Paliperidone palmitate LAI
ERZOFRI
“Ears are free”
Alt brand of Invega Sustenna q 1 month LAI
What it isDepot D2 and 5-HT2A antagonist paliperidone; adult schizophrenia and schizoaffective disorder.
Why this oneThe single-day, one-injection start is the differentiator from INVEGA SUSTENNA’s two-injection day-1/day-8 loading.
What limits itOtherwise it is paliperidone: renal clearance governs dosing, and prolactin elevation is the trade-off.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Schizophrenia | Adults | 351 mg IM (deltoid) on Day 1 | 117 mg IM monthly (deltoid or gluteal); range 39–234 mg | 234 mg/month |
| Schizoaffective disorder (monotherapy or adjunct to mood stabilizers/antidepressants) | Adults | 351 mg IM (deltoid) on Day 1 | 78–234 mg IM monthly (deltoid or gluteal) | 234 mg/month |
Renal Mild (CrCl 50–<80): 234 mg Day 1 then 78 mg monthly (max 156 mg/month); moderate or severe (CrCl <50): not recommended
Hepatic Undefined
Administered once monthly (after Day 1 initial dose)
Instructions
- For patients naïve to paliperidone/risperidone, establish tolerability with oral paliperidone or risperidone first
- Initial dose in the deltoid muscle; monthly doses in deltoid or gluteal muscle
- IM injection administered by a healthcare professional only
Available strengths
- inj 39, 78, 117, 156, 234, 351 mg
Contraindications
- Known hypersensitivity to paliperidone, risperidone, or to any excipients in ERZOFRI
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
- Injection-site reactions
- Somnolence/sedation
- Dizziness
- Akathisia
- Extrapyramidal disorder
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 | |
|---|---|---|---|---|---|
| 39 mg | inj | per unit | — | $2338.75/mL | not offered |
| 78 mg | inj | per unit | — | $2337.05/mL | not offered |
| 117 mg | inj | per unit | — | $2339.67/mL | not offered |
| 156 mg | inj | per unit | — | $2337.71/mL | not offered |
| 234 mg | inj | per unit | — | $2338.47/mL | not offered |
| 351 mg | inj | per unit | — | not offered |
Other forms: Paliperidone palmitate LAI (INVEGA SUSTENNA) · Paliperidone palmitate LAI (INVEGA TRINZA) · Paliperidone palmitate LAI (INVEGA HAFYERA)
⚠ 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.
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