UZEDY

The pharmacokinetics of the risperidone and 9-hydroxyrisperidone combined and the individual components (risperidone and 9-hydroxyrisperidone), following subcutaneous injection of UZEDY, were evaluated in both healthy subjects (n = 53) and in patients with clinically stable schizophrenia and schizoaffective disorder after single doses (12.5 to 225 mg, n = 195) and 3 repeated monthly doses (75 mg and 150 mg, n=24). For all doses, steady-state levels of risperidone and 9-hydroxyrisperidone were ap...

14.1 Schizophrenia The efficacy of UZEDY for the treatment of schizophrenia in adults is based, in part, on the established effectiveness of oral risperidone as well as in a randomized withdrawal study (

Study 1NCT03503318) with UZEDY in adults who met the DSM-5 criteria for schizophrenia. The results from Study 1 are presented below. Study 1 was a randomized withdrawal study in patients with schizophrenia consisting of a 12-week open-label oral risperidone (2 mg to 5 mg) stabilization phase, followed by a placebo-controlled phase in which patients were randomized to UZEDY (once monthly or on...

The following are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions ( 5.2 )] Neuroleptic malignant syndrome [see Warnings and Precautions ( 5.3 )] Tardive dyskinesia [see Warnings and Precautions ( 5.4 )] Metabolic changes [see W...

UZEDY is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone. Known hypersensitivity to risperidone, paliperidone, or to any of the components in UZEDY. ( 4 )

Cerebrovascular Adverse Reactions, in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular reactions (e.g., stroke, transient ischemia attack). ( 5.2 ) Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring. ( 5.3 ) Tardive Dyskinesia: Discontinue treatment if clinically appropriate. ( 5.4 ) Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. ( 5.5 ) Hyperprolactinemia: Prolac...

7 DRUG INTERACTIONS The interactions of UZEDY with co-administration of other drugs have not been studied. The drug interaction data provided in this section is based on studies with oral risperidone. Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): Increase risperidone plasma concentration. ( 2.6 , 7.1 ) Strong CYP3A4 inducers (e.g., carbamazepine): Decrease plasma concentrations of rispe...