Invega Sustenna (paliperidone palmitate) Long-Acting Injectable Dosing Regimen
INVEGA SUSTENNA initiation for adults with schizophrenia is 234 mg IM in the deltoid muscle on treatment Day 1, followed by 156 mg IM in the deltoid muscle 1 week later (treatment Day 8), then monthly maintenance dosing. [1]
After the 2-dose initiation regimen, monthly maintenance injections may be administered in either the deltoid or gluteal muscle. [1]
Standard Initiation and Maintenance Dosing (Adults With Schizophrenia)
- Treatment Day 1: 234 mg IM in the deltoid muscle. [1]
- Treatment Day 8 (1 week after Day 1): 156 mg IM in the deltoid muscle. [1]
- Maintenance dose after Day 8: 117 mg IM once monthly (monthly dose range 39–234 mg based on tolerability and/or efficacy). [1]
- Maximum monthly dose: 234 mg. [1]
Renal-Function–Based Dosing Clarifications
- Mild renal impairment (creatinine clearance ≥ 50 mL/min to < 80 mL/min): initiation is 156 mg IM on Day 1 and 117 mg IM on Day 8, both in the deltoid muscle, then monthly maintenance dose is 78 mg IM once monthly (adjustable within 39–156 mg; maximum monthly dose 156 mg). [1]
- Moderate to severe renal impairment (creatinine clearance < 50 mL/min): INVEGA SUSTENNA is not recommended. [1]
Injection Site and Timing
- Initiation injections are administered in the deltoid muscle. [1]
- Maintenance injections are administered in either the deltoid or gluteal muscle. [1]
Dose Adjustment Approach for Ongoing Monthly Therapy
- Monthly maintenance dose adjustments may be made monthly using available strengths of 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg. [1]
- When maintenance dose adjustments are made, full effect of dose adjustment may not be evident for several months due to prolonged-release characteristics. [1]
Missed-Dose Timing References
- Missed dosing guidance is provided in the prescribing information for missed second initiation doses and missed monthly maintenance doses. [1]
- The recommendation to avoid missed dosing is documented, with specific restart instructions based on the time since the last injection. [1]
Switching and Oral Supplementation Requirements
- Establishment of tolerability with oral paliperidone or oral risperidone is recommended prior to initiating INVEGA SUSTENNA for patients naïve to oral paliperidone or oral or injectable risperidone. [1]
- No oral supplementation is required as part of the standard 2-dose initiation regimen schedule. [1]
Schizoaffective Disorder Dosing Differences (If Applicable)
- Initiation dosing for adults with schizoaffective disorder: 234 mg IM on Day 1 in the deltoid muscle and 156 mg IM on Day 8 in the deltoid muscle. [1]
- Monthly maintenance dosing for schizoaffective disorder: 78 mg (monthly dose range 78–234 mg based on tolerability and/or efficacy; 39 mg strength not studied in the long-term schizoaffective disorder study). [1]
- Maximum monthly dose: 234 mg. [1]