(paliperidone palmitate)
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INVEGA SUSTENNA® (paliperidone palmitate)
Medical Information
INVEGA SUSTENNA - Specific Populations - Renal Impairment
Last updated : 11/11/2024
SPECIFIC RESPONSE
INVEGA SUSTENNA has not been systematically studied in patients with renal impairment.1
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Results from PK modeling simulations suggest that a dose reduction of 25% is necessary for patients with mild renal impairment to achieve exposure comparable to that in patients with normal kidney function.2
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For patients with mild renal impairment (CrCL ≥50 mL/min to <80 mL/min [Cockcroft-Gault Formula]), initiate INVEGA SUSTENNA with a dose of 156 mg on treatment day 1 and 117 mg one week later. Administer both doses in the deltoid muscle. Follow with the recommended monthly maintenance dose of 78 mg, administered in either the deltoid or gluteal muscle. Thereafter, adjust monthly maintenance dose based on tolerability and/or efficacy within the strengths of 39 mg, 78 mg, 117 mg, or 156 mg.1,2
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INVEGA SUSTENNA is not recommended in patients with moderate or severe renal impairment (CrCL <50 mL/min).1
CrCL, creatinine clearance; PK, pharmacokinetic.
References
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1.INVEGA SUSTENNA [(paliperidone palmitate) Extended-Release Injectable Suspension] [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; https://imedicalknowledge.veevavault.com/ui/approved_viewer?token=7994-54c7ff1c-5e50-4845-a605-24e8c5104cd7.
2.Samtani MN, Gopal S, Kern Sliwa J, et al. Paliperidone palmitate dosing in special populations including the elderly and those with renal impairment or differing in body mass index: guidance based on pharmacokinetic modeling and simulation. Poster presented at: The American Conference on Pharmacometrics; October 4-7, 2009; Mashantucket, CT.
