro 10 mg 126 ± ± 4 20 mg 230 ± ± mg 400 ± ± 18 Sparshatt A, et al. J Clin Psych 2010; 71(11):
45 Aripiprazole Monohydrate Kinetics 400 mg dose achieves steady state levels equivalent to 20 mg oral Meyer JM. CNS Spectrums 2013.
46 Aripiprazole Monohydrate: Missed Doses If the second or third doses are missed: If more than 4 weeks and less than 5 weeks have elapsed since the last injection, administer the injection as soon as possible. If more than 5 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection. If the fourth or subsequent doses are missed: If more than 4 weeks and less than 6 weeks have elapsed since the last injection, administer the injection as soon as possible. If more than 6 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection. Maintena (Aripiprazole Monohydrate) Package Insert. Otsuka 2015
47 Maintena Dose Adjustments Patients Taking 400 mg of ABILIFY MAINTENA CYP2D6 Poor metabolizers CYP2D6 Poor metabolizers taking concomitant CYP3A4 inhibitors Patients Taking 400 mg of ABILIFY MAINTENA Strong CYP2D6 or CYP3A4 inhibitors CYP2D6 and CYP3A4 inhibitors CYP3A4 inducers Patients Taking 300 mg of ABILIFY MAINTENA Strong CYP2D6 or CYP3A4 inhibitors CYP2D6 and CYP3A4 inhibitors CYP3A4 inducers Adjusted Dose 300 mg 200 mg 300 mg 200 mg Avoid Use 200 mg 160 mg Avoid Use Maintena [Prescribing Information]. Otsuka USA
48 Aripiprazole Lauroxil (Aristada)
49 Aripiprazole Lauroxil Approved in October 2015 Lyophilized powder of aripiprazole lauroxil crystals The particles are poorly soluble, resulting in slow and prolonged dissolution and absorption. Administered as aqueous suspension. Due to long half-life, 4 week, 6 week and 8 week dosing available Oral coverage required for 21 days Different missed dose and CYP adjustment rules than Maintena Aristada (Aripiprazole Lauroxil) Package Insert. Alkermes 2017
50 Aripiprazole Lauroxil: Dosing Equivalence Oral Aripiprazole Dose ARISTADA Dose Intramuscular Site 10 mg per day 441 mg per month Deltoid or Gluteal 15 mg per day 662 mg per month 882 mg every 6 weeks 1064 mg every 2 months Gluteal 20 mg or higher per day 882 mg per month Gluteal Aristada (Aripiprazole Lauroxil) Package Insert. Alkermes 2017
51 Simulated Average Aripiprazole Concentrations The box represents the 75th and 25th percentiles, the line within each box marks the median, the whiskers indicate the 10th and 90th percentiles, and the dots represent the 5th and 95th percentiles. Hard ML, et al. Poster presented at the 16th International Congress on Schizophrenia Research, San Diego, California, March 24 28, 2017.
52 Simulated Mean Aripiprazole Concentration Time Profiles FDA Center For Drug Evaluation and Research Application Number orig1s000 Clinical Pharmacology and Biopharmaceutics Reviews for NDA #: ; Proposed Brand Name: ARISTADA; Generic Name: Aripiprazole Lauroxil
53 Aripiprazole Lauroxil: Plasma Levels After Last Dose Hard ML, et al. Poster presented at the 16th International Congress on Schizophrenia Research, San Diego, California, March 24 28, 2017.
54 Aripiprazole Lauroxil: Missed Dose Guidelines Dose of Patient s Last Injection No Oral Supplementation Required Length of Time Since Last Injection Supplement with 7 Days Oral Aripiprazole Supplement with 21 Days Oral Aripiprazole Monthly 441 mg 6 weeks > 6 and 7 weeks > 7 weeks Monthly 662 mg 8 weeks > 8 and 12 weeks > 12 weeks Monthly 882 mg 8 weeks > 8 and 12 weeks > 12 weeks 882 mg every 6 weeks 8 weeks > 8 and 12 weeks > 12 weeks 1064 mg every 2 months 10 weeks > 8 and 12 weeks > 12 weeks Aristada (Aripiprazole Lauroxil) Package Insert. Alkermes 2017
55 Aristada Dose Adjustments Concomitant Medicine Dose Change * Strong CYP3A4 Inhibitor Strong 2D6 Inhibitor Both Strong CYP3A4 and Strong 2D6 Inhibitor CYP3A4 Inducers Reduce the dose of ARISTADA to the next lower strength. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated. For patients known to be poor metabolizers of CYP2D6: Reduce dose to 441 mg from 662 mg, 882 mg, or 1064 mg. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated. Reduce the dose of ARISTADA to the next lower strength. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated. For patients known to be poor metabolizers of CYP2D6: No dose adjustment required. Avoid use for patients at 662 mg, 882 mg, or 1064 mg dose. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated. No dose adjustment for 662 mg, 882 mg, or 1064 mg dose; increase the 441 mg dose to 662 mg. * For the 882 mg dose administered every 6 weeks and the 1064 mg administered every 2 months, the next lower strength should be 441 mg administered monthly. Aristada (Aripiprazole Lauroxil) Package Insert. Alkermes 2017
56 Summary 1. Depot medications offer most schizophrenia patients their best chance at stability 2. Plasma antipsychotic levels are the best guide to the extent of patient medication exposure. Many treatment resistant patients are nonadherent or simply underdosed. Oral meds: trough levels are obtained before the morning dose, approximately 12 hours after the QHS dose Depot meds: trough levels are obtained the last few days of the injection cycle 3. Kinetics determine which agents can be loaded and the appropriate loading strategies to achieve levels comparable to the desired oral equivalents
Clinician's Guide to Prescribing Depot Antipsychotics
Handout for the Neuroscience Education Institute (NEI) online activity: Clinician's Guide to Prescribing Depot Antipsychotics Learning Objectives Explain the benefits and risks of depot antipsychotics
More informationAntipsychotic agents are the mainstay of treatment for patients
Long-acting injectable antipsychotics: What to do about missed doses Use a stepwise approach based on the unique properties of the specific medication Jasmine Carpenter, PharmD, BCPS, BCPP PACT/Mental
More informationLAI Antipsychotics Frequently Asked Questions
LAI Antipsychotics Frequently Asked Questions Click each question to see the answer. Click the link to return to this list. Who should receive LAIs (long acting injectable antipsychotics)? Which antipsychotics
More informationOral antipsychotic nonadherence is a
Risperidone extended-release injectable suspension Jonathan M. Meyer, MD Oral antipsychotic nonadherence is a significant contributor to relapse in patients with schizophrenia spectrum disorders. Long-acting
More informationDosing and Switching Strategies for Long-Acting Risperidone
Clinical Guidelines: Dosing Long-Acting Risperidone Clinical Guidelines Dosing and Switching Strategies for Long-Acting Risperidone Stephen R. Marder, M.D.; Robert Conley, M.D.; Larry Ereshefsky, Pharm.D.,
More informationRegier 1993; Kessler 2005; Stevens 2016; Parellada 206; Mohr 2012; Prajapati 2016;
Regier 1993; Kessler 2005; Stevens 2016; Parellada 206; Mohr 2012; Prajapati 2016; Miyamoto 2017 Risperdal Consta (risperidone) Zyprexa Relprevv (olanzapine pamoate) Invega Sustenna (paliperidone palmiate)
More informationGUIDELINES FOR THE USE OF ARIPIPRAZOLE LONG-ACTING INJECTION (ABILIFY MAINTENA)
GUIDELINES FOR THE USE OF ARIPIPRAZOLE LONG-ACTING INJECTION (ABILIFY MAINTENA) Introduction Aripiprazole long-acting injection (LAI)is licensed for the maintenance treatment of adult patients with schizophrenia
More informationIn February 2013, the FDA approved a
Long-acting injectable aripiprazole for adult schizophrenia Jana Lincoln, MD Depot formulation and once-monthly dosing might improve adherence in patients with schizophrenia 46 May 2013 In February 2013,
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Invega Sustenna, Invega Trinza) Reference Number: CP.PHAR.291 Effective Date: 12.01.16 Last Review Date: 08.18 Line of Business: Medicaid See Important Reminder at the end of this policy
More informationCNS SPECTRUMS. CME Review Article. Understanding depot antipsychotics: an illustrated guide to kinetics
CNS SPECTRUMS CME Review Article Understanding depot antipsychotics: an illustrated guide to kinetics This activity is sponsored by the Neuroscience Education Institute CME Information Accreditation and
More informationModel-based Approaches to Assist Clinical Development of Psychiatric Products
Model-based Approaches to Assist Clinical Development of Psychiatric Products Session Chair: Hao Zhu, Ph.D., Co-chair: Mitchell Mathis, M.D., ASCP Meeting (May, 2017) Agenda 1. Presentation Exposure-Response
More informationAbbreviated Class Review: Long-Acting Injectable Antipsychotics
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationImproving Outcomes in Schizophrenia: Long-acting Depots and Long-term Treatment
Improving Outcomes in Schizophrenia: Long-acting Depots and Long-term Treatment page 247 in syllabus Stephen M. Stahl, MD, PhD Adjunct Professor, Department of Psychiatry University of California, San
More informationPharmacy Medical Necessity Guidelines: Antipsychotic Medications
Pharmacy Medical Necessity Guidelines: Antipsychotic Medications Effective: July. 1, 2016 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Abilify Maintena, Aristada, Aristada Initio) Reference Number: CP.PHAR.290 Effective Date: 12.01.16 Last Review Date: 08.18 Line of Business: Medicaid Coding Implications Revision Log
More informationAbbreviated Class Review: Long-Acting Injectable Antipsychotics
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationClozapine Case 6: Half-Life Jose de Leon, MD
Clozapine Case 6: Half-Life 1-16-16 Jose de Leon, MD 6. Clozapine Case 6 J Clin Psychopharmacol 1996;16:193-4. http://www.ncbi.nlm.nih.gov/pubmed/8690839 Educational Objectives At the conclusion of this
More informationLong-Acting Injectable Antipsychotic Medications in Schizophrenia Management
Sanika and Aparasu: Long-Acting Injectable Antipsychotic Medications in Schizophrenia Management 3507 International Journal of Pharmaceutical Sciences and Nanotechnology Volume 9 Issue 6 November December
More informationpaliperidone palmitate 50mg, 75mg, 100mg and 150mg prolonged release suspension for injection (Xeplion) SMC No. (713/11) Janssen-Cilag Ltd
Re-Submission paliperidone palmitate 50mg, 75mg, 100mg and 150mg prolonged release suspension for injection (Xeplion) SMC No. (713/11) Janssen-Cilag Ltd 07 October 2011 The Scottish Medicines Consortium
More informationPharmacy Medical Necessity Guidelines: Antipsychotic Medications
Pharmacy Medical Necessity Guidelines: Effective: October 1, 2016 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy (RX) or Medical (MED) Benefit
More informationNew Medicines Committee Briefing November 2011
New Medicines Committee Briefing November 2011 Paliperidone long-acting injection (Xeplion ) for schizophrenia Paliperidone palmitate long-acting injection (Xeplion ) is to be reviewed for use within:
More informationLiterature Scan: Parenteral Antipsychotics
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationDEPOT ANTIPSYCHOTIC MEDICATION: GUIDELINES FOR PRESCRIBING AND ADMINISTERING
DEPOT ANTIPSYCHOTIC MEDICATION: GUIDELINES FOR PRESCRIBING AND ADMINISTERING DECEMBER 2016 This policy supersedes all previous policies Policy title Depot Antipsychotic Medication: Guidelines for Prescribing
More informationLong Acting Injectable (LAI) Atypical Antipsychotic Drugs: A Practical Guide for Nursing. Lucinda Whitney DNP, APRN, PMHNP-BC
Long Acting Injectable (LAI) Atypical Antipsychotic Drugs: A Practical Guide for Nursing Lucinda Whitney DNP, APRN, PMHNP-BC Disclosures I have no pertinent financial disclosures Information provided here
More informationAntipsychotics. Something Old, Something New, Something Used to Treat the Blues
Antipsychotics Something Old, Something New, Something Used to Treat the Blues Objectives To provide an overview of the key differences between first and second generation agents To an overview the newer
More informationNebraska Medicaid Criteria. Abilify Maintena
Nebraska Medicaid Criteria All initial and renewal authorizations are for 12 months in duration. Abilify Maintena *Criteria for Authorization for Abilify Maintena The individual has a current DSM diagnosis
More informationPharmacy Medical Necessity Guidelines: Antipsychotic Medications
Pharmacy Medical Necessity Guidelines: Effective: April 1, 2018 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy (RX) or Medical (MED) Benefit
More informationA review of the efficacy and tolerability of antipsychotic long-acting injections
A review of the efficacy and tolerability of antipsychotic long-acting injections Allison Whyte MPharm-IP, Caroline Parker FFRPS, FRPharmS, FCMHP The formulation of long-acting injections (LAIs) as a method
More informationAripiprazole Long-Acting Injection (Abilify Maintena ) Guidelines for Prescribing and Administration (Version 3 August 2014)
1. Key Points. Aripiprazole Long-Acting Injection (Abilify Maintena ) Guidelines for Prescribing and Administration (Version 3 August 2014) 1.1 Aripiprazole long acting injection (LAI) is licensed / indicated
More informationFebruary 7-9, 2019 The Westin Fort Lauderdale Florida. Provided by
February 7-9, 2019 The Westin Fort Lauderdale Florida Provided by Addressing Your Greatest Concerns in Schizophrenia Management: From Suicide to Relapse Prevention and the Role of LAIs John Lauriello,
More informationPALIPERIDONE (Trevicta ) 3 MONTHLY Long acting injection (LAI) Guidance for Prescribing and Administration
PALIPERIDONE (Trevicta ) 3 MONTHLY Long acting injection (LAI) Guidance for Prescribing and Administration Paliperidone 1 monthly long acting injection (Xeplion ) This is included in the Trust medicines
More informationInterested parties (organisations or individuals) that commented on the draft document as released for consultation.
23 February 2017 EMA/CHMP/810545/2016 Committee for Medicinal Products for Human Use (CHMP) Overview of comments received on Paliperidone palmitate depot suspension for injection 25 mg, 50 mg, 75 mg, 100
More informationStep Therapy Group. Atypical Antipsychotic Agents
Atypical Antipsychotic Agents Any beneficiary newly enrolled into Community Care, Inc. currently receiving aripiprazole, aripiprazole ODT, risperidone, risperidone ODT, olanzapine, olanzapine ODT, quetiapine,
More informationSafer Prescribing of Antipsychotic Medications Guideline
Edwin Lee Mayor S an Francis co He alth N e twork B e havioral He alth Se rvice s M e dication Us e Improve me nt Committe e 1380 Howard St. 5 th Floor S an Francisco, C A 94103 Safer Prescribing of Antipsychotic
More informationDosing & Administration
Dosing & Administration REAL LIFE. REAL RESULTS. INDICATION INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: Schizophrenia. Schizoaffective disorder as monotherapy and as an
More informationSlide 1. Slide 2. Slide 3. About this module. About this module. Antipsychotics: The Essentials Module 5 A Primer on Selected Antipsychotics
Slide 1 Antipsychotics: The Essentials Module 5 A Primer on Selected Antipsychotics Flavio Guzmán, MD Slide 2 About this module 13 antipsychotics will be studied 3 first generation antipsychotics 10 second
More informationLocal Policy Recommendation
Local Policy Recommendation Aripiprazole (Abilify Maintena ) prolonged-release (PR) suspension for injection/long-acting antipsychotic injection (LAI) Recommendation: Red Aripiprazole prolonged-release
More informationPharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model
CNS Drugs (2017) 31:617 624 DOI 10.1007/s40263-017-0447-7 ORIGINAL RESEARCH ARTICLE Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic
More informationPaliperidone Palmitate 3-monthly Long-Acting Injection (Trevicta ) Guidelines for Prescribing and Administration (Version 1 October 2016)
Paliperidone Palmitate 3-monthly Long-Acting Injection (Trevicta ) Guidelines for Prescribing and Administration (Version 1 October 2016) 1. Key Points 1.1 Paliperidone palmitate 3-monthly long-acting
More informationINJECTABLE ANTIPSYCHOTICS AUTHORIZATION FORM
SUBMIT TO Utilization Management Department Phone: 1.866.912.6285 Fax: 1.866.694.3649 MEMBER INFORMATION INJECTABLE ANTIPSYCHOTICS AUTHORIZATION FORM Fax completed form to Cepatico at 866.694.3649. Upon
More informationMeasure #383 (NQF 1879): Adherence to Antipsychotic Medications For Individuals with Schizophrenia National Quality Strategy Domain: Patient Safety
Measure #383 (NQF 1879): Adherence to Antipsychotic Medications For Individuals with Schizophrenia National Quality Strategy Domain: Patient Safety 2017 OPTIONS F INDIVIDUAL MEASURES: REGISTRY ONLY MEASURE
More informationEffects of Discontinuation of Paliperidone Long-Acting Injectable After Switching from Risperidone Long-Acting Injectable Switching
Evidence-Based Medicine Key Words: antipsychotics, paliperidone palmitate, risperidone, long-acting injectable, successful switching, discontinuation Effects of Discontinuation of Paliperidone Long-Acting
More informationAntipsychotics in Bipolar
Use of Second-Generation Antipsychotics in Bipolar Disorder: A Practical Guide Flavio Guzman, MD Editor Psychopharmacology Institute This practical guide is an update on the use of second-generation antipsychotics
More informationMeasure #383 (NQF 1879): Adherence to Antipsychotic Medications For Individuals with Schizophrenia National Quality Strategy Domain: Patient Safety
Measure #383 (NQF 1879): Adherence to Antipsychotic Medications For Individuals with Schizophrenia National Quality Strategy Domain: Patient Safety 2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY
More informationEffectiveness of paliperidone long-acting injection in clinical practice.
Ther Adv Psychopharmacol (2018) 1 7 doi: 10.1177/ 2045125317753332 Effectiveness of paliperidone long-acting injection in clinical practice. Paul Nicholas Deslandes 1,2, Elan Haf Ward 3, Kathryn Norris
More informationAntipsychotics Prior Authorization Criteria for Louisiana Fee for Service and MCO Medicaid Recipients
Antipsychotics Prior Authorization Criteria for Louisiana Fee for Service and MCO Medicaid Recipients Preferred Agents (Oral) a Amitriptyline/Perphenazine (Generic) Aripiprazole Tablet (Generic) b Chlorpromazine
More informationAddressing an Underutilized Best Practice for Severe and Persistent Mental Illness: Long-Acting Injectables
Addressing an Underutilized Best Practice for Severe and Persistent Mental Illness: Long-Acting Injectables TREATMENT CHALLENGES People with severe and persistent mental illness (SPMI) are at significant
More informationComparison of Atypical Antipsychotics
PL Detail-Document #281006 This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER October 2012 Comparison of
More informationKey Words: schizophrenia, psychopharmacology, antipsychotic medication, long-acting injectable antipsychotics; paliperidone palmitate
Evidence-Based Medicine Key Words: schizophrenia, psychopharmacology, antipsychotic medication, long-acting injectable antipsychotics; paliperidone palmitate Long-Acting Injectable Paliperidone Palmitate:
More informationMarjie L. Hard 1 Angela Y. Wehr. Lisa von Moltke 1
Eur J Drug Metab Pharmacokinet (2018) 43:461 469 https://doi.org/10.1007/s13318-018-0488-4 ORIGINAL RESEARCH ARTICLE Population Pharmacokinetic Analysis and Model-Based Simulations of Aripiprazole for
More informationNEWER ATYPICAL ANTIPSYCHOTICS: NOVEL IDEAS OR
NEWER ATYPICAL ANTIPSYCHOTICS: NOVEL IDEAS OR METOOS? Sanaz Farhadian, Pharm.D., BCPP Clinical Psychiatric Pharmacist Veterans Affairs Healthcare System, San Diego, CA OBJECTIVES Discuss new antipsychotics
More informationLurasidone In Vitro Receptor Binding
Lurasidone Lurasidone In Vitro Receptor Binding 5-HT 2A D 2 Log of Ki Values (nm) M 1 * 5-HT 7 5-HT 1A α 2C α H 1 * 2A 0.1 1 10 100 1000 10000 HIGH AFFINITY Dopamine D 2 Serotonin 5-HT 2A Serotonin 5-HT
More informationRisperidone Case 1: Drug-Drug Interactions
Risperidone Case 1: Drug-Drug Interactions 1-14-16 de Leon & Bork (a resident) J Clin Psychiatry 1997;58:450-1 http://www.ncbi.nlm.nih.gov/pubmed/9375597 Jose de Leon, MD Educational Objectives At the
More informationDetermination of Plasma Concentration Reference Ranges for Risperidone and Paliperidone
Citation: CPT Pharmacometrics Syst. Pharmacol. (), ; VC ASCPT All rights reserved doi:./psp. ORIGINAL ARTICLE Determination of Plasma Concentration Reference Ranges for Risperidone and Paliperidone J Korell,
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Reference Number: AZ.CP.PHAR.10.11.10 Effective Date: 07.16 Last Review Date: 09.12.18 Line of Business: Medicaid Arizona Revision Log See Important Reminder at the end of this policy
More informationSTEP THERAPY CRITERIA
DRUG CLASS PRODUCTS) BRAND NAME (BRAND ONLY) (generic) STEP THERAPY CRITERIA ATYPICAL ANTIPSYCHOTICS (BRAND ONLY ABILIFY (AL TABLET & AL SOLUTION ONLY) (aripiprazole) FANAPT (BRAND ONLY) (iloperidone)
More informationLAO Aripiprazole OW Long Acting Oral aripiprazole Once Weekly
LAO Aripiprazole OW Long Acting Oral aripiprazole Once Weekly An alternative option to Long Acting Injectables (LAI) in the rapidly expanding market for prevention of psychotic relapse Zysis Management
More informationSlide 1. Slide 2. Slide 3. Risperidone Binding Profile. Risperidone Prescribing Facts. Risperidone Prescribing Facts
Slide 1 Risperidone Binding Profile (high affinity for D2 receptors) a 1 antagonist a 2 antagonist Slide 2 Risperidone Prescribing Facts 2 8 mg/day for acute psychosis and bipolar disorder 0.5-2 mg /day
More informationARIPIPRAZOLE. THERAPEUTICS Brands Abilify Abilify Maintena Aristada see index for additional brand names. Generic? Yes
ARIPIPRAZOLE THERAPEUTICS Brands Abilify Abilify Maintena Aristada see index for additional brand names Generic? Yes Class Neuroscience-based Nomenclature: dopamine, serotonin receptor partial agonist
More informationINSTRUCTIONS FOR USE Please read complete instructions prior to use
INSTRUCTIONS FOR USE Please read complete instructions prior to use For deltoid or gluteal intramuscular injection only 3 MONTHS Administer every 3 months 1 With the syringe tip pointing up, shake syringe
More informationDepots Improving patient care?
Depots Improving patient care? Caroline Parker Consultant Pharmacist NAPICU Conference 9 th September 2010 Depots Coercion Paternalistic Degrading Standard treatment Necessary Old fashioned Forced Easier
More informationDSM-5 Criteria: Schizophrenia
DSM-5 Criteria: Schizophrenia Box 4. DSM-5 Diagnosis: Schizophrenia Two (or more) of the following, each present for a significant portion of time during a 1-month period (or less if successfully treated).
More informationQuetiapine Case 2 Therapeutic Drug Monitoring Jose de Leon, MD
Quetiapine Case 2 Therapeutic Drug Monitoring 1-27-16 Jose de Leon, MD 2. Quetiapine Case Therapeutic Drug Monitoring (unpublished) Educational Objectives At the conclusion of this presentation, the participant
More informationIs Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients?
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Scholarship Student Dissertations, Theses and Papers 12-2016 Is Aristada (Aripiprazole Lauroxil)
More informationFDA Approves Deltoid Injection Site for Abilify Maintena (aripiprazole) for extendedrelease injectable suspension in the Treatment of Schizophrenia
FOR IMMEDIATE RELEASE FDA Approves Deltoid Injection Site for Abilify Maintena (aripiprazole) for extendedrelease injectable suspension in the Treatment of Schizophrenia Patients being treated for schizophrenia
More informationVersion 5.1: June ZYPADHERA Olanzapine powder & solvent for prolonged release suspension for injection
ZYPADHERA Olanzapine powder & solvent for prolonged release suspension for injection Patients Treated with Depot Antipsychotics May.. Have had multiple relapses and/or recent hospitalizations Have a history
More informationCLINICAL STUDY REPORT SYNOPSIS
CLINICAL STUDY REPORT SYNOPSIS Document No.: EDMS-PSDB-6511694:4.0 Name of Sponsor/Company Johnson & Johnson Pharmaceutical Research & Development Name of Finished Product Name of Active Ingredient Protocol
More informationMinimising the Impact of Medication on Physical Health in Schizophrenia
Minimising the Impact of Medication on Physical Health in Schizophrenia John Donoghue Liverpool Imagination is more important than knowledge Albert Einstein LIFESTYLE Making choices TREATMENT Worse Psychopathology,
More informationSwitching antipsychotics: Basing practice on pharmacology & pharmacokinetics
Switching antipsychotics: Basing practice on pharmacology & pharmacokinetics John Donoghue Liverpool L imagination est plus important que le savoir Albert Einstein Switching Antipsychotics: Objectives
More informationANTIPSYCHOTIC POLYPHARMACY
Psychiatry and Addictions Case Conference UW Medicine Psychiatry and Behavioral Sciences ANTIPSYCHOTIC POLYPHARMACY RYAN KIMMEL, MD MEDICAL DIRECTOR HOSPITAL PSYCHIATRY UWMC GENERAL DISCLOSURES The University
More informationAre Two Antipsychotics Better Than One?
Are Two Antipsychotics Better Than One? Lauren Hanna, M.D and Delbert Robinson, M.D. Northwell Health National Council for Behavioral Health Montefiore Medical Center Northwell Health New York State Office
More informationAripiprazole Lauroxil: Preparing for Commercial Success
Aripiprazole Lauroxil: Preparing for Commercial Success Mark Stejbach Chief Commercial Officer Alkermes R&D Day July 17, 2013 Forward-Looking Statements This presentation contains forward-looking statements
More informationTreatment of Schizophrenia
Treatment of Schizophrenia Conduct comprehensive assessment and use measurement-based care as found in the Principles of Practice (review pages 4-7). Most importantly assess social support system (housing,
More informationWhat Team Members Other Than Prescribers Need To Know About Antipsychotics
What Team Members Other Than Prescribers Need To Know About Antipsychotics The Care Transitions Network National Council for Behavioral Health Montefiore Medical Center Northwell Health New York State
More informationMental Health Medicines Management Pilot. Community Pharmacy. High Dose Antipsychotic Screening, Education & Advice Service
Mental Health Medicines Management Pilot Community Pharmacy High Dose Antipsychotic Screening, Education & Advice Service Approved Version 1 Date of First Issue Review Date Date of Issue Author / Contact
More informationMEDICATIONS IN PSYCHOSIS
MEDICATIONS IN PSYCHOSIS Paula Wadell, MD Medical Director Early Diagnosis & PreventaAve Treatment Clinic (EDAPT) SacEDAPT Clinic UC Davis Department of Psychiatry none DISCLOSURES OUTLINE Oral medica-ons
More informationBritish Journal of Clinical Pharmacology
British Journal of Clinical Pharmacology Br J Clin Pharmacol (2016) 82 1364 1370 1364 METHODS IN CLINICAL PHARMACOLOGY Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation
More informationNational Academy of Science July 17-18, 2018 Washington DC Larry Alphs, MD, PhD RESTRICTION OF TREATMENT QUALITY IN PRAGMATIC CLINICAL TRIALS
National Academy of Science July 17-18, 2018 Washington DC Larry Alphs, MD, PhD RESTRICTION OF TREATMENT QUALITY IN PRAGMATIC CLINICAL TRIALS Key Points for RWE in Randomized Clinical Trials What is the
More informationInvega Trinza: The First Four-Times-a-Year, Long-Acting Injectable Antipsychotic Agent
Invega Trinza: The First Four-Times-a-Year, Long-Acting Injectable Antipsychotic Agent Noor Daghistani, PharmD; and Jose A. Rey, PharmD, BCPP INTRODUCTION Schizophrenia is a chronic mental illness known
More informationTreatment of Schizophrenia Appendix Three Page 1 of 8
Prescribing Guidelines Treatment of Schizophrenia Scope of this guidance This guidance aims to describe the pharmacological management of schizophrenia at a simple and intermediate level, with a brief
More informationPreferred Prescribing Choices of Antipsychotic Drugs (APD) in Adults for Schizophrenia and Other Psychoses
Preferred Prescribing Choices of Antipsychotic Drugs (APD) in Adults for Schizophrenia and Other Psychoses HPFT Medicines Formulary lists the APDs that have been approved for use, however, it does not
More informationLong-Acting Injectables: Pharmacological Information
Long-Acting Injectables: Pharmacological Information J Code/ J2315 INJECTION NALTREXONE DEPOT FORM 1 MG Injection, naltrexone, depot form, 1 mg [Vivitrol ] VIVITROL (naltrexone for extended-release injectable
More informationFaculty Disclosure. Strategies to Improve Treatment Adherence in Schizophrenia: A Focus on Long-Acting Injectable Antipsychotics
Strategies to Improve Treatment Adherence in Schizophrenia: A Focus on Long-Acting Injectable Antipsychotics Presented by: Richard Jackson, MD Associate Clinical Professor of Psychiatry Wayne State University
More informationSiGMA/ MMHSCT GUIDELINES FOR ANTIPSYCHOTIC DRUG TREATMENT OF SCHIZOPHRENIA. [compatible with NICE guidance]
SiGMA/ MMHSCT GUIDELINES FOR ANTIPSYCHOTIC DRUG TREATMENT OF SCHIZOPHRENIA [compatible with NICE guidance] Medicines Management Committee August 2002 For review August 2003 Rationale The SiGMA algorithm
More informationThe Use of Long Acting Injectable Antipsychotics: More Practical Considerations
The Use of Long Acting Injectable Antipsychotics: More Practical Considerations The Care Transitions Network National Council for Behavioral Health Montefiore Medical Center Northwell Health New York State
More informationRexulti (brexpiprazole)
Market DC Rexulti (brexpiprazole) Override(s) Approval Duration Prior Authorization 1 year Quantity Limit *Indiana see State Specific Mandates below *Maryland see State Specific Mandates below *Virginia
More informationDrugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical criteria
Drug/Drug Class Antipsychotics Clinical Criteria Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical criteria Prior
More informationQuetiapine Case 1 Warfarin Jose de Leon, MD
Quetiapine Case 1 Warfarin 1-23-16 Jose de Leon, MD 1. Quetiapine Case 1 J Clin Psychopharm 1999;19:382-3 http://www.ncbi.nlm.nih.gov/pubmed/10440472 Educational Objectives At the conclusion of this presentation,
More informationANTIPSYCHOTICS 2006 COST-CONSCIOUS USAGE
ANTIPSYCHOTICS 2006 COST-CONSCIOUS USAGE ASCP Model Curriculum David N. Osser, M.D. Harvard Medical School Pre-Lecture Exam Question 1 1. Which of the following is an antipsychotic dose that is in excess
More informationPALIPERIDONE. THERAPEUTICS Brands INVEGA INVEGA SUSTENNA INVEGA TRINZA see index for additional brand names
PALIPERIDONE THERAPEUTICS Brands INVEGA INVEGA SUSTENNA INVEGA TRINZA see index for additional brand names Generic? No Class Neuroscience-based Nomenclature: dopamine, serotonin receptor antagonist (DS-RAn)
More informationLurasidone: A New Antipsychotic For Schizophrenia. Objectives. Introduction. Pharmacology/Pharmacokinetics. Mechanism of Action. Mechanism of Action
Lurasidone: A New Antipsychotic For Schizophrenia Theodore Pikoulas, PharmD PGY2 Psychiatric Pharmacy Resident Louis Stokes Cleveland VAMC Objectives Review the pharmacology and the pharmacokinetics Identify
More informationAWMSG SECRETARIAT ASSESSMENT REPORT (FULL SUBMISSION)
AWMSG SECRETARIAT ASSESSMENT REPORT (FULL SUBMISSION) Advice No. 2512 Paliperidone palmitate (Xeplion ) 50 mg, 75 mg, 100 mg and 150 mg prolonged release suspension for injection In collaboration with
More informationAggression (Severe) in Children under Age 6
Aggression (Severe) in Children under Age 6 Level 0 Comprehensive diagnostic assessments. Refer to Principles of Practice on page 6. Evaluate and treat comorbid conditions (i.e. medical, other psychiatric
More informationClozapine Case 1 The Relevance of CYP Jose de Leon, MD
Clozapine Case 1 The Relevance of CYP 12-18-15 Jose de Leon, MD 1. Clozapine Case 1 J Clin Psychiatry 1996;57:175-176 http://www.ncbi.nlm.nih.gov/pubmed/8601555 Educational Objectives At the conclusion
More informationComparison of pre-treatment clinical characteristics and post-treatment outcomes of patients treated with Clozapine and long acting antipsychotics
Research Comparison of pre-treatment clinical characteristics and post-treatment outcomes of patients treated with Dante M Durand,1, Phillip Harvey 1,2, Ricardo Cáceda 3 ABSTRACT Introduction: Clozapine
More informationA Double-blind Study Of Paliperidone Palmitate And Risperidone Long-acting Injectable In Adults With Schizophrenia
A Double-blind Study Of Paliperidone Palmitate And Risperidone Long-acting Injectable In Adults With Schizophrenia Gahan Pandina, Rosanne Lane, Srihari Gopal, Cristiana Gassmann-mayer, David Hough, Bart
More informationThe 2009 Schizophrenia PORT Psychopharmacological Treatment Recommendations and Summary Statements
Schizophrenia Bulletin vol. 36 no. 1 pp. 71 93, 2010 doi:10.1093/schbul/sbp116 Advance Access publication on December 2, 2009 The 2009 Schizophrenia PORT Psychopharmacological Treatment Recommendations
More informationPharmacotherapy of psychosis and schizophrenia in youth
Pharmacotherapy of psychosis and schizophrenia in youth Benedetto Vitiello Pavia, 2 December 2017 Disclosure Benedetto Vitiello, M.D. Professor of Child and Adolescent Neuropsychiatry University of Turin,
More information