Lixisenatide

SOLIQUA 100/33 SOLIQUA 100/33 is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.

• 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.ICD-10: E11.9

• SOLIQUA 100/33 is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions (5.6) ] . In patients with serious hypersensitivity to insulin glargine, lixisenatide, or any of the excipients in SOLIQUA 100/33.contraindicated

Inject subcutaneously once a day within the hour prior to the first meal of the day. ( 2.1 ) SOLIQUA 100/33 pen delivers 15 units to 60 units per injection. ( 2.1 , 2.2 ) Maximum daily dosage is 60 units (60 units of insulin glargine and 20 mcg of lixisenatide). ( 2.1 ) Discontinue basal insulin or GLP-1 receptor agonist prior to initiation. ( 2.2 ) In patients naive to basal insulin or to a GLP-1 receptor agonist, currently on less than 30 units of basal insulin, or on a GLP-1 receptor agonist, the recommended starting dosage is 15 units subcutaneously once daily. ( 2.2 ) In patients inadequately controlled on 30 to 60 units of basal insulin, the starting dosage is 30 units subcutaneously once daily. ( 2.2 ) See Full Prescribing Information for titration recommendations. ( 2.3 ) Inject subcutaneously in abdominal area, thigh, or upper arm and rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.5 ) Do not administer intravenously, or via an infusion pump. ( 2.5 ) Do not dilute or mix with any other insulin products or solutions. ( 2.5 ) 2.1 Important Dosage Information SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide. Administer SOLIQUA 100/33 subcutaneously once a day within the hour prior to the first meal of the day. The SOLIQUA 100/33 pen delivers doses from 15 to 60 units in a single injection. Table 1 presents the units of insulin glargine and the micrograms of lixisenatide in each dosage of SOLIQUA 100/33 [see Dosage and Administration (2.2) ] .

Anaphylaxis and Serious Hypersensitivity Reactions : Severe, life-threatening, and generalized allergic reactions can occur. Instruct patients to discontinue use if a reaction occurs and promptly seek medical attention. ( 5.1 ) Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including SOLIQUA 100/33. Discontinue if pancreatitis is suspected. ( 5.2 ) Never share a SOLIQUA 100/33 prefilled pen between patients, even if the needle is changed. ( 5.3 ) Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen : Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.4 ) Overdose Due to Medication Errors : SOLIQUA 100/33 contains two drugs. Instruct patients to always check the label before each injection since accidental mix-ups with insulin products can occur. Do not exceed the maximum dose or use with other GLP-1 receptor agonists. ( 5.5 ) Hypoglycemia : May be life-threatening. Increase frequency of glucose monitoring with changes to insulin dosage, coadministered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. ( 5.6 ) Acute kidney injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. SOLIQUA 100/33 is not recommended in patients with end-stage renal disease.

The following adverse reactions are discussed elsewhere: Anaphylaxis and Serious Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Acute Pancreatitis [see Warnings and Precautions (5.2) ] Hypoglycemia [see Warnings and Precautions (5.6) ] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions (5.7) ] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.8) ] Hypokalemia [see Warnings and Precautions (5.10) ] Acute Gallbladder Disease [see Warnings and Precautions (5.12) ] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.13) ] The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. The safety of SOLIQUA 100/33 (n=834, with a mean treatment duration of 203 days) has been evaluated in two clinical studies (30 weeks duration) in type 2 diabetes patients.

Pregnancy : SOLIQUA 100/33 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ( 8.1 ) 8.1 Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to lixisenatide, a component of SOLIQUA 100/33, during pregnancy. SOLIQUA 100/33 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The 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. Published studies with insulin glargine use during pregnancy have not reported a clear association with insulin glargine and major birth defect or miscarriage risk [see Data ] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] . Lixisenatide administered to pregnant rats and rabbits during organogenesis was associated with visceral closure and skeletal defects at systemic exposures that decreased maternal food intake and weight gain during gestation, and that are 1-time and 6-times higher than the 20 mcg/day highest clinical dose, respectively, based on plasma AUC [see Data ] .

Metabolism

SOLIQUA 100/33 The insulin glargine/lixisenatide ratio has no relevant impact on the PK of insulin glargine in SOLIQUA 100/33. Compared to administration of lixisenatide alone, the C max is lower whereas the AUC is generally comparable when administered as SOLIQUA 100/33.

Insulin Glargine Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.6 , 5.10) ] . Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia must be corrected appropriately. Lixisenatide During clinical studies, doses up to 30 mcg of lixisenatide twice daily (3-times the daily recommended dose) were administered to type 2 diabetic patients in a 13-week study. An increased incidence of gastrointestinal disorders was observed. In case of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

• Nov 21, 2016BLABLA208673Sanofi-aventis Us

1. 1Blood Glucose Increased45113%
2. 2Product Storage Error40212%
3. 3Accidental Exposure To Product3099.0%
4. 4Off Label Use2848.3%
5. 5Exposure Via Skin Contact1725.0%
6. 6Nausea1464.3%
7. 7Inappropriate Schedule Of Product Administration1444.2%
8. 8Visual Impairment1434.2%
9. 9Drug Ineffective1143.3%
10. 10Blood Glucose Decreased962.8%
11. 11Device Issue912.7%
12. 12Diarrhoea782.3%
13. 13Wrong Technique In Device Usage Process772.2%
14. 14Injection Site Pain762.2%
15. 15Vomiting752.2%

The 10 most recently updated of 75 ClinicalTrials.gov registrations naming Lixisenatide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
  Active not recruiting · Observational · 781,430 enrolled · Brigham and Women's Hospital
  NCT05220917updated 2026-05-15
• A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus
  Active not recruiting · Phase 4 · Interventional · 105 enrolled · Sanofi
  NCT06716424updated 2026-04-08
• iGlarLixi CGM Study in Chinese T2D Individuals After OADs
  Recruiting · Phase 4 · Interventional · 678 enrolled · Sanofi
  NCT06671587updated 2026-03-17
• Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes
  Not yet recruiting · Phase 4 · Interventional · 324 enrolled · Yanbing Li
  NCT07173712updated 2026-02-06
• Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents
  Not yet recruiting · Phase 4 · Interventional · 1,316 enrolled · Shanghai Zhongshan Hospital
  NCT07307235updated 2025-12-29
• Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease
  Completed · Phase 2 · Interventional · 156 enrolled · University Hospital, Toulouse
  NCT03439943updated 2025-11-28
• iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
  Completed · Phase 3 · Interventional · 582 enrolled · Sanofi
  NCT05413369updated 2025-09-24
• Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
  Active not recruiting · Observational · 23,280,000 enrolled · Ohio State University
  NCT07188545updated 2025-09-23
• Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes
  Enrolling by invitation · Phase 4 · Interventional · 100 enrolled · Medical University of Warsaw
  NCT07117240updated 2025-09-19
• Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus
  Completed · Phase 4 · Interventional · 124 enrolled · Sanofi
  NCT05114590updated 2025-09-09

Frequently asked questions

How does Lixisenatide work?

SOLIQUA 100/33 SOLIQUA 100/33 is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.

What is Lixisenatide used for?

According to FDA labeling, Lixisenatide carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Lixisenatide?

Lixisenatide is classified as Glucagon-like peptide-1 (GLP-1) analogues, GLP-1 Receptor Agonist, Glucagon-like Peptide-1 (GLP-1) Agonists, Decreased Gastric Motility, Decreased Glucagon Secretion, Increased Insulin Secretion.

What are the brand names for Lixisenatide?

Lixisenatide is marketed under brand names including Soliqua.

What are the contraindications for Lixisenatide?

Lixisenatide labeling lists contraindications including: SOLIQUA 100/33 is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions (5.6) ] . In patients with serious hypersensitivity to insulin glargine, lixisenatide, or any of the excipients in SOLIQUA 100/33.. Always consult the full prescribing information and a clinician.