For U.S. Healthcare Professionals Only
  • 74% of patients got to ADA goal (<7%) with
    SOLIQUA 100/33
    • 33% of GLP-1 RA (lixisenatide) patients and 59% of Lantus® patients got to goal

Reduction in A1C from baseline to Week 30

  • In the LixiLan-O Clinical Trial, the final mean basal insulin daily dose was similar between SOLIQUA 100/33 (39.8 Units) and Lantus (40.5 Units), determined by the FPG titration
  • 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 dosage can be used
  • In the LixiLan-O Clinical Trial, the final mean basal insulin daily dose was similar between SOLIQUA 100/33 (39.8 Units) and Lantus (40.5 Units), determined by the FPG titration
  • 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 dosage can be used

*p<0.0001 vs Lantus.

For patients with A1C ≥9%

SOLIQUA 100/33 reduced A1C by 2.9%2

Reduction in A1C from baseline to Week 30

  • In this post hoc subgroup analysis, LixiLan-O patients with A1C ≥9%-10.4% at baseline were evaluated. Doses were similar between SOLIQUA 100/33 (45 Units) and Lantus (44 Units)2,3
  • Analysis limitations: This study was not designed or powered to detect differences between treatments within this subgroup. Analysis included limited sample size, N=134. P values are for descriptive purposes only without multiplicity adjustments
  • The difference in effect observed in this subgroup analysis may not necessarily reflect the effect that will be observed in the care setting where alternative insulin glargine dosage can be used

For patients with A1C ≥9%

MORE PATIENTS GOT TO ADA GOAL (<7%) WITH SOLIQUA 100/332

SOLIQUA 100/33 demonstrated a result consistent with the result in the pivotal trial

  • In this post hoc subgroup analysis, LixiLan-O patients with A1C ≥9%-10.4% at baseline were evaluated. Doses were similar between SOLIQUA 100/33 (45 Units) and Lantus (44 Units)2,3
  • Analysis limitations: This study was not designed or powered to detect differences between treatments within this subgroup. Analysis included limited sample size, N=134. P values are for descriptive purposes only without multiplicity adjustments
  • The difference in effect observed in this subgroup analysis may not necessarily reflect the effect that will be observed in the care setting where alternative insulin glargine dosage can be used

FPG, fasting plasma glucose.

  • Eligible patients (N=1479) were enrolled in a 4-week run-in period during which they stopped taking any second OAD and titrated metformin to ≥2000 mg/d or maximum tolerated dose (≥1500 mg/d)
  • Patients inadequately controlled at the end of the run-in period (N=1170) were randomized to either SOLIQUA 100/33 (n=469), Lantus (n=467), or lixisenatide (n=234), with metformin
  • Criteria for randomization:
    • A1C between 7% and 10%
    • FPG ≤250 mg/dL
  • The maximum allowable insulin glargine dose was 60 Units for both the SOLIQUA 100/33 and Lantus treatment groups

SOLIQUA 100/33 is a combination of a long-acting human insulin analog with a glucagon-like peptide-1 (GLP-1) receptor agonist (RA) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

  • Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
  • Not recommended for use in combination with any other product containing a GLP-1 receptor agonist.
  • Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
  • Not recommended for use in patients with gastroparesis.
  • Has not been studied in combination with prandial insulin.

Important Safety Information

Contraindications

  • During episodes of hypoglycemia.
  • In patients with known hypersensitivity to the active substance(s) 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. If hypersensitivity reactions occur, discontinue SOLIQUA 100/33. Use caution in patients with a history of anaphylaxis or angioedema with another GLP-1 RA because it is unknown whether such patients will be predisposed to anaphylaxis.
  • Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 RAs. Cases of pancreatitis were reported in clinical trials of lixisenatide. After initiation of SOLIQUA 100/33, observe patients for signs and symptoms of pancreatitis (e.g., persistent severe abdominal pain, sometimes radiating to the back and which may be accompanied by vomiting). If pancreatitis is suspected, SOLIQUA 100/33 should promptly be discontinued. If pancreatitis is confirmed, restarting SOLIQUA 100/33 is not recommended and other antidiabetic therapies should be considered.
  • 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 SOLIQUA 100/33 regimen 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.
  • 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: There have been reports of acute renal failure and worsening of chronic failure, which may sometimes require hemodialysis in patients treated with GLP-1 RAs, such as lixisenatide. Some of these events were reported in patients without known underlying renal disease. Most reports occurred in patients who experienced nausea, vomiting, diarrhea, or dehydration; advise patients to take precautions to avoid fluid depletion. Monitor blood glucose and renal function in patients with renal impairment. SOLIQUA 100/33 is not recommended in patients with end-stage renal disease.
  • 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.
  • Macrovascular Outcomes: Clinical studies have not shown macrovascular risk reduction with 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, beta-blockers, 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.

References:

  1. SOLIQUA 100/33 Prescribing Information.
  2. Davies MJ, Russell-Jones D, Barber TM, et al. Glycaemic benefit of iGlarLixi in insulin-naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial. Diabetes Obes Metab. 2019;21:1967–1972. doi:10.1111/dom.13791.
  3. Data on file. CSR 12404. Sanofi US.

References:

1. SOLIQUA 100/33 Prescribing Information.

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

OAD, oral antidiabetic therapy.

References:

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

2. SOLIQUA 100/33 Prescribing Information.

OAD, oral antidiabetic therapy.

References:

  1. SOLIQUA 100/33 Prescribing Information.
  2. Niemoeller E, Souhami E, Wu Y, Jensen KH. iGlarLixi reduces glycated hemoglobin to a greater extent than basal insulin regardless of levels at screening: post hoc analysis of LixiLan-L. Diabetes Ther. 2018;9:373-382. doi.org/10.1007/s13300-017-0336-6.
  3. American Diabetes Association. Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019;42. (suppl 1):S1-S193. doi.org:10.2337/dc19-S006.
  4. Data on file. CSR 12405. Sanofi US.

Reference:

1. SOLIQUA 100/33 Prescribing Information.

Reference:

1. SOLIQUA 100/33 Prescribing Information.

OAD, oral antidiabetic therapy.

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