BYSANTI (milsaperidone) · VANDA PHARMS INC

Following oral administration of iloperidone (iloperidone and milsaperidone rapidly interconvert in vivo), the plasma exposure of milsaperidone increased approximately proportionally over the therapeutic dosage range and plasma exposure of iloperidone increased slightly more than dose proportional. Steady-state concentrations of milsaperidone are attained within 3 to 4 days of dosing. Accumulation of iloperidone is at least 2-fold with twice daily dosing regimen after administration of oral ilop...

14.1 Schizophrenia The effectiveness of BYSANTI in the treatment of schizophrenia in adults has been established from adequate and well-controlled studies of iloperidone tablets (referred to as “iloperidone” (iloperidone and milsaperidone rapidly interconvert in vivo)) in adults with schizophrenia. Below is a display of the efficacy results of iloperidone in these adequate and well-controlled studies. Iloperidone was studied in two placebo- and active-controlled short-term trials (a 6-week trial (Study 1) and a 4-week trial (Study 2)) and one long-term placebo-controlled randomized withdrawal ...

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 [se...

BYSANTI is contraindicated in individuals with a known hypersensitivity reaction to milsaperidone or the inactive ingredients in BYSANTI. Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported [see Adverse Reactions (6.2) ] . Known hypersensitivity to milsaperidone or the inactive ingredients in BYSANTI. ( 4 , 6.2 )

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack). ( 5.2 ) QTc Interval Prolongation: may be associated with torsade de pointes and sudden death. Avoid concomitant use of BYSANTI with other drugs that prolong the QTc interval, and in patients with a significant risk of developing torsade de pointes; consider decreasing the BYSANTI dosage when prescribing BYSANTI...

7 DRUG INTERACTIONS Strong CYP2D6 Inhibitors: Reduce the dosage of BYSANTI when administered with a strong CYP2D6 inhibitor ( 7.1 ) Strong CYP3A4 Inhibitors: Reduce the dosage of BYSANTI when administered with a strong CYP3A4 inhibitor ( 7.1 ) Strong CYP2D6 and Strong CYP3A4 Inhibitors: Reduce the dosage of BYSANTI if administered concomitantly with both a CYP2D6 and a CYP3A4 inhibitor ( 7.1 ). Dr...