Invega Sustenna Generic Name & Formulations
Legal Class
Rx
General Description
Paliperidone (as palmitate) 39mg, 78mg, 117mg, 156mg, 234mg; ext-rel susp for IM inj.
Pharmacological Class
Atypical antipsychotic.
See Also
How Supplied
Kit—1 (prefilled syringe + needles)
Manufacturer
Generic Availability
NO
Invega Sustenna Indications
Indications
Schizophrenia. Schizoaffective disorder as monotherapy or as an adjunct to mood stabilizers or antidepressants.
Invega Sustenna Dosage and Administration
Adult
Establish tolerability with oral paliperidone or oral risperidone prior to initiating. Give by deep deltoid IM inj, initially 234mg on Day 1, then 156mg one week later. Maintenance: Give by deep deltoid or gluteal IM inj once monthly. Schizophrenia: 117mg; may increase or decrease in the range of 39–234mg. Schizoaffective: usual range of 78–234mg. Both max: 234mg/month. Renal impairment: CrCl ≥50–<80mL/min: initially 156mg on Day 1, then 117mg one week later, then 78mg monthly; CrCl<50mL/min: not recommended. Missed doses or switching from other antipsychotics: see full labeling.
Children
<18yrs: not established.
Invega Sustenna Contraindications
Contraindications
Risperidone hypersensitivity.
Invega Sustenna Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis.
Invega Sustenna Warnings/Precautions
Warnings/Precautions
Elderly with dementia-related psychosis (not approved use): increased risk of death. Discontinue immediately if neuroleptic malignant syndrome (NMS) is suspected. Avoid in congenital long QT syndrome, history of cardiac arrhythmias. Consider discontinuation if tardive dyskinesia occurs. Cardio- or cerebrovascular disease; risks may be increased due to metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Conditions that predispose to hypotension (eg, dehydration, hypovolemia). Diabetes risk factors (obtain baseline fasting blood sugar and periodically thereafter). Perform fall risk assessments when initiating and recurrently on long-term therapy (esp. in elderly). History of significant low WBC/ANC or drug-induced leukopenia/neutropenia; obtain CBCs frequently during 1st few months of treatment; consider discontinuation if significant decline in WBC. Monitor for signs/symptoms of infection in those with neutropenia; discontinue if severe (ANC <1000mm3) and follow WBC until recovery. History of seizures. Conditions that lower the seizure threshold. Patients at risk for aspiration pneumonia. Exposure to extreme temperatures. Write ℞ for smallest practical amount. Reevaluate periodically. Parkinson's disease. Dementia with Lewy bodies. Renal impairment. Severe hepatic impairment. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: monitor infants.
Invega Sustenna Pharmacokinetics
See Literature
Invega Sustenna Interactions
Interactions
Avoid drugs that prolong QT interval (eg, Class 1A and Class III antiarrhythmics, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin). Avoid concomitant strong CYP3A4 and/or P-gp inducers (eg, carbamazepine, rifampin, St. John's Wort); if coadmin necessary, consider oral paliperidone ext-rel tabs. Caution with other CNS drugs, alcohol, drugs that may cause orthostatic hypotension (monitor). Caution with anticholinergic drugs that may elevate body temperature. May antagonize levodopa, other dopamine agonists. Additive effects with concomitant risperidone or oral paliperidone for long-term use; caution.
Invega Sustenna Adverse Reactions
Adverse Reactions
Inj site reactions, somnolence/sedation, dizziness, akathisia, extrapyramidal disorder, upper respiratory tract infection, weight increased, headache, parkinsonism; may cause NMS, tardive dyskinesia, QT prolongation, metabolic changes, hyperprolactinemia, orthostatic hypotension, syncope, agranulocytosis, priapism.
Invega Sustenna Clinical Trials
See Literature
Invega Sustenna Note
Not Applicable
Invega Sustenna Patient Counseling
See Literature