(paliperidone palmitate 6-month)
Medical inquiries
This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
INVEGA HAFYERA® (paliperidone palmitate 6-month)
Medical Information
INVEGA HAFYERA - Conversion to INVEGA SUSTENNA®
Last Updated: 10/01/2024
Summary
- When transitioning from INVEGA HAFYERA to INVEGA SUSTENNA (paliperidone palmitate 1-month) extended-release injectable suspension, INVEGA SUSTENNA should be started 6 months after the last INVEGA HAFYERA dose. INVEGA SUSTENNA dosing should then continue at 1-month intervals.1
See table: Conversion from INVEGA HAFYERA to INVEGA SUSTENNA. - Pharmacokinetic (PK) Modeling: PK simulations were conducted to transition from paliperidone palmitate 1-month (PP1M) to paliperidone palmitate 6-month (PP6M) with continuing maintenance treatment with PP6M, and then a switch from PP6M back to PP1M.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 SUSTENNAand INVEGA HAFYERA dosage strengths in the United States. The conversion factor from mg eq. to mg is 1.56.
- INVEGA SUSTENNA doses expressed as 100 and 150 mg eq. are equal to 156 and 234 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 SUSTENNA
INVEGA HAFYERA, administered at doses of 1,092 and 1,560 mg results in paliperidone exposures comparable to exposures obtained with INVEGA SUSTENNA 156 and 234 mg, respectively.2 The information regarding conversion to INVEGA SUSTENNA is summarized in Table: Conversion from INVEGA HAFYERA to INVEGA SUSTENNA.
| Initiate INVEGA SUSTENNA 6 Months Later at the Following Dose: | |
|---|---|
| 1,092 mg | 156 mg |
| 1,560 mg | 234 mg |
PK Modeling
A population pharmacokinetic (POP-PK) model simulated a transition from PP1M to PP6M with continuing maintenance treatment with PP6M, and then a switch from PP6M back to PP1M.2 Simulations considered the following dosing schedules: treatment was initiated with PP1M 234 mg on day 1 (deltoid) followed by 156 mg on day 8 (deltoid). After 4 months of PP1M treatment (deltoid or gluteal), patients received 4 doses of PP6M (gluteal) and were transitioned again to PP1M (deltoid or gluteal). When transitioning patients back from paliperidone steady-state with PP6M to PP1M, the paliperidone exposure is maintained. See Figure: Simulated Paliperidone Plasma Concentrations Versus Time After Switch from PP6M to PP1M
PP1M2
The middle solid line and the shaded area represents the median paliperidone concentration the 90% prediction band. Standard 4-month PP1M treatment (initiation doses dark grey followed by maintenance doses light grey) followed by PP6M dosing (blue) in parallel to PP1M (light grey). After 4 doses of PP6M, patients are transitioned again to PP1M. The green shaded band between the dotted lines is the 90% prediction band following treatment with oral paliperidone ER. In the left panel the PP1M maintenance doses were given in the deltoid muscle, while in the right panel the PP1M maintenance doses were given in the gluteal muscle. The top row is for the high dose (PP1M 234 mg, PP6M 1,560 mg), the bottom row is for the moderate dose (PP1M 156 mg, PP6M 1,092 mg) level.
Abbreviations: PP1M, paliperidone palmitate 1-month; PP6M, paliperidone palmitate 6-month; ER: paliperidone extended-release.
LITERATURE SEARCH
A literature search of MEDLINE®
References
| 1 | Data on File. Paliperidone palmitate 6-month injection, Version 002. Janssen Research & Development, LLC; Paliperidone Palmitate CCDS; 2022. |
| 2 |