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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 SUSTENNA® (paliperidone palmitate)

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Alternative Initiation Regimen of INVEGA SUSTENNA

Last Updated: 12/08/2024

Summary

Tolerability Testing: For patients who have never taken oral paliperidone or oral or injectable risperidone, it is recommended to establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA SUSTENNA.¹
Initiation Dosing: The recommended initiation of INVEGA SUSTENNA is with a dose of 234 mg on treatment day 1 and 156 mg one week later, both administered in the deltoid muscle. To avoid a missed dose, patients may be given the second initiation dose 4 days before or after the one-week time point. The initiation regimen for INVEGA SUSTENNA was designed to rapidly attain steady state paliperidone concentrations when initiating therapy without the use of oral supplementation. Following the second initiation dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.²^,³
Initiation Regimen Development: The dosing recommendations for INVEGA SUSTENNA are the result of a clinical development program that evaluated refinements aimed at optimizing the dosing strategy for the treatment of schizophrenia. Earlier phase 2/3 trials did not utilize the recommended initiation dosing regimen (234 mg injection followed by 156 mg injection one week later, both administered in the deltoid muscle). However, following the results of population pharmacokinetic (PK) modeling,³ the initiation regimen in subsequent trials was optimized.
- Simulation results from the PK model suggest the percentage of patients achieving paliperidone concentration >7.5 ng/mL at one week after initiating treatment with paliperidone palmitate 1-month (PP1M) is: 52%, 66%, 73%, and 84% for 156 mg gluteal, 234 mg gluteal, 156 mg deltoid, and 234 mg deltoid, respectively. This concentration corresponds to a central D₂-receptor occupancy of approximately 60% (receptor occupancy of 60%-80% is generally required for antipsychotic efficacy).³
An alternative initiation regimen (dose and/or injection site) was utilized in 4 acute, short-term, fixed dose studies,⁴^,⁵^,⁶^,⁷ a long term maintenance study,⁸ a long term active-controlled non-inferiority study,⁹ and 3 real-world observational studies.¹⁰^-¹²

DOSAGE STRENGTH INFORMATION

Doses of paliperidone palmitate extended-release injectable suspension may be expressed in milligram equivalents (mg eq) 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 dosage strengths in the United States (US). 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.

CLINICAL STUDIES

An alternative initiation regimen (dose and/or injection site) was utilized in 4 acute, short-term, fixed dose studies,⁴^,⁵^,⁶^,⁷ a long term maintenance study,⁸ and a long term active-controlled non-inferiority study.⁹

Table: Paliperidone Palmitate Clinical Trial Results provides an overview of INVEGA SUSTENNA clinical studies.

Paliperidone Palmitate Clinical Trial Results

Paliperidone Palmitate Clinical Trial Results
Long-term Non-Inferiority Study in Schizophrenia
Fleischhacker et al (2012)⁹ conducted a double-blind, active-controlled, non-inferiority trial comparing the efficacy, PK, and safety of flexibly dosed PP1M (n=379) with those of flexibly dosed RLAI (n=368) in patients with schizophrenia. INVEGA SUSTENNA Initiation Regimen: 78 mg on day 1 and day 8 (both gluteal) INVEGA SUSTENNA Maintenance Dosing: flexible gluteal injections of 78 mg - 156 mg once monthly + oral PBO (during 1st 4 weeks) RLAI Dosing Schedule: 25 mg (gluteal) Day 8 and 22. Then 25, 37.5 or 50 mg every 2 weeks + oral RIS 1-6 mg (during 1st 4 weeks) *Primary Efficacy*: Mean change in PANSS total score	Improvement in PANSS Total Scores: Mean change from baseline: -12 in INVEGA SUSTENNA and -14 in RLAI; mean change of 2.6 favoring RLAI (95% CI; -5.84). Non-inferiority of INVEGA SUSTENNA to RLAI was not demonstrated INVEGA SUSTENNA 39 to 156 mg initiated at a dose of 78 mg on Day 1 and Day 8 in the gluteal muscle was not shown to be non-inferior to RLAI 25 to 50 mg with supplemental oral risperidone in the treatment of the symptoms of schizophrenia. *PK Findings:* The median plasma concentration of paliperidone in the PP1M group had not reached 7.5 ng/ml by day 64, suggesting that the initiation regimen was not adequate to rapidly and consistently achieve therapeutically effective plasma levels of paliperidone. *Safety:* AEs similar frequency between the populations; TEAE leading to discontinuation (7% INVEGA SUSTENNA; 6% RLAI) Most common TEAEs were: insomnia, psychotic disorder, schizophrenia, anxiety, agitation, headache, akathisia, nasopharyngitis, and weight increased
Acute, Short-term Clinical Studies in Schizophrenia
Trial Design	Efficacy and Safety Results
Pandina et al (2010)⁴; Haskins et al (2009)¹³ conducted a 13-week, randomized, double-blind, parallel-group, multicenter, PBO-controlled, dose-response study evaluating three fixed doses of INVEGA SUSTENNA in patients with schizophrenia (n=636, ITT analysis set) INVEGA SUSTENNA Initiation Regimen: Following a ≤7-day screening, washout, and tolerability period, patients were randomized to one of three INVEGA SUSTENNA treatment arms (39, 156, or 234 mg) or to PBO. Patients received initiation doses of 234 mg (all INVEGA SUSTENNA patients) or PBO on day 1 (deltoid IM injection) followed by their fixed dose (39, 156, or 234 mg) or PBO on day 8 (deltoid or gluteal IM injection) INVEGA SUSTENNA Maintenance Regimen: Fixed dose (39, 156, 234 mg) on days 36, and 64 (deltoid or gluteal IM injection). This was the 1^st phase 3 study evaluating a dosing regimen of INVEGA SUSTENNA revised from earlier studies with initiation at 234 mg in the deltoid to increase initial exposure to paliperidone *Primary Efficacy*: Mean change in PANSS total score	*Change in PANSS Total Score: INVEGA SUSTENNA 39 mg (n=155): -8.1 (P<0.05 vs PBO) INVEGA SUSTENNA 156 mg (n=161): -11.6 (P<0.05 vs PBO) INVEGA SUSTENNA 234 mg (n=160): -13.2 (P<0.05 vs PBO) PBO (n=160): -2.9 Estimated Effect Size Compared with PBO: INVEGA SUSTENNA 39 mg: 0.28 INVEGA SUSTENNA 156 mg: 0.49 INVEGA SUSTENNA 234 mg: 0.55 Onset of effect was seen as early as day 8 in the INVEGA SUSTENNA 39- and 234-mg groups and day 22 in the 156-mg group Safety*: Most common TEAEs (≥2% in any treatment group) that occurred more frequently (≥1% difference) in the total INVEGA SUSTENNA group than in the PBO group were injection-site pain (INVEGA SUSTENNA: 7.6% versus PBO: 3.7%), dizziness (2.5% versus 1.2%), sedation (2.3% versus 0.6%), pain in extremity (1.6% versus 0%), and myalgia (1% versus 0%)
Kramer et al (2010)⁵ conducted a 9-week, double-blind, randomized, international study assessing the safety and efficacy of two fixed INVEGA SUSTENNA doses compared to PBO in the treatment of schizophrenia (n=247) INVEGA SUSTENNA Initiation Regimen: Following a 5-day screening/washout phase and a 7-day oral run-in period, patients were randomized to receive gluteal IM injections of INVEGA SUSTENNA doses (78 or 156 mg) or PBO without oral supplementation on days 1 and 8 INVEGA SUSTENNA Maintenance Regimen: INVEGA SUSTENNA (78, or 156 mg) or PBO administered by gluteal IM injection on day 36 *Primary Efficacy*: Mean change in PANSS total score	*Change in PANSS Total Score: INVEGA SUSTENNA 78 mg (n=63): -5.2 (P=0.001 vs PBO) INVEGA SUSTENNA 156 mg (n=68): -7.8 (P<0.001 vs PBO) PBO (n=66): 6.2 Safety:* TEAEs were similar between the treatment groups: PBO: 64% INVEGA SUSTENNA 78 mg: 65% INVEGA SUSTENNA 156 mg: 60%
Nasrallah et al (2010)⁶ conducted a 13-week, multicenter, randomized, double-blind, PBO-controlled, parallel-group, dose-response study evaluating the efficacy and safety of 3 fixed doses of INVEGA SUSTENNA in patients with schizophrenia (n=514; ITT analysis set) INVEGA SUSTENNA Initiation Regimen: Following a ≤7-day screening, washout, and tolerability period, patients were randomized to one of three fixed INVEGA SUSTENNA doses (39, 78, or 156 mg) or PBO administered by gluteal IM injection on days 1 and 8 INVEGA SUSTENNA Maintenance Regimen: INVEGA SUSTENNA (39, 78, or 156 mg) or PBO administered by gluteal IM injection on days 36, and 64. *Primary Efficacy*: Mean change in PANSS total score	*Change in PANSS Total Score: INVEGA SUSTENNA 39 mg (n=129): -13.6 (P=0.015 vs PBO) INVEGA SUSTENNA 78 mg (n=128): -13.2 (P=0.017 vs PBO) INVEGA SUSTENNA 156 mg (n=131): -16.1 (P<0.001 vs PBO) PBO (n=125): -7.0 Safety*: AEs in at least 5% of patients in any treatment group were similar except for the following: weight increase (4% INVEGA SUSTENNA versus 0% PBO) somnolence (4% INVEGA SUSTENNA versus 1% PBO) A higher rate of serious TEAEs was reported for PBO-treated patients (18%) than for INVEGA SUSTENNA -treated patients (8-14%)
Gopal et al (2010)⁷ conducted a 13-week, multicenter, randomized, double-blind, PBO-controlled, parallel-group, dose-response study evaluating the efficacy and safety of three fixed doses of INVEGA SUSTENNA in patients with schizophrenia (n=349, primary efficacy analysis set) INVEGA SUSTENNA Initiation Regimen: Following a washout, screening, and tolerability period that lasted for ≤7 days, patients were randomized to receive one of three fixed doses of INVEGA SUSTENNA (78, 156, or 234 mg) or PBO administered by gluteal IM injection on days 1, and 8, INVEGA SUSTENNA Maintenance Regimen: INVEGA SUSTENNA (78, 156, or 234 mg) or PBO administered by gluteal IM injection on days 36, and 64. *Primary Efficacy*: Mean change in PANSS total score	*Change from Baseline to Endpoint in PANSS Total Score (LOCF): INVEGA SUSTENNA 78 mg (n=93): -7.9 (P=0.19 vs PBO) INVEGA SUSTENNA 156 mg (n=94): -11.0 (P=0.019 vs PBO) INVEGA SUSTENNA 234 mg (n=30): -5.5 (no p-value vs PBO) (The 234 mg group was to be tested against PBO only if both the INVEGA SUSTENNA 78 mg and 156 mg doses were significantly different from PBO. Since the 78 mg group did not reach statistical significance, no statistical comparison was performed for the 234 mg group) PBO (n=132): -4.1 Differences from PBO in LS Mean Change in PANSS Total Score: INVEGA SUSTENNA 78 mg (n=93): -3.5 (P=0.19 vs PBO) INVEGA SUSTENNA 156 mg (n=94): -6.9 (P=0.019 vs PBO) INVEGA SUSTENNA 234 mg (n=30): no statistical comparison performed Safety*: AEs occurring more frequently (≥5% difference) with INVEGA SUSTENNA than with PBO were headache, vomiting, injection-site pain, and pain in extremity
Longer-term Maintenance Study in Schizophrenia
Hough et al (2010)⁸ conducted a longer-term, double-blind, randomized, multicenter, PBO-controlled, parallel-group study examining the efficacy and safety of INVEGA SUSTENNA in the prevention of schizophrenia symptom relapse following an initial 9-week, open-label transition phase and a 24-week, open-label maintenance phase (double-blind phase, n=410) INVEGA SUSTENNA Initiation Regimen: Following a ≤7-day screening and washout period, patients received gluteal IM injections of INVEGA SUSTENNA 78 mg on days 1 and 8 of the transition phase INVEGA SUSTENNA Maintenance Regimen: Adjustable doses of INVEGA SUSTENNA 39, 78, or 156 mg administered every four weeks for the remainder of the transition phase and for the first 12 weeks of the maintenance phase. Doses remained fixed for the last 12 weeks of the maintenance phase and during the double-blind relapse-prevention phase. *Primary Efficacy*: Time to first relapse event (psychiatric hospitalization, deliberate self-injury, suicidal or homicidal ideation, or certain predefined PANSS scores)	*Median Time to Relapse (interim analysis): INVEGA SUSTENNA: not estimable (P<0.0001 vs PBO) PBO: 163 days Number (%) of relapse events: INVEGA SUSTENNA: 15/156 (10%) PBO: 53/156 (34%) Study terminated early because of a significant difference in interim results for time to relapse Final analysis: Time to relapse was significantly longer with INVEGA SUSTENNA than with PBO (P<0.0001) Hazard ratio for PBO versus INVEGA SUSTENNA (95% CI): 3.60 (2.45 to 5.28) Safety*: TEAEs occurred in 45% of the PBO group and 44% of the INVEGA SUSTENNA group in the double-blind phase. AEs occurring more frequently (≥2% difference) with INVEGA SUSTENNA than with PBO included weight increase (7% vs 1%) and blood glucose increase (3% vs 1%). Serious AEs occurred in 13% of PBO and 5% of INVEGA SUSTENNA patients.
Abbreviations: AE, adverse event; CGI-S-SCA, Clinical Global Impression of Severity-Schizoaffective Disorder; CI, confidence interval; IM, intramuscular; ITT, intent-to-treat; LOCF, last observation carried forward; LS, least-squares; PANSS, Positive and Negative Syndrome Scale; PBO, placebo; PK, pharmacokinetics; PP1M, paliperidone palmitate 1-month; RIS, Risperidone; RLAI, Risperdal long-acting injection; TEAE, treatment-emergent adverse event. ^aRelapse was defined as the first occurrence of: psychiatric hospitalization due to worsening of symptoms; any intervention to avert imminent hospitalization due to worsening of symptoms, clinically significant self-injury, suicidal or homicidal ideation, or violent behaviors; worsening of ≥1 of the following PANSS items to a score ≥6 after randomization if the score was ≤4 at randomization: delusions, conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, uncooperativeness or poor impulse control; worsening in any of the following measures at 2 consecutive visits within 7 days: ≥25% increase in PANSS total score from randomization if the score was >45 at randomization, ≥10-point increase in PANSS total score from randomization if the score was ≤45 at randomization, worsening of ≥1 of the following PANSS items to a score ≥5 after randomization if the score was ≤3 at randomization: delusions, conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, uncooperativeness or poor impulse control; OR increase in CGI-S-SCA ≥2 points if the score at randomization was 1 (not ill) to 3 (mildly ill) OR increase ≥1 point if the score at randomization was ≥4 (moderately ill or worse).

Real-world Observational Studies

Sun et al (2024)¹⁰ conducted a single-center retrospective chart review from October 2015 to October 2022 at an acute care psychiatric hospital in the US. The dosing strategies, safety and effectiveness of 5 long-acting injectable (LAI) antipsychotics, including INVEGA SUSTENNA, in adolescent and pediatric patients with psychiatric disorders were evaluated.

Results

Forty-five patients were newly initiated on LAIs (mean age [±standard deviation (SD)], 15.6 [±1.67] years; male, 57.8%; Black or African-American, 60%; White, 37.8%), with a primary diagnosis of schizophrenia spectrum and other psychotic disorders (42.2%); bipolar disorders (31.1%); disruptive, impulse control, and conduct disorders (13.3%); autistic disorder (11.1%); and attention-deficit or hyperactivity disorder (ADHD; 2.2%).
INVEGA SUSTENNA was the most commonly prescribed LAI antipsychotic (n=21; 46.7%).
Of the patients receiving INVEGA SUSTENNA, 14 each received a loading dose and a maintenance dose per the adult dosing recommendation, and 7 each received a loading dose and a maintenance dose different from the adult dosing recommendation.
The non-standardized dosing regimens for INVEGA SUSTENNA are summarized in Table: Non-Standard INVEGA SUSTENNA Dosing Regimens.

Non-Standard INVEGA SUSTENNA Dosing Regimens¹⁰

Age, Sex, and Primary Diagnosis	Oral Antipsychotic for Dose Stabilization	Regimen Provided
17, female, bipolar disorder	Risperidone 1 mg daily	156 mg IM followed by 117 mg IM 3-11 days later, and 78 mg IM monthly maintenance dose
16, male, conduct disorder	Risperidone 1.5 mg daily	156 mg IM followed by 117 mg IM 3-11 days later, and 117 mg IM monthly maintenance dose
15, female, schizoaffective disorder	Paliperidone 6 mg daily	156 mg IM followed by 117 mg IM 3-11 days later
17, female, bipolar disorder	Paliperidone 3 mg daily	156 mg IM followed by 117 mg IM 3-11 days later, and 117 mg IM monthly maintenance dose
14, male, unspecified psychotic disorder	Paliperidone 3 mg daily	156 mg IM followed by 117 mg IM 3-11 days later
15, male, intermittent explosive disorder	Paliperidone 6 mg daily	156 mg IM followed by 117 mg IM 3-11 days later
10, male, autistic disorder	Risperidone 5 mg daily	No loading dose was provided. 156 mg IM given with oral overlap for 3 weeks; maintenance dose subsequently increased to 234 mg IM, given alongside oral overlap for 2 weeks
17, male, unspecified psychotic disorder	Risperidone 2 mg daily	117 mg IM monthly maintenance dose
10, male, autistic disorder	Risperidone 1.5 mg daily	156 mg IM monthly maintenance dose
17, male, schizoaffective disorder	Risperidone 6 mg daily	156 mg IM monthly maintenance dose
17, male, bipolar disorder	Risperidone 3 mg daily	117 mg IM monthly maintenance dose
Abbreviation: IM, intramuscular.

The study did not report outcomes based on the alternate initiation regimen. However, the overall results from the INVEGA SUSTENNA regimens used above were as follows:
- The mean (SD) length of hospital stay was 20.9 (13.0) days, and days to readmission was 70.6 (32.6) days.
- Five patients reported adverse effects, including weight gain, metabolic effect, constipation, difficulty thinking or concentrating, and extrapyramidal symptoms (n=1, each).

Kim et al (2023)¹¹ conducted a retrospective study to evaluate the clinical and safety outcomes associated with earlier than label-recommended administration of the second INVEGA SUSTENNA initiation dose.

Study Design/Methods

The study divided patients into 2 groups: those who received the second initiation dose of INVEGA SUSTENNA 3-11 days after the initial dose (traditional, per label; n=316; median age, 31 years) and those who received the second initiation dose 1-2 days after the initial dose (nontraditional, earlier than indicated per label; n=47; median age, 32 years). The primary outcomes included 30-day readmission, index hospitalization length of stay, and time (days) until the next psychiatric hospitalization. The secondary outcomes included 6-month readmission and safety or tolerability upon regimen completion.

Results

The second INVEGA SUSTENNA injection was administered after a median of 4 and 2 days after the first injection in the traditional and nontraditional groups, respectively.
Some patients in both groups received either one or both initiation doses as gluteal injections (not consistent with the label), however, there was no difference between the groups in the number of patients who received one or both doses as gluteal injections.
Primary outcomes were as follows:
- Readmission rate within 30 days of index hospitalization was not significantly different (traditional, 9.2%; nontraditional, 12.8%; P=0.604).
- Median index hospitalization length of stay was significantly shorter in the nontraditional group (traditional, 11 days; nontraditional, 7 days; P<0.001).
- Median time until the next psychiatric hospitalization was not significantly different (traditional, 47 days; nontraditional, 25 days; P=0.50).
Secondary outcomes were as follows:
- Readmission rate within 6 months was similar (traditional, 21.2%; nontraditional, 21.3%; P=1.0).
- Minimal to no adverse drug reactions were reported in either group.

Menendez Gil et al (2022)¹² conducted a real-world, retrospective, noninterventional study to evaluate the effectiveness of alternate initiation doses of INVEGA SUSTENNA in 51 patients acutely hospitalized with schizophrenia and other psychotic diagnoses.

The study evaluated patients initiated on 1 of the 3 regimens of INVEGA SUSTENNA: standard doses (n=31; day 1, 150 mg eq; day 8±4, 100 mg eq), low doses (n=13; doses lower than the standard doses), and high doses (n=7; day 1, 150 mg eq; day 8±4, 150 mg eq). The effectiveness of the alternate initiation regimens was evaluated based on the number of psychiatric hospital admissions and psychiatric emergency visits 6 months after discharge. The study reported no significant difference in the effectiveness of the alternate initiation doses of INVEGA SUSTENNA between the groups.

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 11 November 2024.

References

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2	Carpenter J, Wong KK. Long-acting injectable antipsychotics: what to do about missed doses: what to do about missed doses. Curr Psychiatry. 2018;17(7):10-12,14-19,56.
3	Samtani MN, Sliwa JK, Haskins JT, et al. Initiation dosing of deltoid intramuscular paliperidone palmitate in schizophrenia: pharmacokinetic rationale based on modeling and simulation. Poster presented at: the Annual Meeting of the College of Psychiatric and Neurologic Pharmacists; April 19-22, 2009; Jacksonville, FL.
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7	Gopal S, Hough DW, Xu H, et al. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacol. 2010;25(5):247-256.
8	Hough D, Gopal S, Vijapurkar U, et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res. 2010;116(2-3):107-117.
9	Fleischhacker WW, Gopal S, Lane R, et al. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Int J Neuropsychopharmacol. 2012;15(1):107-118.
10	Sun C, Temelie A, Goulding H, et al. Long-acting injectable antipsychotic initiation in child and adolescent patients with psychiatric disorders. [Published online August 26, 2024]. J Child Adolesc Psychopharmacol. 2024. doi:10.1089/cap.2024.0024.
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13	Haskins JT, Sliwa JK, Ma Y-W, et al. Efficacy and safety of 234 mg initiation dose and 3-fixed maintenance doses of paliperidone palmitate-a once-monthly injectable atypical antipsychotic. Poster presented at: the US Psychiatric and Mental Health Congress; November 2-5, 2009; Las Vegas, NV.