FDA Approves Perseris (risperidone) for Treatment of Schizophrenia in Adults

Not reported in label.

Perseris is indicated for the treatment of schizophrenia in adults. It is an atypical antipsychotic.

Establish tolerability with oral risperidone prior to initiating Perseris. Administer monthly by subcutaneous injection in the abdomen or back of the upper arm by a healthcare provider. Do not administer by any other route. Perseris may be initiated at a dose of 90 mg or 120 mg once monthly. Do not administer more than one dose per month. Supplementation with oral risperidone is not recommended. For patients switching from oral risperidone: 3 mg oral daily to 90 mg Perseris; 4 mg oral daily to 120 mg Perseris. Patients on stable oral doses lower than 3 mg or higher than 4 mg daily may not be candidates. For renal or hepatic impairment, titrate with oral risperidone to at least 3 mg daily, then 90 mg Perseris monthly. For concomitant strong CYP2D6 inhibitors, switch to 90 mg Perseris. For strong CYP3A4 inducers, increase Perseris to 120 mg and consider additional oral risperidone.

Trial data not available in label.

Not reported in label.

Perseris is a long-acting injectable atypical antipsychotic for maintenance treatment of schizophrenia in adults, offering monthly dosing as an alternative to daily oral risperidone. It requires prior tolerability to oral risperidone and is not recommended for patients on stable oral doses outside the 3-4 mg daily range.