(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®
Last Updated: 10/01/2024
Summary
- When transitioning from INVEGA HAFYERA injection to INVEGA (paliperidone extended-release) tablets, INVEGA should be started 6 months after the last INVEGA HAFYERA dose and the daily dosing of INVEGA should be transitioned over the next several months.1
See table: Conversion from INVEGA HAFYERA to INVEGA. - Pharmacokinetic (PK) Modeling: PK simulations were conducted to transition from paliperidone palmitate 6-month (PP6M) at steady-state to oral paliperidone extended release (ER).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 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
When transitioning from INVEGA HAFYERA to INVEGA, INVEGA should be started 6 months after the last INVEGA HAFYERA dose and the daily dosing of INVEGA should be transitioned over the next several months as described in Table: Conversion from INVEGA HAFYERA to INVEGA.
| Months after last INVEGA HAFYERA dose | |||
|---|---|---|---|
| 6 months to 9 months | >9 months to 12 months | >12 months | |
| Daily dose of INVEGA | |||
| 1,092 mg | 3 mg | 6 mg | 9 mg |
| 1,560 mg | 6 mg | 9 mg | 12 mg |
| aAll doses of once daily INVEGA should be individualized to the specific patient, taking into consideration variables such as reasons for transitioning, response to previous paliperidone treatment, severity of psychotic symptoms, and/or propensity for side effects. | |||
PK Modeling
A population pharmacokinetic (POP-PK) model simulated a transition to paliperidone ER after being stabilized on PP6M.2 Up-titration of 2 to 6 months in between paliperidone ER doses (PP6M moderate dose: 3-6-9 mg every day [QD]; PP6M high dose: 6-9-12 mg QD) did not indicate a substantial difference in paliperidone PK profiles. When transitioning from PP6M steady-state to oral paliperidone ER 6 months after the last PP6M dose, a period of 3 months in between up-titration steps for the paliperidone ER doses is considered adequate. See Figure: Simulated Paliperidone Plasma Concentrations versus Time After Switch from PP6M to Oral Paliperidone ER.
Oral Paliperidone ER2
The middle solid line and the shaded area represents the median paliperidone concentration the 90% prediction band. Standard 4-month PP1M treatment in deltoid (initiation doses dark grey followed by maintenance doses light grey) followed by PP6M dosing (blue), followed by oral paliperidone ER (green). The left panel is for the high dose (PP1M 234 mg, PP6M 1,560 mg), the right panel 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®, 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 |