paliperidone palmitate
Brands: INVEGA SUSTENNA, INVEGA TRINZA, INVEGA HAFYERA
Last reviewed 2025-12-30
Reviewed by PsychMed Editorial Team.
Quick answers
What is paliperidone palmitate?
Paliperidone palmitate is a long-acting injectable prodrug of paliperidone with multiple interval options: monthly (PP1M), every 3 months (PP3M), and every 6 months (PP6M), depending on product and prior stabilization.
What is INVEGA SUSTENNA?
INVEGA SUSTENNA is a brand name for paliperidone palmitate (other brands: INVEGA TRINZA, INVEGA HAFYERA).
What is INVEGA SUSTENNA (paliperidone palmitate) used for?
Label indications include: Schizophrenia; schizoaffective disorder (monthly formulation).
What drug class is INVEGA SUSTENNA (paliperidone palmitate)?
Long-acting injectable antipsychotic.
What is the mechanism of action of INVEGA SUSTENNA (paliperidone palmitate)?
Long-acting injectable prodrug of paliperidone (D2 and 5-HT2A antagonist; active metabolite of risperidone) used for maintenance treatment with monthly, 3-month, or 6-month dosing intervals depending on formulation.
What strengths does INVEGA SUSTENNA (paliperidone palmitate) come in?
PP1M: intramuscular injection monthly after labeled loading sequence.
Is INVEGA SUSTENNA (paliperidone palmitate) a controlled substance?
No — it is not scheduled as a controlled substance under U.S. federal law.
How is paliperidone palmitate started as a long-acting injectable (LAI)?
PP1M initiation uses a labeled loading sequence (deltoid injections on day 1 and day 8) followed by monthly maintenance. Oral overlap is not typically required after the loading sequence.
Snapshot
- Class: Long-acting injectable antipsychotic
- Common US brands: INVEGA SUSTENNA, INVEGA TRINZA, INVEGA HAFYERA
- Long-acting injectable formulation available.
- Therapeutic drug monitoring not routinely recommended.
- Last reviewed: 2025-12-30
Clinical Highlights
Paliperidone palmitate is a long-acting injectable prodrug of paliperidone with multiple interval options: monthly (PP1M), every 3 months (PP3M), and every 6 months (PP6M), depending on product and prior stabilization. In the U.S., paliperidone palmitate products are used for schizophrenia maintenance, and the monthly formulation is also labeled for schizoaffective disorder. Longer-interval options are typically introduced after a period of stability on a shorter interval.
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- Pharmacology mirrors paliperidone/risperidone-class D2/5-HT2A blockade: prolactin elevation and EPS risk are common clinical constraints, while hepatic CYP interactions are limited because renal excretion is the dominant clearance pathway.
- The compare view provides a depot-focused risk snapshot; the evidence feed can help track newer effectiveness and interval studies.
- Schizophrenia (adults): long-acting maintenance formulation.
- Schizoaffective disorder: monthly formulation (PP1M) is commonly used.
Dosing & Formulations
PP1M initiation uses a labeled loading sequence (deltoid injections on day 1 and day 8) followed by monthly maintenance. Oral overlap is not typically required after the loading sequence. Maintenance dosing is individualized to prior response and tolerability within labeled dose ranges. Deltoid versus gluteal administration can influence absorption; initiation is often deltoid per label.
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- PP3M and PP6M products require prior stabilization (usually on PP1M, then PP3M before PP6M). Conversion tables are formulation-specific and depend on the stabilized dose.
- Missed-dose management is product-specific and time-sensitive; clinic workflows often include a “what to do if late” protocol to determine whether re-loading or interim oral coverage is needed.
Monitoring & Risks
Boxed warning: increased mortality in elderly patients with dementia-related psychosis (antipsychotic class warning). Prolactin elevation is common and can present as sexual dysfunction, menstrual changes, galactorrhea, or bone health concerns; monitoring is typically symptom-driven rather than routine lab surveillance.
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- EPS and akathisia can occur, especially with higher doses or when combined with other dopamine-blocking agents; movement-disorder screening is part of routine follow-up.
- Metabolic monitoring remains standard (weight/BMI, lipids, glucose), as weight gain and cardiometabolic change can still occur.
- Renal function matters: exposure increases with renal impairment and can constrain dose selection or eligibility for longer-interval products.
Drug Interactions
Paliperidone is not heavily metabolized by hepatic CYP enzymes, so classic inhibitor/inducer interactions are less prominent than with drugs like aripiprazole or clozapine. Additive sedation, orthostasis, or QTc risk can occur with other CNS depressants or QT-prolonging medications; clinical monitoring is individualized to baseline cardiac risk.
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- Combined dopamine-blocking agents increase EPS and neuroleptic adverse effect burden; careful dose selection is typical when combinations are unavoidable.
Practice Notes
Product selection is often a sequencing decision: PP1M is used to establish stability, then PP3M/PP6M can reduce visit burden when symptoms and logistics are stable. A practical workflow tool is a standardized injection log (product, dose, site, date) plus a missed-dose algorithm so late injections do not silently become undertreatment.
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- Use the print handout for clinic workflows and the schizophrenia hub for relapse-prevention pathways.
Long-acting injectable (LAI) options
- Interval
- Monthly / q3mo / q6mo
- Oral overlap
- None after loading sequence
- Injection site
- Deltoid (initiation) or gluteal
- Notes
- PP1M loading: Day 1 deltoid 234 mg, Day 8 deltoid 156 mg
- PP3M/PP6M require stabilization on PP1M/PP3M first
References
- INVEGA SUSTENNA prescribing information (DailyMed, 2025). — DailyMed / Janssen Pharmaceuticals (2025)
- INVEGA TRINZA (paliperidone palmitate) prescribing information — DailyMed / Janssen Pharmaceuticals (2025)
- INVEGA HAFYERA (paliperidone palmitate) prescribing information — DailyMed / Janssen Pharmaceuticals (2025)
- Paliperidone palmitate maintenance treatment in delaying time to relapse in patients with schizophrenia — Schizophrenia Research (2010)