(paliperidone palmitate 6-month)
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INVEGA HAFYERA® (paliperidone palmitate 6-month)
Medical Information
INVEGA HAFYERA Dosing and Administration - Missed Dose
Last Updated: 02/18/2025
Summary
- INVEGA HAFYERA should be administered every 6 months.1
- 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.1
- Missed Dose >6 Months and 3 weeks up to but <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 <8 Months of INVEGA HAFYERA.2
- 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: Re-initiation Regimen After Missing ≥8 Months and ≤11 Months of INVEGA HAFYERA.2
- 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 be resumed after the patient has been adequately treated with INVEGA SUSTENNA for at least 4 months.2 When switching from INVEGA SUSTENNA to INVEGA HAFYERA, the two injection cycles immediately preceding the switch should be the same dosage strength before starting INVEGA HAFYERA.1
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 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 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.
RE-INITIATING REGIMEN AFTER MISSED DOSE
Missed Dose >6 Months and 3 Weeks up to <8 Months Since Last Injection: Do NOT administer the next dose of
| 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.2 When switching from INVEGA SUSTENNA to INVEGA HAFYERA, the two injection cycles immediately preceding the switch should be the same dosage strength before starting INVEGA HAFYERA.1
Population PK model based simulations2 were performed to determine the dosing recommendations for missed doses for INVEGA HAFYERA, using clinical trial data from the pivotal phase 3, randomized, double-blind non-inferiority study3
| INVEGA HAFYERAa | Regime | Cmax(ng/mL)a | % change vs base | Ctrough (ng/mL)b | % change vs base |
|---|---|---|---|---|---|
| 1,560 mg | Base INVEGA HAFYERA | 76.1 | - | ||
| 1 week earlier | 76.3 | +0.3% | |||
| 2 weeks earlier | 76.6 | +0.7% | |||
| 1,092 mg | Base INVEGA HAFYERA | 15.8 | - | ||
| 1 week later | 15.3 | -3.2% | |||
| 2 weeks later | 14.9 | -5.7% | |||
| 3 weeks later | 14.4 | -8.9% | |||
| aCmax is derived as the maximal concentration from the dose following the schedule change dosing.bCtrough is derived as the minimal concentration prior to the dose following the schedule change. | |||||
Missed Dose
Simulations performed in which more than 6 months and 3 weeks and up to (not including) 8 months have elapsed since the last steady-state INVEGA HAFYERA dose, a rapid return to plasma paliperidone levels as prior to the missed dose can be achieved with one deltoid INVEGA SUSTENNA dose for one month before continuing the regular INVEGA HAFYERA schedule (see Figure: Missed Dose Simulations When More Than 6 Months and 3 Weeks and Up to (Not Including) 8 Months Have Elapsed Since the Last Steady-State 1,560 mg INVEGA HAFYERA Injection [6.75 Months (i.e. 6 Months and 3 Weeks), 7 Months, and 7.5 Months (i.e. 7 Months and 2 Weeks) after the Last INVEGA HAFYERA Dose]).2
Abbreviations: PP3M, paliperidone palmitate 3-month; PP6M, paliperidone palmitate 6-month formulation.
aThe middle solid line represents the median paliperidone concentration and the shaded area between the bottom and top dotted lines represents the 90% prediction band. Standard INVEGA SUSTENNA 4-month treatment in deltoid (initiation doses dark grey followed by maintenance doses light grey) followed by INVEGA HAFYERA dosing (blue). The delay in the last INVEGA HAFYERA dose is indicated in purple, and re-initiation, performed with one dose of INVEGA SUSTENNA 234 mg in deltoid for the high dose level, is indicated in green. The grey shaded area represents the peak-to trough range (defined by the 90% prediction band) before the INVEGA HAFYERA dosing interval changed.
Simulations performed in which 8 months and up to (including) 11 months have elapsed after the last steady-state INVEGA HAFYERA dose, a rapid return to similar paliperidone plasma concentrations as before the missed dose can be achieved by re-initiation with a 156 mg INVEGA SUSTENNA deltoid injection on Day 1 and Day 8, followed by the regular INVEGA HAFYERA injection schedule starting one month after the 2nd INVEGA SUSTENNA dose (see Figure: Missed Dose Simulations When 8 Months and Up to (Including) 11 Months Have Elapsed Since the Last 1,056 mg Injection of INVEGA HAFYERA for 8, 10, and 11 Months After the Last INVEGA HAFYERA Dose).2
Abbreviations: PP3M, paliperidone palmitate 3-month; PP6M, paliperidone palmitate 6-month formulation.
aThe middle solid line represents the median paliperidone concentration and the shaded area between the bottom and top dotted lines represents the 90% prediction band. Standard INVEGA SUSTENNA 4-month treatment in deltoid (initiation doses dark grey followed by maintenance doses light grey) followed by INVEGA HAFYERA dosing (blue). The delay in the last INVEGA HAFYERA dose is indicated in purple, and re-initiation, performed with two doses of INVEGA SUSTENNA 156 mg in deltoid, is indicated in green. The grey shaded area represents the peak-to-trough range (defined by the 90% prediction band) before the INVEGA HAFYERA dosing interval changed.
Simulations performed in which more than 11 months have elapsed after the last steady-state INVEGA HAFYERA dose, a rapid return to similar paliperidone plasma concentrations as before the missed dose can be achieved by re-initiation with a 4-month INVEGA SUSTENNA cycle, i.e. INVEGA SUSTENNA initiation (234 mg INVEGA SUSTENNA deltoid injection on Day 1 and 156 mg INVEGA SUSTENNA deltoid injection on Day 8), followed by three months of INVEGA SUSTENNA maintenance (three 156 or 234 mg INVEGA SUSTENNA deltoid/gluteal injections each month for moderate or high dose, respectively) before transitioning to INVEGA HAFYERA (see Figure: Missed Dose Simulations When More Than 11 Months Have Elapsed Since the Last 1,056 mg Injection of INVEGA HAFYERA for 12, 15, and 18 Months After the Last INVEGA HAFYERA Dose).2
Abbreviations: PP3M, paliperidone palmitate 3-month; PP6M, paliperidone palmitate 6-month formulation.
aThe middle solid line represents the median paliperidone concentration and the shaded area between the bottom and top dotted lines represents the 90% prediction band. Standard INVEGA SUSTENNA 4-month treatment in deltoid (initiation doses dark grey followed by maintenance doses light grey) followed by INVEGA HAFYERA dosing (blue). The delay in the last INVEGA HAFYERA dose is indicated in purple, and re-initiation is performed as a 4-month INVEGA SUSTENNA treatment in deltoid. The grey shaded area represents the peak-to-trough range (defined by the 90% prediction band) before the INVEGA HAFYERA dosing interval changed.
LITERATURE SEARCH
A literature search of MEDLINE®
References
| 1 | INVEGA HAFYERA (paliperidone palmitate) extended-release injectable suspension [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVEGA+HAFYERA-pi.pdf |
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