ARXO-2026-0313 · Reported
cabozantinib: 2.4 and 2.5 give different instructions for one patient
2.4 reads “180 mg”. 2.5 reads “80 mg”. Example: A patient started at 180 mg (strong CYP3A4 inducer, 2.4) or at 80 mg (hepatic impairment, 2.5) who has an adverse reaction has no resume level in 2.2, which lists only 140, 100 and 60 mg. 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
- cabozantinib prescribing information (SPL set ID 1a0c3bea-c87b-4d25-bb44-5f0174da6b34)
- Place
- 2.4 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
Pair of quotations. Quotations are verbatim from the official material; translations are ours and marked.
180 mg80 mg
How to check it without Arxo's tools
- Open Prescribing information, Exelixis, Inc., SPL set ID 1a0c3bea-c87b-4d25-bb44-5f0174da6b34, version 16 (DailyMed) and find 2.4; 2.5. Compare the text with the quotation above. A copy is kept in this register: 9abd57dbe4460dd3-1a0c3bea-c87b-4d25-bb44-5f0174da6b34-v16.xml (SHA-256
9abd57dbe4460dd339c4af7cc566d141c55a1b3a152c2de6d2268c23438b24f0, 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
- Exelixis, 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 | Exelixis, Inc. | ||
| 2026-10-31 | U.S. Food and Drug Administration, Center for Drug Evaluation and Research |
Responses
No response recorded.
History
- 2026-10-31Confirmed by Arxo
- 2026-10-31Reported to Exelixis, 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-2026-0313, https://arxo.io/findings/ARXO-2026-0313/ (status as of 2026-10-31). Data: ARXO-2026-0313.json.