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Neuropsychiatric Disease and Treatment Volume 9, 2013 - Issue
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Original Research

Expansion of guidance for the day 8 initiation dose of paliperidone palmitate to avoid a missed dose

Mahesh N Samtani1 Janssen Research and Development, LLC, NJ, USACorrespondence[email protected]
,
Isaac Nuamah1 Janssen Research and Development, LLC, NJ, USA
,
Srihari Gopal1 Janssen Research and Development, LLC, NJ, USA
,
Bart Remmerie2 Janssen Research and Development, LLC, Division of Janssen Pharmaceutica NV, Beerse, Belgium
,
Jennifer Kern Sliwa3 Janssen Scientific Affairs, LLC, NJ, USA
&
Larry Alphs3 Janssen Scientific Affairs, LLC, NJ, USA
Pages 721-730 | Published online: 20 May 2013

Figures & data

Table 1 Summary of paliperidone palmitate initiation regimen simulations

Figure 1 Comparison of model-based projections versus observed data for the initial 5 weeks of treatment with PP 150 mg eq on day 1 followed by 100 mg eq on day 8. Abbreviations: mg eq, milligram equivalents; PP, paliperidone palmitate.

Figure 1 Comparison of model-based projections versus observed data for the initial 5 weeks of treatment with PP 150 mg eq on day 1 followed by 100 mg eq on day 8. Abbreviations: mg eq, milligram equivalents; PP, paliperidone palmitate.

Figure 2 Comparison of model-based projections versus observed data for the initial 5 weeks of treatment with PP 150 mg eq on both days 1 and 8.

Abbreviations: mg eq, milligram equivalents; PP, paliperidone palmitate.
Figure 2 Comparison of model-based projections versus observed data for the initial 5 weeks of treatment with PP 150 mg eq on both days 1 and 8.

Figure 3 Comparison of model-based projections versus observed steady-state data for the recommended daily dose of paliperidone ER (6 mg).

Abbreviation: ER, extended-release.
Figure 3 Comparison of model-based projections versus observed steady-state data for the recommended daily dose of paliperidone ER (6 mg).

Figure 4 Pharmacokinetic simulations of the PP with second initiation dose (day 8) window expanded to ±4 days. (A) PP 150 mg eq on day 1 and 100 mg eq on day 8 versus 150 mg eq on day 1and 100 mg eq on day 4. (B) PP 150 mg eq on day 1 and 100 mg eq on day 8 versus 150 mg eq on day 1 and 100 mg eq on day 12.

Notes: Y axis represents paliperidone concentrations in ng/mL. Lines and shaded areas (pink and gray hatched regions) represent the medians and 90% prediction intervals.
Abbreviations: PP, paliperidone palmitate; mg eq, milligram equivalents.
Figure 4 Pharmacokinetic simulations of the PP with second initiation dose (day 8) window expanded to ±4 days. (A) PP 150 mg eq on day 1 and 100 mg eq on day 8 versus 150 mg eq on day 1and 100 mg eq on day 4. (B) PP 150 mg eq on day 1 and 100 mg eq on day 8 versus 150 mg eq on day 1 and 100 mg eq on day 12.

Table 2 Quantitative comparison of simulated peak exposures with paliperidone palmitate initiation regimens

Figure 5 Pharmacokinetic simulations for PP doses 150 mg eq and 100 mg eq with day 1/day 4, day 1/day 8, and day 1/day 12 initiation regimens compared with the highest initiation regimen (150 mg eq/day 1 followed by 150 mg eq/day 8). (A) PP 150 mg eq on both days 1 and 8 versus 150 mg eq on day 1 and 100 mg eq on day 4. (B) PP 150 mg eq on both days 1 and 8 versus 150 mg eq on day 1 and 100 mg eq on day 8. (C) PP 150 mg eq on both days 1 and 8 versus 150 mg eq on day 1 and 100 mg eq on day 12.

Notes: Y axis represents paliperidone concentrations in ng/mL. Lines and shaded areas (blue and gray hatched regions) represent the medians and 90% prediction intervals.
Abbreviations: PP, paliperidone palmitate; mg eq, milligram equivalents.
Figure 5 Pharmacokinetic simulations for PP doses 150 mg eq and 100 mg eq with day 1/day 4, day 1/day 8, and day 1/day 12 initiation regimens compared with the highest initiation regimen (150 mg eq/day 1 followed by 150 mg eq/day 8). (A) PP 150 mg eq on both days 1 and 8 versus 150 mg eq on day 1 and 100 mg eq on day 4. (B) PP 150 mg eq on both days 1 and 8 versus 150 mg eq on day 1 and 100 mg eq on day 8. (C) PP 150 mg eq on both days 1 and 8 versus 150 mg eq on day 1 and 100 mg eq on day 12.

Figure 6 Pharmacokinetic simulations for PP doses 150 mg eq and 100 mg eq with day 1/day 4, day 1/day 8, and day 1/day 12 initiation regimens compared with the recommended daily dose of paliperidone ER (6 mg). (A) Steady-state 6 mg paliperidone ER versus PP 150 mg eq on day 1 and 100 mg eq on day 4. (B) Steady-state 6 mg paliperidone ER versus PP 150 mg eq on day 1 and 100 mg eq on day 8. (C) Steady-state 6 mg paliperidone ER versus PP 150 mg eq on day 1 and 100 mg eq on day 12.

Notes: Y axis represents paliperidone concentrations in ng/mL. Lines and shaded areas (blue and gray hatched regions) represent the medians and 90% prediction intervals.
Abbreviations: PP, paliperidone palmitate; ER, extended-release; mg eq, milligram equivalents.
Figure 6 Pharmacokinetic simulations for PP doses 150 mg eq and 100 mg eq with day 1/day 4, day 1/day 8, and day 1/day 12 initiation regimens compared with the recommended daily dose of paliperidone ER (6 mg). (A) Steady-state 6 mg paliperidone ER versus PP 150 mg eq on day 1 and 100 mg eq on day 4. (B) Steady-state 6 mg paliperidone ER versus PP 150 mg eq on day 1 and 100 mg eq on day 8. (C) Steady-state 6 mg paliperidone ER versus PP 150 mg eq on day 1 and 100 mg eq on day 12.

Table 3 Treatment-emergent adverse events reported in ≥5% of patients in any dose arm, by clinical trial

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