(paliperidone palmitate 6-month)
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INVEGA HAFYERA® (paliperidone palmitate 6-month)
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INVEGA HAFYERA - Conversion to INVEGA TRINZA®
Last Updated: 10/01/2024
Summary
- When transitioning from INVEGA HAFYERA to INVEGA TRINZA (paliperidone palmitate 3-month) extended-release injectable suspension, INVEGA TRINZA should be started 6 months after the last INVEGA HAFYERA dose. INVEGA TRINZA dosing should then continue at 3-month intervals.1
See table: Conversion from INVEGA HAFYERA to INVEGA TRINZA. - Pharmacokinetic (PK) Modeling: PK simulations were conducted to transition from
paliperidone palmitate 3-month (PP3M) to paliperidone palmitate 6-month (PP6M) with continuing maintenance treatment with PP6M, and then a switch from PP6M back to PP3M.2
DOSAGE STRENGTH INFORMATION
Doses of paliperidone palmitate extended-release injectable suspension may be expressed in milligram equivalents of paliperidone (active moiety) or milligrams of paliperidone palmitate. Dosage information in this response has been converted to mg of paliperidone palmitate to reflect the commercially available INVEGA SUSTENNA®
- INVEGA SUSTENNA doses expressed as 100 and 150 mg eq. are equal to 156 and 234 mg of paliperidone palmitate, respectively.
- INVEGA TRINZA doses expressed as 350 and 525 mg eq. are equal to 546 and 819 mg of paliperidone palmitate, respectively.
- INVEGA HAFYERA doses expressed as 700 and 1,000 mg eq. are equal to 1,092 and 1,560 mg of paliperidone palmitate, respectively.
SWITCHING TO INVEGA TRINZA
INVEGA HAFYERA, administered at doses of 1,092 and 1,560 mg results in paliperidone exposures comparable to exposures obtained with INVEGA TRINZA 546 and 819 mg, respectively.2 The information regarding conversion to INVEGA TRINZA is summarized in Table: Conversion from INVEGA HAFYERA to INVEGA TRINZA.
| Initiate INVEGA TRINZA 6 Months Later at the Following Dose: | |
|---|---|
| 1,092 mg | 546 mg |
| 1,560 mg | 819 mg |
PK Modeling
A population pharmacokinetic (POP-PK) model simulated a transition from PP3M to PP6M with continuing maintenance treatment with PP6M, and then a switch from PP6M back to PP3M.2 Simulations considered the following dosing schedules: treatment was initiated with paliperidone palmitate 1-month (PP1M) 234 mg on day 1 (deltoid) followed by 156 mg on day 8 (deltoid). After 4 months of PP1M treatment (deltoid or gluteal) followed by one 3-month cycle of PP3M (deltoid or gluteal), patients received 4 doses of PP6M (gluteal) and were transitioned again to PP3M (deltoid or gluteal). When transitioning patients back from paliperidone steady-state with PP6M to PP3M, the paliperidone exposure is maintained. See Figure: Simulated Paliperidone Plasma Concentrations Versus Time After Switch from PP6M to PP3M
PP3M2
Abbreviations: PP1M, paliperidone palmitate 1-month; PP3M, paliperidone palmitate 3-month; PP6M, paliperidone palmitate 6-month;
ER, paliperidone extended-release.
The middle solid line and the shaded area represents the median paliperidone concentration and the 90% prediction band. Standard 4-month PP1M treatment (initiation doses dark grey followed by maintenance doses light grey) followed by PP3M (light grey) and PP6M dosing (blue) in parallel. After 4 doses of PP6M, patients are transitioned again to PP3M. In the left panel the PP1M and PP3M maintenance dose(s) are given in the deltoid muscle, while in the right panel the PP1M and PP3M maintenance dose(s) were given in the gluteal muscle. The top row is for the high dose (PP1M 234 mg, PP3M 819 mg, PP6M 1,560 mg), the bottom row is for the moderate dose (PP1M 156 mg, PP3M 546 mg, PP6M 1,092 mg). The green shaded band between the dotted lines is the 90% prediction band following treatment with oral paliperidone ER.
LITERATURE SEARCH
A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 16 September 2024.
References
| 1 | Data on File. Paliperidone palmitate 6-month injection, Version 002. Janssen Research & Development, LLC; Paliperidone Palmitate CCDS; 2022. |
| 2 |