Илоперидон

QT Prolongation: In an open-label QTc study in patients with schizophrenia or schizoaffective disorder (N=160), Fanapt was associated with QTc prolongation of 9 msec at an iloperidone dose of 12 mg twice daily. This affect was augmented by the presence of CYP450, 2D6 or 3A4 metabolic inhibition. The use of Fanapt should be avoided in combination with other drugs that are known to prolong QTc. Caution is warranted when prescribing Fanapt with drugs that inhibit Fanapt metabolism.

Weight Gain: Based on the pooled data from the four placebo-controlled, 4- or 6-week, fixed- or flexible-dose studies, the proportions of patients having a weight gain of greater than or equal to 7% body weight was 12% for Fanapt 10-16 mg/day, 18% for Fanapt 20-24 mg/day, and 13% for Fanapt (combined doses) versus 4% for placebo.

Orthostatic Hypotension and Syncope: Fanapt can induce orthostatic hypotension and syncope. Fanapt should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that predispose the patient to hypotension.

Leukopenia, Neutropenia, and Agranulocytosis: In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents. Agranulocytosis (including fatal cases) have been reported. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue Fanapt at the first sign of a decline in WBC in the absence of other causative factors.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, Fanapt elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia and impotence have been reported in patients receiving prolactin-elevating compounds.

Novartis Enters Into Agreement for Exclusive US and Canadian Rights to Fanapt(TM), an FDA-Approved Oral Therapy for Schizophrenia