(paliperidone palmitate 6-month)
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INVEGA HAFYERA® (paliperidone palmitate 6-month)
Medical Information
Dosage and Administration of INVEGA HAFYERA - General Information
Last Updated: 02/18/2025
Click on the following links to related sections within the document: Dosage strength Information, Dosage Information, and Missed Dose.
Note: To view instructions for preparation and administration of INVEGA HAFYERA, please access the following link: https://www.janssenmd.com/video/administrationvideo.
Abbreviations: CrCl, creatinine clearance; G, gauge; HCP, healthcare practitioner; IM, intramuscular.
a
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 milligrams of paliperidone palmitate to reflect the commercially available dosage strengths in the United States. The conversion factor from mg eq to mg is 1.56.
- INVEGA SUSTENNA doses expressed as 39, 78, 117, 156, and 234 mg of paliperidone palmitate are equal to 25, 50, 75, 100, and 150 mg eq of paliperidone, respectively.
- INVEGA TRINZA doses expressed as 273, 410, 546, and 819 mg of paliperidone palmitate are equal to 175, 263, 350, and 525 mg eq of paliperidone, respectively.
INVEGA HAFYERA doses expressed as 1,092 or 1,560 mg of paliperidone palmitate are equal to 700 and 1,000 mg eq of paliperidone, respectively.
- Transitioning to INVEGA HAFYERA from INVEGA SUSTENNA:
- INVEGA HAFYERA is to be used only after adequate treatment has been established with INVEGA SUSTENNA for at least 4 months, with the last 2 doses of INVEGA SUSTENNA of the same dosage strength (156 or 234 mg).1
- Initiate INVEGA HAFYERA when the INVEGA SUSTENNA dose is scheduled with an INVEGA HAFYERA dose based on the previous INVEGA SUSTENNA injection dose, using Table: INVEGA HAFYERA Doses for Adults Adequately Treated with INVEGA SUSTENNA. INVEGA HAFYERA may be administered up to 1 week before or after the monthly time point of the next scheduled INVEGA SUSTENNA dose.1
| If the last dose of INVEGA SUSTENNA dose wasa: | Initiate INVEGA HAFYERA at the following dose: |
|---|---|
| 156 mg | 1,092 mg |
| 234 mg | 1,560 mg |
| aThere are no equivalent doses of INVEGA HAFYERA for the 39, 78, and 117 mg doses of INVEGA SUSTENNA. | |
- Transitioning to INVEGA HAFYERA from INVEGA TRINZA:
- INVEGA HAFYERA is to be used only after adequate treatment has been established with INVEGA TRINZA for at least one 3-month injection cycle with doses of 546 mg or 819 mg.
- Initiate INVEGA HAFYERA when the next INVEGA TRINZA dose is scheduled with an INVEGA HAFYERA dose based on the INVEGA TRINZA dose, using Table: INVEGA HAFYERA Doses for Adults Adequately Treated with INVEGA TRINZA. INVEGA HAFYERA may be administered up to 2 weeks before or after the time point of the next scheduled INVEGA TRINZA dose.
| If the last dose of INVEGA TRINZA isa: | Initiate INVEGA HAFYERA at the following dose: |
|---|---|
| 546 mg | 1,092 mg |
| 819 mg | 1,560 mg |
| aThere are no equivalent doses of INVEGA HAFYERA for the 273, and 410 mg INVEGA TRINZA as this conversion were not studied. | |
- Following the initial dose, INVEGA HAFYERA should be administered every 6 months.1
- If needed, dose adjustment of INVEGA HAFYERA can be made every 6 months between the dose levels of 1,092 mg and 1,560 mg based on individual patient tolerability and/or efficacy. Due to the long-acting nature of INVEGA HAFYERA, the patient’s response to adjusted dose may not be apparent for several months.1
Management of a Missed Dose
To avoid a missed dose, patients may be given the injection up to 2 weeks before or 3 weeks after the scheduled 6-month time point.
Missed Dose >6 Months and 3 weeks up to <8 Months Since Last Injection: Do NOT administer the next dose of INVEGA HAFYERA. Instead, use the re-initiation regimen detailed in Table: Re-initiation Regimen After Missing >6 Months and 3 Weeks up to but <8 Months of INVEGA HAFYERA1
| If the last dose of INVEGA HAFYERA was: | Administer INVEGA SUSTENNA (into deltoid muscle) | Then administer INVEGA HAFYERA (into gluteal muscle) |
|---|---|---|
| Day 1 | 1 month after Day 1 | |
| 1,092 mg | 156 mg | 1,092 mg |
| 1,560 mg | 234 mg | 1,560 mg |
Missed Dose ≥8 Months and ≤11 Months Since Last Injection: Do NOT administer the next dose of INVEGA HAFYERA. Instead, use the re-initiation regimen detailed in Table:
| If the last dose of INVEGA HAFYERA was: | Administer INVEGA SUSTENNA (into deltoid muscle) | Then administer INVEGA HAFYERA (into gluteal muscle) | |
|---|---|---|---|
| Day 1 | Day 8 | 1 month after Day 8 | |
| 1,092 mg | 156 mg | 156 mg | 1,092 mg |
| 1,560 mg | 156 mg | 156 mg | 1,560 mg |
Missed Dose >11 Months Since Last Injection: Re-initiate treatment with INVEGA SUSTENNA as described in the local product prescribing information for INVEGA SUSTENNA. INVEGA HAFYERA can then be resumed after the patient has been adequately treated with INVEGA SUSTENNA for at least 4 months.1
A literature search of MEDLINE®
References
| 1 | Data on File. Company Core Data Sheet - Paliperidone Palmitate 6-Month Injection. Version 3. Janssen Research & Development, LLC. EDMS-RIM-137311; 2022. |
| 2 | |
| 3 |