dolutegravir: Highlights and 1 has no instruction for a patient the label covers

Highlights and 1 reads “weighing at least 2 kg”. Example: A child aged 5 weeks who weighs 2.5 kg is within the indication and has no row in Table 2 (neonates under 4 weeks) or Table 3 (from 3 kg). 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

dolutegravir prescribing information (SPL set ID 63df5af3-b8ac-4e76-9830-2dbb340af922)

Place

Highlights and 1

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.

weighing at least 2 kg

How to check it without Arxo's tools

1. Open Prescribing information, ViiV Healthcare Company, SPL set ID 63df5af3-b8ac-4e76-9830-2dbb340af922, version 34 (DailyMed) and find Highlights and 1. Compare the text with the quotation above. A copy is kept in this register: 61977454e3b3c46b-63df5af3-b8ac-4e76-9830-2dbb340af922-v34.xml (SHA-256 61977454e3b3c46b5b967b3a90538b56b8b4a2f3b3c1600b45c859042ea23ff1, 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

• ViiV Healthcare Company — 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 ViiV Healthcare Company (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-2026-0316, https://arxo.io/findings/ARXO-2026-0316/ (status as of 2026-10-31). Data: ARXO-2026-0316.json.