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FDA approved Perseris (risperidone) for Treatment of Schizophrenia in AdultsFDA approved new monthly shot Perseris for schizophrenia in adults.

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Key Takeaway
Consider Perseris for adults with schizophrenia who require monthly long-acting injectable risperidone after oral tolerability is established.

The FDA has approved Perseris (risperidone) for the treatment of schizophrenia in adults, as announced on July 27, 2018. Perseris is a long-acting injectable formulation of risperidone, an atypical antipsychotic, designed for once-monthly subcutaneous administration by a healthcare provider. This new formulation offers an alternative to daily oral risperidone for patients who may benefit from less frequent dosing. The approval provides clinicians with another option for maintenance treatment in adults with schizophrenia, potentially improving adherence. The label emphasizes that tolerability with oral risperidone must be established before starting Perseris, and that supplementation with oral risperidone is not recommended.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Not reported in label.

Indication & Patient Population

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

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

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.

The U.S. Food and Drug Administration has approved Perseris (risperidone) for the treatment of schizophrenia in adults. Perseris is a long-acting injectable medication that is given once a month by a healthcare provider. It contains the same active ingredient as the oral medication risperidone, which is an atypical antipsychotic. This new formulation offers an alternative for adults who may benefit from less frequent dosing.

Schizophrenia is a chronic mental health condition that affects how a person thinks, feels, and behaves. Treatment often involves daily medication, which can be challenging for some patients. Perseris provides a way to receive the medication through a monthly injection, which may help improve adherence to treatment.

The approval means that doctors now have another option for maintenance treatment in adults with schizophrenia. However, it is important to note that patients must first tolerate oral risperidone before starting Perseris. Supplementation with oral risperidone is not recommended while on Perseris.

If you or a loved one has schizophrenia, talk to your doctor about whether Perseris might be a suitable option. Do not stop or change your current treatment without medical guidance. This approval adds to the available choices but does not replace the need for personalized care.

What this means for you:
Perseris is a new monthly injection for schizophrenia that may help with medication adherence, but always consult your doctor first.

Study Details

Study typeFda approval
PublishedJul 2018
View Original Abstract ↓
1 INDICATIONS AND USAGE PERSERIS is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14 )] . PERSERIS is an atypical antipsychotic indicated for the treatment of schizophrenia in adults. ( 1 )
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