Sign Out
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 Neuroleptic Malignant Syndrome under 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 Tardive Dyskinesia under 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 Metabolic Changes under 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 Orthostatic Hypotension and Syncope under 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 HAFYERA [see Leukopenia, Neutropenia, and Agranulocytosis under Precautions].
Hyperprolactinemia: Counsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of INVEGA HAFYERA. 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 Hyperprolactinemia under Precautions].
Interference with Cognitive and Motor Performance: As INVEGA HAFYERA 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 HAFYERA therapy does not affect them adversely [see Potential for Cognitive and Motor Impairment under 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 Priapism under Precautions].
Heat Exposure and Dehydration: Counsel patients on the importance of avoiding overheating and dehydration [see Disruption of Body Temperature Regulation under 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 to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with INVEGA HAFYERA. Advise patients that INVEGA HAFYERA may cause extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to INVEGA HAFYERA during pregnancy [see Pregnancy under Use in Pregnancy & Lactation].
Lactation: Advise breastfeeding women using INVEGA HAFYERA to monitor infants for somnolence, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs [see Lactation under Use in Pregnancy & Lactation].
Infertility: Advise females of reproductive potential that INVEGA HAFYERA may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
