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ADLYXIN Label.pdf

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Preview of ADLYXIN Label
🔗 Source: accessdata.fda.gov
📊 Size: 7.21 MB
👤 Author: FDA/CDER
⬇️ Downloads: 130

Summary

ADLYXIN (lixisenatide) is a glucagon-like peptide-1 receptor agonist for subcutaneous use, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is initiated at 10 mcg once daily for 14 days, then increased to 20 mcg once daily, administered within one hour before the first meal of the day. Contraindications include hypersensitivity to ADLYXIN or its components. Warnings and precautions include anaphylaxis, pancreatitis, hypoglycemia, acute kidney injury, and immunogenicity. Common adverse reactions (≥5%) are nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia.

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Description

ADLYXIN (lixisenatide) is a glucagon-like peptide-1 receptor agonist for subcutaneous use, indicated as an adjunct to diet and exercise to improve glycemic...

Technical Information

  • File Format: PDF
  • File Size: 7.21 MB
  • Pages: 72
  • Language: EN
  • Author: FDA/CDER
  • Total Downloads: 130
  • Last Updated: 2 months ago

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