Summary

• How Supplied: INVEGA SUSTENNA^® is supplied in prefilled syringes that contain 39 mg, 78 mg, 117 mg, 156 mg, or 234 mg paliperidone palmitate.  The kit contains a prefilled syringe (156 mg/mL) and two safety needles (a 1½-inch, 22-gauge safety needle and a 1-inch, 23-gauge safety needle). Needle selection should be made with consideration for patient's weight and administration site.¹
• Kit Components - Safety Needles: INVEGA SUSTENNA should be administered with the needles provided in the dose pack. Janssen Research & Development has established delivery of the labeled dose with these needles only. Therefore, DO NOT substitute with commercially available safety needles as they may have a different dead space volume that may result in the administration of a lower or higher INVEGA SUSTENNA dose.²

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.

PRODUCT LABELING

Please refer to the following sections of the Full Prescribing Information¹ that are relevant to your inquiry: DOSAGE AND ADMINISTRATION and HOW SUPPLIED/STORAGE AND HANDLING.

KIT COMPONENTS

INVEGA SUSTENNA is provided in a prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit contains a prefilled syringe (156 mg/mL) and two safety needles for intramuscular (IM) injection: a 1½-inch, 22-gauge safety needle and a 1-inch, 23-gauge safety needle. Needle selection should be made with consideration for injection site and patient's weight. The hubs on the two needles contained in the kit are different colors to distinguish between the 1½-inch, 22-gauge needle (gray hub) and the 1-inch, 23-gauge needle (blue hub).¹

DOSAGE STRENGTHS AND INJECTION VOLUMES

INVEGA SUSTENNA is supplied in prefilled syringes with a concentration of 156 mg/mL of paliperidone palmitate. The volume has been rounded on the carton due to space considerations. Each syringe contains the correct volume for injection based on the dose of paliperidone palmitate (see Table: Dosage Strengths and Injection Volumes per Dose of INVEGA SUSTENNA).¹

LITERATURE SEARCH

A literature search of Ovid MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 11 November 2024.