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Paliperidone ER

Oral
Intramuscular
Class
Antipsychotics
Subclass
Atypical antipsychotics
Substance name
Paliperidone ER
Brand names
Invega®
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment of schizoaffective disorder
•
3-12 mg PO daily
Other off-label uses
•
Treatment of bipolar disorder
Indications for use
Labeled indications
Adults
•
Treatment of schizoaffective disorder
•
Treatment of schizophrenia
Children
•
Treatment of schizophrenia
Off-label indications
Adults
•
Treatment of bipolar disorder
Safety risks
Contraindications
Pre-existing severe gastrointestinal narrowing
A hypersensitivity to paliperidone or any of its components
Warnings and precautions
Aspiration pneumonia
•
Use caution with dysphagia or who are at risk for aspiration pneumonia.
Cardiovascular risk
•
Use caution with pre-existing conditions such as obesity, pre-diabetes, established diabetes mellitus, or hyperlipidemia.
Cognitive impairment
•
Use caution with significant CNS depression, or coadministration with other CNS depressants and alcohol.
Extrapyramidal signs
•
Use caution with Parkinson's disease.
Hematologic disorder
•
Use caution with a history of drug-induced leukopenia or neutropenia or pre-existing low WBC count.
High risk for fractures
•
Use caution with conditions, diseases (e.g., neurological disease), or taking concurrent medications that could exacerbate motor and sensory instability.
Hyperglycemia
•
Use caution with diabetes mellitus.
Orthostatic hypotension
•
Use caution with a history of myocardial infarction, recent acute myocardial infarction, ischemia, HF, volume depletion, or concomitant antihypertensive agent use.
Seizures
•
Use caution with a history of seizure disorder.
Tardive dyskinesia
•
Use caution with a history of movement disorder.
Torsades de pointes
•
Use caution with a history of congenital long QT syndrome, cardiac arrhythmias, or conditions that may increase the risk of QT prolongation.
Specific populations
Renal impairment
eGFR 50-80 mL/min/1.73 m²
•
Cap dose. Start at dose of 3 mg. Do not exceed frequency of once daily. Titrate to response.
eGFR 30-50 mL/min/1.73 m²
•
Start at dose of 1.5 mg. Maximal dose of 3 mg. Do not exceed frequency of once daily. Titrate to response.
eGFR 10-30 mL/min/1.73 m²
•
Start at dose of 1.5 mg. Maximal dose of 3 mg. Do not exceed frequency of once daily. Titrate to response.
eGFR < 10 mL/min/1.73 m²
•
Avoid use as much as possible. Maximal dose of 3 mg. Do not exceed frequency of q48h. Titrate to response.
Renal replacement therapy
Continuous renal replacement
•
Dose as in eGFR 10-30 mL/min/1.73 m². Start at a dose of 1.5 mg. Maximal dose of 3 mg. Maximal frequency of daily. Titrate to response.
Intermittent hemodialysis
•
Avoid use as much as possible. Dose as in eGFR < 10 mL/min/1.73 m². Maximal dose of 3 mg. Maximal frequency of q48h. Titrate to response.
Peritoneal dialysis
•
Avoid use as much as possible. Dose as in eGFR < 10 mL/min/1.73 m². Maximal dose of 3 mg. Maximal frequency of q48h. Titrate to response.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in humans. Monitor neonates for extrapyramidal and/or withdrawal symptoms. When considering the use of paliperidone during pregnancy, the possibility of paliperidone-related adverse outcomes in the fetus or neonate should be weighed against the risks of an untreated maternal psychiatric condition, which may include hospitalization, relapse, suicide, and increased adverse perinatal outcomes (e.g., pre-term birth).
•
There was a small increase in major birth defects and cardiac malformations in a subgroup of 1,566 women exposed to risperidone during their first trimester of pregnancy; however, there is no mechanism of action to explain the increased malformation rate.
•
Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates exposed to antipsychotics during the third trimester.
Breastfeeding
Acceptable for use during breastfeeding.
•
Use with caution during breastfeeding.
Undetectable levels in breastfed infants.
Unlikely to cause adverse effects in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Dystonia, extrapyramidal symptoms, hyperactivity, parkinsonism, akathisia, somnolence, vomiting, weight gain, tachycardia, tremor
Common 1-10%
•
Anaphylaxis, bradycardia, dyskinesia, erectile dysfunction, hypotension, nasopharyngitis, orthostatic hypotension, ↑QT interval, abdominal pain, amenorrhea, anxiety, back pain, constipation, ↓ libido, dizziness, dry mouth, hypersalivation, ↑ appetite, indigestion, limb pain, musculoskeletal pain
Uncommon < 1%
•
Seizure, syncope
Unknown frequency
•
AV block, acute cystitis, agranulocytosis, catatonia, ↓ WBC count, ↓ blood neutrophil count, ↓ serum HDL, ↓ serum sodium, drug-induced liver injury, erythema multiforme, extrapyramidal signs, hypertriglyceridemia, ↑ LFTs, ↑ blood glucose, ↑ serum LDL, ↑ serum prolactin, metabolic syndrome, neuroleptic malignant syndrome, pulmonary embolism, peripheral edema, arthralgia, depression, dysphagia, insomnia, priapism, skin rash, urinary incontinence, urinary retention, vertigo, respiratory tract infections, syndrome of inappropriate antidiuretic hormone secretion, thrombotic thrombocytopenic purpura, tardive dyskinesia, toxic epidermal necrolysis, urinary tract infections
Interactions
Drug(s)
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