Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone is not approved for the treatment of patients with dementia-related psychosis.
Irritability associated with autistic disorder: Limited data available: Children ≥12 years and Adolescents: Oral: Extended-release tablet: Initial: 3 mg once daily; titrate on a weekly basis in 3 mg/day increments until clinical response or intolerance; maximum daily dose: 12 mg/day. Dosing based on an open-label trial of 25 patients (mean age: 15.3 years; age range: 12 to 21 years); therapeutic response was reported in 84% of patients at a mean final dose: 7.1 mg/day (Stigler 2012).
Schizoaffective disorder:
Oral: Extended-release tablet: Adolescents ≥18 years: Usual: 6 mg once daily (administered in the morning in clinical trials); titration not required, though some may benefit from lower or higher doses (range: 3 to 12 mg daily). If exceeding 6 mg daily, increases of 3 mg daily are recommended at intervals of more than 4 days, up to a maximum daily dose: 12 mg/day.
Parenteral: Adolescents ≥18 years: Monthly paliperidone injection (Invega Sustenna): IM: Note: Prior to initiation of monthly IM paliperidone, patients naive to oral paliperidone or oral or injectable risperidone should have tolerability established with a test dose of oral paliperidone or oral risperidone. Previous oral antipsychotic regimen can be gradually discontinued at the time of initiation of monthly IM paliperidone.
Initiation of therapy (2-dose series):
Initial: 234 mg on treatment day 1 followed by 156 mg 1 week later with both doses administered in the deltoid muscle. The second dose may be administered 4 days before or after the weekly time point.
Missed second initiation dose: If the target administration date of 1 week ± 4 days for the second dose is missed, catch-up dosing depends on the time elapsed since the first dose.
Time elapsed since last first dose |
Catch-up dose for therapy initiation |
---|---|
<4 weeks |
Administer the missed dose 156 mg (in the deltoid) as soon as possible, followed by a third dose of 117 mg (in either the deltoid or gluteal muscle) 5 weeks after the first injection (regardless of when the second injection was administered), then begin normal monthly maintenance dosing. |
≥4 weeks to ≤7 weeks |
Administer a dose of 156 mg (in the deltoid) as soon as possible, followed by another 156 mg dose (in the deltoid) 1 week later, then begin normal monthly maintenance dosing |
>7 weeks |
Reinitiate following dosing recommendations for initiation of therapy |
Maintenance: First maintenance injection should be administered 5 weeks after the first injection of the initial series. Adjust the dose based on response and tolerability and begin a maintenance dose of 78 to 234 mg (every month administered in either the deltoid or gluteal muscle). The monthly maintenance dose may be administered 7 days before or after the monthly time point.
Missed maintenance dose: Dose and interval dependent upon time since last dose, see table:
Time elapsed since last monthly maintenance injection |
Catch-up dosing |
---|---|
≥4 weeks to ≤6 weeks |
Administer the missed dose as soon as possible and continue therapy at monthly interval |
>6 weeks to ≤6 months and dose <234 mg |
Administer the same dose the patient was previously stabilized on in the deltoid as soon as possible, followed by a second equivalent dose in the deltoid 1 week later, then resume maintenance dose at monthly intervals. |
>6 weeks to ≤6 months and dose 234 mg |
Administer a 156 mg dose in the deltoid as soon as possible, followed by a second dose of 156 mg in the deltoid 1 week later, then resume maintenance dose at monthly intervals. |
>6 months |
Reinitiate following dosing recommendations for initiation of therapy. |
Conversion from oral extended-release paliperidone to monthly IM paliperidone:
Initiate monthly IM paliperidone as described using the 1-week initiation regimen. Patients previously stabilized on oral doses can expect similar steady state exposure during maintenance treatment with monthly IM paliperidone using the following conversion:
Oral extended release once daily dose |
Monthly maintenance IM dose (Invega Sustenna) |
---|---|
3 mg |
39 to 78 mg |
6 mg |
117 mg |
9 mg |
156 mg |
12 mg |
234 mg |
Conversion from other oral antipsychotics to monthly IM paliperidone: There is no systematically collected data to address switching patients from other oral antipsychotics to monthly IM paliperidone.
Switching from other long-acting injectable antipsychotics (at steady-state) to monthly IM paliperidone: Initiate monthly IM paliperidone in the place of the next scheduled injection and continue at monthly intervals; may be administered in the deltoid or gluteal muscle. The two initiation doses are not required in these patients.
Dosage adjustments: Adjustments may be made monthly (full effect from adjustments may not be seen for several months)
Schizophrenia:
Oral: Extended-release tablet:
Children ≥12 years and Adolescents <18 years: 3 mg once daily; titration not necessary; if after clinical assessment a dosage increase is required, may increase dose in 3 mg/day increments at least every 5 days; maximum daily dose is weight dependent: <51 kg: 6 mg/day; ≥51 kg: 12 mg/day; Note: During adolescent clinical trials, higher doses were not associated with greater efficacy, but increased risk of adverse effects.
Adolescents: ≥18 years: Usual dose: 6 mg once daily (administered in the morning in clinical trials); titration not required, though some may benefit from lower or higher doses (range: 3 to 12 mg daily). If exceeding 6 mg daily, increases of 3 mg daily are recommended no more frequently than every 5 days, up to a maximum of 12 mg daily.
Parenteral: Adolescents ≥18 years:
Monthly paliperidone injection (Invega Sustenna): IM: Note: Prior to initiation of monthly IM therapy, tolerability should be established with oral paliperidone or oral risperidone; may require test dose of oral paliperidone or risperidone. Previous oral antipsychotics can be discontinued at the time of initiation of IM therapy.
Initiation of therapy (2-dose series):
Initial: 234 mg on treatment day 1 followed by 156 mg 1 week later with both doses administered in the deltoid muscle. The second dose may be administered 4 days before or after the weekly time point.
Missed second initiation dose: If the target administration date of 1 week ± 4 days for the second dose is missed, catch-up dosing depends on the time elapsed since the first dose.
Time elapsed since last first dose |
Catch-up dose for therapy initiation |
---|---|
<4 weeks |
Administer the missed dose of 156 mg (in the deltoid) as soon as possible, followed by a third dose of 117 mg (in either the deltoid or gluteal muscle) 5 weeks after the first injection (regardless of when the second injection was administered), then begin normal monthly maintenance dosing. |
≥4 weeks to ≤7 weeks |
Administer a dose of 156 mg (in the deltoid) as soon as possible, followed by another 156 mg dose (in the deltoid) 1 week later, then begin normal monthly maintenance dosing |
>7 weeks |
Reinitiate following dosing recommendations for initiation of therapy |
Maintenance: First maintenance injection should be administered 5 weeks after the first injection of the initial series. Begin with a maintenance dose 117 mg every month administered in either the deltoid or gluteal muscle. Some patients may benefit from higher or lower monthly maintenance doses (monthly maintenance dosage range: 39 to 234 mg). The monthly maintenance dose may be administered 7 days before or after the monthly time point.
Missed maintenance dose: Dose and interval dependent upon time since last dose, see table:
Time elapsed since last monthly maintenance injection |
Catch-up dosing |
---|---|
≥4 weeks to ≤6 weeks |
Administer the missed dose as soon as possible and continue therapy at monthly interval |
>6 weeks to ≤6 months and dose <234 mg |
Administer the same dose the patient was previously stabilized on in the deltoid as soon as possible, followed by a second equivalent dose in the deltoid 1 week later, then resume maintenance dose at monthly intervals. |
>6 weeks to ≤6 months and dose 234 mg |
Administer a 156 mg dose in the deltoid as soon as possible, followed by a second dose of 156 mg in the deltoid 1 week later, then resume maintenance dose at monthly intervals. |
>6 months |
Reinitiate following dosing recommendations for initiation of therapy. |
Conversion from oral paliperidone to IM paliperidone monthly injection: Initiate IM therapy as described using the 1-week initiation regimen. Patients previously stabilized on oral doses can expect similar steady state exposure during maintenance treatment with IM therapy using the following conversion:
Oral extended release once daily dose |
Monthly maintenance IM dose |
---|---|
3 mg |
39 to 78 mg |
6 mg |
117 mg |
9 mg |
156 mg |
12 mg |
234 mg |
Switching from other long acting injectable antipsychotics to IM paliperidone: Initiate IM paliperidone in the place of the next scheduled injection and continue at monthly intervals. The 1-week initiation regimen is not required in these patients.
Dosage adjustments: Adjustments may be made monthly (full effect from adjustments may not be seen for several months)
Three-month paliperidone (Invega Trinza): IM: Note: 3-month IM paliperidone is to be used only after monthly IM paliperidone (Invega Sustenna) has been established as adequate treatment for at least 4 months. The last 2 doses of monthly IM paliperidone should be the same dosage strength before starting 3-month IM paliperidone.
Conversion from monthly injection and 3-month injection:
Monthly to 3-month injections: Initiate 3-month IM paliperidone when the next monthly IM paliperidone dose is scheduled. Base the 3-month dose on the previous monthly dose, using the equivalent 3.5 times higher dose (see following table). Three-month IM paliperidone may be administered up to 7 days before or after the next monthly dose date. Following the initial injection, administer every 3 months. Patients may be given the injection up to 2 weeks before or after the 3-month time point.
Three-month to monthly injections: Initiate monthly IM paliperidone when the next 3-month IM paliperidone dose is scheduled. Base the monthly dose on the previous 3-month dose, using the equivalent 3.5 times lower dose (see following table). After initial injection, administer once monthly.
Monthly IM paliperidone dose (Invega Sustenna) |
3-month paliperidone dose (Invega Trinza) |
---|---|
Note: Conversion from monthly IM paliperidone (Invega Sustenna) 39 mg to 3-month IM paliperidone (Invega Trinza) has not been studied. | |
78 mg |
273 mg |
117 mg |
410 mg |
156 mg |
546 mg |
234 mg |
819 mg |
Conversion from 3-month IM paliperidone to oral paliperidone extended-release tablets: Initiate paliperidone extended-release tablets at least 3 months after the last dose of 3-month IM paliperidone. Base the once daily extended-release tablet dose on the last 3-month injection dose and weeks since last administered. Use the following conversion.
3-month paliperidone dose (Invega Trinza) |
Time elapsed since last IM dose |
Oral extended release once daily dose |
---|---|---|
273 mg |
≥12 weeks |
3 mg |
410 mg |
12 weeks to ≤24 weeks |
3 mg |
>24 weeks |
6 mg | |
546 mg |
12 to ≤18 weeks |
3 mg |
>18 to ≤24 weeks |
6 mg | |
>24 weeks |
9 mg | |
819 mg |
12 to ≤18 weeks |
6 mg |
>18 to ≤24 weeks |
9 mg | |
>24 weeks |
12 mg |
Dosage adjustments: Dosage adjustments can be made every 3 months in increments within the range of 273 to 819 mg based on response and tolerability. Due to the long-acting nature, the patient's response to an adjusted dose may not be apparent for several months.
Missed doses: Dose and interval dependent upon time since last dose; use of the monthly dosage form (Invega Sustenna) may be necessary in some cases; see table:
Time elapsed since last 3 month maintenance dose |
Catch-up dosing |
---|---|
31/2 months to 4 months |
Administer the previous 3-month dose as soon as possible and continue with normal dosing |
4 months to 9 months and dose 273 mg |
Administer 78 mg of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle. Repeat same dose of monthly IM paliperidone (Invega Sustenna) 1 week later. One month following the second injection, administer 273 mg of 3-month IM paliperidone (Invega Trinza) into the deltoid or gluteal muscle and resume normal dosing at 3-month intervals |
4 months to 9 months and dose 410 mg |
Administer 117 mg of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle. Repeat same dose of monthly IM paliperidone (Invega Sustenna) 1 week later. One month following the second injection, administer 410 mg of 3-month IM paliperidone (Invega Trinza) into the deltoid or gluteal muscle and resume normal dosing at 3-month intervals. |
4 months to 9 months and dose 546 mg |
Administer 156 mg of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle. Repeat same dose of monthly IM paliperidone (Invega Sustenna) 1 week later. One month following the second injection, administer 546 mg of 3-month IM paliperidone (Invega Trinza) into the deltoid or gluteal muscle and resume normal dosing at 3-month intervals. |
4 months to 9 months and dose 819 mg |
Administer 156 mg of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle. Repeat same dose of monthly IM paliperidone (Invega Sustenna) 1 week later. One month following the second injection, administer 819 mg of 3-month IM paliperidone (Invega Trinza) into the deltoid or gluteal muscle and resume normal dosing at 3-month intervals. |
>9 months |
Re-initiate treatment with monthly IM paliperidone (Invega Sustenna). Three-month IM paliperidone can be resumed after the patient has been adequately treated with monthly IM paliperidone for at least 4 months. |
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosage adjustment for toxicity: Children ≥12 years and Adolescents: Severe neutropenia (ANC <1,000/mm3): Discontinue treatment.
All patients:
Clearance is decreased in renal impairment; adjust dose according to renal function:
Oral: There are no dosage adjustment provided in the manufacturer's labeling for pediatric patients ≤17 years. For older adolescents the following has been suggested:
Adolescents ≥18 years:
Mild impairment (CrCl 50 to 79 mL/minute): Initial dose: 3 mg once daily; maximum dose: 6 mg once daily
Moderate to severe impairment (CrCl 10 to 49 mL/minute): Initial dose: 1.5 mg once daily; maximum dose: 3 mg once daily
Severe impairment (CrCl <10 mL/minute): Use not recommended (has not been studied)
IM: Adolescents ≥18 years:
Mild impairment (CrCl 50 to 79 mL/minute):
Monthly IM paliperidone (Invega Sustenna): Initiation of therapy: 156 mg on treatment day 1, followed by 117 mg 1 week later with both doses administered in the deltoid, followed by a maintenance dose of 78 mg every month (administered in the deltoid or gluteal muscle)
Three-month IM paliperidone (Invega Trinza): Adjust dosage and stabilize the patient using the monthly IM injection, then transition to the 3-month IM injection. Note: Monthly IM paliperidone (Invega Sustenna) 78 mg = 3-month IM paliperidone (Invega Trinza) 273 mg.
Moderate to severe impairment (CrCl <50 mL/minute): Use not recommended
All patients: Oral, IM:
Mild to moderate (Child-Pugh class A or B): No adjustment necessary
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
(For additional information see "Paliperidone: Drug information")
Note: Paliperidone is a major, active metabolite of risperidone.
Schizophrenia and schizoaffective disorder:
Oral: Initial: 6 mg once daily; may adjust daily dose based on response and tolerability in increments of 3 mg every ≥5 days up to a maximum of 12 mg/day. Usual dosage range: 6 to 12 mg/day. Note: According to manufacturer's labeling, 3 mg/day may be effective for some patients (eg, those who do not tolerate 6 mg/day).
IM:
Note: Formulation contains paliperidone palmitate. Dosing in the US labeling is based on paliperidone palmitate; dosing in the Canadian labeling is based on paliperidone base (paliperidone palmitate 1 mg is equivalent to paliperidone base ~0.64 mg).
Monthly paliperidone (Invega Sustenna): Note: Before starting monthly IM paliperidone, establish tolerability with a test dose of oral paliperidone or oral risperidone. After initiating monthly IM paliperidone, overlap with oral antipsychotics is not necessary (Lauriello 2020).
Initiation: 234 mg (150 mg as base) on treatment day 1 followed by 156 mg (100 mg as base) 1 week later, with both doses administered in the deltoid muscle. The second dose may be administered 4 days before or after the 1-week time point. Note: When converting from other long-acting injectable antipsychotics (at steady state), initiation doses are not required.
Time since first injection |
Instructions |
---|---|
<4 weeks |
Administer 156 mg (100 mg as base) in the deltoid muscle as soon as possible, followed by 117 mg (75 mg as base) in either the deltoid or gluteal muscle 5 weeks after the first injection (regardless of when 156 mg dose was administered). Then begin monthly maintenance dose 4 weeks later. |
4 to 7 weeks |
Administer 156 mg (100 mg as base) in the deltoid muscle as soon as possible, followed by another 156 mg (100 mg as base) dose in the deltoid muscle 1 week later. Then begin monthly maintenance dose 4 weeks later. |
>7 weeks |
Reinitiate entire dose titration. |
Maintenance: Five weeks after the first initiation dose, begin a maintenance dose of 39 to 234 mg (25 to 150 mg as base) every month administered in either the deltoid or gluteal muscle. See the “Dose Conversions That Attain Similar Steady-State Paliperidone Exposure During Maintenance Treatment” table to identify an appropriate maintenance dose based on previous oral paliperidone dose or risperidone dose. The monthly maintenance dose may be administered 7 days before or after the monthly time point.
Time since last injection |
Instructions |
---|---|
4 to 6 weeks |
Administer the missed dose as soon as possible. Then resume usual monthly maintenance dose 4 weeks later. |
>6 weeks to 6 months |
Maintenance dose 39 to 156 mg (25 to 100 mg as base): Administer 2 maintenance doses in the deltoid muscle 1 week apart. Then resume usual monthly maintenance dose 4 weeks later. Maintenance dose 234 mg (150 mg as base): Administer 156 mg (100 mg as base) in the deltoid muscle as soon as possible, followed by another 156 mg (100 mg as base) in the deltoid muscle 1 week later. Then resume usual monthly maintenance dose 4 weeks later. |
>6 months |
Reinitiate entire dose titration. |
Dosage adjustments: Adjustments may be made monthly based on response and tolerability; the full effect from dose adjustments may not be apparent for several months.
3-month paliperidone (FDA-approved for schizophrenia only) (Invega Trinza): Note: 3-month IM paliperidone is to be used only after 4 doses of monthly IM paliperidone (Invega Sustenna). The last 2 doses of monthly IM paliperidone should be the same dosage strength before starting 3-month IM paliperidone.
Conversion from monthly IM paliperidone to 3-month IM paliperidone : Initiate 3-month IM paliperidone when the next monthly IM paliperidone dose is scheduled. Base the 3-month dose on the previous monthly dose, using the “Dose Conversions That Attain Similar Steady-State Paliperidone Exposure During Maintenance Treatment” table. 3-month IM paliperidone may be administered up to 7 days before or after the next monthly dose is due. Following the initial injection, administer every 3 months. Maintenance injections may be administered up to 2 weeks before or after the 3-month time point.
Time since last injection |
Instructions |
---|---|
3.5 to <4 months |
Administer the missed dose as soon as possible. Then resume usual maintenance dose 3 months later. |
4 to 9 months |
Maintenance dose 273 mg (175 mg as base): Administer 78 mg (50 mg as base) of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle on days 1 and 8. One month following the second injection, administer 273 mg (175 mg as base) of 3-month IM paliperidone (Invega Trinza) into the deltoid or gluteal muscle and resume usual dosing at 3-month intervals. Maintenance dose 410 mg (263 mg as base): Administer 117 mg (75 mg as base) of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle on days 1 and 8. One month following the second injection, administer 410 mg (263 mg as base) of 3-month IM paliperidone (Invega Trinza) into the deltoid or gluteal muscle and resume usual dosing at 3-month intervals. Maintenance dose 546 mg (350 mg as base): Administer 156 mg (100 mg as base) of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle on days 1 and 8. One month following the second injection, administer 546 mg (350 mg as base) of 3-month IM paliperidone (Invega Trinza) into the deltoid or gluteal muscle and resume usual dosing at 3-month intervals. Maintenance dose 819 mg (525 mg as base): Administer 156 mg (100 mg as base) of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle on days 1 and 8. One month following the second injection, administer 819 mg (525 mg as base) of 3-month IM paliperidone (Invega Trinza) into the deltoid or gluteal muscle and resume usual dosing at 3-month intervals. |
>9 months |
Reinitiate treatment with monthly IM paliperidone (Invega Sustenna). 3-month IM paliperidone (Invega Trinza) can be resumed after the patient has been adequately treated with monthly IM paliperidone for at least 4 months. |
Dosage adjustments: Incremental dose adjustment can be made every 3 months based on response and tolerability to achieve usual dose of 273 to 819 mg (175 to 525 mg as base); response to an adjusted dose may not be apparent for several months.
6-month paliperidone (FDA-approved for schizophrenia only) (Invega Hafyera): Note: 6-month IM paliperidone is to be used only after either 4 doses of monthly IM paliperidone (Invega Sustenna) or 1 dose of 3-month IM paliperidone (Invega Trinza). The dose immediately preceding the 6-month IM injection can either be a monthly IM injection or a 3-month IM injection.
Conversion from monthly IM paliperidone to 6-month IM paliperidone: Administer the same dose for the 2 monthly injection cycles immediately preceding the first 6-month IM injection. Initiate 6-month IM paliperidone when the next monthly IM paliperidone dose is scheduled. Base the 6-month dose on the previous monthly dose, using the “Dose Conversions That Attain Similar Steady-State Paliperidone Exposure During Maintenance Treatment” table. 6-month IM paliperidone may be administered up to 1 week before or after the next monthly dose is due. Following the initial injection, administer every 6 months. Maintenance injections may be administered up to 2 weeks before or 3 weeks after the 6-month time point.
Conversion from 3-month IM paliperidone to 6-month IM paliperidone: Initiate 6-month IM paliperidone when the next 3-month IM paliperidone dose is scheduled. Base the 6-month dose on the previous 3-month dose, using the “Dose Conversions That Attain Similar Steady-State Paliperidone Exposure During Maintenance Treatment” table. 6-month IM paliperidone may be administered up to 2 weeks before or after the next 3-month dose is due. Following the initial injection, administer every 6 months. Maintenance injections may be administered up to 2 weeks before or 3 weeks after the 6-month time point.
Time since last injection |
Instructions |
---|---|
6 months and 3 weeks to <8 months |
Maintenance dose 1,092 mg: Do not administer the missed dose. Administer 156 mg (100 mg as base) of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle on day 1. One month after the day 1 injection, administer 1,092 mg of 6-month IM paliperidone (Invega Hafyera) into the gluteal muscle and resume usual dosing at 6-month intervals. Maintenance dose 1,560 mg: Do not administer the missed dose. Administer 234 mg (150 mg as base) of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle on day 1. One month after the day 1 injection, administer 1,560 mg of 6-month IM paliperidone (Invega Hafyera) into the gluteal muscle and resume usual dosing at 6-month intervals. |
8 to 11 months |
Maintenance dose 1,092 mg: Do not administer the missed dose. Administer 156 mg (100 mg as base) of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle on days 1 and 8. One month after the day 8 injection, administer 1,092 mg of 6-month IM paliperidone (Invega Hafyera) into the gluteal muscle and resume usual dosing at 6-month intervals. Maintenance dose 1,560 mg: Do not administer the missed dose. Administer 156 mg (100 mg as base) of monthly IM paliperidone (Invega Sustenna) into the deltoid muscle on days 1 and 8. One month after the day 8 injection, administer 1,560 mg of 6-month IM paliperidone (Invega Hafyera) into the gluteal muscle and resume usual dosing at 6-month intervals. |
>11 months |
Reinitiate treatment with monthly IM paliperidone (Invega Sustenna). 6-month IM paliperidone (Invega Hafyera) can be resumed after the patient has been adequately treated with monthly IM paliperidone for at least 4 months. |
Dosage adjustments: Incremental dose adjustment can be made every 6 months based on response and tolerability to achieve usual dose of 1,092 to 1,560 mg; response to an adjusted dose may not be apparent for several months.
Paliperidone ER tablet |
Paliperidone palmitate monthly IM injection (Invega Sustenna) |
Paliperidone palmitate 3-month IM injection (Invega Trinza) |
Paliperidone palmitate 6-month IM injection (Invega Hafyera) |
Risperidone ER IM injection (Risperdal Consta) |
Risperidone tablet |
---|---|---|---|---|---|
Converting from 3-month IM paliperidone to paliperidone ER tablets: Do not use above table to determine appropriate dose, which is based on injection dose and weeks since last administration. Refer to the “Conversion From 3-Month IM Paliperidone to Paliperidone ER Tablets” table to determine oral dose. Converting from 3-month IM paliperidone to monthly IM paliperidone: Initiate monthly IM paliperidone when the next 3-month IM paliperidone dose is scheduled. Base the monthly dose on the previous 3-month dose. Following the initial injection, administer once monthly. Converting from other oral antipsychotics to long-acting injectable paliperidone: There are no systematically collected data to address switching patients from other oral antipsychotics to IM paliperidone. Converting from other long-acting injectable antipsychotics (at steady state) to monthly IM paliperidone: Initiate monthly IM paliperidone in the place of the next scheduled injection and continue at monthly intervals. The 2 initiation doses are not required in these patients. | |||||
3 mg/day |
39 mg (25 mg as base) every month |
Has not been studied |
Has not been studied |
No information available |
1 mg/day |
78 mg (50 mg as base) every month |
273 mg (175 mg as base) every 3 months |
Has not been studied |
25 mg every 2 weeks |
2 mg/day | |
6 mg/day |
117 mg (75 mg as base) every month |
410 mg (263 mg as base) every 3 months |
Has not been studied |
37.5 mg every 2 weeks |
3 mg/day |
9 mg/day |
156 mg (100 mg as base) every month |
546 mg (350 mg as base) every 3 months |
1,092 mg every 6 months |
50 mg every 2 weeks |
4 mg/day |
12 mg/day |
234 mg (150 mg as base) every month |
819 mg (525 mg as base) every 3 months |
1,560 mg every 6 months |
No information available |
5 mg/day |
Conversion from 3-month IM paliperidone to paliperidone ER tablets: Initiate paliperidone ER tablets ≥3 months after the last dose of 3-month IM paliperidone. Base the once-daily ER tablet dose on the last 3-month injection dose and weeks since last administered, using the following table:
Weeks since last 3-month IM injection | |||
---|---|---|---|
≥12 weeks to 18 weeks |
>18 weeks to 24 weeks |
>24 weeks | |
Last 3-month IM injection dose |
Daily dose of oral paliperidone ER tablet | ||
273 mg (175 mg as base) |
3 mg |
3 mg |
3 mg |
410 mg (263 mg as base) |
3 mg |
3 mg |
6 mg |
546 mg (350 mg as base) |
3 mg |
6 mg |
9 mg |
819 mg (525 mg as base) |
6 mg |
9 mg |
12 mg |
Discontinuation of therapy:
Oral : In the treatment of chronic psychiatric disease switching therapy rather than discontinuation is generally advised if side effects are intolerable or treatment is not effective. If patient insists on stopping treatment, gradual dose reduction (ie, over several weeks to months) is advised to detect a re-emergence of symptoms and to avoid withdrawal reactions (eg, agitation, alternating feelings of warmth and chill, anxiety, diaphoresis, dyskinesias, GI symptoms, insomnia, irritability, myalgia, paresthesia, psychosis, restlessness, rhinorrhea, tremor, vertigo) unless discontinuation is due to significant adverse effects. Monitor closely to allow for detection of prodromal symptoms of disease recurrence (APA [Keepers 2020]; Lambert 2007; Moncrieff 2020; Post 2021).
Long- acting injectable: Switching to other treatments is generally advised if side effects are intolerable or treatment is not effective. However, if a patient insists on stopping treatment, gradual dose reduction to avoid withdrawal reactions is generally not needed with long-acting injectable antipsychotics. The risk of withdrawal symptoms from discontinuation of long-acting injectables is low because the rate of drug elimination is slow. Monitor closely to allow for detection of prodromal symptoms of disease recurrence (APA [Keepers 2020]; Spanarello 2014; Steinman 2021).
Switching antipsychotics: An optimal universal strategy for switching antipsychotic drugs has not been established. Strategies include: Cross-titration (gradually discontinuing the first antipsychotic while gradually increasing the new antipsychotic) and abrupt change (abruptly discontinuing the first antipsychotic and either increasing the new antipsychotic gradually or starting it at a treatment dose). In patients with schizophrenia at high risk of relapse, the current medication may be maintained at full dose as the new medication is increased (ie, overlap); once the new medication is at therapeutic dose, the first medication is gradually decreased and discontinued over 1 to 2 weeks (Cerovecki 2013; Remington 2005; Takeuchi 2017). Based upon clinical experience, some experts generally prefer cross-titration and overlap approaches rather than abrupt change (Stroup 2020).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Clearance is decreased in renal impairment; adjust dose according to renal function:
Oral:
Mild impairment (CrCl 50 to 79 mL/minute): Initial dose: 3 mg once daily; maximum dose: 6 mg once daily.
Moderate to severe impairment (CrCl 10 to 49 mL/minute): Initial dose: 1.5 mg once daily; maximum dose: 3 mg once daily.
Severe impairment (CrCl <10 mL/minute): Use not recommended (has not been studied).
IM:
CrCl ≥90 mL/minute: No dosage adjustment necessary.
CrCl ≥80 to <90 mL/minute:
Monthly IM paliperidone (Invega Sustenna) or 3-month IM paliperidone (Invega Trinza): No dosage adjustment necessary.
6-month IM paliperidone (Invega Hafyera): Use not recommended.
CrCl 50 to <80 mL/minute:
Monthly IM paliperidone (Invega Sustenna): Initiation of therapy: 156 mg (as palmitate) or 100 mg (as base) on treatment day 1, followed by 117 mg (as palmitate) or 75 mg (as base) 1 week later with both doses administered in the deltoid, followed by a maintenance dose of 78 mg (as palmitate) or 50 mg (as base) every month (administered in the deltoid or gluteal muscle).
3-month IM paliperidone (Invega Trinza): Adjust dosage and stabilize the patient using the monthly IM injection, then transition to the 3-month IM injection. Note: Monthly IM paliperidone (Invega Sustenna) 78 mg (as palmitate) or 50 mg (as base) = 3-month IM paliperidone (Invega Trinza) 273 mg (as palmitate) or 175 mg (as base).
6-month IM paliperidone (Invega Hafyera): Use not recommended.
CrCl <50 mL/minute: Use not recommended.
Oral, IM (monthly, 3-month or 6-month):
Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intramuscular, as palmitate:
Invega Trinza: 410 mg/1.315 mL (1.315 mL); 273 mg/0.875 mL (0.875 mL); 546 mg/1.75 mL (1.75 mL); 819 mg/2.625 mL (2.625 mL) [contains polyethylene glycol]
Suspension Prefilled Syringe, Intramuscular, as palmitate:
Invega Sustenna: 39 mg/0.25 mL (0.25 mL); 78 mg/0.5 mL (0.5 mL); 117 mg/0.75 mL (0.75 mL); 156 mg/mL (1 mL); 234 mg/1.5 mL (1.5 mL) [contains polyethylene glycol]
Suspension Prefilled Syringe, Intramuscular, as palmitate [preservative free]:
Invega Hafyera: 1092 mg/3.5 mL (3.5 mL); 1560 mg/5 mL (5 mL) [contains polyethylene glycol]
Tablet Extended Release 24 Hour, Oral:
Invega: 1.5 mg, 3 mg, 6 mg, 9 mg
Generic: 1.5 mg, 3 mg, 6 mg, 9 mg
May be product dependent
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension Prefilled Syringe, Intramuscular:
Invega Sustenna: 25 mg/0.25 mL ([DSC]); 50 mg/0.5 mL (0.5 mL); 75 mg/0.75 mL (0.75 mL); 100 mg/mL (1 mL); 150 mg/1.5 mL (1.5 mL) [contains polyethylene glycol]
Invega Trinza: 175 mg/0.875 mL (0.875 mL); 263 mg/1.315 mL (1.315 mL); 350 mg/1.75 mL (1.75 mL); 525 mg/2.625 mL (2.625 mL) [contains polyethylene glycol]
Tablet Extended Release 24 Hour, Oral:
Invega: 3 mg, 6 mg, 9 mg
Generic: 3 mg, 6 mg
Oral: Administer in the morning without regard to meals; swallow extended-release tablets whole with liquids; do not crush, chew, or divide.
IM: Administer only as a single injection (do not divide); do not administer by any other route. Avoid inadvertent injection into vasculature.
Monthly paliperidone (Invega Sustenna): Do not mix with any other product or diluent. Prior to injection, shake syringe for at least 10 seconds to ensure a homogenous suspension. Administer using only the needles that are provided in the kit. The 2 initial injections should be administered in the deltoid muscle using a 11/2-inch, 22-gauge needle for patients ≥90 kg, and a 1-inch, 23-gauge needle for patients <90 kg. The two initial deltoid intramuscular injections help attain therapeutic concentrations rapidly. Alternate deltoid injections (right and left deltoid muscle). The second dose may be administered 4 days before or after the weekly time point. Monthly maintenance doses can be administered in either the deltoid or gluteal muscle. Administer injections in the gluteal muscle using a 11/2-inch, 22-gauge needle (regardless of patient weight) in the upper-outer quadrant of the gluteal area. Alternate gluteal injections (right and left gluteal muscle). The monthly maintenance dose may be administered 7 days before or after the monthly time point.
Three-month paliperidone (Invega Trinza): Should only be administered by a health care professional. Prior to injection, shake syringe with tip pointing up for at least 15 seconds to ensure a homogenous suspension. Inject within 5 minutes of shaking vigorously. Inject slowly, deep into the deltoid or gluteal muscle. Must be administered using only the thin wall needles that are provided in the pack. Do not use needles from monthly IM paliperidone or other commercially-available needles to reduce the risk of blockage. Administer into the center of the deltoid muscle using a 11/2-inch, 22-gauge thin wall needle for patients ≥90 kg, and a 1-inch, 22-gauge thin wall needle for patients <90 kg. Alternate deltoid injections (right and left deltoid muscle). Administer injections in the gluteal muscle using a 11/2-inch, 22-gauge thin wall needle (regardless of patient weight) in the upper-outer quadrant of the gluteal area. Alternate gluteal injections (right and left gluteal muscle). In the event of an incompletely administered dose, do not re-inject the dose remaining in the syringe and do not administer another dose. Closely monitor and treat the patient with oral supplementation as clinically appropriate until the next scheduled 3-month injection.
Oral: Administer without regard to meals. ER tablets should be swallowed whole with liquids; do not crush, chew, or divide.
Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. An IM formulation of Invega is available. If safety and efficacy can be effectively monitored, no change in formulation or administration is required after bariatric surgery; however, close clinical monitoring is advised in the immediate postoperative phase for the theoretical circumstance of reduced absorption after bariatric surgery.
IM injection: Administer by IM route only as a single injection (do not divide); do not administer by any other route. Do not mix with any other product or diluent. Avoid inadvertent injection into vasculature.
Monthly paliperidone (Invega Sustenna): Prior to injection, shake syringe for at least 10 seconds to ensure a homogenous suspension. Administer using only the needles that are provided in the kit. The 2 initial injections should be administered in the deltoid muscle using a 11/2 inch, 22-gauge needle for patients ≥90 kg, and a 1 inch, 23-gauge needle for patients <90 kg. The 2 initial deltoid intramuscular injections help attain therapeutic concentrations rapidly. Alternate deltoid injections (right and left deltoid muscle). The second dose may be administered 4 days before or after the weekly time point. Monthly maintenance doses can be administered in either the deltoid or gluteal muscle. Administer injections in the gluteal muscle using a 11/2 inch, 22-gauge needle (regardless of patient weight) in the upper-outer quadrant of the gluteal area. Alternate gluteal injections (right and left gluteal muscle).
Three-month paliperidone (Invega Trinza): Prior to injection, shake syringe for with tip pointing up at least 15 seconds to ensure a homogenous suspension. Inject within 5 minutes of shaking vigorously. Inject slowly, deep into the deltoid or gluteal muscle. Must be administered using only the thin wall needles that are provided in the pack. Do not use needles from monthly IM paliperidone or other commercially available needles to reduce the risk of blockage. Administer into the center of the deltoid muscle using a 11/2 inch, 22-gauge thin wall needle for patients ≥90 kg, and a 1 inch, 22-gauge thin wall needle for patients <90 kg. Alternate deltoid injections (right and left deltoid muscle). Administer injections in the gluteal muscle using a 11/2 inch, 22-gauge thin wall needle (regardless of patient weight) in the upper-outer quadrant of the gluteal area. Alternate gluteal injections (right and left gluteal muscle). In the event of an incompletely administered dose, do not re-inject the dose remaining in the syringe and do not administer another dose.
Six-month paliperidone (Invega Hafyera): Prior to injection, shake syringe with tip pointing up very fast for at least 15 seconds. Rest briefly, then shake again for 15 seconds to ensure a homogenous suspension. Inject within 5 minutes of shaking vigorously; resuspend by shaking for ≥30 seconds if >5 minutes pass before injection. Inject slowly (over ~30 seconds), deep into the gluteal muscle. Must be administered using only the thin wall needles that are provided in the pack. Do not use needles from monthly IM paliperidone, 3-month IM paliperidone, or other commercially available needles to reduce the risk of blockage. Administer using a 1½ inch, 20-gauge thin-wall needle, regardless of patient weight, in the upper-outer quadrant of the gluteal area; alternate injections between right and left gluteal muscle. In the event of an incompletely administered dose, do not reinject the dose remaining in the syringe and do not administer another dose.
Oral, Monthly IM: Store at ≤25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect tablets from moisture.
3- and 6-month IM: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not mix with any other product or diluent. Store the 6-month IM product in a horizontal position.
Oral: Treatment of schizophrenia (FDA approved in ages ≥12 years and adults); treatment of schizoaffective disorder as monotherapy or adjunctive therapy to mood stabilizers and/or antidepressants (FDA approved in adults); has also been used for treatment of irritability associated with autistic disorder
Parenteral: Treatment of schizophrenia and schizoaffective disorder (monotherapy) and as adjunct to mood stabilizer and antidepressants (Invega Sustenna: FDA approved in ages ≥18 years and adults); treatment of schizophrenia in patients adequately treated for 4 months with the 1-month paliperidone extended-release formulation (Invega Trinza: FDA approved in ages ≥18 years and adults)
Invega may be confused with Intuniv
Beers Criteria: Antipsychotics are identified in the Beers Criteria as potentially inappropriate medications to be avoided in patients 65 years and older due to an increased risk of cerebrovascular accidents (stroke) and a greater rate of cognitive decline and mortality in patients with dementia. Antipsychotics may be appropriate for schizophrenia, bipolar disorder, other mental health conditions or short-term use as antiemetic during chemotherapy but should be given in the lowest effective dose for the shortest duration possible. In addition, antipsychotics should be used with caution in older adults due to their potential to cause or exacerbate syndrome of inappropriate antidiuretic hormone secretion (SIADH) or hyponatremia; monitor sodium closely with initiation or dosage adjustments in older adults (Beers Criteria [AGS 2019]).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Unless otherwise noted, frequency of adverse effects is reported for both the oral and IM formulations.
>10%:
Cardiovascular: Tachycardia (3% to 14%)
Endocrine & metabolic: Decreased HDL cholesterol (IM: 13% to 16%; oral: 23% to 29%) hyperglycemia (≤11%), increased LDL cholesterol (IM: <1%; oral: 4% to 14%), increased serum cholesterol (≤11%), increased serum prolactin (males: ≤56%; females: ≤44%), increased serum triglycerides (5% to 13%), weight gain (2% to 19%)
Gastrointestinal: Vomiting (5% to 11%)
Local: Erythema at injection site (IM: ≤13%), induration at injection site (≤13%), injection site reaction (IM: 3% to 11%; including pain at injection site), swelling at injection site (IM: ≤13%), tenderness at injection site (IM: 31%)
Nervous system: Akathisia (3% to 17%), drowsiness (≤26%), dystonia (1% to 14%), extrapyramidal reaction (IM: 2% to 12%; oral: 4% to 40%; including torticollis, trismus), headache (6% to 15%), parkinsonism (2% to 18%; including parkinsonian gait)
Neuromuscular & skeletal: Hyperkinetic muscle activity (IM: 4% to 5%; oral: 4% to 17%), tremor (IM: ≤1%; oral: 2% to 12%)
Respiratory: Upper respiratory tract infection (2% to 12%)
1% to 10%:
Cardiovascular: Bradycardia (<2%), bundle branch block (3%), edema (oral: <2%), first degree atrioventricular block (2%), hypertension (2%), orthostatic hypotension (IM: <1%; oral: 2% to 4%), palpitations (<2%), sinoatrial nodal rhythm disorder (oral: ≤2%)
Dermatologic: Pruritus (<2%), skin rash (<2%)
Endocrine & metabolic: Amenorrhea (2% to 6%), decreased libido (IM: 1%), galactorrhea not associated with childbirth (1% to 4%), gynecomastia (3%)
Gastrointestinal: Abdominal distress (≤4%), constipation (4% to 5%), decreased appetite (1% to 2%), diarrhea (IM: 2% to 3%), dyspepsia (5% to 6%), flatulence (<2%), increased appetite (2% to 3%), nausea (4% to 8%), sialorrhea (1% to 6%), stomach discomfort (2%), swollen tongue (3%), upper abdominal pain (≤4%), xerostomia (2% to 3%)
Genitourinary: Breast tenderness (<2%), erectile dysfunction (IM: ≤1%), irregular menses (<2%), retrograde ejaculation (oral: <2%), urinary tract infection (≤3%)
Hepatic: Increased serum alanine aminotransferase (<2%), increased serum aspartate aminotransferase (<2%)
Hypersensitivity: Anaphylaxis (<2%)
Nervous system: Agitation (IM: 8% to 10%; oral: <2%), anxiety (3% to 9%), dizziness (2% to 6%), dysarthria (1% to 4%), fatigue (2% to 4%), insomnia (≤3%), lethargy (3%), nightmares (≤2%), opisthotonus (oral: <2%), psychosis (3%), sedated state (≤7%), sleep disorder (oral: 2% to 3%)
Neuromuscular & skeletal: Arthralgia (<2%), asthenia (≤4%), back pain (3%), dyskinesia (1% to 9%), limb pain (≤3%), muscle rigidity (2%), musculoskeletal pain (3%), myalgia (1% to 4%), tongue paralysis (oral: 3%)
Ophthalmic: Abnormal eye movements (<2%; includes eye rolling), blurred vision (3%)
Respiratory: Cough (2% to 3%), epistaxis (oral: 2%), nasal congestion (<2%), nasopharyngitis (2% to 5%), pharyngolaryngeal pain (oral: 1% to 2%), rhinitis (1% to 3%)
<1%: Cardiovascular: Prolonged QT interval on ECG, syncope
Frequency not defined (any formulation):
Cardiovascular: Cerebrovascular accident, ECG abnormality, postural orthostatic tachycardia
Dermatologic: Urticaria
Endocrine & metabolic: Menstrual disease, suppressed menstruation (delayed), weight loss
Gastrointestinal: Hyperinsulinism, oromandibular dystonia
Hematologic & oncologic: Anemia
Genitourinary: Breast engorgement, breast hypertrophy, breast swelling, cystitis, ejaculatory disorder, mastalgia, nipple discharge, priapism, sexual disorder
Hematologic & oncologic: Anemia
Hypersensitivity: Fixed drug eruption, hypersensitivity reaction
Nervous system: Cogwheel rigidity, depression, drooling, hypertonia, orthostatic dizziness, psychomotor agitation, restlessness, seizure, vertigo
Neuromuscular & skeletal: Bradykinesia, joint stiffness, muscle spasm, muscle twitching
Ophthalmic: Oculogyric crisis
Respiratory: Respiratory tract infection, tonsillitis
Postmarketing (any formulation):
Endocrine & metabolic: Diabetes mellitus
Gastrointestinal: Intestinal obstruction
Genitourinary: Urinary incontinence, urinary retention
Hematologic & oncologic: Agranulocytosis, leukopenia, neutropenia, thrombotic thrombocytopenic purpura
Hypersensitivity: Angioedema
Nervous system: Abnormal sensory symptoms (sensory instability), catatonia, motor dysfunction, neuroleptic malignant syndrome, somnambulism, tardive dyskinesia
Hypersensitivity (anaphylaxis, angioedema) to paliperidone, risperidone, or any component of the formulation.
Concerns related to adverse effects:
• Altered cardiac conduction: May alter cardiac conduction and prolong the QTc interval; life-threatening arrhythmias have occurred with therapeutic doses of antipsychotics (Ray 2009). Risk may be increased by conditions or concomitant medications that cause bradycardia, hypokalemia, and/or hypomagnesemia. Avoid use in combination with QTc-prolonging drugs. Avoid use in patients with congenital long QT syndrome and in patients with history of cardiac arrhythmia.
• Blood dyscrasias: Leukopenia, neutropenia, and agranulocytosis (sometimes fatal) have been reported in clinical trials and postmarketing reports with antipsychotic use. Risk factors include preexisting low WBC or ANC or a history of drug-induced leuko-/neutropenia.
• Cerebrovascular effects: An increased incidence of cerebrovascular adverse effects (eg, transient ischemic attack, stroke), including fatalities, has been reported in placebo-controlled trials of risperidone (paliperidone is the primary active metabolite of risperidone) for the unapproved use in elderly patients with dementia-related psychosis.
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
• Dyslipidemia: Increased cholesterol and triglycerides and decreased HDL have been noted. Use with caution in patients with a preexisting abnormal lipid profile.
• Esophageal dysmotility/Aspiration: Antipsychotic use has been associated with esophageal dysmotility and aspiration; risk increases with age. Use with caution in patients at risk for aspiration pneumonia (eg, Alzheimer disease), particularly in patients >75 years of age (Herzig 2017; Maddalena 2004).
• Extrapyramidal symptoms: May cause extrapyramidal symptoms (EPS), including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia (risk of these reactions is generally much lower relative to typical/conventional antipsychotics; frequencies reported are similar to placebo). Risk of dystonia (and probably other EPS) may be greater with increased doses, use of conventional antipsychotics, males, and younger patients. Factors associated with greater vulnerability to tardive dyskinesia include older patients, postmenopausal female patients, Parkinson disease, pseudoparkinsonism symptoms, affective disorders (particularly major depressive disorder), concurrent medical diseases such as diabetes, previous brain damage, alcoholism, poor treatment response, and use of high doses of antipsychotics (APA [Lehman 2004]; Soares-Weiser 2007). Tardive dyskinesia may also occur, or partially or completely remit, after discontinuation of treatment.
• Falls: May increase the risk for falls due to somnolence, orthostatic hypotension, and motor or sensory instability.
• Hyperglycemia: Atypical antipsychotics have been associated with development of hyperglycemia; in some cases, may be extreme and associated with ketoacidosis, hyperosmolar coma, or death. All patients should be monitored for symptoms of hyperglycemia (eg, polydipsia, polyuria, polyphagia, weakness). Use with caution in patients with diabetes (or risk factors) or other disorders of glucose regulation; monitor for worsening of glucose control. Patients with risk factors for diabetes (eg, obesity or family history) should have a baseline fasting blood sugar and periodically during treatment.
• Hyperprolactinemia: Use is associated with increased prolactin levels; clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown.
• Hypersensitivity: Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported.
• Intraoperative floppy iris syndrome: Few case reports describe intraoperative floppy iris syndrome (IFIS) in patients receiving risperidone and undergoing cataract surgery (Ford 2011). IFIS has not been reported with paliperidone, but caution is advised because it is the active metabolite of risperidone. Prior to cataract surgery, evaluate for prior or current paliperidone or risperidone use. The benefits or risks of interrupting paliperidone or risperidone prior to surgery have not been established; clinicians are advised to proceed with surgery cautiously.
• Neuroleptic malignant syndrome: Neuroleptic malignant syndrome has been reported with antipsychotics, including paliperidone. Risk may be increased in patients with Parkinson disease or Lewy body dementia.
• Orthostatic hypotension: May cause orthostatic hypotension and syncope; use with caution in patients with known cardiovascular disease (heart failure, history of myocardial infarction or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).
• Priapism: Rare cases of priapism have been reported.
• Temperature regulation: Impaired core body temperature regulation may occur; use caution with strenuous exercise, heat exposure, dehydration, and concomitant medication possessing anticholinergic effects.
• Weight gain: Significant weight gain has been observed with antipsychotic therapy; incidence varies with product. Monitor waist circumference and body mass index.
Disease-related concerns:
• Dementia: [US Boxed Warning]: Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo. Most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Use with caution in patients with Lewy body dementia or Parkinson disease dementia due to greater risk of adverse effects, increased sensitivity to extrapyramidal effects, and association with irreversible cognitive decompensation or death. (APA [Reus 2016]). Paliperidone is not approved for the treatment of dementia-related psychosis.
• Renal impairment: Use with caution in patients with mild renal disease; dosage reduction is recommended. Not recommended in patients with moderate (IM route only) to severe impairment.
• Seizures: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications that may lower seizure threshold. Elderly patients may be at increased risk of seizures due to an increased prevalence of predisposing factors.
Dosage form specific issues:
• Extended-release tablet: Use is not recommended in patients with preexisting severe GI-narrowing disorders (nondeformable controlled-release formulation). Patients with upper GI tract alterations in transit time may have increased or decreased bioavailability of paliperidone. Formulation consists of drug within a nonabsorbable shell; following drug release/absorption, the shell is expelled in the stool.
Other warnings/precautions:
• Discontinuation of therapy: When discontinuing antipsychotic therapy, gradually taper antipsychotics to avoid physical withdrawal symptoms and rebound symptoms (APA [Keepers 2020]; WFSBP [Hasan 2012]). Withdrawal symptoms may include agitation, alternating feelings of warmth and cold, anxiety, diaphoresis, dyskinesia, GI symptoms, insomnia, irritability, myalgia, paresthesia, psychosis, restlessness, rhinorrhea, tremor and vertigo (Lambert 2007; Moncrieff 2020). The risk of withdrawal symptoms is highest following abrupt discontinuation of highly anticholinergic or dopaminergic antipsychotics (Cerovecki 2013). Patients with chronic symptoms, repeated relapses, and clear diagnostic features of schizophrenia are at risk for poor outcomes if medications are discontinued (APA [Keepers 2020]).
Risk of dystonia is increased with the use of high potency and higher doses of conventional antipsychotics and in males and younger patients; occurring in up to 18% of children. Use with caution in children and adolescents; adverse effects due to elevated prolactin levels have been observed; long-term effects on growth or sexual maturation have not been evaluated.
Paliperidone may cause a higher than normal weight gain in children and adolescents; monitor growth (including weight, height, BMI, and waist circumference) in pediatric patients receiving paliperidone; in adolescent trials, ≤19% of patients experienced a weight gain of ≥7%; monitor weight and compare to standard growth curves.
Paliperidone may cause increases in metabolic indices (eg, serum cholesterol, triglycerides). Biannual monitoring of cardiometabolic indices after the first 3 months of therapy is suggested for atypical antipsychotics (Correll 2009).
Adolescents may experience a higher frequency of certain adverse effects than adults, particularly akathisia (4% to 17% vs 1% to 10%; dose dependent), somnolence (9% to 26% vs 1% to 12%), and vomiting (≤11% vs 2% to 5%). Adolescents may experience some adverse effects not reported in adults, including amenorrhea, blurred vision, galactorrhea, gynecomastia, and tongue swelling.
Long-term usefulness of paliperidone should be periodically re-evaluated in patients receiving the drug for extended periods of time. Invega is an extended-release tablet based on the OROSA osmotic delivery system. Water from the GI tract enters through a semipermeable membrane coating the tablet, solubilizing the drug into a gelatinous form which, through hydrophilic expansion, is then expelled through laser-drilled holes in the coating.
Similar to adult experience, the American Academy of Child and Adolescent Psychiatry (AACAP) guidelines recommend gradually tapering antipsychotics to avoid withdrawal symptoms and minimize the risk of relapse (AACAP [McClellan 2007]).
Substrate of CYP3A4 (minor), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Acetylcholinesterase Inhibitors (Central): May enhance the neurotoxic (central) effect of Antipsychotic Agents. Severe extrapyramidal symptoms have occurred in some patients. Risk C: Monitor therapy
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Risk C: Monitor therapy
Amisulpride (Oral): May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk of neuroleptic malignant syndrome may be increased. Risk X: Avoid combination
Amphetamines: Antipsychotic Agents may diminish the stimulatory effect of Amphetamines. Risk C: Monitor therapy
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Anti-Parkinson Agents (Dopamine Agonist): Antipsychotic Agents (Second Generation [Atypical]) may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Management: Consider avoiding atypical antipsychotic use in patients with Parkinson disease. If an atypical antipsychotic is necessary, consider using clozapine, quetiapine, or ziprasidone at lower initial doses, or a non-dopamine antagonist (eg, pimavanserin). Risk D: Consider therapy modification
Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider therapy modification
Blood Pressure Lowering Agents: May enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy
Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Bromopride: May enhance the adverse/toxic effect of Antipsychotic Agents. Risk X: Avoid combination
Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider therapy modification
BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Risk C: Monitor therapy
Cabergoline: May diminish the therapeutic effect of Antipsychotic Agents. Risk X: Avoid combination
Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification
Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
Daridorexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification
Deutetrabenazine: May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Risk C: Monitor therapy
Dexmethylphenidate-Methylphenidate: Antipsychotic Agents may enhance the adverse/toxic effect of Dexmethylphenidate-Methylphenidate. Dexmethylphenidate-Methylphenidate may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk of extrapyramidal symptoms may be increased when these agents are combined. Risk C: Monitor therapy
Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Risk C: Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification
Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider therapy modification
Guanethidine: Antipsychotic Agents may diminish the therapeutic effect of Guanethidine. Risk C: Monitor therapy
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Inducers of CYP3A4 (Strong) and P-glycoprotein: May decrease the serum concentration of Paliperidone. Management: Monitor for reduced paliperidone effects when combined with strong inducers of both CYP3A4 and P-gp. Avoid use of these inducers with extended-release injectable paliperidone and instead manage patients with paliperidone extended-release tablets. Risk C: Monitor therapy
Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification
Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification
Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification
Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider therapy modification
Levoketoconazole: QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of Levoketoconazole. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Lithium: May enhance the neurotoxic effect of Antipsychotic Agents. Lithium may decrease the serum concentration of Antipsychotic Agents. Specifically noted with chlorpromazine. Risk C: Monitor therapy
Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Mequitazine: Antipsychotic Agents may enhance the arrhythmogenic effect of Mequitazine. Management: Consider alternatives to one of these agents when possible. While this combination is not specifically contraindicated, mequitazine labeling describes this combination as discouraged. Risk D: Consider therapy modification
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider therapy modification
Metoclopramide: May enhance the adverse/toxic effect of Antipsychotic Agents. Risk X: Avoid combination
MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy
MetyroSINE: May enhance the adverse/toxic effect of Antipsychotic Agents. Risk C: Monitor therapy
Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination
Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Oxybate Salt Products: CNS Depressants may enhance the CNS depressant effect of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider therapy modification
OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination
Perampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Piribedil: Antipsychotic Agents may diminish the therapeutic effect of Piribedil. Piribedil may diminish the therapeutic effect of Antipsychotic Agents. Management: Use of piribedil with antiemetic neuroleptics is contraindicated, and use with antipsychotic neuroleptics, except for clozapine, is not recommended. Risk X: Avoid combination
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Quinagolide: Antipsychotic Agents may diminish the therapeutic effect of Quinagolide. Risk C: Monitor therapy
RisperiDONE: May enhance the adverse/toxic effect of Paliperidone. Management: Additive paliperidone exposure is expected with this combination. Consider using an alternative combination when possible. Risk D: Consider therapy modification
Ropeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modification
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy
Serotonergic Agents (High Risk): May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonergic agents may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Risk C: Monitor therapy
St John's Wort: May decrease the serum concentration of Paliperidone. Management: Monitor for reduced paliperidone effects when combined St. John's wort. Avoid use of St. John's wort with extended-release injectable paliperidone and instead manage patients with paliperidone extended-release tablets. Risk C: Monitor therapy
Sulpiride: Antipsychotic Agents may enhance the adverse/toxic effect of Sulpiride. Risk X: Avoid combination
Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification
Tetrabenazine: May enhance the adverse/toxic effect of Antipsychotic Agents. Risk C: Monitor therapy
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination
Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Valproate Products: May increase the serum concentration of Paliperidone. Risk C: Monitor therapy
Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification
Paliperidone may cause hyperprolactinemia, which may cause a reversible decrease in fertility in females.
Information specific to paliperidone in pregnancy is limited (Onken 2018; Özdemir 2015; Zamora Rodriguez 2017).
Antipsychotic use during the third trimester of pregnancy has a risk for extrapyramidal symptoms (EPS) and/or withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor. These effects may be self-limiting and allow recovery within hours or days with no specific treatment, or they may be severe requiring prolonged hospitalization.
The ACOG recommends that therapy during pregnancy be individualized; treatment with psychiatric medications during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary healthcare provider, and pediatrician. Safety data related to atypical antipsychotics during pregnancy is limited and routine use is not recommended. However, if a woman is inadvertently exposed to an atypical antipsychotic while pregnant, continuing therapy may be preferable to switching to a typical antipsychotic that the fetus has not yet been exposed to; consider risk:benefit (ACOG 2008).
Paliperidone is the active metabolite of risperidone; refer to Risperidone monograph for additional information.
Health care providers are encouraged to enroll women 18 to 45 years of age exposed to paliperidone during pregnancy in the Atypical Antipsychotics Pregnancy Registry (1-866-961-2388 or http://womensmentalhealth.org/research/pregnancyregistry/).
Blood pressure (including orthostatic) and heart rate, particularly during dosage titration; mental status, abnormal involuntary movement scale (AIMS), extrapyramidal symptoms; growth, BMI, waist circumference, and weight (in adults, weight should be assessed prior to treatment, at 4 weeks, 8 weeks, 12 weeks, and then at quarterly intervals; consider titrating to a different antipsychotic agent for a weight gain ≥5% of the initial weight); CBC with differential; liver enzymes in children (especially obese children or those who are rapidly gaining weight while receiving therapy); lipid profile; fasting blood glucose/Hgb A1c (prior to treatment, at 3 months, then annually); prolactin serum concentrations
Paliperidone is considered a benzisoxazole atypical antipsychotic as it is the primary active metabolite of risperidone. As with other atypical antipsychotics, its therapeutic efficacy is believed to result from mixed central serotonergic and dopaminergic antagonism. The addition of serotonin antagonism to dopamine antagonism (classic neuroleptic mechanism) is thought to improve negative symptoms of psychoses and reduce the incidence of extrapyramidal side effects (Huttunen 1995). Similar to risperidone, paliperidone demonstrates high affinity to α1, α2, D2, H1, and 5-HT2A receptors and low affinity for muscarinic receptors. In contrast to risperidone, paliperidone displays nearly 10-fold lower affinity for α2 and 5-HT2A receptors, and nearly three- to fivefold less affinity for 5-HT1A and 5-HT1D, respectively.
Note: Pharmacokinetic parameters in adolescent patients weighing >51 kg were similar to adults; an increased drug exposure (23%) was observed in adolescent patient weighing <51 kg compared to adults and was not considered clinically significant.
Onset of action: Oral: Initial effects may be observed within 1 to 2 weeks of treatment with continued improvements through 4 to 6 weeks (Agid 2003; Levine 2010).
Absorption: IM: Slow release (Monthly: Begins on day 1 and continues up to 126 days; 3- and 6-month: Begins on day 1 and continues up to 18 months).
Distribution: Vd: Oral: 487 L; Monthly IM: 391 L; 3- and 6-month IM: 1,960 L.
Protein binding: 74%.
Metabolism: Hepatic via CYP2D6 and 3A4 (limited role in elimination); minor metabolism (<10% each) via dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Bioavailability: Oral: 28%.
Half-life elimination:
Oral: 23 hours; 24 to 51 hours with renal impairment (CrCl <80 mL/minute).
Monthly IM (following a single-dose administration): Range: 25 to 49 days.
3-month IM: Deltoid injection range: 84 to 95 days; Gluteal injection range: 118 to 139 days.
6-month IM (following a single-dose administration): Gluteal injection range: 148 to 159 days.
Time to peak, plasma: Oral: ~24 hours; Monthly IM: 13 days; 3-month IM: 30 to 33 days; 6-month IM: 29 to 32 days.
Excretion: Urine (80%; 59% as unchanged drug); feces (11%).
Renal function impairment: Elimination of paliperidone decreased with decreasing estimated creatinine clearance.
Gender: Slower monthly IM absorption observed in women.
Suspension Prefilled Syringe (Invega Hafyera Intramuscular)
1092MG/3.5ML (per mL): $4,249.83
1560 mg/5 mL (per mL): $4,462.23
Suspension Prefilled Syringe (Invega Sustenna Intramuscular)
39 mg/0.25 mL (per 0.25 mL): $619.72
78 mg/0.5 mL (per 0.5 mL): $1,239.47
117 mg/0.75 mL (per 0.75 mL): $1,859.23
156 mg/mL (per mL): $2,479.07
234 mg/1.5 mL (per mL): $2,479.01
Suspension Prefilled Syringe (Invega Trinza Intramuscular)
273MG/0.88ML (per 0.88 mL): $3,718.40
410MG/1.32ML (per mL): $4,225.53
546MG/1.75ML (per mL): $4,249.84
819MG/2.63ML (per mL): $4,241.66
Tablet, 24-hour (Invega Oral)
1.5 mg (per each): $14.71
3 mg (per each): $14.71
6 mg (per each): $14.71
9 mg (per each): $22.07
Tablet, 24-hour (Paliperidone ER Oral)
1.5 mg (per each): $13.21 - $30.60
3 mg (per each): $13.21 - $30.60
6 mg (per each): $13.21 - $30.60
9 mg (per each): $19.82 - $45.89
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