ARXO-2026-0314 · Reported

bendamustine: Highlights, Use in Specific Populations and 8.7 give different instructions for one patient

Highlights, Use in Specific Populations reads “2.5-1.0 x ULN”. 8.7 reads “2.5 to 10 times upper limit of normal (ULN)”. Example: For a patient with AST 5 times ULN and bilirubin 2 times ULN, the Highlights range is empty and expresses no limit; 8.7 covers the case. The same text is in 2 labels from 2 labelers in the DailyMed release of 29 October 2026.

Consequence

Potential effect on a prescribing decision: low; careful reading of the whole label usually resolves it. Arxo does not say which instruction is correct and gives no dose.

Jurisdiction: United States — federal
Act: bendamustine prescribing information (SPL set ID 4df6548f-c4ad-4eb2-a54f-19766a3d90ca)
Place: Highlights, Use in Specific Populations and 8.7
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

Pair of quotations. Quotations are verbatim from the official material; translations are ours and marked.

2.5-1.0 x ULN

Official publication · Prescribing information, Azurity Pharmaceuticals, Inc., SPL set ID 4df6548f-c4ad-4eb2-a54f-19766a3d90ca, version 2 (DailyMed) · Highlights, Use in Specific Populations · version 2 · retrieved 2026-10-29 · SHA-256 328333d269ccf8da7d853cc1267fedcc2d14bbda434774e1b3e4cc7f5473de4e · copy

2.5 to 10 times upper limit of normal (ULN)

Official publication · Prescribing information, Azurity Pharmaceuticals, Inc., SPL set ID 4df6548f-c4ad-4eb2-a54f-19766a3d90ca, version 2 (DailyMed) · 8.7 · version 2 · retrieved 2026-10-29 · SHA-256 328333d269ccf8da7d853cc1267fedcc2d14bbda434774e1b3e4cc7f5473de4e · copy

How to check it without Arxo's tools

Open Prescribing information, Azurity Pharmaceuticals, Inc., SPL set ID 4df6548f-c4ad-4eb2-a54f-19766a3d90ca, version 2 (DailyMed) and find Highlights, Use in Specific Populations; 8.7. Compare the text with the quotation above. A copy is kept in this register: 328333d269ccf8da-4df6548f-c4ad-4eb2-a54f-19766a3d90ca-v2.xml (SHA-256 328333d269ccf8da7d853cc1267fedcc2d14bbda434774e1b3e4cc7f5473de4e, 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

Azurity Pharmaceuticals, Inc. — 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	Azurity Pharmaceuticals, Inc.	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

Azurity Pharmaceuticals, Inc.

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 Azurity Pharmaceuticals, Inc. (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-2026-0314, https://arxo.io/findings/ARXO-2026-0314/ (status as of 2026-10-31). Data: ARXO-2026-0314.json.