ARXO-2026-0330 · Reported
lorlatinib: Highlights, Dosage and Administration, line "Renal Impairment" and 2.6 give different instructions for one patient
Highlights, Dosage and Administration, line "Renal Impairment" reads “75 mg orally once daily”. 2.6 reads “15 to < 30 mL/min”. Example: A patient with CLcr 60 mL/min gets the reduced dose by Highlights; by 2.6 and 8.7 no adjustment applies. The text is in this label.
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
- lorlatinib prescribing information (SPL set ID 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d)
- Place
- Highlights, Dosage and Administration, line "Renal Impairment" and 2.6
- 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.
75 mg orally once daily15 to < 30 mL/min
How to check it without Arxo's tools
- Open Prescribing information, Pfizer Laboratories Div Pfizer Inc, SPL set ID 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d, version 13 (DailyMed) and find Highlights, Dosage and Administration, line "Renal Impairment"; 2.6. Compare the text with the quotation above. A copy is kept in this register: 046f06875fd09d25-2b34d62d-e02a-4af3-bc0d-1571dd4ee76d-v13.xml (SHA-256
046f06875fd09d2510a67b15c13bc79680a5380e40f4979645a940152905baa0, 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
- Pfizer — 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 | Pfizer | ||
| 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 Pfizer (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-2026-0330, https://arxo.io/findings/ARXO-2026-0330/ (status as of 2026-10-31). Data: ARXO-2026-0330.json.