title: Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia.
abstract: OBJECTIVE
  This commentary summarizes recommended dosing strategies for a recently developed 3 monthly long-acting injectable 1 (LAI) formulation of paliperidone palmitate (PP3M) for the treatment of schizophrenia in adults.
  
  
  METHODS
  Recommendations for different dosing scenarios are based on the pharmacokinetic, efficacy and safety outcomes from phase 1 and phase 3 studies, population pharmacokinetic models, and model based simulations.
  
  
  RESULTS
  Switching to PP3M treatment is recommended only in patients previously treated with once monthly paliperidone palmitate LAI (PP1M) for at least 4 months. The first injection of PP3M (175 to 525 mg equivalent [eq.]) should be given at the time of next scheduled injection of PP1M as a 3.5-fold multiple of the last PP1M dose (50-150 mg eq.), with a dosing window of ± 1 week. Following that first injection of PP3M, once-every-three-months maintenance injections with PP3M are recommended, with a dosing window of ± 2 weeks. The doses of PP3M can be administered in either deltoid (≥ 90 kg: 1.5 inch 22 G needle; <90 kg: 1.0 inch 22 G needle) or gluteal muscles (1.5 inch 22 G needle regardless of weight). In patients with mild renal impairment (creatinine clearance: 50-80 mL/min), a 25% dose reduction in PP1M and subsequent switching to a corresponding 3.5-dose multiple of PP3M (but not exceeding 350 mg eq.) is recommended. Appropriate dosing is recommended in elderly patients with diminished renal function not exceeding mild renal impairment. Similarly to PP1M, PP3M is not recommended in patients with moderate/severe renal impairment. Like PP1M, no dosage adjustment is required in patients with mild or moderate hepatic impairment or elderly patients with normal renal function.
  
  
  CONCLUSIONS
  These data provide clinical guidelines for the optimum use of PP3M in patients with schizophrenia previously treated with PP1M for at least 4 months.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01559272 and NCT01529515.
authors: a a Janssen Research & Development LLC , Raritan , NJ , USA.
authors: Srihari
authors: S
authors: Gopal
authors: b b Janssen Research & Development, Division of Janssen Pharmaceutica NV , Beerse , Belgium.
authors: An
authors: A
authors: Vermeulen
authors: a a Janssen Research & Development LLC , Raritan , NJ , USA.
authors: Partha
authors: P
authors: Nandy
authors: b b Janssen Research & Development, Division of Janssen Pharmaceutica NV , Beerse , Belgium.
authors: Paulien
authors: P
authors: Ravenstijn
authors: a a Janssen Research & Development LLC , Raritan , NJ , USA.
authors: Isaac
authors: I
authors: Nuamah
authors: a a Janssen Research & Development LLC , Raritan , NJ , USA.
authors: José Antonio
authors: JA
authors: Buron Vidal
authors: a a Janssen Research & Development LLC , Raritan , NJ , USA.
authors: Joris
authors: J
authors: Berwaerts
authors: a a Janssen Research & Development LLC , Raritan , NJ , USA.
authors: Adam
authors: A
authors: Savitz
authors: a a Janssen Research & Development LLC , Raritan , NJ , USA.
authors: David
authors: D
authors: Hough
authors: a a Janssen Research & Development LLC , Raritan , NJ , USA.
authors: Mahesh N
authors: MN
authors: Samtani
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical; D006801:Humans; D007273:Injections, Intramuscular; D018482:Muscle, Skeletal; D000068882:Paliperidone Palmitate / Q000008:administration & dosage*; D012559:Schizophrenia / Q000188:drug therapy*
chemical_list: D014150:Antipsychotic Agents; D000068882:Paliperidone Palmitate
keywords: 3 monthly formulation; Paliperidone palmitate; Schizophrenia