Mild Renal Impairment

  • Legend
    • initiation-dosing-symbol

      Initiation Doses

    • maintenace-dose-symbol

      Maintenance Doses

    • legend-pp1m-plasma-concentration

      Cumulative INVEGA SUSTENNA® Plasma Concentration

    • legend-pp3m-plasma-concentration

      Cumulative INVEGA TRINZA® Plasma Concentration

    • legend-er-plasma-concentration

      Cumulative Oral INVEGA® ER Plasma Concentration

    • legend-er-doses

      Daily Oral INVEGA® Doses

    • legend-rl-dose-symbol

      Cumulative RISPERDAL CONSTA® Plasma Concentration

    • median-plasma-concentration-symbol

      Median Plasma Concentration for Oral INVEGA® ER 6-12 mg/day

    • initiation-dosing-symbol

      Initiation Doses

    • maintenace-dose-symbol

      Maintenance Doses

    • legend-old-browser-paliperidone-palmitate-concentration

      Cumulative Paliperidone Palmitate Concentration

    • legend-er-doses

      Daily Oral INVEGA® ER Dose

    • legend-rl-dose-symbol-greyscale

      Cumulative RISPERDAL CONSTA® Plasma Concentration

    • Week 1 = Day 8

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Typical Paliperidone Plasma Concentration (ng/mL)
Typical Paliperidone Plasma Concentration (ng/mL)
Dose Information

The dosage strength (156 mg) and dosage location (deltoid muscle) of the first INVEGA SUSTENNA® initiation dose in patients with mild renal impairment is fixed per the INVEGA SUSTENNA® Prescribing Information.

Dosage Timing: The first INVEGA SUSTENNA® initiation dose occurs on Day 1 (on the x-axis).

The dosage strength (117 mg) and dosage location (deltoid muscle) of the second INVEGA SUSTENNA® initiation dose in patients with mild renal impairment is fixed per the INVEGA SUSTENNA® Prescribing Information.

Dosage Timing: While the INVEGA SUSTENNA® Prescribing Information does permit a dosing window of ±4 days to help avoid a missed second initiation dose, for illustrative purposes, the timing of the second INVEGA SUSTENNA® dose cannot be adjusted.

Dosage Strength: The recommended maintenance dosage strength for the treatment of schizophrenia is 78 mg in patients with mild renal impairment per the INVEGA SUSTENNA® Prescribing Information.

Dosage Location: The INVEGA SUSTENNA® monthly maintenance doses can be administered in either the deltoid or gluteal muscle per the INVEGA SUSTENNA® Prescribing Information. For illustrative purposes only, once you select the deltoid or gluteal muscle for an INVEGA SUSTENNA® maintenance dose, the site of injection will remain constant for all remaining INVEGA SUSTENNA® maintenance doses.

Dosage Timing: While the INVEGA SUSTENNA® Prescribing Information does permit a dosing window of ±7 days to help avoid a missed monthly dose, for illustrative purposes, the timing of the INVEGA SUSTENNA® maintenance doses cannot be adjusted.

Dosage Strength: The recommended maintenance dosage strength for the treatment of schizophrenia is 78 mg in patients with mild renal impairment per the INVEGA SUSTENNA® Prescribing Information. The option is available to adjust the INVEGA SUSTENNA® maintenance dosage strength down by one dosage strength to 39 mg (from the previous 78 mg dose administered).

Dosage Location: For illustrative purposes only, once you select the deltoid or gluteal muscle for an INVEGA SUSTENNA® maintenance dose, the site of injection will remain constant for all remaining INVEGA SUSTENNA® maintenance doses.

Dosage Timing: While the INVEGA SUSTENNA® Prescribing Information does permit a dosing window of ±7 days to help avoid a missed monthly dose, for illustrative purposes, the timing of the INVEGA SUSTENNA® maintenance doses cannot be adjusted.

Dosage Strength: Patients must be adequately treated with INVEGA SUSTENNA® 78 mg before initiating INVEGA TRINZA®. Conversion from INVEGA SUSTENNA® 39 mg to INVEGA TRINZA® was not studied, per the INVEGA TRINZA® Prescribing Information.

Dosage Location: For illustrative purposes only, once you select the deltoid or gluteal muscle for an INVEGA SUSTENNA® maintenance dose, the site of injection will remain constant for all remaining INVEGA SUSTENNA® maintenance doses.

Dosage Timing: While the INVEGA SUSTENNA® Prescribing Information does permit a dosing window of ±7 days to help avoid a missed monthly dose, for illustrative purposes, the timing of the INVEGA SUSTENNA® maintenance doses cannot be adjusted.

Dosage Strength: The last two doses of INVEGA SUSTENNA® must be the same dosage strength in order to establish a consistent maintenance dose before starting INVEGA TRINZA®, as recommended per the INVEGA TRINZA® Prescribing Information.

Dosage Location: For illustrative purposes only, once you select the deltoid or gluteal muscle for an INVEGA SUSTENNA® maintenance dose, the site of injection will remain constant for all remaining INVEGA SUSTENNA® maintenance doses.

Dosage Timing: While the INVEGA SUSTENNA® Prescribing Information does permit a dosing window of ±7 days to help avoid a missed monthly dose, for illustrative purposes, the timing of the INVEGA SUSTENNA® maintenance doses cannot be adjusted.

Dosage Strength: The first INVEGA TRINZA® dose is determined by the consistent INVEGA SUSTENNA® maintenance dose, using the equivalent 3.5-fold higher INVEGA TRINZA® dosage strength per the INVEGA TRINZA® Prescribing Information.

Dosage Location: The INVEGA TRINZA® dose can be administered in either the deltoid or gluteal muscle per the INVEGA TRINZA® Prescribing Information.

Dosage Timing: For illustrative purposes only, the timing of the first INVEGA TRINZA® dose cannot be adjusted. However, the INVEGA TRINZA® Prescribing Information does allow the first INVEGA TRINZA® dose to be administered ±7 days of the next scheduled INVEGA SUSTENNA® dose.

Dosage Strength: For illustrative purposes only, the INVEGA TRINZA® maintenance dosage strength will remain constant for all INVEGA TRINZA® maintenance doses. INVEGA TRINZA® dosage adjustments can be made every 3 months in increments within the range of 273 mg to 819 mg based on individual patient tolerability and/or efficacy per the INVEGA TRINZA® Prescribing Information.

Dosage Location: For illustrative purposes only, once you select the deltoid or gluteal muscle for an INVEGA TRINZA® maintenance dose, the site of injection will remain constant for all remaining INVEGA TRINZA® maintenance doses.

Dosage Timing: While the INVEGA TRINZA® Prescribing Information does permit a dosing window of ±2 weeks to help avoid a missed dose, for illustrative purposes, the timing of the INVEGA TRINZA® maintenance dose cannot be adjusted.

Dosage Strength: For illustrative purposes only, the INVEGA TRINZA® maintenance dosage strength will remain constant for all INVEGA TRINZA® maintenance doses. INVEGA TRINZA® dosage adjustments can be made every 3 months in increments within the range of 273 mg to 819 mg based on individual patient tolerability and/or efficacy per the INVEGA TRINZA® Prescribing Information.

Dosage Location: For illustrative purposes only, once you select the deltoid or gluteal muscle for an INVEGA TRINZA® maintenance dose, the site of injection will remain constant for all remaining INVEGA TRINZA® maintenance doses.

Dosage Timing: While the INVEGA TRINZA® Prescribing Information does permit a dosing window of ±2 weeks to help avoid a missed dose, for illustrative purposes, the timing of the INVEGA TRINZA® maintenance dose cannot be adjusted.

Dosage Strength: For illustrative purposes only, the INVEGA TRINZA® maintenance dosage strength will remain constant for all INVEGA TRINZA® maintenance doses. INVEGA TRINZA® dosage adjustments can be made every 3 months in increments within the range of 273 mg to 819 mg based on individual patient tolerability and/or efficacy per the INVEGA TRINZA® Prescribing Information.

Dosage Location: For illustrative purposes only, once you select the deltoid or gluteal muscle for an INVEGA TRINZA® maintenance dose, the site of injection will remain constant for all remaining INVEGA TRINZA® maintenance doses.

Dosage Timing: While the INVEGA TRINZA® Prescribing Information does permit a dosing window of ±2 weeks to help avoid a missed dose, for illustrative purposes, the timing of the INVEGA TRINZA® maintenance dose cannot be adjusted.

Dosage Strength: For illustrative purposes only, the INVEGA TRINZA® maintenance dosage strength will remain constant for all INVEGA TRINZA® maintenance doses. INVEGA TRINZA® dosage adjustments can be made every 3 months in increments within the range of 273 mg to 819 mg based on individual patient tolerability and/or efficacy per the INVEGA TRINZA® Prescribing Information.

Dosage Location: For illustrative purposes only, once you select the deltoid or gluteal muscle for an INVEGA TRINZA® maintenance dose, the site of injection will remain constant for all remaining INVEGA TRINZA® maintenance doses.

Dosage Timing: While the INVEGA TRINZA® Prescribing Information does permit a dosing window of ±2 weeks to help avoid a missed dose, for illustrative purposes, the timing of the INVEGA TRINZA® maintenance dose cannot be adjusted.

Dosage Strength: For illustrative purposes only, the INVEGA TRINZA® maintenance dosage strength will remain constant for all INVEGA TRINZA® maintenance doses. INVEGA TRINZA® dosage adjustments can be made every 3 months in increments within the range of 273 mg to 819 mg based on individual patient tolerability and/or efficacy per the INVEGA TRINZA® Prescribing Information.

Dosage Location: For illustrative purposes only, once you select the deltoid or gluteal muscle for an INVEGA TRINZA® maintenance dose, the site of injection will remain constant for all remaining INVEGA TRINZA® maintenance doses.

Dosage Timing: While the INVEGA TRINZA® Prescribing Information does permit a dosing window of ±2 weeks to help avoid a missed dose, for illustrative purposes, the timing of the INVEGA TRINZA® maintenance dose cannot be adjusted.

Graph Information

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Transitioning a Patient with Mild Renal Impairment to INVEGA TRINZA®

Consistent with the INVEGA TRINZA® Prescribing Information:

  • INVEGA TRINZA® is to be used only after INVEGA SUSTENNA® has been established as adequate treatment for at least four months.
  • In order to establish a consistent maintenance dose, it is recommended that the last two doses of INVEGA SUSTENNA® be the same dosage strength before starting INVEGA TRINZA®.
  • INVEGA TRINZA® has not been systematically studied in patients with renal impairment. INVEGA TRINZA® is not recommended in patients with moderate or severe renal impairment (creatinine clearance <50 mL/min).
  • For patients with mild renal impairment (creatinine clearance ≥50 mL/min to <80 mL/min [Cockcroft-Gault Formula], adjust dosage and stabilize the patient using INVEGA SUSTENNA®, then transition to INVEGA TRINZA® using the equivalent 3.5-fold higher dose as shown in the table below.
  • While the INVEGA TRINZA® Prescribing Information does permit a dosing window to avoid a first INVEGA TRINZA® missed dose, in this scenario, the timing of the first INVEGA TRINZA® dose is locked and cannot be adjusted ±7 days.

INVEGA TRINZA® Doses for Adult Patients Adequately Treated with INVEGA SUSTENNA®

If the Last Dose of INVEGA SUSTENNA® is:

Initiate INVEGA TRINZA® at the Following Dose:

78 mg

273 mg

117 mg

410 mg

156 mg

546 mg

234 mg

819 mg

Conversion from the INVEGA SUSTENNA® 39 mg dose was not studied.

  • INVEGA TRINZA® should be administered every 3 months.
  • Administration: For intramuscular injection only by a healthcare professional. Care should be taken to avoid inadvertent injection into a blood vessel.

INVEGA TRINZA® Prescribing Information [http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVEGA+TRINZA-pi.pdf]

Educational Dose Illustrator for:
INVEGA SUSTENNA® (paliperidone palmitate)
INVEGA TRINZA® (paliperidone palmitate)

The Educational Dose Illustrator can be used to visualize how dosing affects paliperidone plasma concentrations following administration of:

INVEGA SUSTENNA® for:

  • the treatment of schizophrenia in adults
  • the treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants

INVEGA TRINZA® for:

  • the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA® for at least four months.

This resource simulates the paliperidone plasma concentrations over time resulting from different dosing scenarios that are set forth in the respective Prescribing Information for INVEGA SUSTENNA® and INVEGA TRINZA®. The Educational Dose Illustrator is intended to be used as a resource to foster a better understanding of, and educate healthcare professionals about, the dosing recommendations provided in the respective Prescribing Information for INVEGA SUSTENNA® and INVEGA TRINZA®. It is intended for educational purposes only.

Because the simulated patient paliperidone plasma levels shown in the dosing scenarios are based upon aggregated pharmacokinetic information from clinical studies, the simulations may not be representative of individual patient response.

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