Paliperidone palmitate (Invega Hayfera™) is an extended-release injectable second-generation (“atypical”) antipsychotic that can be administered once every 6 months.
On this page, we will provide basic information about this medication. Links to other articles on this website with more advanced information and tips related to this medication and related topics are provided below—under Related Pages below.
FDA indication
Schizophrenia in adults after:
a) Adequate treatment with 1-month paliperidone palmitate extended-release (Invega Sustenna®) for at least four months or
b) Adequate treatment with 3-month paliperidone palmitate extended-release (Invega Trinza®) for at least one 3-month cycle
Mechanism of action/ Pharmacodynamics
Paliperidone is an antagonist of central dopamine D2 and serotonin 5HT2A receptors.
Side effects
The commonest side effects of Invega Hayfera™ (occurring in 5% or more of patients) were: upper respiratory tract infection, injection site reaction, weight gain, headache, and parkinsonism.
Less common side effects (occurring in 2% or more of patients) were: akathisia, anxiety, back pain, insomnia, musculoskeletal pain, psychosis, urinary tract infection, and diarrhea.
Boxed warning
The image below shows the boxed warning from the full Prescribing Information for Invega Hayfera™.
Warnings and Precautions
1. Increased incidence of cerebrovascular accidents has been observed in elderly patients with dementia-related psychosis. Invega Hayfera™ is not approved for use in these patients.
2. If neuroleptic malignant syndrome occurs, immediate discontinuation of the drug with close monitoring is recommended.
3. Since QT prolongation is a concern, avoid use with drugs that also increase QT interval.
4. Some patients may experience tardive dyskinesia. Discontinue treatment if clinically appropriate in these cases.
5. Metabolic changes may be observed in some patients. Monitor for symptoms of hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.
6. Should be used with caution in patients with a history of cardiovascular/cerebrovascular disease and patients predisposed to hypotension since orthostatic hypotension and syncope are a concern in some patients.
7. Leukopenia, neutropenia, and agranulocytosis may occur. In the first few months after starting treatment, perform complete blood counts (CBC) regularly in patients with a pre-existing history of leukopenia or neutropenia.
8. Prolactin elevations may occur and persist if treatment is continued for a long time. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported.
9. Cognitive and motor impairment is a concern. Patients should be advised to use caution while operating machinery.
10. May lower seizure threshold. Use with caution in patients with a history of seizures.
Administration
– 6-month paliperidone palmitate is administered as a gluteal intramuscular injection once every 6 months.
– It comes prepackaged as a single-dose prefilled syringe.
– Before injecting, shake the syringe vigorously for 15 seconds with the syringe tip cap pointing upwards, rest for a few seconds, and then shake again vigorously for another 15 seconds.
Important! Clinicians must read the full instructions in the Prescribing Information regarding how exactly to administer this injection.
Dosage
The dose of 6-month paliperidone palmitate extended-release injection (Invega Hayfera™) will depend on the last dose of 1-month paliperidone palmitate extended-release (Invega Sustenna®) or the last dose of 3-month paliperidone palmitate extended-release (Invega Trinza®).
6-month paliperidone palmitate extended-release injection (Invega Hayfera™) is available as 1,092 mg and 1,560 mg.
a) Switching from 1-month Invega Sustenna®
|
Last dose of |
Starting dose of |
|
156 mg |
1,092 mg |
| 234 mg |
1,560mg |
b) Switching from 3-month Invega Trinza®
|
Last dose of |
Starting dose of |
|
546 mg |
1,092 mg |
| 819 mg |
1,560mg |
Dosage forms and strengths
Extended-release injectable suspension: 1,092 mg/3.5 mL or 1,560 mg/5 mL in a single dose prefilled syringe
Important! This page does not provide all the information needed to prescribe this medication. Please refer to the full Prescribing Information (see link below) before prescribing this medication.
Related Pages
LAI second-generation antipsychotics: General articles
Long-acting injectable antipsychotics: Overview
Dose equivalents of long-acting injectable second-generation antipsychotics
How *NOT* to offer long-acting injectable (LAI) antipsychotics to patients
CPT billing code for administration of injections
Long-acting injectable (LAI) second-generation (atypical) antipsychotics: Paliperidone
Paliperidone palmitate (Invega Sustenna®): Basic Information
3-month paliperidone palmitate (Invega Trinza®): Basic Information
Long-acting injectable (LAI) second-generation (atypical) antipsychotics: Aripiprazole
How to convert from oral to long-acting injectable (LAI) aripiprazole
Aripiprazole (Abilify Maintena®)
Aripiprazole lauroxil (Aristada®)
Aripiprazole lauroxil (Aristada®) versus Aripiprazole (Abilify Maintena®)
Be careful in converting from Abilify Maintena® to Aristada®
Long-acting injectable (LAI) second-generation (atypical) antipsychotics: Olanzapine
Olanzapine (Zyprexa Relprevv®)
Long-acting injectable (LAI) second-generation (atypical) antipsychotics: Risperidone
Risperidone long-acting injection (Risperdal Consta®)
Equivalence of risperidone oral and long-acting injection (RLAI; Risperdal Consta®)
References
Invega Hayfera™ Prescribing Information
Peters L, Dyer M, Schroeder E, D’Souza MS. Invega Hafyera (Paliperidone Palmitate): Extended-Release Injectable Suspension for Patients With Schizophrenia. J Pharm Technol. 2023 Apr;39(2):88-94. doi: 10.1177/87551225231153541. Epub 2023 Mar 16. PMID: 37051282; PMCID: PMC10084407.
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