See Supplemental Patient Information
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [US Black Box Warning]
- Iloperidone is not approved for dementia-related psychosis due to an increased risk of death as compared to placebo [US Black Box Warning]
- CV adverse events including fatalities have been reported in elderly patients with dementia related psychosis (non approved use)
- Iloperidone may be associated with prolongation of the QTc interval and should be avoided with other drugs that are known to prolong QTc including Class 1A, Class III antiarrhythmic medications
- Neuroleptic Malignant Syndrome (NMS) has been reported with therapy
- Tardive dyskinesia may develop in patients treated with antipsychotic drugs. The prevalence appears to be highest among elderly patients, especially elderly women; the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and total cumulative dose of antipsychotic administered increase
- Therapy may cause metabolic changes such as hyperglycemia, dyslipidemia, and weight gain which may increase CV and cerebrovascular risk. Hyperglycemia in rare cases has been associated with ketoacidosis or hyperosmolar coma or death. Patient should be monitored or worsening of glucose control and evaluate FPG testing before initiating therapy and periodically in patients who are at risk of diabetes mellitus (DM)
- Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold
- Therapy may induce orthostatic hypotension linked with dizziness, tachycardia, and syncope
- Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotics. Should Monitor CDC. Discontinue on any signs of decreased WBC
- Increased prolactin levels has been observed in patients receiving iloperidone leading to galactorrhea, amenorrhea, gynecomastia, and impotence
- Therapy may disrupt body's ability to reduce core body temperature; use cautiously in conditions that may elevate body core temperature
- Esophageal dysmotility and aspiration have been reported with iloperidone; use cautiously in patients who are at risk of aspiration pneumonia
- Closely supervise high-risk patients for suicide attempt
- Cases of priapism have been reported in association with iloperidone treatment
- May impair judgment, thinking or motor skills; caution patient to avoid driving or other activities requiring alertness until response to medication is known
Cautions: Use cautiously in
- Diabetes mellitus (monitor blood glucose levels)
- Conditions that may contribute to elevated body temperature
- Co-administration of CYP2D6 inhibitors (reduce iloperidone dose)
- Co-administration of CYP3A4 inhibitors (reduce iloperidone dose)
- Bradycardia
- Hypokalemia
- Hypomagnesemia
- Exposure to extreme heat
- Seizure disorder
- Alzheimer's disease
- Dehydration
- Hypotension
- Aspiration pneumonia risk
- Hypovolemia
- Recent MI
- Suicidal tendencies
- Uncompensated heart failure
- Concommitant use of QTc prolonging agent
- Drug-induced leukopenia or neutropenia history
- Geriatric Patients (increased mortality and CV events)
Supplemental Patient Information
- Advise patient to avoid concurrent use of alcohol, other CNS depressants, OTC, or herbal products without consulting health care professional
- May cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known
- Advise patient to change positions slowly to minimize orthostatic hypotension
- Instruct patient to report extrapyramidal symptoms immediately to health care professional
- Advise patients to notify their physician if they become pregnant or intent to become pregnant during treatment with an antipsychotic agent, but not abruptly discontinue therapy without physician's recommendation
Pregnancy category: C; neonates exposed to antipsychotic agents during last trimester of pregnancy are at an increased risk of developing extrapyramidal and withdrawal symptoms following birth.
Breastfeeding: Safety unknown, an alternate drug may be preferred, especially while nursing a newborn or preterm infant based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 January 2011).
