Molecule
Paliperidone palmitate is an atypical antipsychotic indicated for the treatment of schizophrenia in adults. It is available as injection and extended-release injectable suspension for intramuscular use. MedsAcross supplies Paliperidone palmitate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: Schizophrenia in adults. Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. INVEGA SUSTENNA is an atypical antipsychotic indicated for Treatment of schizophrenia in adults. Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Source: US FDA prescribing information
Paliperidone palmitate is hydrolyzed to paliperidone. Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone is unclear. However, the drug's therapeutic effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2A ) receptor antagonism.
Source: US FDA prescribing information
For intramuscular injection only. Each injection must be administered only by a healthcare professional. For deltoid injection, use 1-inch 23G needle for patients weighing less than 90 kg or 1½-inch 22G needle for patients weighing 90 kg or more. For gluteal injection, use 1½-inch 22G needle regardless of patient weight. Indication Initiation Dosing (deltoid) Monthly Maintenance Dose Administered 5 weeks after the first injection. (deltoid or gluteal) Maximum Monthly Dose Day 1 Day 8 Schizophrenia 234 mg 156 mg 39–234 mg The recommended maintenance dose for treatment of schizophrenia 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). 234 mg Schizoaffective disorder 234 mg 156 mg 78–234 mg Adjust dose based on tolerability and/or efficacy using available strengths.
Source: US FDA prescribing information
INVEGA SUSTENNA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA SUSTENNA formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone. Known hypersensitivity to paliperidone, risperidone, or to any excipients in INVEGA SUSTENNA.
Source: US FDA prescribing information
Boxed warning (increased mortality in elderly patients with dementia-related psychosis): Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA SUSTENNA is not approved for use in patients with dementia-related psychosis. Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack). Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of drug and close monitoring. QT Prolongation: Avoid use with drugs that also increase QT interval and in patients with risk factors for prolonged QT interval. Tardive Dyskinesia: Discontinue drug if clinically appropriate. Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain.
Source: US FDA prescribing information
The following are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis Neuroleptic malignant syndrome QT prolongation Tardive dyskinesia Metabolic changes Orthostatic hypotension and syncope Falls Leukopenia, neutropenia, and agranulocytosis Hyperprolactinemia Potential for cognitive and motor impairment Seizures Dysphagia Priapism Disruption of body temperature regulation The most common adverse reactions (incidence ≥ 5% and occurring at least twice as often as placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.
Source: US FDA prescribing information
Drugs that may cause orthostatic hypotension: An additive effect may occur when co-administered with INVEGA SUSTENNA. Strong CYP3A4/P-glycoprotein (P-gp) inducers: Avoid using a strong inducer of CYP3A4 and/or P-gp (e.g., carbamazepine, rifampin, St John's Wort) during a dosing interval for INVEGA SUSTENNA. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended-release tablets.
Source: US FDA prescribing information
Store at room temperature (25 °C, 77 °F), excursions between 15 °C and 30 °C (between 59 °F and 86 °F) are permitted.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
17 presentations of Paliperidone palmitate, sorted by availability.
4 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 31 July 2009 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 17 presentations of Paliperidone palmitate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 4 brand names for Paliperidone palmitate, including Erzofri extended-release, Invega Hafyera, Invega Sustenna, Invega Trinza.
Yes. The US FDA first approved Paliperidone palmitate on 31 July 2009, according to Drugs@FDA.
No listed presentation of Paliperidone palmitate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.