ARXO-2026-0328 · Reported

azacitidine: 2.5 and 2.5 give different instructions for one patient

2.5 reads “30-60”. 2.5 reads “15-30”. Example: At bone marrow biopsy cellularity exactly 30%, the table gives two columns, 100% and 50% of the dose. There is no column above 60%. The same text is in 19 labels from 14 labelers in the DailyMed release of 29 October 2026.

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: azacitidine prescribing information (SPL set ID 3495a71a-cc04-4776-851f-f185956f32af)
Place: 2.5 and 2.5
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.

30-60

Official publication · Prescribing information, Celgene Corporation, SPL set ID 3495a71a-cc04-4776-851f-f185956f32af, version 22 (DailyMed) · 2.5 · version 22 · retrieved 2026-10-29 · SHA-256 9c1e1aad99c0363335cd2b6cf109ed51c3ee61da1146937ea8a371257ca94640 · copy

15-30

How to check it without Arxo's tools

Open Prescribing information, Celgene Corporation, SPL set ID 3495a71a-cc04-4776-851f-f185956f32af, version 22 (DailyMed) and find 2.5. Compare the text with the quotation above. A copy is kept in this register: 9c1e1aad99c03633-3495a71a-cc04-4776-851f-f185956f32af-v22.xml (SHA-256 9c1e1aad99c0363335cd2b6cf109ed51c3ee61da1146937ea8a371257ca94640, copy of the official file).
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

Bristol-Myers Squibb — holder of the labeling
U.S. Food and Drug Administration, Center for Drug Evaluation and Research — regulator of prescription drug labeling

Reported to

Date	Institution	Channel	Reference
2026-10-31	Bristol-Myers Squibb	e-mail
2026-10-31	U.S. Food and Drug Administration, Center for Drug Evaluation and Research	e-mail

Date

Institution

Channel

Reference

2026-10-31

Bristol-Myers Squibb

e-mail

2026-10-31

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

e-mail

Responses

No response recorded.

History

2026-10-31Confirmed by Arxo
2026-10-31Reported to Bristol-Myers Squibb (e-mail)
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-2026-0328, https://arxo.io/findings/ARXO-2026-0328/ (status as of 2026-10-31). Data: ARXO-2026-0328.json.