Advise the patient to read the approved patient labeling (Patient Information).
Neuroleptic Malignant Syndrome (NMS): Counsel patients about a potentially fatal side effect referred to as Neuroleptic Malignant Syndrome (NMS) that has been reported in association with administration of antipsychotic drugs. Patients should contact their health care provider or report to the emergency room if they experience the following signs and symptoms of NMS, including hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia (see Precautions).
Tardive Dyskinesia: Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their health care provider if these abnormal movements occur (see Precautions).
Metabolic Changes: Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia (high blood sugar) and diabetes mellitus (e.g., polydipsia, polyuria, polyphagia, and weakness), and the need for specific monitoring, including blood glucose, lipids, and weight (see Precautions).
Orthostatic Hypotension: Educate patients about the risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose (see Precautions).
Leukopenia/Neutropenia: Advise patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia they should have their CBC monitored while taking INVEGA TRINZA (see Precautions).
Hyperprolactinemia: Counsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of INVEGA TRINZA. Advise them to seek medical attention if they experience any of the following: amenorrhea or galactorrhea in females, erectile dysfunction or gynecomastia in males. (See Precautions.)
Interference with Cognitive and Motor Performance: As INVEGA TRINZA has the potential to impair judgment, thinking, or motor skills, caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that INVEGA TRINZA therapy does not affect them adversely (see Precautions).
Priapism: Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism (see Precautions).
Heat Exposure and Dehydration: Counsel patients on the importance of avoiding overheating and dehydration (see Precautions).
Concomitant Medication: Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter drugs, as there is a potential for interactions (see Interactions).
Pregnancy: Advise patients that INVEGA TRINZA may cause extrapyramidal and/or withdrawal symptoms in a neonate and to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with INVEGA TRINZA. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to INVEGA TRINZA during pregnancy (see Use in Pregnancy & Lactation).