What should clinicians know about Invega Sustenna (paliperidone palmitate LAI)?

Invega Sustenna
Indication(s)	Schizophrenia; Schizoaffective Disorder
Dosing available as prefilled syringes	39 mg (injection volume of 0.25 ml) corresponds to a daily oral dose of paliperidone 3 mg 78 mg (injection volume of 0.5 ml) corresponds to a daily oral dose of paliperidone 3 mg 117 mg (injection volume of 0.75 ml) corresponds to a daily oral dose of paliperidone 6 mg 156 mg (injection volume of 1 ml) corresponds to a daily oral dose of paliperidone 9 mg 234 mg (injection volume of 1.5 ml) corresponds to a daily oral dose of paliperidone 12 mg
Recommended starting and maintenance dose	The recommended maintenance dose for treatment of schizophrenia is 117 mg.
Drug Metabolizing Enzyme	CYP3A4
Dosing exclusions	CrCL dosing: For patients with mild renal impairment (CrCl >/= 50 mL/min to < 80 mL/min: Initiate Sustenna with a dose of 156 mg on treatment day 1, 117 mg one week later. Monthly maintenance dose of 78 mg ; adjust monthly maintenance dose based on tolerability and/or efficacy Not recommended in patients with moderate or severe renal impairment (CrCl < 50 mL/min)
Loading dose	Loading dose strategy is recommended after tolerability has been established with oral risperidone or paliperidone (for patients naïve to Invega Sustenna):On day 1 administer Invega Sustenna 234 mg in the deltoid muscle. One week later administer Invega Sustenna 156 mg in the deltoid muscle per medication label. Seven days is recommended for the second loading dose, but a window of 4-10 days is acceptable. The first maintenance dose should be administered 5 weeks following the first (of 2) loading doses. Maintenance dose should be selected to correspond with appropriate oral dose equivalent (as detailed above). The loading dose strategy should NOT be used for patients switching from one LAI to another, i.e., Aristada to Invega Sustenna. For patients at steady-state on a long-acting injectable other than Invega Sustenna, prescribers can initiate Invega Sustenna in place of the next scheduled injection.
Oral overlap	No oral supplementation is necessary.
Establishing tolerability	Prior to initiating Invega Sustenna, establish tolerability with oral paliperidone or risperidone.
Storage	Room temperature
Reconstitution or mixing	N/A
Injection site	Choose between the deltoid or gluteal muscle (for maintenance doses) based on the patient preference and body habitus. Both loading doses should be administered in the deltoid muscle.Rotate injection sites to avoid muscle hypertrophy, abscesses, and tissue damage by repeated, frequent injections at the same site. For deltoid injections: For patients weighing less than 90 kg, the 1-inch, 23 gauge needle is recommended. For patients weighing 90 kg or more, the 1 ½-inch, 22 gauge needle is recommended. For gluteal injections:The recommended needle size for administration of Invega Sustenna into the gluteal muscle is the 1½-inch, 22 gauge needle regardless of patient weight. Deltoid is specifically recommended for faster distribution during the initiation phase.
Injection interval	Every 4 weeks
Preparation	Shake the syringe vigorously for a minimum of 10 seconds to ensure a homogeneous suspension. Priming the syringe is recommended.
Administration considerations	Administer the injection within 5 minutes of shaking. Inject the entire contents intramuscularly slowly, deep into the selected deltoid or gluteal muscle of the patient.
Timing variations	For initiation dosing: the second initiation dose can be given within a 4 to 10 day window after the first injection. To avoid a missed maintenance injection, patients may be given the injection up to 7 days before or after the monthly time point.
When a dose is missed	See this tip on how to manage missed doses of Invega Sustenna. Monthly doses can be flexibly administered one week before or after the scheduled dose to avoid missed doses.
REMS	No

Dose Conversion of Oral Paliperidone to Paliperidone Palmitate LAI
PO Dose	LAI/IM Dose
Initiate LAI doses	Loading doses – 234 mg day 1, followed by 156 mg day 8, followed by maintenance dose 5 weeks after first injection
3 mg paliperidone	39-78 mg Invega Sustenna every 4 weeks
6 mg paliperidone	117 mg Invega Sustenna every 4 weeks
9 mg paliperidone	156 mg Invega Sustenna every 4 weeks
12 mg paliperidone	234 mg Invega Sustenna every 4 weeks
Recommended available dose formulations include 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg pre-filled syringes. Dose reduction may be necessary for CYP450 interactions of side effect intolerance. References: 1. Stahl, S. M. (2017). The prescriber’s guide: Stahl’s essential psychopharmacology (6th ed.). New York: Cambridge University Press. 2. American Psychiatric Association. (2020). The American Psychiatric Association Practice Guideline for the Treatment of Patients With Schizophrenia. American Psychiatric Association Publishing. https://doi.org/10.1176/appi.books.9780890424841 3. INVEGA SUSTENNA USPI, Section 2.1 Administration Instructions; Section 2.2: Schizophrenia and Schizoaffective Disorder; Section 2.6: Switching from Other Antipsychotics; Section 17: How Supplied/Storage and Handling

FDA medication label

Information on this topic is found in the FDA medication label. Not all information in the FDA medication label is included here, and clinicians should read the entire FDA medication label before making treatment decisions.
Here is the most recent label, at time of writing.
Medication labels can be found by searching Drugs@FDA at the FDA website. Labels are also available using the Drugs@FDA app for Apple or Android devices. Labels change over time, and the current label should always be consulted.

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