Perseris Dosing for Schizophrenia
Perseris (RBP-7000) should be dosed at 90 mg or 120 mg administered subcutaneously once monthly in the abdomen, with no oral supplementation required at initiation. 1
Standard Dosing Regimens
FDA-Approved Doses
- 90 mg monthly: Equivalent to oral risperidone 3 mg/day 1
- 120 mg monthly: Equivalent to oral risperidone 4 mg/day 1
Both doses demonstrated superiority over placebo in Phase 3 trials for acute schizophrenia, with efficacy measured by PANSS total score reduction. 1
Higher Dose Option (180 mg)
- 180 mg monthly (administered as two 90-mg injections) can be used for patients stable on oral risperidone 6 mg/day 2
- This higher dose provides similar steady-state plasma concentrations of total active moiety compared to 6 mg/day oral risperidone 2
- Clinical efficacy measures remained stable with this dosing regimen 2
Administration Details
Injection Technique
- Administer subcutaneously in the abdomen as the primary site 1
- Upper arm is an acceptable alternative injection site with similar pharmacokinetics 2
- Use an 18-gauge, 5/8-inch needle 1
- The injection kit contains two syringes (liquid polymer and risperidone powder) that must reach room temperature before mixing 1
- Requires refrigerated storage 1
Key Advantage Over Other Long-Acting Injectables
No oral supplementation is required when initiating Perseris, unlike risperidone microspheres which require weeks of oral overlap. 1 This represents a significant practical advantage as the first subcutaneously administered second-generation antipsychotic long-acting injectable. 1
Treatment Duration and Monitoring
Efficacy Assessment Timeline
- Maintain therapeutic doses for at least 4 weeks before determining efficacy 3, 4
- If significant positive symptoms persist after 4 weeks with good adherence, discuss switching to an alternative antipsychotic 3
Maintenance Therapy
- Continue monthly injections for patients who respond acutely 5
- Periodically reassess to determine the need for ongoing maintenance treatment 5
Safety and Tolerability Profile
Common Adverse Effects
The most common adverse reactions (≥5% and greater than twice placebo) include:
Injection Site Pain
- Mean pain scores (Visual Analog Scale 0-100) were approximately 27 at 1 minute post-injection 1
- Pain decreased rapidly to 3-7 at 30-60 minutes post-injection 1
- Pain levels were similar across all treatment groups and both injection sites 1, 2
Overall Safety
All Perseris injections were well tolerated with no unexpected safety findings, consistent with the known safety profile of risperidone/paliperidone. 1, 2
Clinical Context: Dose Selection
Choosing Between 90 mg and 120 mg
While both doses are effective, the 120 mg dose may be preferred when stronger efficacy is needed, as Phase 3 data showed generally stronger efficacy results for the higher dose. 1 However, consider that oral risperidone doses above 6 mg/day were not demonstrated to be more efficacious than lower doses and were associated with more extrapyramidal symptoms. 5
When to Consider 180 mg
Reserve the 180 mg dose for patients who are clinically stable on oral risperidone 6 mg/day and require this higher dose for symptom control. 2 This dosing requires two separate 90-mg injections at the same administration time. 2