pralsetinib: Highlights, Warnings and Precautions has no instruction for a patient the label covers

Highlights, Warnings and Precautions reads “Permanently discontinue for Grade 3 or 4 reactions”. Example: Grade 3 ILD or pneumonitis: Highlights requires permanent discontinuation; Table 2 has ILD rows only for Grade 1 or 2 and Grade 4, so it gives no action for Grade 3, and the general row for other adverse reactions allows resumption at a reduced dose. 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

pralsetinib prescribing information (SPL set ID 16edd46e-28b8-f06d-e063-6394a90ae31b)

Place

Highlights, Warnings and Precautions

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.

Permanently discontinue for Grade 3 or 4 reactions

How to check it without Arxo's tools

1. Open Prescribing information, Rigel Pharmaceuticals, Inc., SPL set ID 16edd46e-28b8-f06d-e063-6394a90ae31b, version 8 (DailyMed) and find Highlights, Warnings and Precautions. Compare the text with the quotation above. A copy is kept in this register: a49c8c2828cc648d-16edd46e-28b8-f06d-e063-6394a90ae31b-v8.xml (SHA-256 a49c8c2828cc648d665007781d893be175b05ca8c23ad0cf8989212cb689b19f, 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

• Rigel 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

Responses

No response recorded.

History

1. 2026-10-31Confirmed by Arxo
2. 2026-10-31Reported to Rigel Pharmaceuticals, Inc. (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-2026-0323, https://arxo.io/findings/ARXO-2026-0323/ (status as of 2026-10-31). Data: ARXO-2026-0323.json.