Iloperidone (2 brand names, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- FANAPT
- ILOPERIDONE
Boxed Warning
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)] .
Indications and Usage
FANAPT® is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2)].
Contraindications
FANAPT is contraindicated in individuals with a known hypersensitivity reaction to the product. Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported [see Adverse Reactions (6.2)].
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.1)] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2)] QT Prolongation [see Warnings and Precautions (5.3)] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4)] Tardive Dyskinesia [see Warnings and Precautions (5.5)] Metabolic Changes [see Warnings and Precautions (5.6)] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.7)] Falls [see Warnings and Precautions (5.8)] Seizures [see Warnings and Precautions (5.9)] Leukopenia, Neutropenia and Agranulocytosis [see Warnings and Precautions (5.10)] Hyperprolactinemia [see Warnings and Precautions (5.11)] Body Temperature Regulation [see Warnings and Precautions (5.12)] Dysphagia [see Warnings and Precautions (5.13)] Priapism [see Warnings and Precautions (5.14)] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.15)] Intraoperative Floppy Iris Syndrome [see Warnings and Precautions (5.16)]
Mechanism of Action
The mechanism of action of iloperidone in schizophrenia and bipolar I disorder is unknown. However, the efficacy of iloperidone could be mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5-HT2) antagonism. Iloperidone forms an active metabolite, P88, that has an in vitro receptor binding profile similar to the parent drug.