dabrafenib: 5.3 and Table 5 give different instructions for one patient

5.3 reads “Permanently discontinue TAFINLAR for all Grade 4 hemorrhagic events”. Table 5 reads “First occurrence of any Grade 4”. Example: At a first Grade 4 hemorrhage, Table 5 allows resuming at a lower dose and 5.3 requires permanent discontinuation. The text is in this label.

Consequence

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

Jurisdiction

United States — federal

Act

dabrafenib prescribing information (SPL set ID fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea)

Place

5.3 and Table 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.

Permanently discontinue TAFINLAR for all Grade 4 hemorrhagic events

First occurrence of any Grade 4

How to check it without Arxo's tools

1. Open Prescribing information, Novartis Pharmaceuticals Corporation, SPL set ID fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea, version 37 (DailyMed) and find 5.3; Table 5. Compare the text with the quotation above. A copy is kept in this register: bb96336976f6f013-fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea-v37.xml (SHA-256 bb96336976f6f013be41317f171017260efb7b04f82b4d0d85c310016351fcc8, 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

• Novartis Pharmaceuticals Corporation — 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 Novartis Pharmaceuticals Corporation (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-2026-0302, https://arxo.io/findings/ARXO-2026-0302/ (status as of 2026-10-31). Data: ARXO-2026-0302.json.