Summary
The provided AI statements are general claims about tacrolimus cost and availability and do not align with (or are not supported by) the supplied FDA label excerpts for PROTOPIC (topical tacrolimus) regarding indications, contraindications, boxed warnings, dosage/administration, and safety. Additionally, some claims (e.g., brand vs generic substitution limits, discount programs, pricing tracking launches/exclusivity/patent status) are not supported by the provided label excerpts and may be inaccurate or misleading in a label-alignment context.
Category Scores
Accurate Statements
Unsupported Statements
Tacrolimus cost varies by formulation (immediate-release capsules, extended-release formulations, and topical ointment).
No cost/pricing/formulation-comparison information is present in the provided PROTOPIC label excerpts.
Tacrolimus cost varies by strength and pack size.
No cost/pricing/strength-pack-size information is present in the provided PROTOPIC label excerpts.
Tacrolimus cost varies by insurance coverage and pharmacy pricing (retail vs. mail order).
No payer/insurance/pharmacy pricing information is present in the provided PROTOPIC label excerpts.
Tacrolimus cost varies by whether it is branded or generic.
No brand-vs-generic pricing information is present in the provided PROTOPIC label excerpts.
Tacrolimus is widely available as a generic.
No availability/market availability information is present in the provided PROTOPIC label excerpts.
Lowest costs for tacrolimus are usually with generic versions.
No cost-ranking or general pricing guidance is present in the provided PROTOPIC label excerpts.
Generic tacrolimus is typically much cheaper than branded versions.
No comparative pricing information is present in the provided PROTOPIC label excerpts.
Out-of-pocket price for generic tacrolimus can vary widely by pharmacy and dose.
No out-of-pocket pricing information is present in the provided PROTOPIC label excerpts.
Branded tacrolimus products generally cost more than generics.
No comparative pricing information is present in the provided PROTOPIC label excerpts.
If a prescription specifies a brand, substitution may be limited depending on local pharmacy rules and the prescriber’s instructions.
No substitution or dispensing-law guidance is present in the provided PROTOPIC label excerpts.
Insurance coverage (tier placement and copay rules) can change tacrolimus cost.
No insurance/copoly/tier information is present in the provided PROTOPIC label excerpts.
Discount programs or switching to an available generic formulation can lower tacrolimus price if eligibility and local rules allow.
No discount-program or switching guidance is present in the provided PROTOPIC label excerpts.
Price changes can track product launches, exclusivity, and patent status.
No information about how pricing changes relate to exclusivity/patent status is present in the provided PROTOPIC label excerpts.
Contradictions
Important Omissions
Any PROTOPIC label-aligned information relevant to safe and accurate use (e.g., indications/usage limits, contraindications, boxed warning/long-term safety restrictions, child age restriction, immunocompromised restriction, avoidance of occlusion, re-examination if no improvement within 6 weeks).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The statements primarily address cost/availability and do not directly claim specific clinical safety actions; however, they are unsupported by the provided PROTOPIC label excerpts and therefore do not demonstrate label alignment for medically relevant guidance.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Misaligned
Primary Issue
Content does not draw from the provided PROTOPIC prescribing information; most claims are unrelated to label content and are unsupported by the supplied excerpts.
Suggested Improvement
Limit claims to information explicitly present in the provided PROTOPIC label excerpts (indication/usage, contraindications, boxed warning and restrictions, dosage/administration instructions such as avoiding occlusive dressings and limiting to affected areas, pediatric age restriction, and precautions). Remove or qualify cost/availability/substitution statements unless supported by label text provided in the prompt.