• Psychosis

Psychosis:

Indications for PERSERIS:

Schizophrenia.

Adult:

Must be administered by a healthcare professional. Give by SC inj in the abdomen only. Risperidone-naive: establish tolerability with oral risperidone prior to starting. Initiate at 90mg or 120mg once monthly; max 1 dose/month. Renal or hepatic impairment: titrate with oral risperidone up to ≥3mg/day; if dose tolerated and is psychiatrically stable, may consider 90mg. Concomitant strong CYP2D6 inhibitors: give 90mg at 2–4 weeks before starting inhibitor; continue with 90mg unless treatment interruption necessary. Concomitant strong CYP3A4 inducers: monitor closely during first 4–8 weeks; consider increasing to 120mg (if taking Perseris 90mg) or additional oral risperidone (if taking Perseris 120mg). Re-evaluate and decrease Perseris or any oral risperidone dose when discontinuing strong CYP3A4 inducers; for those treated with Perseris 90mg, continue with 90mg dose unless treatment interruption necessary.

Children:

Not established.

Contraindications:

Hypersensitivity to paliperidone.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis.

Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue if neuroleptic malignant syndrome (NMS) occurs. Consider discontinuing if tardive dyskinesia occurs. Monitor for metabolic changes that may increase cardio- or cerebrovascular risk (eg, hyperglycemia, dyslipidemia, weight gain). Diabetes risk factors (eg, obesity, family history); obtain baseline and periodic fasting blood glucose. Pre-existing low WBCs or history of leukopenia/neutropenia: monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Known cardio- or cerebrovascular disease, and other conditions (eg, dehydration, hypovolemia): monitor orthostatic vital signs and consider dose reduction if hypotension occurs. Perform fall risk assessments when initiating and recurrently on long-term therapy. History of seizures or conditions that can lower the seizure threshold. Risk of aspiration pneumonia. Exposure to extreme temperatures. Re-evaluate periodically. Renal or hepatic impairment. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: monitor infants.

Pharmacologic Class:

Atypical antipsychotic.

Interactions:

See Adults. May be potentiated by strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine). May be antagonized by strong CYP3A4 inducers (eg, rifampin, cabamazepine, phenytoin, phenobarbital). May potentiate antihypertensives. May antagonize levodopa, dopamine agonists. Additive effects with centrally-acting drugs (eg, antipsychotics), alcohol; caution.

Adverse Reactions:

Increased weight, sedation/somnolence, musculoskeletal pain/stiffness, constipation, akathisia, extrapyramidal disorder, back pain, anxiety, abdominal discomfort, dry mouth, increased appetite, pain in extremity, muscle spasms; NMS, tardive dyskinesia, hyperprolactinemia, orthostatic hypotension, leukopenia/neutropenia, agranulocytosis, potential cognitive/motor impairment, dysphagia, priapism.

Note:

Register patients in National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

Generic Availability:

NO

How Supplied:

Single-dose kit—1 (w. supplies)