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Usual Dosing (Adults)

Extended release tablets:

Initial Dose Recommended Dose Maximum Dose
Schizophrenia - adults 6 mg/day 3 – 12 mg/day 12 mg/day
Schizophrenia-adolescents Weight < 51kg 3 mg/day 3 – 6 mg/day 6 mg/day
Weight ≥ 51kg 3 mg/day 3 – 12 mg/day 12 mg/day
Schizoaffective disorder - adults 6 mg/day 3 – 12 mg/day 12 mg/day

Injection:
For intramuscular injection only.    For deltoid injection, use 1 ½-inch 22G needle for patients ≥ 90 kg or 1-inch 23G needle for patients < 90 kg. For gluteal injection, use 1 ½-inch 22G needle regardless of patient weight.   For patients naïve to oral paliperidone or oral or injectable risperidone, establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA® SUSTENNA®.    Initiate dosing with 234 mg on treatment day 1 and 156 mg one week later, both administered in the deltoid muscle.    Recommended monthly maintenance dose is 117 mg. Some patients may benefit from lower or higher maintenance doses within the additional available strengths (39 mg, 78 mg, 156 mg, and 234 mg).    Administer monthly maintenance in either the deltoid or gluteal muscle.
Missed Doses: To manage either a missed second initiation dose or a missed monthly maintenance dose, refer to the Full Prescribing Information.

Renal Dosing

dialysis Renal Impairment
Dosing must be individualized according to the patient's renal function status.

Extended release tablets:
For patients with mild renal impairment (creatinine clearance ≥ 50 mL/min to < 80 mL/min), the recommended initial dose of INVEGA® is 3 mg once daily. The dose may then be increased to a maximum of 6 mg once daily based on clinical response and tolerability.

For patients with moderate to severe renal impairment (creatinine clearance ≥ 10 mL/min to < 50 mL/min), the recommended initial dose of INVEGA® is 1.5 mg once daily, which may be increased to a maximum of 3 mg once daily after clinical reassessment.

As INVEGA® has not been studied in patients with creatinine clearance below 10 mL/min, use is not recommended in such patients.

Injection:
Moderate to severe renal impairment (creatinine clearance < 50 mL/min): INVEGA® SUSTENNA® is not recommended.

Mild renal impairment (creatinine clearance ≥ 50 mL/min to < 80 mL/min): Administer 156 mg on treatment day 1 and 117 mg one week later, both administered in the deltoid muscle. Follow with monthly injections of 78 mg in either the deltoid or gluteal muscle.

Hemodialysis

dialysis Tablets:  As INVEGA® has not been studied in patients with creatinine clearance below 10 mL/min, use is not recommended in such patients.

Injection:  Moderate to severe renal impairment (creatinine clearance < 50 mL/min): INVEGA® SUSTENNA® is not recommended.

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.
Paliperidone