Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia

References

• American Psychiatric Association. Practice guidelines for the treatment of patients with schizophrenia. Am J Psychiatry 1997;154(Suppl. 4):1-63
   Web of Science ®Google Scholar
• Andreasen NC. Signs, symptoms and diagnosis of schizophrenia. Lancet 1995;346:477-81
   PubMed Web of Science ®Google Scholar
• Keith SJ, Kane JM. Partial compliance and patient consequences in schizophrenia: our patients can do better. J Clin Psychiatry 2003;64:1308-15
   PubMed Web of Science ®Google Scholar
• Nasrallah HA. The case for long-acting antipsychotic agents in the post-CATIE era. Acta Psychiatr Scand 2007;115:260-67
   PubMed Web of Science ®Google Scholar
• Marder SR, Kramer M, Ford L, et al. Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study. Biol Psychiatry 2007;62:1363-70
   PubMed Web of Science ®Google Scholar
• Kane J, Canas F, Kramer M, et al. Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial. Schizophr Res 2007;90:147-61
   PubMed Web of Science ®Google Scholar
• Davidson M, Emsley R, Kramer M, et al. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophr Res 2007;93:117-30
   PubMed Web of Science ®Google Scholar
• Samtani MN, Vermeulen A, Stuyckens K. Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once monthly, long-acting formulation of an atypical antipsychotic. Clin Pharmacokinet 2009;48:585-600
   PubMed Web of Science ®Google Scholar
• Paliperidone palmitate Prescribing Information 2009. Available at: http://www.invegasustenna.com/invegasustenna/shared/pi/invegasustenna.pdf. Accessed November 2009
   Google Scholar
• Bhattaram VA, Booth BP, Ramchandani RP, et al. Impact of pharmacometrics on drug approvals and labeling decisions: survey of 42 new drug applications. AAPS J 2005;7:E503-E512
   PubMed Web of Science ®Google Scholar
• Bhattaram VA, Bonapace C, Chilukuri DM, et al. Impact of pharmacometric reviews on new drug approval and labeling decisions – a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther 2007;81:213-21
   PubMed Web of Science ®Google Scholar
• Tornoe CW, Bhattaram V, Earp JC, et al. Impact of pharmacometric reviews on new drug approval and labeling decisions – a survey of 65 NDAs Between 2006 and 2008. American Conference on Pharmacometrics, Mashantucket, CT, USA, Oct 4–7 2009. Poster no. S1
   Google Scholar
• Megens AA, Awouters FHL. In vivo pharmacological profile of 9-hydroxyrisperidone the major metabolite of the novel antipsychotic risperidone. Drug Dev Res 1994;33:399-412
   Web of Science ®Google Scholar
• Schotte A, Janssen PF, Gommeren W, et al. Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding. Psychopharmacology (Berl) 1996;124:57-73
   PubMed Web of Science ®Google Scholar
• Vermeir M, Naessens I, Remmerie B, et al. Absorption, metabolism, and excretion of paliperidone, a new monoaminergic antagonist, in humans. Drug Metab Dispos 2008;36:769-79
   PubMed Web of Science ®Google Scholar
• Thyssen, A, Cleton A, Talluri K, et al. No pharmacokinetic interaction between paliperidone extended-release tablets and trimethoprim in healthy subjects. Human Psychopharmacol 2009;24:532-9
   PubMed Web of Science ®Google Scholar
• Nasrallah HA, Gopal S, Quiroz J, et al. Efficacy and safety of 3 doses of paliperidone palmitate, an investigational long-acting injectable antipsychotic, in schizophrenia. Biol Psychiatry 2008;63:1S-319S
   PubMedGoogle Scholar
• Kramer M, Litman R, Lane R, et al. Efficacy and tolerability of two fixed dosages of paliperidone palmitate in the treatment of schizophrenia: results of a 9-week placebo-controlled trial. Biol Psychiatry 2008;63:1S-319S
   PubMed Web of Science ®Google Scholar
• Gopal S, Lindenmayer JP, Hough D, et al. Safety and tolerability of paliperidone palmitate injected in the deltoid or gluteus muscle in patients with schizophrenia. Biol Psychiatry 2008;63:1S-319S
   PubMed Web of Science ®Google Scholar
• Hough D, Lindenmayer JP, Gopal S, et al. Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry 2009;33:1022-33
   PubMed Web of Science ®Google Scholar
• Pandina G, Lindenmayer JO, Lull J. A randomized, double-blind, placebo-controlled, dose–response study to assess efficacy and safety of paliperidone palmitate in adult subjects with schizophrenia. Annual Meeting of the International Congress of Schizophrenia Research, San Diego, CA, USA, March 28 – April 2009. Poster no. 31
   Google Scholar
• Bloch Y, Mendlovic S, Strupinsky S, et al. Injections of depot antipsychotic medications in patients suffering from schizophrenia: Do they hurt?. J Clin Psychiatry 2001;62:855-59
   PubMed Web of Science ®Google Scholar
• Samtani MN, Kern-Sliwa J, Haskins JT. Initiation dosing of deltoid intramuscular paliperidone palmitate in schizophrenia: pharmacokinetic rationale based on modeling and simulation. Annual Meeting of the College of Psychiatric and Neurologic Pharmacists, Jacksonville, FL, USA, April 19–22, 2009. Poster no. 19
   Google Scholar
• Samtani MN, Kern-Sliwa J, Haskins JT, et al. Initiation dosing of deltoid intramuscular paliperidone palmitate in schizophrenia: pharmacokinetic rationale based on modeling and simulation. Annual Meeting of the American Psychiatric Association, San Francisco, CA, USA, May 16–21 2009. Poster no. NRI-046
   Google Scholar
• Samtani MN, Haskins JT, Alphs S, et al. Maintenance dosing of once-monthly (4-weekly) paliperidone palmitate in schizophrenia: pharmacokinetic rationale based on population simulations. Annual Meeting of the College of Psychiatric and Neurologic Pharmacists, Jacksonville, FL, USA, 19–22 April 2009. Poster no. 21
   Google Scholar
• Samtani MN, Gopal S, Kern Sliwa J, et al. Switching to paliperidone palmitate from other antipsychotics: guidance based on pharmacokinetic modeling and simulations. New Clinical Drug Evaluation Unit, Hollywood, FL, USA, Jun 29 – Jul 2 2009. Poster no. I-68
   Google Scholar
• Samtani MN, Gopal S, Kern Sliwa J, et al. Management of missed paliperidone palmitate doses based on pharmacokinetic modeling and simulation. New Clinical Drug Evaluation Unit, Hollywood, FL, USA, 29 Jun – 2 Jul 2009. Poster no. II-62
   Google Scholar
• Fleischhacker WW, Gopal S, Samtani MN, et al. Optimization of the dosing strategy for the long-acting injectable antipsychotic paliperidone palmitate: results of two randomized double-blind studies and population pharmacokinetic simulations. Annual Meeting of the American College of Neuropsychopharmacology, Scottsdale, AZ, USA, Dec 7–11 2008. Poster no. 21
   Google Scholar
• Karlsson P, Dencker E, Nyberg S, et al. Pharmacokinetics, dopamine D2 and serotonin 5-HT2A receptor occupancy and safety profile of paliperidone ER in healthy subjects. Schizophrenia Res 2006;81(Suppl. 1):85-6
   Google Scholar
• Kapur S, Remington G, Jones C, et al. High levels of dopamine D2 receptor occupancy with low-dose haloperidol treatment: a PET study. Am J Psychiatry 1996;153:948-50
   PubMed Web of Science ®Google Scholar
• Nordstrom AL, Farde L, Wiesel FA, et al. Central D2-dopamine receptor occupancy in relation to antipsychotic drug effects: a double-blind PET study of schizophrenic patients. Biol Psychiatry 1993;33:227-35
   PubMed Web of Science ®Google Scholar
• Nyberg S, Nordstrom AL, Halldin C, et al. Positron emission tomography studies on D2 dopamine receptor occupancy and plasma antipsychotic drug levels in man. Int Clin Psychopharmacol 1995;10(Suppl. 3):81-5
   PubMed Web of Science ®Google Scholar
• Kane J, Aguglia E, Altamura, AC, et al. Guidelines for depot antipsychotic treatment for schizophrenia. European Neuropsychopharmacology 1998;8:55-66
   PubMed Web of Science ®Google Scholar
• Samtani MN, Haskins JT, Alphs L, et al. Maintenance dosing of once-monthly (4-weekly) paliperidone palmitate in schizophrenia: pharmacokinetic rationale based on population simulations. Annual Meeting of the American Psychiatric Association 2009: San Francisco, CA, USA, May 16–21, 2009. Poster no. NRI-036
   Google Scholar
• Cirincione B, Redman M, Fielder-Kelley J, et al. Population pharmacokinetics of paliperidone ER in healthy subjects and patients with schizophrenia. Clin Pharmacol Ther 2007;81:S19
   PubMed Web of Science ®Google Scholar
• Cleton A, Rossenu S, Hough D, et al. Assessment of the dose proportionality of paliperidone palmitate, a long-acting injectable antipsychotic, following deltoid or gluteal administration. Annual Meeting of the Institute of Psychiatric Services, Chicago, IL, USA, October 2–5, 2008. Poster no. 59
   Google Scholar
• Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the advisory committee on immunization practices. MMWR 2006;55(No. RR-15):16
   PubMedGoogle Scholar
• Poland GA, Borrud A, Jacobson RM, et al. Determination of deltoid fat pad thickness. Implications for needle length in adult immunization. JAMA 1997;277:1709-11
   Google Scholar