raltegravir: Table 2 and Table 2 give different instructions for one patient

Table 2 reads “at least 4 weeks of age and weighing 3 kg to less than 25 kg”. Table 2 reads “weighing at least 2 kg”. Example: A child aged 5 weeks who weighs 2.5 kg has no row in Table 2. 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

raltegravir prescribing information (SPL set ID 89a5ec53-d956-4329-8004-0f40f51c88a3)

Place

Table 2 and Table 2

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.

at least 4 weeks of age and weighing 3 kg to less than 25 kg

weighing at least 2 kg

How to check it without Arxo's tools

1. Open Prescribing information, Merck Sharp & Dohme LLC, SPL set ID 89a5ec53-d956-4329-8004-0f40f51c88a3, version 71 (DailyMed) and find Table 2. Compare the text with the quotation above. A copy is kept in this register: e2469625d5e949fe-89a5ec53-d956-4329-8004-0f40f51c88a3-v71.xml (SHA-256 e2469625d5e949fe24389d4cd3aea3f58bc79b655a87d4464e6534295d0bb70a, 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

• Merck Sharp & Dohme LLC — 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 Merck Sharp & Dohme LLC (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-2026-0315, https://arxo.io/findings/ARXO-2026-0315/ (status as of 2026-10-31). Data: ARXO-2026-0315.json.