Avoid use in patients with congenital long QT syndrome or history of cardiac arrhythmia. Increased risk of tardive dyskinesia in the elderly, especially in women. Monitor glucose control in patients with or with risk factors for diabetes or other disorders of glucose regulation. Monitor for mental status changes, fever, muscle rigidity and/or autonomic instability. May cause orthostatic hypotension, impaired core body temperature, significant weight gain and/or sedation. Monitor for behavior changes or suicidal ideation. Patients with breast cancer or other prolactin-dependent tumors, renal impairment or at risk of seizures. May mask toxicity of other drugs or conditions eg, intestinal obstruction, Reye's syndrome and brain tumor. Care must be taken to avoid inadvertent injection of Invega Sustenna into blood vessel.
Use in pregnancy: The safety of IM injected paliperidone palmitate for use during human pregnancy has not been established. No teratogenic effect was noted in any animal study.
Use in children: Safety and efficacy of Invega Sustenna have not been established in children <18 years.
Use in the elderly: Not to be used in elderly patients with dementia-related psychosis due to increased risk of mortality.