idarubicin: 2.4, Table 2 and 5.8 give different instructions for one patient

2.4, Table 2 reads “Less than or equal to 2.6”. 5.8 reads “2.6 to 5 mg/dL”. Example: At serum bilirubin exactly 2.6 mg/dL, Table 2 gives no adjustment and 5.8 and Highlights give a 50% reduction. At exactly 5 mg/dL, Table 2 has no row. The text is in this label.

Consequence

Potential effect on a prescribing decision: medium. Arxo does not say which instruction is correct and gives no dose.

Jurisdiction

United States — federal

Act

idarubicin prescribing information (SPL set ID 0a5a6d93-cc1e-4d7f-8da1-446c134503b3)

Place

2.4, Table 2 and 5.8

Record

Discrepancy

Class

Text of the act

Where it arose

The text of the act

Arxo's conclusion

Confirmed

Official text

Unchanged at last check

Last checked

2026-10-31

Evidence

Reproduced by execution. Quotations are verbatim from the official material; translations are ours and marked.

Less than or equal to 2.6

2.6 to 5 mg/dL

How to check it without Arxo's tools

1. Open Prescribing information, Pfizer Laboratories Div Pfizer Inc, SPL set ID 0a5a6d93-cc1e-4d7f-8da1-446c134503b3, version 27 (DailyMed) and find 2.4, Table 2; 5.8. Compare the text with the quotation above. A copy is kept in this register: 7b4358464a0fe8f4-0a5a6d93-cc1e-4d7f-8da1-446c134503b3-v27.xml (SHA-256 7b4358464a0fe8f4fc2af0bf425208a578d717002ec83d9d1a7bdb1ec4a91fa6, copy of the official file).
2. The finding holds if the quoted passages read as shown and the comparison gives the result stated at the top of this page. If it does not, write to us with the record ID.

How this finding was made

AI agents read the labels, compared their parts and, where marked, ran the example patient through executable rules; an AI agent then read each place in full, with tables and footnotes, and confirmed it. No clinician has assessed these places. A person at Arxo approved publication (2026-10-31).

Responsible institutions

• Pfizer — holder of the labeling
• U.S. Food and Drug Administration, Center for Drug Evaluation and Research — regulator of prescription drug labeling

Reported to

Responses

No response recorded.

History

1. 2026-10-31Confirmed by Arxo
2. 2026-10-31Reported to Pfizer (e-mail)
3. 2026-10-31Reported to U.S. Food and Drug Administration, Center for Drug Evaluation and Research (e-mail)

Cite this record

Arxo Law, Arxo Findings Register, ARXO-2026-0307, https://arxo.io/findings/ARXO-2026-0307/ (status as of 2026-10-31). Data: ARXO-2026-0307.json.