For U.S. Healthcare Professionals Only

For adult patients with T2DM uncontrolled on basal insulin as an adjunct to diet and exercise

Soliqua 100/33 demonstrated ~2X greater A1C reduction vs Lantus®1

  • In the LixiLan-L Clinical Trial at Week 30, the 1.1% mean reduction in A1C from baseline with SOLIQUA 100/33 was ~2X greater than the 0.6% reduction with Lantus
  • The mean final dose of SOLIQUA 100/33 and Lantus at Week 30 was equivalent: 46.7 Units (for SOLIQUA 100/33: 46.7 Units insulin glargine/15.6 mcg lixisenatide)
  • 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

Explore safety.

See DOSING for patients on basal insulin.

Designed to evaluate the efficacy and safety of SOLIQUA 100/33 vs Lantus®

In the LixiLan-L Clinical Trial, a total of 736 patients with T2DM participated in a randomized, 30-week, open-label, multicenter study to evaluate the efficacy and safety of SOLIQUA 100/33 compared to Lantus.1

  • Adults with T2DM, mean age 60 years, uncontrolled on a stable daily basal insulin dose ±1 or 2 oral antidiabetic therapy (OADs) for ≥6 months (A1C of 7.5%-10%; fasting plasma glucose [FPG] ≤180 mg/dL) were screened
  • Eligible patients (n=1018) were enrolled in a 6-week run-in period during which they remained on or were switched to Lantus if on another basal insulin, and had their dose titrated/stabilized while continuing on metformin (if previously taken). Any other OADs were discontinued
  • Patients inadequately controlled at the end of the run-in period (n=736; A1C between 7% and 10%; FPG ≤140 mg/dL) and on an insulin glargine dose of 20-50 Units (mean dose of 35 Units) were randomized to either SOLIQUA 100/33 (n=367) or Lantus (n=369)
  • 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 the dosing algorithm were selected to isolate the effect of the GLP-1 RA component

For patients with A1C >9%

More T2DM patients got below 7% with SOLIQUA 100/332

>9.0% needs powerful A1C reduction

  • Analysis description: LixiLan-L Clinical Trial post hoc analysis of patients who completed the 6-week run-in phase (treatment with Lantus only) and completed the 30-week treatment phase (patients randomized to remain on Lantus or switch to SOLIQUA 100/33)
  • Analysis limitations: Patients who used rescue therapy or discontinued treatment early (including 40 SOLIQUA 100/33 patients and 34 Lantus patients) were not included. P values are for descriptive purposes only1,2
  • The difference in effect observed in the trial may not necessarily be reflected in the care setting where alternative insulin glargine dosage can be used

For patients with A1C >9%

More T2DM patients got below 7% with SOLIQUA 100/332

Additional A1C results from this study

  • Analysis description: LixiLan-L Clinical Trial post hoc analysis of patients who completed the 6-week run-in phase (treatment with Lantus only) and completed the 30-week treatment phase (patients randomized to remain on Lantus or switch to SOLIQUA 100/33)
  • Analysis limitations: Patients who used rescue therapy or discontinued treatment early (including 40 SOLIQUA 100/33 patients and 34 Lantus patients) were not included. P values are for descriptive purposes only1,2
  • The difference in effect observed in the trial may not necessarily be reflected in the care setting where alternative insulin glargine dosage can be used

When A1C is high, the ADA recommends the transition to a basal insulin plus a GLP-1 RA to get A1C down3

The 2019 ADA Guidelines recommends initial injectable combinations, such as basal insulin plus a GLP-1 RA, when A1C is 2% above target.

Demonstrated Safety and Tolerability FOR adult patients with T2DM UNCONTROLLED ON BASAL INSULIN1

Incidence of hypoglycemia in adult patients with T2DM treated with SOLIQUA 100/33

Severe symptomatic hypoglycemia*
(4 out of 365 patients)

Hypoglycemia
(65 out of 365 patients)

  • Hypoglycemia is the most common adverse event with insulin-containing therapy

*Severe symptomatic hypoglycemia defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

Hypoglycemia defined as self-monitored plasma glucose <54 mg/dL.

Treatment-emergent adverse events4

Gastrointestinal adverse reactions occur more frequently at the beginning of therapy.1

DISCONTINUATION DUE TO GI EVENTS IN THIS CLINICAL TRIAL WAS 1.1%.4

Choose the right starting dose for APPROPRIATE adult patients with T2DM uncontrolled on Injectable therapy1

SOLIQUA 100/33 is delivered subcutaneously, via the SOLIQUA 100/33 SoloStar® pen, once daily within one hour prior to the first meal of the day

For adult patients uncontrolled on these injectable therapies:

  • GLP-1 RA
  • Basal insulin <30 Units

This starting dose provides 15 Units of Lantus and 5 mcg of lixisenatide, a GLP-1 RA.

  • Basal insulin 30 Units

This starting dose provides 30 Units
of Lantus and 10 mcg of lixisenatide, a GLP-1 RA.

Dosing is once daily within the hour prior to the first meal of the day

Dosing is once daily
within the hour prior to
the first meal of the day

  • SOLIQUA 100/33 is delivered subcutaneously, via the SOLIQUA 100/33 SoloStar® pen, once daily

  • One Unit of SOLIQUA 100/33 contains 1 Unit of Lantus and 0.33 mcg of lixisenatide

Titrate by 2-4 Units weekly until target FPG is reached

Titration Instructions

  • SOLIQUA 100/33 is to be dosed based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic goals

  • The dose on the SOLIQUA 100/33 SoloStar pen can be adjusted in 1-unit increments

  • The maximum dose of SOLIQUA 100/33 is 60 Units

  • Use alternative treatments if doses below 15 Units or above 60 Units are required

SoloStar® technology you and your office staff will find familiar

See Dosing for Patients Uncontrolled on OADs.

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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