Poor
Mostly Aligned
Patient Risk:
Low
Summary
Only the schizophrenia-in-adults indication claim is supported by the provided label section. All pricing and regulatory-status/patent-dispute claims are absent from the supplied label text and are therefore not label-adherent.
Category Scores
Accurate Statements
UZEDY (risperidone extended-release injectable suspension) is used for schizophrenia in adults.
Supported by label section 1.1 Schizophrenia: “UZEDY is indicated for the treatment of schizophrenia in adults.”
Unsupported Statements
UZEDY has a wholesale acquisition cost (WAC) of about $3,000 to $4,200 per dose.
Pricing/WAC amounts are not present in the supplied FDA label section (1.1 Schizophrenia).
UZEDY WAC depends on strength (50 mg to 250 mg every 1 or 2 months).
Strength/dosing-interval-linked WAC/pricing details are not present in the supplied label section.
A 100 mg monthly dose of UZEDY lists around $3,485 WAC as of mid-2024.
Specific historical WAC pricing and dose-specific pricing are not present in the supplied label section.
Prices paid for UZEDY vary by insurance, pharmacy, and discounts.
Patient payor/discount variability and pricing context are not present in the supplied label section.
With commercial insurance, UZEDY copays can drop to $0–$50 after manufacturer coupons from Teva Pharmaceuticals.
Copay amounts, coupon programs, and specific entities are not present in the supplied label section.
Medicare patients may face $100–$400 out-of-pocket for UZEDY depending on Part D plans.
Out-of-pocket estimates and Part D variability are not present in the supplied label section.
Uninsured patients can use the UZEDY savings card for as low as $0 for up to 12 fills.
Savings card details and usage limits are not present in the supplied label section.
The UZEDY savings card provides a maximum savings of $1,800 per year.
Maximum savings amounts are not present in the supplied label section.
UZEDY has an approximate WAC per dose of $3,000–$4,200 with a dose frequency of 1–2 months.
Dose-frequency-linked WAC/pricing is not present in the supplied label section.
UZEDY’s 2-month option is often cheaper per month ($1,500–$2,100) than monthly rivals.
Comparative pricing claims are not present in the supplied label section.
UZEDY has no major patent disputes listed yet.
Patent dispute/regulatory-status statements are not present in the supplied label section.
Core patents for UZEDY expire around 2036–2040.
Patent expiration timelines are not present in the supplied label section.
Contradictions
Important Omissions
No label-adherent dosing/administration, contraindications, boxed warnings, warnings/precautions, contraindications, drug interactions, adverse reactions, or monitoring information was provided in the extracted claims beyond the indication.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The only label-supported claim concerns indication. The other extracted claims are pricing and patent/regulatory-status statements, which do not directly provide dosing or safety instructions based on the supplied label text.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Most extracted claims (pricing, copays, savings card, discounts, and patent-related assertions) are not supported by the provided FDA label section.
Suggested Improvement
Limit statements to what is supported by the FDA-approved label (e.g., indication). Remove or qualify all pricing and patent/regulatory-status claims unless additional label sections explicitly support them.