Poor
Not Aligned
Patient Risk:
Moderate
Summary
Substantial portions of the claims are not supported by the provided FDA label excerpts (notably pricing/coupons/savings card, patent expiration, several adverse-effect items, and schizophrenia dosing/efficacy details). Some safety and mechanism claims are supported, but unsupported/non-label content is extensive.
Category Scores
Accurate Statements
Rexulti is an atypical antipsychotic indicated for treatment of schizophrenia in adults and pediatric patients ages 13 years and older.
Supported by Indications and Usage.
Rexulti is indicated as adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults.
Supported by Indications and Usage.
Rexulti carries a risk of tardive dyskinesia.
Supported by Warnings and Precautions (Tardive Dyskinesia).
Tardive dyskinesia associated with Rexulti can be irreversible.
Supported by Warnings and Precautions (Tardive Dyskinesia: potentially irreversible).
Rexulti carries a risk of neuroleptic malignant syndrome (NMS).
Supported by Warnings and Precautions (NMS).
Rexulti is associated with an increased risk of death in elderly patients with dementia-related psychosis.
Supported by Warnings and Precautions (Increased Mortality in Elderly Patients with Dementia-Related Psychosis).
Rexulti is a partial agonist at central serotonin 5-HT1A receptors.
Supported by Mechanism of Action.
Rexulti is an antagonist at serotonin 5-HT2A receptors.
Supported by Mechanism of Action.
For adjunctive treatment of MDD in adults, the recommended starting dosage is 0.5 mg or 1 mg orally once daily; titrate to 1 mg once daily, then to target 2 mg once daily; maximum 3 mg/day; increase at weekly intervals.
Supported by Dosage and Administration (2.2).
Clinical trials demonstrated Rexulti as adjunctive therapy for MDD with statistically significant reductions in depression symptom scores (MADRS vs placebo + ADT).
Supported by Clinical Studies (14.1; superiority and placebo-subtracted differences).
Rexulti is dosed orally once daily for MDD adjunctive treatment.
Supported by Dosage and Administration (2.2: orally once daily).
Unsupported Statements
Rexulti pricing varies based on insurance coverage, pharmacy, and dosage.
Provided label excerpts contain no pricing, cost, or reimbursement information.
A 30-day supply of Rexulti 1 mg tablets could cost around $500 without insurance.
No cash price or dollar-cost claim is present in provided label excerpts.
A manufacturer coupon or patient assistance program may reduce out-of-pocket cost to as little as $10 per prescription for eligible patients.
No coupon/patient assistance program or $10 claim is present in provided label excerpts.
Insurance plans significantly impact the final cost of Rexulti.
No insurance/cost impact statements are present in provided label excerpts.
Patients may still face a co-pay for Rexulti despite insurance coverage.
No copay/deductible statements are present in provided label excerpts.
The co-pay for Rexulti can range from tens to hundreds of dollars per month depending on the specific plan's formulary and deductible.
No copay ranges or formulary/deductible information is present in provided label excerpts.
The manufacturer Otsuka Pharmaceutical offers a Rexulti Savings Card.
No savings card or manufacturer program information is present in provided label excerpts.
The Rexulti Savings Card can lower out-of-pocket cost for eligible commercially insured patients.
No savings card/out-of-pocket reduction eligibility statements are present in provided label excerpts.
The Rexulti Savings Card can bring the cost down to as little as $10 for a 30-day supply.
No savings card terms or $10/30-day cost claim is present in provided label excerpts.
Rexulti Savings Card is not available for patients with government-provided insurance such as Medicare or Medicaid.
No eligibility restrictions for savings cards (Medicare/Medicaid) are present in provided label excerpts.
Patents related to Rexulti have expiration dates that extend into the future.
No patent information is present in provided label excerpts.
Some Rexulti-related patents could expire around 2030.
No patent timing/expiration information is present in provided label excerpts.
Common side effects of Rexulti include akathisia (restlessness).
The provided label excerpts do not list akathisia as a common adverse reaction.
Common side effects of Rexulti include weight gain.
The provided label excerpts do not list weight gain as a common adverse reaction.
Common side effects of Rexulti include headache.
The provided label excerpts do not list headache as a common adverse reaction.
Common side effects of Rexulti include insomnia.
The provided label excerpts do not list insomnia as a common adverse reaction.
Rexulti exhibits antagonist activity at noradrenergic receptors.
Mechanism of Action excerpt provided does not state noradrenergic receptor antagonist activity.
Rexulti is prescribed orally in tablet form.
Provided label excerpts support oral dosing, but do not explicitly confirm tablet formulation.
For schizophrenia in adults, the recommended starting dose of Rexulti is 1 mg once daily.
Schizophrenia dosing details (2.3) are not included in the provided label excerpts.
For schizophrenia in adults, Rexulti dosing may be titrated to 2 mg or 3 mg once daily.
Schizophrenia dosing details (2.3) are not included in the provided label excerpts.
Clinical trials have demonstrated Rexulti's efficacy in treating symptoms of schizophrenia.
Schizophrenia clinical study results (14.2) are not included in the provided label excerpts.
In schizophrenia, Rexulti improved symptom scores compared to placebo.
Schizophrenia efficacy outcomes are not included in the provided label excerpts.
Physician samples of Rexulti may be available through healthcare providers.
No sample-availability information is present in the provided label excerpts.
Contradictions
Important Omissions
Contraindications, boxed-warning scope beyond dementia-related psychosis, and other warnings/precautions (e.g., suicidal thoughts/behaviors, metabolic changes, etc.) were not evaluated because the claim set did not address them.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Unsupported non-label claims about pricing/coupons/savings cards and several adverse-effect items could mislead stakeholders. Some safety-relevant warnings (NMS, tardive dyskinesia, increased mortality in elderly with dementia-related psychosis) are correctly reflected, but the overall label alignment is poor.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Large portion of claims (pricing/coupons/savings card, patent expiration, several 'common side effects', schizophrenia dosing/efficacy, receptor activity) are not supported by the provided FDA label excerpts.
Suggested Improvement
Limit statements strictly to label-supported content from the provided sections; remove pricing/coupon/patent-related claims and any adverse-effect or receptor-activity statements not explicitly supported by the included label excerpts.