Invega Sustenna

— THERAPEUTIC CATEGORIES —
  • Psychosis

Invega Sustenna Generic Name & Formulations

General Description

Paliperidone (as palmitate) 39mg, 78mg, 117mg, 156mg, 234mg; ext-rel susp for IM inj.

Pharmacological Class

Atypical antipsychotic.

How Supplied

Kit—1 (prefilled syringe + needles)

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