Perseris FDA Approval History
Reviewed by J.Stewart B.Pharm. Last updated on Jul 30, 2018.
FDA Approved: Yes (First approved July 27, 2018)
Brand name: Perseris
Generic name: risperidone
Dosage form: for Extended-Release Injectable Suspension
Company: Indivior Inc.
Treatment for: Schizophrenia
Perseris (risperidone) is a once-monthly, subcutaneous formulation of the approved atypical antipsychotic risperidone indicated for the treatment of schizophrenia in adults.
DOSAGE AND ADMINISTRATION
- Perseris is administered by a healthcare professional as an abdominal subcutaneous injection of 90 mg or 120 mg once monthly.
- For patients who have never taken risperidone, tolerability should be established with oral risperidone prior to starting Perseris.
- Patients may develop a lump at the injection site that could last for several weeks, but will decrease in size over time. It is important that the injection site is not rubbed or massaged, and patients need to be aware of the placement of any belts or waistbands.
- Patients should avoid alcohol during treatment with Perseris. They should also inform their healthcare professional if they are taking, or plan to take, any prescription or over-the-counter drugs as there may be an interaction.
WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis: Increased risk of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities. Perseris is not approved for use in patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring.
Tardive Dyskinesia: Discontinue treatment if clinically appropriate.
Metabolic Changes: Monitor for hyperglycemia, dyslipidemia and weight gain.
Hyperprolactinemia: Prolactin elevations occur and persist during chronic administration. Long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in females and males.
Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular disease or cerebrovascular disease, and risk of dehydration or syncope.
Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with a history of a clinically significant low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing Perseris if a clinically significant decline in WBC occurs in absence of other causative factors.
Potential for Cognitive and Motor Impairment: Use caution when operating machinery or driving automobiles.
Seizures: Use caution in patients with a history of seizures or with conditions that lower the seizure threshold.
The most common adverse reactions in clinical trials (≥ 5% and greater than twice placebo) were increased weight, sedation/somnolence and musculoskeletal pain. The most common injection site reactions (≥ 5%) were injection site pain and erythema (reddening of the skin).
Development Timeline for Perseris
|Jul 27, 2018||FDA Approves Perseris (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.