Poor
Not Aligned
Patient Risk:
High
Summary
The extracted claims contain multiple direct contradictions to the provided Sancuso label (granisetron transdermal system) including incorrect active ingredients, mechanism, administration location, and delivery system description. Additionally, no label-critical safety sections (contraindications/boxed warnings/warnings-precautions/specific populations) are evaluated, so full FDA-label adherence cannot be verified.
Category Scores
Accurate Statements
Sancuso is indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.
1 INDICATIONS AND USAGE; 14 CLINICAL STUDIES
The patch should be applied to clean, dry, intact healthy skin on the upper outer arm and should not be placed on red, irritated or damaged skin.
2 DOSAGE AND ADMINISTRATION
Unsupported Statements
Sancuso is a single-use, pre-activated, adhesive transdermal patch.
Provided label sections do not state 'single-use' or 'pre-activated'.
Sancuso is not equivalent to other transdermal fentanyl patches such as Duragesic.
No comparison to Duragesic is present in the provided label sections.
Duragesic transdermal fentanyl patches require activation before use.
No Duragesic-related information is present in the provided label sections.
A Sancuso patent assigned to DureCT Corporation expires in 2025.
No patent or DureCT information is present in the provided label sections.
The Sancuso patent protection covers the composition, formulation, and delivery mechanism of Sancuso.
No patent-scope language is present in the provided label sections.
Contradictions
High
AI Statement
Sancuso is an onapristone, fentanyl transdermal patch.
Label Reference
11 DESCRIPTION
High
AI Statement
The Sancuso patch is placed on the stomach or lower back.
Label Reference
2 DOSAGE AND ADMINISTRATION
High
AI Statement
Sancuso provides continuous delivery of opioid medication to help alleviate symptoms of nausea and vomiting.
Label Reference
11 DESCRIPTION; 12.1 Mechanism of Action
High
AI Statement
Sancuso uses an active ion-transport mechanism to drive the release of onapristone, fentanyl, and additional ingredients throughout the 72-hour treatment duration.
Label Reference
11 DESCRIPTION; 12.3 Pharmacokinetics; 1 INDICATIONS AND USAGE
Low
AI Statement
Sancuso is intended to enhance and maintain steady-state plasma concentrations of the active ingredients.
Label Reference
12.3 Pharmacokinetics
High
AI Statement
Sancuso includes onapristone, a selective progesterone receptor modulator (SPRM).
Label Reference
11 DESCRIPTION
High
AI Statement
Onapristone is used in combination with fentanyl to target and reduce chemotherapy-induced emesis.
Label Reference
11 DESCRIPTION; 1 INDICATIONS AND USAGE; 12.1 Mechanism of Action
High
AI Statement
Sancuso provides a combination of onapristone and fentanyl in a single-use patch.
Label Reference
11 DESCRIPTION
Important Omissions
No evaluation of label-critical safety sections (contraindications, boxed warnings, warnings/precautions, drug interactions, adverse reactions, or use in specific populations such as pediatrics/elderly/renal/hepatic impairment) is present in the provided audit output.
Importance:
High
Label-defined administration timing (e.g., patch applied 24 to 48 hours before first chemotherapy dose) and duration context (patch kept in place for 7 days; regimen up to 5 consecutive days) are not assessed against the extracted claims.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
High
The extracted claims include multiple high-severity contradictions to the product identity and delivery/mechanism, plus incorrect anatomical placement (stomach/lower back vs upper outer arm). These could materially mislead about the drug and how/where to apply the patch.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Multiple direct contradictions to the label’s described active ingredient (granisetron) and patch administration site/mechanism; several claims rely on information not present in the provided label sections.
Suggested Improvement
Replace all onapristone/fentanyl and ion-transport/72-hour mechanism claims with label-supported granisetron transdermal identity and the provided administration instructions (upper outer arm; not on red/irritated/damaged skin), and evaluate remaining FDA label safety sections before final compliance claims.