Paliperidone palmitate LAI
INVEGA HAFYERA
“Half year in Vegas”
Two heads → twice yearly IM injection
Half birthday cake → half-year duration
What it isLong-acting injectable D2 and 5-HT2A antagonist paliperidone palmitate; schizophrenia maintenance.
Why this oneTwo injections a year, reached after adequate stabilization on the monthly or three-month paliperidone products.
What limits itCommitment is the constraint: anything unwanted — prolactin effects, EPS — has a six-month horizon, so patient selection is everything.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Schizophrenia, after adequate treatment with once-monthly paliperidone palmitate (PP1M) for ≥4 months or every-3-month (PP3M) for ≥1 cycle | Adults | Based on prior product: 1,092 mg (from PP1M 156 mg or PP3M 546 mg) or 1,560 mg (from PP1M 234 mg or PP3M 819 mg) | Gluteal IM injection once every 6 months |
Renal Mild (CrCl 50–<80): stabilize on PP1M first, then transition; moderate or severe (CrCl <50): not recommended
Hepatic Undefined
Administered once every 6 months
Instructions
- Initiate only after adequate treatment with PP1M ≥4 months or PP3M ≥1 three-month cycle
- Gluteal IM injection by a healthcare professional once every 6 months
- When switching from PP1M, the two preceding injection cycles should be the same strength
Available strengths
- inj 1092, 1560 mg
Contraindications
- Known hypersensitivity to paliperidone, risperidone, or to any excipients in INVEGA HAFYERA
Cautions
- Cerebrovascular adverse reactions in elderly with dementia-related psychosis
- Neuroleptic malignant syndrome
- QT prolongation
- Tardive dyskinesia
- Metabolic changes (hyperglycemia/diabetes, dyslipidemia, weight gain)
- Orthostatic hypotension and syncope
- Leukopenia, neutropenia, agranulocytosis
- Hyperprolactinemia
- Seizures
- Cognitive and motor impairment
Adverse reactions
- Upper respiratory tract infection
- Injection-site reaction
- Weight increased
- Headache
- Parkinsonism
Pregnancy Third-trimester exposure risks neonatal extrapyramidal and/or withdrawal symptoms; epidemiologic data have not established a drug-associated risk of major birth defects
Lactation Paliperidone present in human milk; monitor breastfed infant for sedation, failure to thrive, jitteriness, and extrapyramidal symptoms
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 1092 mg | inj | per unit | — | $4047.71/mL | not offered |
| 1560 mg | inj | per unit | — | $4233.40/mL | not offered |
Other forms: Paliperidone palmitate LAI (INVEGA SUSTENNA) · Paliperidone palmitate LAI (INVEGA TRINZA) · Paliperidone palmitate LAI (ERZOFRI)
⚠ BOXED WARNING
- Increased mortality in elderly patients with dementia-related psychosis
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityMetabolic effects, extrapyramidal symptoms/tardive dyskinesia and agent-specific QT or orthostatic risk.
Open Paliperidone palmitate LAI in the interactive console ↗