PERSERIS IFU VIDEO TRANSCRIPT


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PERSERIS® (risperidone) for extended-release injectable suspension, 90 mg and 120 mg, for abdominal subcutaneous injection only. Do not administer by any other route.


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PERSERIS® (risperidone) for extended-release injectable suspension, for subcutaneous use

For abdominal subcutaneous injection only. Do not administer by any other route. For sterile, single use.


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Instructions for Use


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On-screen text: For Healthcare Professionals


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Indications and Usage

PERSERIS is indicated for the treatment of schizophrenia in adults.


IMPORTANT SAFETY INFORMATION


WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. PERSERIS is not approved for the treatment of patients with dementia- related psychosis and has not been studied in this population.


Contraindications: PERSERIS 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.


WARNINGS AND PRECAUTIONS

Cerebrovascular Adverse Reactions: In trials of elderly patients with dementia related psychosis, there was a significantly higher incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, in patients treated with oral risperidone compared to placebo. PERSERIS is not approved for use in patients with dementia-related psychosis.


Please see additional Important Safety Information after Step 13 and full accompanying Prescribing Information, including BOXED WARNING.


PERSERIS is for abdominal subcutaneous injection only and must be prepared and administered by a healthcare professional only.

The following measures are important to help ensure proper administration of PERSERIS:

USE IN SPECIFIC POPULATIONS


Pregnancy: PERSERIS may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare professional if they become or intend to become pregnant during treatment with PERSERIS. Patients exposed to PERSERIS during pregnancy

may be registered with the National Pregnancy Registry for Atypical Antipsychotics (1-866-961-2388 or http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/).

Lactation: Infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms.

Pediatric Use: Safety and effectiveness of PERSERIS has not been established in pediatric patients.

Renal or Hepatic Impairment: Carefully titrate on oral risperidone up to at least 3 mg before initiating treatment with PERSERIS at a dose of 90 mg.

To report pregnancy or side effects associated with taking PERSERIS, please call 1-877-782-6966.

For more information about PERSERIS, see the full Prescribing Information including BOXED WARNING or visit www.PERSERISHCP.com.


PERSERIS is a registered trademark of Indivior UK Limited.

© 2020 Indivior PLC | INDIVIOR is a registered trademark of Indivior UK Limited | All rights reserved.

P-RAG-US-00320


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