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Soliqua 100/33

INSULIN GLARGINE AND LIXISENATIDE

Manufacturer: sanofi-aventis U.S. LLC

Score: 141.0

Quick Summary

Soliqua 100/33 is a combination of insulin glargine and lixisenatide used to improve glycemic control in adults with type 2 diabetes mellitus. The recommended starting dosage is 15 units subcutaneously once daily for patients naive to basal insulin or to a GLP-1 receptor agonist, and 30 units subcutaneously once daily for patients inadequately controlled on 30 to 60 units of basal insulin. Important safety information includes the risk of hypoglycemia, pancreatitis, and hypersensitivity reactions. Contraindications include hypersensitivity to insulin glargine, lixisenatide, or any of the excipients, and episodes of hypoglycemia. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Improves glycemic control in adults with type 2 diabetes mellitus
  • Combination of insulin glargine and lixisenatide
  • Indicated as an adjunct to diet and exercise

Important Safety Information

Warning

Risk of hypoglycemia, pancreatitis, and hypersensitivity reactions

Contraindications

  • Hypersensitivity to insulin glargine, lixisenatide, or any of the excipients
  • Episodes of hypoglycemia

Adverse Reactions

  • Hypoglycemia
  • Nausea
  • Nasopharyngitis
  • Diarrhea
  • Upper respiratory tract infection
  • Headache

Dosing Recommendations

General Guidance

Titrate the dosage upwards or downwards by two to four units every week based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal

Type 2 diabetes mellitus

Adult Dose

15 units subcutaneously once daily for patients naive to basal insulin or to a GLP-1 receptor agonist, and 30 units subcutaneously once daily for patients inadequately controlled on 30 to 60 units of basal insulin

Pediatric Dose

Special Population Considerations

Pregnancy

  • Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • Limited available data with Soliqua 100/33 and lixisenatide in pregnant women is not sufficient to inform a drug-associated risk of major birth defects and miscarriage

Nursing Mothers

Pediatric Use

  • Safety and effectiveness have not been established in pediatric patients

Geriatric Use

  • Caution should be exercised when Soliqua 100/33 is administered to geriatric patients
  • Initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions

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