FDA LABEL RECORD

Soliqua 100/33

INSULIN GLARGINE AND LIXISENATIDE. FDA prescribing information for this product, as published on the retrieval date below.

AS THE LABEL RECORDS IT

Product details

Brand nameSoliqua 100/33
Generic nameINSULIN GLARGINE AND LIXISENATIDE
LabellerSanofi-Aventis U.S. LLC
RouteSUBCUTANEOUS
Label version25
Effective2026-03-18
Retrieved by this site2026-10-03
Full labelhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bba538b-cf7c-4310-ae8f-cb711ed21bcc

INDICATIONS AND USAGE

Quoted from the FDA label

1 INDICATIONS AND USAGE SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use ( 1 ) : Concomitant use in combination with any other product containing a GLP-1 receptor agonist is not recommended. Not recommended for the treatment of diabetic ketoacidosis. Has not been studied in combination with prandial insulin. Limitations of Use : SOLIQUA 100/33 contains lixisenatide. Coadministration with any other product containing lixisenatide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended [see Warnings and Precautions (5.5) ] . SOLIQUA 100/33 is not recommended for the treatment of diabetic ketoacidosis. SOLIQUA 100/33 has not been studied in combination with prandial insulin.

What this page is

A reproduction of a public FDA label record. Everything quoted above is the labeller's wording as published by the FDA, not this site's. Nothing here is regulatory, legal or medical advice, and a label being reproduced says nothing about whether a product is available in any particular country. Labels are revised often; the retrieval date above says when this copy was taken, and the full current label is at the link.

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