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SOLIQUA® 100/33 (insulin glargine and lixisenatide) injection 100 Units/mL & 33 mcg/mL logo
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What Is SOLIQUA 100/33?
Dosing

Safety Profile for Soliqua® 100/33 (Insulin Glargine and Lixisenatide) Injection

The safety of SOLIQUA 100/33 was tested in 2 pivotal trials and in a variety of patient types. SOLIQUA 100/33 was generally well tolerated in each of those trials.¹⁻⁴

In the LixiLan-O Pivotal Trial, No Patients Studied Experienced Severe Symptomatic Hypoglycemia With SOLIQUA 100/331

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Severe symptomatic hypoglycemia1*
(0 out of 469 patients)

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Hypoglycemia1†
(38 out of 469 patients)

Hypoglycemia is the most common adverse event with insulin-containing therapies.1

*Severe symptomatic hypoglycemia defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.1
†Hypoglycemia defined as self-monitored plasma glucose <54 mg/dL.1 

Table showing treatment-emergent adverse events with frequency ≥5% for SOLIQUA 100/33 (n=469). Reported events include nausea (9.6%), diarrhea (9.0%), upper respiratory tract infection (7.0%), nasopharyngitis (5.5%), and headache (5.1%). Gastrointestinal adverse reactions are noted to occur more frequently at the beginning of therapy, based on the LixiLan-O pivotal study.

Study Design:
A randomized, 30-week, open-label, multicenter, phase III study of adult patients with type 2 diabetes inadequately controlled on metformin (with or without a second oral glucose-lowering drug) was conducted to evaluate the efficacy and safety of iGlarLixi (a titratable fixed-ratio combination of insulin glargine and lixisenatide), insulin glargine alone, or lixisenatide alone. After a 4-week run-in period to optimize metformin and discontinue other oral agents, patients (N=1,170) were randomized in a 2:2:1 ratio to receive once-daily iGlarLixi, insulin glargine, or lixisenatide for 30 weeks. Metformin was continued throughout the study. The primary endpoint was change from baseline HbA1c at Week 30. The maximum allowable insulin glargine dose was 60 units for both iGlarLixi and insulin glargine groups. The trial was designed to assess the contribution of the GLP-1 RA component to glycemic lowering while maintaining comparable insulin titration algorithms across arms.2

Analysis Limitations:
The open-label design may introduce bias, as blinding was impractical due to differences in injection devices and administration patterns. Additionally, the 30-week duration limits assessment of long-term durability of glycemic control and safety outcomes.2

Incidence of Hypoglycemia in Clinical Studies1

Icon of 1.1% in a purple circle.

Severe symptomatic hypoglycemia1*
(4 out of 365 patients)

Icon of 17.8% in a purple circle.

Hypoglycemia1†
(65 out of 365 patients)

Hypoglycemia is the most common adverse event with insulin-containing therapies.1

*Severe symptomatic hypoglycemia defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.1
†Hypoglycemia defined as self-monitored plasma glucose <54 mg/dL.1 

Table showing treatment-emergent adverse events for SOLIQUA 100/33 (n=365). Reported events include nausea (10.4%), nasopharyngitis (8.8%), headache (5.8%), diarrhea (4.4%), vomiting (3.6%), and upper respiratory tract infection (3.6%). Gastrointestinal adverse reactions occur more frequently at the beginning of therapy. Discontinuation due to GI adverse events was 1.1%, based on the LixiLan-L pivotal study.

Study Design: 
A randomized, 30-week, open-label, multicenter study of adult patients with T2DM was conducted to evaluate the efficacy and safety of SOLIQUA 100/33 (n=365) or Lantus (n=365). Metformin was continued if previously taken and any other OADs were discontinued. The primary endpoint was change from baseline A1C at Week 30. The maximum allowable insulin glargine dose was 60 Units for both treatment groups. The trial was designed to show the contribution of the GLP-1 RA component to glycemic lowering, and the insulin glargine dose and dosing algorithm were selected in order to isolate the effect of the GLP-1 RA component.1,2

Analysis limitations:
The difference in effect observed in the trial may not necessarily reflect the effect that will be observed in the care setting where alternative insulin glargine dosages can be used.1

5x Lower Discontinuation Rate vs GLP-1 RA (lixisenatide)2

0.9% of patients discontinued SOLIQUA 100/33 due to GI adverse events vs 5.2% for the GLP-1 RA (lixisenatide)2
Table comparing the incidence of GI side effects in adult patients with T2DM uncontrolled on OADs² between SOLIQUA® 100/33 and GLP-1 RA (lixisenatide). Nausea occurred in 9.6% of SOLIQUA® 100/33 patients versus 24.0% with GLP-1 RA, a 60% difference. Diarrhea incidence was equal at 9.0% for both treatments. Vomiting occurred in 3.2% of patients treated with SOLIQUA® 100/33 and 6.4% with GLP-1 RA, a 50% difference.

Hypoglycemia is the most common adverse event with insulin-containing therapies.1

Important Safety Information

Important Safety Information for SOLIQUA 100/33 (insulin glargine and lixisenatide) injection 100 Units/mL and 33 mcg/mL

Contraindications

  • During episodes of hypoglycemia.
  • In patients with known serious hypersensitivity to insulin glargine, lixisenatide, or to any of the product components.

Warnings and Precautions

  • Anaphylaxis and Serious Hypersensitivity Reactions: In clinical trials of lixisenatide, there have been cases of anaphylaxis and other serious hypersensitivity reactions including angioedema. Severe, life threatening, generalized allergic reactions, including anaphylaxis and angioedema, can occur with insulins, including insulin glargine. There have been reports of serious hypersensitivity reactions, including anaphylactic reactions and angioedema, in patients treated with SOLIQUA 100/33. If hypersensitivity reactions occur, discontinue SOLIQUA 100/33. Use caution in patients with a history of anaphylaxis or angioedema with another glucagon-like peptide-1 (GLP-1) receptor agonist (RA) because it is unknown whether such patients will be predisposed to anaphylaxis.
  • Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 RAs. After initiation of SOLIQUA 100/33, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue SOLIQUA 100/33 and initiate appropriate management.
  • Never Share a SOLIQUA 100/33 SoloStar® Pen between Patients: Pen-sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed.
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in insulin regimen including, strength, manufacturer, type, injection site or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Changes should be made cautiously, and the frequency of blood glucose monitoring should be increased. Adjustments in concomitant oral antidiabetic treatment may be needed. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia.
  • Medication Errors: SOLIQUA 100/33 contains two drugs. Do not administer more than 60 units of SOLIQUA 100/33, which may result in overdose of the lixisenatide component. Do not use other GLP-1 RAs. Accidental mix-ups between insulin products have been reported. Instruct patients to always check the label before administration. Do not withdraw SOLIQUA 100/33 from the pen with a syringe.
  • Hypoglycemia: Hypoglycemia is the most common adverse reaction associated with insulin-containing therapy, which may be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity, and in patients with renal or hepatic impairment and hypoglycemia unawareness.
  • Acute Kidney Injury Due to Volume Depletion: There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists. The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting or diarrhea. Monitor renal function in patients reporting adverse reactions to SOLIQUA 100/33 that could lead to volume depletion, especially during dosage initiation and escalation of SOLIQUA 100/33. SOLIQUA 100/33 is not recommended in patients with end-stage renal disease.
  • Severe Gastrointestinal Adverse Reactions: Use of GLP-1 receptor agonists, including SOLIQUA 100/33, has been associated with gastrointestinal adverse reactions, sometimes severe. SOLIQUA 100/33 is not recommended in patients with severe gastroparesis.
  • Immunogenicity: Patients may develop antibodies to insulin and lixisenatide. If there is worsening glycemic control or failure to achieve targeted glycemic control, significant injection site reactions or allergic reactions, then other antidiabetic therapy should be considered.
  • Hypokalemia: All insulin containing products can cause hypokalemia, which may be life-threatening. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) and insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.
  • Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and post-marketing. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
  • Pulmonary Aspiration During General Anesthesia or Deep Sedation: SOLIQUA 100/33 delays gastric emptying. There have been rare post marketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking SOLIQUA 100/33.

Most Common Adverse Reactions

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.

Drug Interactions

  • Certain drugs may affect glucose metabolism, requiring dose adjustment of SOLIQUA 100/33 and close monitoring of blood glucose.
  • The signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs (eg, betablockers, clonidine, guanethidine, and reserpine).
  • The lixisenatide in SOLIQUA 100/33 delays gastric emptying, which may reduce the rate of absorption of orally administered medication with a narrow therapeutic ratio or that require careful clinical monitoring. If such medications are to be administered with food, do not co-administer with SOLIQUA 100/33.
  • Antibiotics, acetaminophen, or other medications that are dependent on threshold concentrations for efficacy, or where a delay in effect is undesirable, should be administered at least 1 hour before SOLIQUA 100/33 injection.
  • Oral contraceptives should be taken at least 1 hour before SOLIQUA 100/33 administration or 11 hours after.

Indication

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.

Limitations of Use:

  • 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.

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Important Safety Information

Indication

Abbreviations: GI, gastrointestinal; GLP-1, glucagon-like peptide-1; OAD, oral antidiabetic drug; RA, receptor agonist; T2DM, type 2 diabetes mellitus.

References:

  1. SOLIQUA 100/33 Prescribing Information.

  2. Data on file. CSR 12404. Sanofi US.

  3. Data on file. CSR 12405. Sanofi US.

  4. Blonde L, Rosenstock J, Del Prato S, et al. Switching to iGlarLixi versus continuing daily or weekly GLP-1 RA in type 2 diabetes inadequately controlled by GLP-1 RA and oral antihyperglycemic therapy: the LixiLan-G randomized clinical trial. Diabetes Care. 2019;42(11):2108-2116.

Soliqua and Sanofi are registered trademarks of Sanofi or an affiliate. MAT-US-2110934-v3.0-11/2025

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