Indicated for the treatment of schizophrenia in adults.

When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that FANAPT is associated with prolongation of the QTc interval. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether FANAPT will cause torsade de pointes or increase the rate of sudden death is not yet known. 

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for use in patients with dementia-related psychosis.

FANAPT is not recommended for patients with severe hepatic impairment.

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including FANAPT.

The possibility of a suicide attempt is inherent in psychotic illness, and close supervision of high-risk patients should accompany drug therapy.

Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain.

In clinical trials and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents. Agranulocytosis (including fatal cases) has also been reported.

As with other drugs that antagonize dopamine D2 receptors, FANAPT elevates prolactin levels.

FANAPT may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing FANAPT for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.

Drugs with alpha-adrenergic blocking effects have been reported to induce priapism. FANAPT shares this pharmacologic activity. Severe priapism may require surgical intervention.

FANAPT, like other antipsychotics, has the potential to impair judgment, thinking or motor skills.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients.

Tardive dyskinesia is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, which may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely on prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome.

As with other antipsychotics, FANAPT should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.

FANAPT dose should be reduced by one-half when administered concomitantly with strong CYP3A4 inhibitors such as ketoconazole or clarithromycin. When the CYP3A4 inhibitor is withdrawn from the combination therapy, FANAPT dose should be increased to where it was before.

FANAPT dose should be reduced by one-half for poor metabolizers of CYP2D6.

Iloperidone doses should be reduced by one-half when administered with fluoxetine. When fluoxetine is withdrawn from the combination therapy, the iloperidone dose should be returned to the previous level. Other strong inhibitors of CYP2D6 would be expected to have similar effects and would need appropriate dose reductions. When the CYP2D6 inhibitor is withdrawn from the combination therapy, iloperidone dose could then be increased to the previous level.

Iloperidone doses should be reduced by one-half when administered with paroxetine. When paroxetine is withdrawn from the combination therapy, the iloperidone dose should be returned to the previous level.

FANAPT should not be used with any other drugs that prolong the QT interval.

Neonates whose mothers are exposed to antipsychotic drugs, including FANAPT, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

There is no information regarding the presence of iloperidone or its metabolites in human milk, the effects of iloperidone on a breastfed child, nor the effects of iloperidone on human milk production. Iloperidone is present in rat milk. Because of the potential for serious adverse reactions in breastfed infants, advise a woman not to breastfeed during treatment with FANAPT.

GoToSource

• Dosage greater than 24 mg per day. GoToSource

• Use in patients under the age of 18. GoToSource

• Anxiety disorder, attention deficit hyperactivity disorder, dementia and severe geriatric agitation, major depressive disorder, eating disorders, insomnia, obsessive compulsive disorder, post traumatic stress disorder, substance abuse and tourette syndrome. GoToSource

• Dementia-related psychosis. GoToSource

• Bipolar disorder. GoToSource

Hyperglycemia (high blood sugar), dyslipidemia (abnormal amount of lipids in the blood) and weight gain. GoToSource

Leukopenia (low white blood cell count), neutropenia (low level of neutrophils, a type of white blood cell) and agranulocytosis (bone marrow does not produce enough white blood cells). GoToSource

Extrapyramidal symptoms including tremors and dystonia. GoToSource

Orthostatic hypotension (excessive fall in blood pressure when upright position is assumed), seizures, suicide risk and priapism (persistent, painful erection). GoToSource

Aggravation of schizophrenia and psychosis. GoToSource

Akathisia (movement disorder). GoToSource

QTc prolongation. GoToSource

Hyperprolactinemia (elevated levels of the hormone prolactin). GoToSource

Retrograde ejaculation. GoToSource

Body temperature dysregulation, dysphagia (difficulty swallowing) and cognitive and motor impairment. GoToSource

Neuroleptic malignant syndrome (life-threatening drug reaction). GoToSource

Tachycardia and palpitations. GoToSource

Lawsuits filed for abnormal muscle movements, withdrawal symptoms in newborns and tardive dyskinesia.