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INVEGA SUSTENNA® (paliperidone palmitate)

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Adverse Event of INVEGA SUSTENNA - Hyperglycemia and Diabetes Mellitus

Last Updated: 04/17/2025

Summary

Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.¹
Hyperglycemia, which may be associated with ketoacidosis, hyperosmolar coma, or death, and diabetes mellitus have been reported in patients treated with atypical antipsychotics.² Hyperinsulinemia and hyperglycemia were uncommon in trial subjects treated with INVEGA SUSTENNA.¹
In 2 randomized, double-blind (DB), placebo (PBO)-controlled clinical trials (n=388; n=652),³^,⁴ one phase 3 cross-over trial (n=252),⁵ two noninferiority trials (n=1,214; n=452),⁶^,⁷ and a long-term safety study (n=212),⁸ glucose-related adverse events were reported in ≤2% of schizophrenia patients. In a longer-term relapse prevention trial,⁹^,¹⁰ a 13-week, DB trial in Asian patients (n=323),¹¹ and an open-label (OL) study in Japanese patients (n=201),¹² glucose-related adverse events were reported in ≤4% of schizophrenia patients.
A long-term open-label extension (OLE) phase of a DB recurrence prevention trial evaluated the effects of INVEGA SUSTENNA on metabolic parameters in subjects with schizophrenia. INVEGA SUSTENNA was associated with a mean change in glucose of +3.6 mg/dL from OLE baseline to endpoint (n=388).¹³

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 mg 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.

BACKGROUND

The use of second-generation antipsychotics (SGAs) has been associated with an increased risk of diabetes and hyperglycemia-related adverse events, including severe hyperglycemia, ketoacidosis, hyperosmolar coma, or death.² Metabolic abnormalities, such as diabetes, and other risk factors observed in patients with schizophrenia are associated with an increased risk of cardiovascular disease (CVD) and mortality.¹⁴ Because there is limited data on drug-naïve patients, it is unclear whether these metabolic abnormalities are due to the drug treatment or to the psychiatric disease itself.

The prevalence of diabetes in patients with schizophrenia has been estimated to be approximately 1.5- to 2-fold higher than the prevalence in the general population.¹⁴ Genetic factors and lifestyle characteristics such as sedentary behavior may contribute to the higher prevalence of metabolic abnormalities. Weight gain may be a contributing factor to metabolic abnormalities such as insulin resistance, pre-diabetes, and diabetes; however, individuals receiving antipsychotics may develop diabetes without weight gain. Another possible mechanism for drug-associated hyperglycemia may be associated with the effects of antipsychotics on pancreatic receptors and normal insulin secretion. Treatment selection must be individualized on the basis of specific patient risk factors to ensure the benefits outweigh the risks.

Guidelines recommend screening for diabetes risk factors at baseline. Fasting plasma glucose or hemoglobin A_1C be monitored at baseline, 4 months post-treatment, and every year thereafter.² Fasting plasma glucose may provide a more appropriate measure of glucose control in the early weeks of treatment while hemoglobin A_1C provides a measure of longer-term control.¹⁴ Glucose values indicative of diabetes are ≥125 mg/dL (fasting blood glucose), >200 mg/dL (random blood glucose), or hemoglobin A_1C >6.5%; any of these values should prompt follow-up with medical consultation.² More frequent monitoring may be indicated in the presence of weight change, symptoms of diabetes, or a random measure of blood glucose >200 mg/dL.

SCHIZOPHRENIA AND SCHIZOAFFECTIVE CLINICAL TRIAL RESULTS

Results from clinical trials in patients with schizophrenia or schizoaffective disorder are summarized in Table: Schizophrenia or Schizoaffective Disorder Clinical Trial Results.

Schizophrenia or Schizoaffective Disorder Clinical Trial Results

Trial Design	Treatment	Glucose-Related Adverse Events
DB Trials including OLE and Post Hoc Analyses
Hough (2010)¹⁰ conducted a longer-term, DB, randomized, multicenter, PBO-controlled, parallel-group study examining the efficacy and safety of INVEGA SUSTENNA. in delaying time to relapse in patients with schizophrenia after an initial 9-week, OL transition phase and a 24-week, OL maintenance phase (transition and maintenance population, n=849; DB safety analysis set, n=408).	Dosing Schedule (all doses administered IM via gluteal muscle): ≤7-day screening, washout, and tolerability period followed by 9-week, OL transition phase INVEGA SUSTENNA 78 mg on day 1 and day 8 followed by adjustable INVEGA SUSTENNA doses (39, 78, or 156 mg) were administered every 4 weeks for the rest of the transition period. 24-week, OL maintenance phase Adjustable INVEGA SUSTENNA doses (39, 78, or 156 mg) were administered every 4 weeks for the first 12 weeks followed by fixed INVEGA SUSTENNA doses of 39, 78, or 156 mg every 4 weeks for the last 12 weeks. DB phase Fixed INVEGA SUSTENNA doses of 39, 78, or 156 mg (n=205) or PBO (n=203) every 4 weeks.	Across all phases of the study, the incidence of glucose-related AEs was ≤4%.
Gopal (2011)⁹; Alphs (2009)¹³ conducted a 52-week, OLE study assessing the long-term safety and efficacy of INVEGA SUSTENNA in patients with schizophrenia following a DB, randomized, multicenter, international, PBO-controlled, parallel-group trial (n=388) (Hough 2010).¹⁰	Study Treatment (all doses administered IM via gluteal muscle): Each patient entering the OLE phase received a total of 12 INVEGA SUSTENNA doses beginning with a 78 mg dose. Every 4 weeks, starting with the second injection, doses were titrated up or down in 39 mg increments to meet clinical needs (doses of INVEGA SUSTENNA 39, 78, 117, or 156 mg). Oral supplementation with PALI ER was permitted for all patients for the first 8 OLE weeks to avoid treatment interruption (initiated at 6 mg/day; titrated up or down in 3 mg/day increments within a range of 3-12 mg/day). Study Groups PBO/INVEGA SUSTENNA (n=153): PBO during DB phase; INVEGA SUSTENNA during OLE phase. INVEGA SUSTENNA/INVEGA SUSTENNA (n=161): INVEGA SUSTENNA during DB and OLE phases. No DB/INVEGA SUSTENNA (n=74): Patients in transition or maintenance phases entering directly into the OLE phase upon DB termination.	Glucose levels increased by 3.6 mg/dL, and insulin levels increased by 0.24 microIU/mL from OLE baseline to endpoint. Glucose-related TEAEs reported in 14 patients (4%) were blood glucose increased (n=9), diabetes mellitus (n=3), hyperglycemia (n=2), and increased insulin requirement (n=2). One PBO/INVEGA SUSTENNA patient discontinued treatment because of diabetes mellitus; the patient had no previous history of diabetes but had increased glucose, insulin, and C-peptide levels at transition baseline. Mean HOMA-IR values of 2.5 at the open-label stabilization baseline indicate that patients had evidence of insulin resistance at study entry. Post Hoc Analysis A post hoc analysis of the Hough (2010) and Gopal (2011) trials assessed the following outcome: recent diagnosis¹⁵
Sliwa (2014)¹⁶ conducted a post hoc analysis of Hough (2010)¹⁰ and Gopal (2011)⁹ that evaluated the long-term effects of INVEGA SUSTENNA on metabolic AEs; patients were grouped according to BMI (underweight, <19 kg/m²; normal, 19-24 kg/m²; overweight, 25-29 kg/m²; obese, ≥30 kg/m²).	See Hough (2010)¹⁰ and Gopal (2011)⁹ Study Groups Underweight (n=29) Normal (n=229) Overweight (n=232) Obese (n=154) Includes only those patients treated with INVEGA SUSTENNA continuously from study entry through discontinuation or study completion.	Elevated blood glucose and insulin were two of the most common (≥2%) metabolic-related TEAEs from OL transition (TR) to OLE endpoint: Underweight: 0%; 0% Normal: 2.2%; 0.9% Overweight: 3.9%; 1.7% Obese: 4.6%; 4.6% Mean change in glucose: Mean glucose levels increased significantly from TR baseline to both DB (P=0.0068) and OLE (P=0.0036) endpoints in the overweight group, and from TR baseline to OLE endpoint (P=0.0019) in the normal weight group. TR baseline to DB endpoint and OLE endpoint: Glucose (mg/dL), mean change (n) Underweight: 14.6 (5); 3.9 (8) Normal: 2.0 (70); 10.2 (85), P=0.0019 Overweight: 7.0 (68), P=0.0068; 9.9 (77), P=0.0036 Obese: -2.1 (52); 3.5 (39) Mean change in insulin: There was no significant difference in mean insulin levels throughout the study between any of the BMI groups. Change in HOMA-IR: Baseline values indicated pre-existing insulin resistance across all BMI groups. Minimal change occurred from TR baseline to OLE endpoint across all BMI groups. Change in HOMA-%β: Baseline geometric mean values were above normal (>100) in overweight and obese groups and below normal in the underweight group. At OLE endpoint, values decreased from TR baseline in the normal, overweight, and obese groups and increased in the underweight group.
Pandina (2011)⁶ conducted a 13-week, randomized, DB, double-dummy, active-controlled, parallel-group, multicenter study assessing noninferiority of INVEGA SUSTENNA to RLAI in patients with schizophrenia (n=1,214, safety analysis set).	Following a ≤7-day screening, washout, and tolerability period, patients were randomized to 1 of 2 treatments for a 13-week, DB period: INVEGA SUSTENNA (n=606) Deltoid injection of INVEGA SUSTENNA 234 mg on day 1 followed by a 156-mg deltoid injection on day 8; thereafter, patients received flexibly dosed INVEGA SUSTENNA injections on days 36 (78 or 156 mg) and 64 (78, 156, or 234 mg) in either the deltoid or gluteal muscle. RIS-matched PBO RLAI-matched PBO RLAI (n=608) RLAI 25 mg on days 8 and 22, followed by 25 or 37.5 mg on days 36 and 50; thereafter, patients received flexible doses of 25, 37.5, or 50 mg on days 64 and 78, all in the gluteal muscle. INVEGA SUSTENNA-matched PBO Oral supplementation with RIS (1-6 mg) for the first 28 days. Optional supplementation with RIS 1-2 mg for 21 days could be administered with dose increases on day 36 and day 64.	No reports of abnormal glucose values. The incidence of glucose-related TEAEs was low between treatment groups (<1%): INVEGA SUSTENNA: 0.5%; RLAI: 0.5%. Post Hoc Analyses Additional post hoc analyses of the Pandina (2011) trial assessed the following outcomes: marked to severe illness¹⁷; recent diagnosis¹⁸; prior oAPs.¹⁹
Gopal (2010)⁴ conducted a 13-week, multicenter, randomized, DB, PBO-controlled, parallel-group, dose-response study evaluating the efficacy and safety of 3 fixed doses of INVEGA SUSTENNA in patients with schizophrenia (n=388, safety analysis set).	Following a washout, screening, and tolerability period that lasted for ≤7 days, patients were each 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, 8, 36, and 64.	The incidence of glucose-related AEs was similar between patients receiving INVEGA SUSTENNA (2%, n=5) and those receiving PBO (2%, n=3). With the exception of 1 PBO-treated patient, all glucose-related AEs occurred in patients with a history of diabetes or increased glucose levels at baseline.
Kramer (2010)²⁰ conducted a 9-week, DB, randomized, international study comparing the safety and efficacy of INVEGA SUSTENNA (two fixed doses) vs PBO in the treatment of adults with schizophrenia (n=247).	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 78 mg (n=79), INVEGA SUSTENNA 156 mg (n=84), or PBO (n=84) on days 1, 8, and 36.	No clinically relevant, treatment-emergent changes in glucose levels occurred during the study. In the INVEGA SUSTENNA 78-mg group, an abnormally high glucose level (>16.7 mmol/L) was reported for 1 patient, and an abnormally low glucose level (<2.2 mmol/L) was reported for another patient.
Pandina (2010)³; Haskins (2009)²¹ conducted a 13-week, multicenter, randomized, DB, PBO-controlled, international dose response INVEGA SUSTENNA study conducted in patients experiencing an acute exacerbation of established schizophrenia (n=652).	Following a ≤7-day screening, washout, and tolerability period, patients were randomized to one of three INVEGA SUSTENNA treatment arms or PBO: Initiation Dose Day 1 (deltoid IM Inj): INVEGA SUSTENNA 234 mg (n=488); PBO (n=164) Fixed Dose Day 8, 36, and 64 (deltoid or gluteal IM Inj): INVEGA SUSTENNA 234 mg (n=163); INVEGA SUSTENNA 156 mg (n=165); INVEGA SUSTENNA 39 mg (n=160); PBO (n=164)	No clinically significant changes were observed in fasting blood glucose levels between patients in the INVEGA SUSTENNA group and those in the PBO group. No glucose-related TEAEs occurred in INVEGA SUSTENNA-treated patients. During days 1-7, increased blood insulin levels were reported in 1 INVEGA SUSTENNA-treated patient and diabetes mellitus was reported in 1 PBO-treated patient. Post Hoc Analyses Additional post hoc analyses of the Pandina (2010) trial assessed the following outcomes: marked to severe exacerbations²²; recent treatment with oral risperidone.²³
Nasrallah (2010)²⁴ conducted a 13-week, multicenter, randomized, DB, PBO-controlled, parallel-group, dose-response study evaluating the efficacy and safety of 3 fixed doses of INVEGA SUSTENNA in patients with schizophrenia (n=517, safety analysis set).	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, 8, 36, and 64.	No clinically relevant mean changes at all time points in glucose levels.
Hough (2009)⁵ conducted a 25-week, randomized, DB, multicenter, cross-over study assessing the safety and tolerability of INVEGA SUSTENNA administered via a deltoid or gluteal IM injection in adults with stable schizophrenia (n=252, safety analysis set).	Following a washout, screening, and tolerability period that lasted ≤7 days, patients were randomized to receive one of two injection-site sequences (Period 1: Doses administered on days 1, 8, 36, and 64 followed by Period 2: Doses administered on days 92, 120, and 148): 1) GD (gluteal IM inj during period 1 followed by deltoid IM inj during period 2) 2) DG (deltoid IM inj during period 1 followed by gluteal IM inj during period 2) INVEGA SUSTENNA doses: 78 mg: GD (n=40); DG (n=42) 117 mg: GD (n=44); DG (n=40) 156 mg: GD (n=40); DG (n=46)	A glucose-related TEAE event of abnormal blood glucose level was reported for one patient in the 117 mg DG group at the end of period 2.
Fu et al (2015)²⁵ conducted an international, long-term, DB, PBO-controlled, randomized-withdrawal study of INVEGA SUSTENNA in patients with schizoaffective disorder.	7-day screening period, during which patients received oral tolerability testing if necessary 13-week, OL, lead-in period, during which patients received INVEGA SUSTENNA (234 mg on day 1 and 156 mg on day 8 in the deltoid muscle, followed by flexible doses [78-234 mg] on days 36, 64, and 92), as monotherapy or as an adjunct to, stable doses of their adjunctive mood stabilizer or antidepressant medications 12-week, OL, fixed-dose phase, during which patients who met predefined stabilization criteria received INVEGA SUSTENNA once every 4 weeks, at the final dose received during the lead-in period 15-month, DB phase, during which patients who maintained stability based on predefined criteria were randomized to PBO or a fixed dose of INVEGA SUSTENNA	667 patients (mean age: 39.5 years; 53.5% male; 53.1% white) were enrolled in the OL phase. The INVEGA SUSTENNA dose distribution during the DB phase: 78 mg (4.9%), 117 mg (9.8%), 156 mg (47%) or 234 mg (38.4%) doses. During the DB phase, glucose-related AEs occurred in 1.8% and 2.4% of INVEGA SUSTENNA and PBO patients, respectively. One INVEGA SUSTENNA patient discontinued treatment due to an increase in blood glucose.
ADDITIONAL DB TRIALS
Savitz et al (2016)²⁶ conducted a randomized, DB, parallel-group, multicenter, noninferiority study of PP3M and INVEGA SUSTENNA.	During the OL stabilization phase, 1429 patients received INVEGA SUSTENNA in the following doses: Initiation doses, IM deltoid (234 mg on day 1; 156 mg on day 8); Weeks 5 and 9: flexible dosing between 78-234 mg (deltoid or gluteal administration). The week 13 dose was the same as week 9. Based on pre-defined criteria, patients who were clinically stable after completing the OL phase were randomized (1:1) into the 48-week, DB phase. Patients received fixed doses of INVEGA SUSTENNA every 4 weeks (78, 117, 156 or 234 mg; n=512) or PP3M every 3 months (273, 410, 546, 819 mg; n=504) in the deltoid or gluteal muscle.	The mean duration of exposure was 295.1 days for PP3M at a mean dose of 647.01 mg and 286.7 days for INVEGA SUSTENNA at a mean dose of 185.8 mg. A lower frequency of diabetes mellitus and hyperglycemia-related TEAEs were reported in the PP3M group (2.6%) vs the INVEGA SUSTENNA group (4.9%). From DB baseline to endpoint, the change in insulin and fasting glucose was 1.1 pmol/L and -0.004 mmol/L, respectively for PP3M and 6.9 pmol/L and 0.086 mmol/L, respectively for INVEGA SUSTENNA.
McEvoy et al (2014)²⁷ conducted the ACLAIMS study, a DB, randomized, multisite, parallel-group US clinical trial comparing the effectiveness of INVEGA SUSTENNA versus haloperidol decanoate for the maintenance treatment of schizophrenia or schizoaffective disorder (N=311).	Eligible patients were randomized on a 1:1 basis to INVEGA SUSTENNA or HAL decanoate: Long-acting injectable treatment (≤24 months): INVEGA SUSTENNA (n=147): Initiation doses, IM deltoid (234 mg on day 1; 156 mg on day 8); Maintenance doses, IM deltoid or gluteal (117 mg monthly) HAL decanoate (n=147): Initiation doses, IM deltoid (50 mg on day 1; 50 mg on day 8); Maintenance doses, IM deltoid or gluteal (75 mg on days 28 and 56, then 50 mg monthly) Injection schedules were adjusted based on clinical judgment.	Secondary outcomes included the “worst” changes in metabolic parameters (interventions to treat abnormalities were permitted). Mean monthly doses of INVEGA SUSTENNA and HAL decanoate ranged from 129-169 mg and 67-83 mg, respectively. Patients were followed for a median of 488 days. There were no statistically significant differences between treatment groups with regard to mean changes in the highest recorded levels of hemoglobin A_1C and glucose.
Takahashi et al (2013)¹¹ conducted a 13-week, randomized, DB, PBO-controlled trial assessing the safety and efficacy of INVEGA SUSTENNA in Asian patients with schizophrenia (N=323; mean age: 45 years; 57% male).	INVEGA SUSTENNA, n=159: 234 mg on day 1 (deltoid IM); 156 mg on day 8 (deltoid IM); once-monthly injections of 117 mg (deltoid IM or gluteal IM) on days 36 and 64. PBO, n=164	Mean duration of INVEGA SUSTENNA and PBO exposure was 87 and 50 days, respectively. Glucose-related TEAEs, mild or moderate in severity, were reported in 2.4% and 3.1% of the PBO and INVEGA SUSTENNA groups.
RATER-BLINDED STUDIES
Li (2011)⁷ 13-week, randomized, active-controlled, parallel-group, multicenter, OL, rater-blinded study assessing noninferiority of INVEGA SUSTENNA to RLAI in Chinese patients with acute schizophrenia (n=452, safety analysis set).	Following a ≤7-day screening, washout, and tolerability period, patients were randomized to receive INVEGA SUSTENNA or RLAI: INVEGA SUSTENNA (n=229) Deltoid IM injection on day 1 (234 mg) and day 8 (156 mg) with the optional injection site of the gluteal muscle for days 36 (78 or 156 mg) and 64 (78 to 234 mg). RLAI (n=223) Gluteal IM injection on days 8 and 22 (25 mg); flexible doses of 25 or 37.5 mg on days 36 and 50; and flexible doses of 25 to 50 mg every 2 weeks thereafter beginning on day 64. Daily oral RIS supplementation occurred during the first 4 weeks (2 mg on day 1 and flexible doses of 1-6 mg on days 2 through 28). Additional oral RIS 1-2 mg was allowed during the 3 weeks after each dose increase.	The only glucose-related TEAE was increased blood glucose, which was reported in ≤2 patients (<1%) in each group: 1 patient (0.4%) in the INVEGA SUSTENNA group; 2 patients (0.9%) in the RLAI group.
OL STUDIES
Wakamatsu et al (2013)¹² conducted a 57-week, OL, flexible-dose study evaluating the long-term safety and efficacy of INVEGA SUSTENNA in Japanese patients with schizophrenia (N=201; mean age: 45.5 years; 51.7% male; n=184/safety analysis set).	INVEGA SUSTENNA 234 mg on day 1 (deltoid IM) INVEGA SUSTENNA 156 mg on day 8 (deltoid IM) Followed by flexible once-monthly injections (deltoid IM or gluteal IM)	Patients received a mean INVEGA SUSTENNA dose of 166.8 mg for a mean duration of 238.7 days. Glucose-related TEAEs were reported in ≤2.5% of patients.
Zhang et al (2015)²⁸ conducted a phase 3b, OL, multicenter study evaluating the safety, tolerability, and efficacy of INVEGA SUSTENNA in Asian/Australian patients with recent-onset schizophrenia who previously failed treatment with oral antipsychotics (n=521 ITT/safety population).	≤7-day screening followed by an 18-month treatment phase INVEGA SUSTENNA 234 mg on day 1 (deltoid IM) INVEGA SUSTENNA 156 mg on day 8 (deltoid IM) Followed by flexible once-monthly injections of 78-234 mg (deltoid IM or gluteal IM)	Mean duration of exposure: 382.6 days. Mean maintenance dose after day 8: 157.2 mg. Glucose-related TEAEs occurred in 0.6% of patients. Two cases of diabetes mellitus were reported (inadequate control of diabetes mellitus; abnormal blood glucose).
Coppola (2012)⁸ 56-week, OL, multidose, multicenter study evaluating the pharmacokinetics and long-term safety and tolerability of INVEGA SUSTENNA 234 mg in adults with stable schizophrenia (n=212, safety analysis set).	Following a screening and washout phase of ≤21 days, each patient received a deltoid IM injection of INVEGA SUSTENNA 234 mg on day 1. Each patient who tolerated the dose (Treatment A, n=186) received a second deltoid IM injection of INVEGA SUSTENNA 234 mg on day 8 and 12 once-monthly injections (deltoid or gluteal muscle) starting on day 36. Patients who were unable to tolerate the 234 mg dose or unwilling to participate in intensive pharmacokinetic sampling (Treatment B, n=26) received a second IM injection of INVEGA SUSTENNA 78-234 mg (flexible dose) on day 8 (deltoid or gluteal muscle) and 12 once-monthly injections starting on day 36 (deltoid or gluteal muscle).	An AE of diabetes mellitus was reported in 4 patients (<2%), all of whom were obese or overweight and had screening or baseline fasting blood glucose levels in the prediabetic or diabetic range. Of these 4 patients, 1 patient had a history of impaired glucose tolerance and 1 patient had elevated hemoglobin A_1C at baseline. No other treatment-emergent glucose-related AEs were reported.
Abbreviations: AE, adverse event; AP, antipsychotic; BMI, body mass index; DB, double-blind; ER, extended-release; FPG, fasting plasma glucose; HOMA-%β, homeostatic model assessment for beta-cell function; HOMA-IR, Homeostatic Model Assessment for Insulin Resistance; IM, intramuscular; OL, open-label; OLE, open-label extension; PALI, paliperidone; PBO, placebo; PP3M, paliperidone palmitate 3-month; RIS, risperidone; RLAI, risperidone long-acting injection; TEAE, treatment-emergent adverse event; TR, transition.

OTHER RELEVANT LITERATURE

Several observational studies²⁹^-³¹ also assessed metabolic changes in patients on INVEGA SUSTENNA treatment.

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 10 April 2025.

References

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