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Use the links below to read the study abstracts at PubMed.gov.
The first head-to-head, randomized controlled clinical trial of Toujeo vs Tresiba®.
Read moreA PK/PD study evaluating the within-day variability of Toujeo and Tresiba in patients with T1DM.
Read moreInsulin-naive patients with type 2 diabetes mellitus on oral glucose-lowering drugs.
Read morePatients with type 2 diabetes mellitus using oral antidiabetic agents and basal insulin.
Read moreToujeo has been studied versus Lantus® (insulin glargine injection) 100 Units/mL in four pivotal clinical trials (the EDITION study program)† involving more than 3000 patients and in two euglycemic clamp studies to assess pharmacokinetics (PK) and pharmacodynamics (PD).
†All studies in the EDITION clinical program were 26-week, open-label, controlled, titrate-to-target, noninferiority studies in adults with diabetes not at A1C goal (range: 7%-10% or 11%), randomized to Toujeo or Lantus once daily. All patients were titrated to an FPG goal of 80-100 mg/dL (T2DM) or 80-130 mg/dL (T1DM).
Hello, I’m Dr John Anderson and I’m here to talk to you about Toujeo and the BRIGHT study. As you may know, Toujeo is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Toujeo is not recommended for treating diabetic ketoacidosis.
You may have heard of this important study as it’s the first head-to-head, randomized, controlled trial comparing the efficacy and safety of Toujeo versus Tresiba. The BRIGHT study evaluated A1C reduction, the odds and event rates of anytime hypoglycemia over the full 24 weeks and during the titration and maintenance phases, and other adverse events. As you know, hypoglycemia is the most frequently reported adverse event for all insulins; therefore, each patient should be evaluated to determine individual risk and taught how to recognize the signs and symptoms of hypoglycemia and the actions to be taken should it occur.
In addition to A1C reduction, a patient’s sensitivity to hypoglycemia, and the impact it can have on the treatment experience, are important considerations for me when starting on an insulin regimen.
Remember, Toujeo is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any or its excipients.
Let’s jump right into BRIGHT, shall we? As you can see below, BRIGHT was a randomized, controlled, noninferiority study. In this study, the efficacy and safety of Toujeo were compared with Tresiba in insulin-naive adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic drug(s), with or without a GLP-1 receptor agonist.
The Toujeo cohort included 466 patients and the Tresiba cohort included 463 patients.
The primary endpoint of the BRIGHT study was A1C reduction from baseline to Week 24. Remember, Toujeo contains the same active ingredient, insulin glargine, as Lantus. The concentration of insulin glargine in Toujeo is 300 Units per milliliter.
As you’ll notice, Toujeo achieved this endpoint with powerful glycemic control. A1C reduction of -1.64% for Toujeo was comparable to that of Tresiba, which was -1.59%, with a noninferiority margin of 0.3% and a difference between treatments of -0.05%.
Also, remind your patients to never share insulin pens and needles.
Some of you may be surprised by these results. There is a misperception among some HCPs that Tresiba offers greater A1C reduction than Toujeo; however, BRIGHT demonstrated that Toujeo and Tresiba had comparable A1C reduction.
As you are all aware, it is important to monitor blood glucose levels in all patients treated with insulin.
In addition to A1C reduction, the likelihood of a hypoglycemic event—referred to as odds—and event rates of severe and/or confirmed anytime hypoglycemia were also evaluated.
Anytime hypoglycemia was defined as hypoglycemia that occurred over 24 hours. This was measured at 3 different time points: anytime hypoglycemia that occurred over the full 24-week study, during the titration phase, and during the maintenance phase.
Anytime hypoglycemia was comparable over the full 24-week study, with Toujeo having 24% lower odds and a 31% lower event rate versus Tresiba.
The most frequently reported treatment-emergent adverse events (greater than or equal to 5%) were viral upper respiratory tract infection reported in 8.2% in the Toujeo group and in 8.7% in the Tresiba group, and upper respiratory tract infection in 5.2% and 4.1%, respectively. Serious treatment-emergent adverse events were 4.5% for Toujeo versus 4.3% for Tresiba.
This trial was not designed to evaluate the relative safety of Toujeo compared with Tresiba, and comparator adverse event rates are not an adequate basis for comparison rates between the products.
All hypoglycemia P values are for descriptive purposes only and are not adjusted for multiplicity.
One interesting aspect of the BRIGHT data was the evaluation of the titration and maintenance phases.
As you can see in the titration phase, Toujeo demonstrated 37% lower odds, and 43% lower event rates of anytime hypoglycemia from Day 1 to Week 12 of the study.
The titration phase can be an important time during a patient’s treatment experience.
Following the titration phase, in Weeks 13 to 24, referred to as the Maintenance Phase, Toujeo and Tresiba showed comparable results, with Toujeo demonstrating 14% lower odds and 19% lower event rates of anytime hypoglycemia.
So what does all this mean? It means that Toujeo delivers powerful efficacy and demonstrated safety.
In BRIGHT, hypoglycemia incidence and event rates were also comparable in the Maintenance Phase and during the entire study period, and lower during the Titration Phase when most of the dose adjustment occurs.
As noted in the PI, patients started on, or changed to, Toujeo required a higher starting dose than patients on Lantus. When hanging from another basal insulin to Toujeo, patients experienced higher average fasting plasma glucose levels in the first few weeks of therapy.
Another aspect of the BRIGHT study is that it confirms Toujeo’s consistent A1C reduction. But before we address that, remember that hypoglycemia is the most common adverse reaction of insulin therapy, including Toujeo, and may be life-threatening.
In EDITION 3, a noninferiority, randomized, open-label study, Toujeo delivered powerful A1C reduction and demonstrated safety in insulin-naive adult patients with type 2 diabetes mellitus versus Lantus.
Toujeo should be administered subcutaneously once a day at the same time every day.
Medication errors have been reported. Patients should always verify the insulin label before each injection.
The mean A1C reduction at Week 26 was -1.42% for Toujeo and -1.46 for Lantus with a prespecified noninferiority margin of 0.4% and 95% confidence interval.
Remember, do not dilute or mix Toujeo with any other insulin solution.
Hypoglycemia and other adverse events were also evaluated in EDITION 3. Toujeo demonstrated a low incidence of severe hypoglycemia at 0.9%, and an 8% incidence of documented symptomatic hypoglycemia.
The incidence of severe hypoglycemia when part of a multiple-dose injection regimen was 6.6% in type 1 diabetes mellitus, and 5% in type 2 diabetes mellitus. When used as a part of a basal insulin-only regimen, the incidence was 1% and 0.9% in two type 2 diabetes mellitus studies.
We’ve gone through quite a bit today! Before we wrap up, let’s quickly recap some of the BRIGHT highlights.
In this randomized, noninferiority study, Toujeo showed a powerful A1C reduction of -1.64% versus -1.59% with Tresiba from baseline to Week 24, which confirms consistent A1C reductions across multiple randomized controlled trials.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Toujeo, monitor and treat if indicated.
Comparable rates of anytime hypoglycemia over the full 24-week study, as well as the Maintenance Phase, were seen with Toujeo vs Tresiba.
During the Titration Phase, Toujeo demonstrated lower odds and event rates of anytime hypoglycemia. Given these data, consider Toujeo as an option for your appropriate adult patients starting basal insulin
DR. PETTUS:
“Hi, everyone, I’m Dr. Jeremy Pettus, endocrinologist at the University of California, San Diego.”
“In the last 10 years, I’ve seen how the number of treatment options have increased, and also how the decisions made by payers, managed care, and insurance companies affect the treatment options I have for my patients.”
“I’ve had to build my experience and adapt my approach to treatment choices—always with the goal of prescribing options that have proven safety and efficacy, and are covered by a variety of insurance plans.”
“I’m typically an early adopter of medications, which means I’ve had experience with treatments that include additional insurance requirements, such as prior authorizations.”
“I’ve also been able to see how a range of insurance providers, both commercial and Medicare Part D, process these prescriptions.”
“While each patient has a unique treatment history, there are concerns that most patients share.”
“Starting a different treatment can make some patients feel uncomfortable for various reasons.”
“So I talk to them about the different treatment we’re adding and how they can manage the treatment change.”
“Then Adriana, our staff Certified Diabetes Educator, helps them with adding the treatment to their routine.”
“Right, I spend a lot of time with patients as they’re starting something different like basal insulin.”
“One of the main things I help them with: is training on how to administer their insulin correctly.”
“I also help them think through how to take this treatment with their current medications.”
DR PETTUS:
“When I think about what basal insulin to prescribe, a lot of factors come to mind.”
“Clinical attributes are always most important, but then there are other things to consider, such as: Has our office’s experience processing this treatment with most insurance carriers been easy?”
“Are there co-pay offerings available for eligible patients?”
“I’ve found that some products take additional processing steps, like prior authorization.”
“While I work to get all the necessary paperwork filled out so patients can start their medication, knowing that some options require additional effort from my staff or me can discourage me from prescribing them as a first choice.”
DR PETTUS:
“Medicare Part D formulary coverage can be an issue for my patients.”
“I’ve had positive experience with coverage for my Medicare Part D patients with Toujeo® (insulin glargine injection) 300 Units/mL.”
DR PETTUS:
“In my practice, more of my patients are covered for Toujeo® than some other basal insulin options that I may consider prescribing.”
DR PETTUS:
“All my patients with commercial insurance are eligible for co-pay savings with Toujeo®.”
“They pay no more than $10 per prescription for the first year, no matter what their formulary status is.”
DR PETTUS:
“I encourage commercially-insured patients to enroll in the program as soon as I write their prescription.”
ADRIANA:
“They can enroll at Toujeo.com, or call 866-390-5622.”
DR PETTUS:
“Toujeo® has been accessible for most of my patients—with a range of insurance providers.”
DR PETTUS:
“To find out what your local coverage is like, go to ToujeoPro.com.”
“You select the state you practice in, and then can see both commercial and Medicare Part D insurance providers and their coverage details.”
DR PETTUS:
“I mentioned before that processing steps like prior authorizations are sometimes needed.”
ADRIANA:
“That’s right - sometimes authorization requires someone from our office staff to present the case, but often times they require a physician to be on the phone call.”
“The process is not always easy or consistent.”
DR PETTUS:
“Since Toujeo® is a Sanofi product, my patients can access support through Sanofi Patient Connection.”
“The program leads them through the steps required to receive their prescription, and helps them fill out insurance paperwork correctly.”
ADRIANA:
“When I’m talking to patients with a Toujeo® prescription I show them the website and help them get signed up right there in the office.”
DR PETTUS:
“I never want to make treatment decisions based on a product’s accessibility alone, but primarily based on the product’s clinical attributes.”
DR PETTUS:
“So I hope sharing our office’s experience prescribing Toujeo, including the co-pay savings program, and Medicare insurance coverage information, has been helpful to you.”
ADRIANA:
“Our office staff has had a positive experience with the resources Sanofi offers.”
DR PETTUS:
“Thanks for spending time watching this video. If you want to learn more about what Toujeo offers your patients, or see what coverage looks like in your local area, visit www.ToujeoPro.com.”
ADRIANA:
“Thanks!”
Toujeo® (insulin glargine injection 300 units per milliliter) is a long-acting, once-daily basal insulin with:
Toujeo® provides a long duration of action due to the substitution of glycine for asparagine on the A chain, and addition of two arginine amino acids to the end of the B chain.
These structural changes render the insulin glargine molecule completely soluble in the low pH of the Toujeo® prefilled pen. But on subcutaneous injection, the insulin glargine molecules form a compact precipitate of insulin glargine hexamers in the neutral pH of the body.
Toujeo® is formulated to contain 3 times as many units of insulin per milliliter as Lantus®, or insulin glargine injection 100 Units per milliliter, which results in a smaller precipitate with less surface area. The change in formulation of insulin glargine in Toujeo® impacts the size of the precipitate and its pharmacologic properties.
Slow dissociation of the precipitate follows, with insulin glargine released at a more gradual rate than Lantus®. It is hypothesized that the size, and hence the surface area, of the subcutaneous precipitate determines the redissolution rate.
Its dissolution from hexamers into dimers, and finally into physiologically active insulin monomers, allows a gradual release of insulin glargine molecules into the bloodstream.
Toujeo® U300 delivers insulin glargine from a smaller precipitate at a more gradual rate than Lantus® U100. As shown in the graph, Toujeo® has a longer activity profile. In this PK/PD study, Toujeo® demonstrated a glucose-lowering effect that lasted up to 36 hours,
and maintained consistent blood glucose levels throughout the day. In this PK/PD study, blood glucose levels were maintained within the ADA-recommended range.
This prolonged release of Toujeo® helps lower blood glucose for up to 36 hours.
Toujeo®: A long-acting, once-daily basal insulin with a reduced injection volume, a small precipitate, and a gradual insulin release.
Toujeo® is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use: Toujeo® is not recommended for treating diabetic ketoacidosis.
Contraindications
Toujeo® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any of its excipients.
Warnings and Precautions
Toujeo® contains the same active ingredient, insulin glargine, as Lantus®. The concentration of insulin glargine in Toujeo® is 300 units per mL.
Insulin pens and needles must never be shared between patients. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Modify insulin regimens cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Changes in insulin regimen may result in hyperglycemia or hypoglycemia.
Unit for unit, patients started on, or changed to, Toujeo® required a higher dose than patients controlled with Lantus®. When changing from another basal insulin to Toujeo®, patients experienced higher average fasting plasma glucose levels in the first few weeks of therapy until titrated to their individualized fasting plasma glucose targets. Higher doses were required in titrate-to-target studies to achieve glucose control similar to Lantus®.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Toujeo®, and may be life-threatening.
Medication errors, such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection.
Do not dilute or mix Toujeo® with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Toujeo® via an insulin pump or intravenously because severe hypoglycemia can occur.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Toujeo®, monitor and treat if indicated.
A reduction in the Toujeo® dose may be required in patients with renal or hepatic impairment.
As with all insulins, Toujeo® use can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) with 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.
Drug Interactions
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).
Adverse Reactions
Adverse reactions commonly associated with Toujeo® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.
Toujeo® SoloStar® and Toujeo® Max SoloStar® are disposable prefilled insulin pens. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose levels. It is especially important to perform a safety test when a patient is using a new pen for the first time.
Do not withdraw Toujeo® from the SoloStar® and Max SoloStar® disposable prefilled pens with a syringe.
Hello, I’m Dr John Anderson and I’m here to talk to you about Toujeo and the BRIGHT study. As you may know, Toujeo is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Toujeo is not recommended for treating diabetic ketoacidosis.
You may have heard of this important study as it’s the first head-to-head, randomized, controlled trial comparing the efficacy and safety of Toujeo versus Tresiba. The BRIGHT study evaluated A1C reduction, the odds and event rates of anytime hypoglycemia over the full 24 weeks and during the titration and maintenance phases, and other adverse events.
As you know, hypoglycemia is the most frequently reported adverse event for all insulins; therefore, each patient should be evaluated to determine individual risk and taught how to recognize the signs and symptoms of hypoglycemia and the actions to be taken should it occur.
In addition to A1C reduction, a patient’s sensitivity to hypoglycemia, and the impact it can have on the treatment experience, are important considerations for me when starting on an insulin regimen.
Remember, Toujeo is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any or its excipients.
Let’s jump right into BRIGHT, shall we? As you can see below, BRIGHT was a randomized, controlled, noninferiority study. In this study, the efficacy and safety of Toujeo were compared with Tresiba in insulin-naive adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic drug(s), with or without a GLP-1 receptor agonist.
The Toujeo cohort included 466 patients and the Tresiba cohort included 463 patients.
The primary endpoint of the BRIGHT study was A1C reduction from baseline to Week 24. Remember, Toujeo contains the same active ingredient, insulin glargine, as Lantus. The concentration of insulin glargine in Toujeo is 300 Units per milliliter.
As you’ll notice, Toujeo achieved this endpoint with powerful glycemic control. A1C reduction of -1.64% for Toujeo was comparable to that of Tresiba, which was -1.59%, with a noninferiority margin of 0.3% and a difference between treatments of -0.05%.
Also, remind your patients to never share insulin pens and needles.
Some of you may be surprised by these results. There is a misperception among some HCPs that Tresiba offers greater A1C reduction than Toujeo; however, BRIGHT demonstrated that Toujeo and Tresiba had comparable A1C reduction.
As you are all aware, it is important to monitor blood glucose levels in all patients treated with insulin.
In addition to A1C reduction, the likelihood of a hypoglycemic event—referred to as odds—and event rates of severe and/or confirmed anytime hypoglycemia were also evaluated.
Anytime hypoglycemia was defined as hypoglycemia that occurred over 24 hours. This was measured at 3 different time points: anytime hypoglycemia that occurred over the full 24-week study, during the titration phase, and during the maintenance phase.
Anytime hypoglycemia was comparable over the full 24-week study, with Toujeo having 24% lower odds and a 31% lower event rate versus Tresiba.
The most frequently reported treatment-emergent adverse events (greater than or equal to 5%) were viral upper respiratory tract infection reported in 8.2% in the Toujeo group and in 8.7% in the Tresiba group, and upper respiratory tract infection in 5.2% and 4.1%, respectively. Serious treatment-emergent adverse events were 4.5% for Toujeo versus 4.3% for Tresiba.
This trial was not designed to evaluate the relative safety of Toujeo compared with Tresiba, and comparator adverse event rates are not an adequate basis for comparison rates between the products.
All hypoglycemia P values are for descriptive purposes only and are not adjusted for multiplicity.
One interesting aspect of the BRIGHT data was the evaluation of the titration and maintenance phases.
As you can see in the titration phase, Toujeo demonstrated 37% lower odds, and 43% lower event rates of anytime hypoglycemia from Day 1 to Week 12 of the study.
The titration phase can be an important time during a patient’s treatment experience.
Following the titration phase, in Weeks 13 to 24, referred to as the Maintenance Phase, Toujeo and Tresiba showed comparable results, with Toujeo demonstrating 14% lower odds and 19% lower event rates of anytime hypoglycemia.
So what does all this mean? It means that Toujeo delivers powerful efficacy and demonstrated safety.
In BRIGHT, hypoglycemia incidence and event rates were also comparable in the Maintenance Phase and during the entire study period, and lower during the Titration Phase when most of the dose adjustment occurs.
As noted in the PI, patients started on, or changed to, Toujeo required a higher starting dose than patients on Lantus. When hanging from another basal insulin to Toujeo, patients experienced higher average fasting plasma glucose levels in the first few weeks of therapy.
Another aspect of the BRIGHT study is that it confirms Toujeo’s consistent A1C reduction. But before we address that, remember that hypoglycemia is the most common adverse reaction of insulin therapy, including Toujeo, and may be life-threatening.
In EDITION 3, a noninferiority, randomized, open-label study, Toujeo delivered powerful A1C reduction and demonstrated safety in insulin-naive adult patients with type 2 diabetes mellitus versus Lantus.
Toujeo should be administered subcutaneously once a day at the same time every day.
Medication errors have been reported. Patients should always verify the insulin label before each injection.
The mean A1C reduction at Week 26 was -1.42% for Toujeo and -1.46 for Lantus with a prespecified noninferiority margin of 0.4% and 95% confidence interval.
Remember, do not dilute or mix Toujeo with any other insulin solution.
Hypoglycemia and other adverse events were also evaluated in EDITION 3. Toujeo demonstrated a low incidence of severe hypoglycemia at 0.9%, and an 8% incidence of documented symptomatic hypoglycemia.
The incidence of severe hypoglycemia when part of a multiple-dose injection regimen was 6.6% in type 1 diabetes mellitus, and 5% in type 2 diabetes mellitus. When used as a part of a basal insulin-only regimen, the incidence was 1% and 0.9% in two type 2 diabetes mellitus studies.
We’ve gone through quite a bit today! Before we wrap up, let’s quickly recap some of the BRIGHT highlights.
In this randomized, noninferiority study, Toujeo showed a powerful A1C reduction of -1.64% versus -1.59% with Tresiba from baseline to Week 24, which confirms consistent A1C reductions across multiple randomized controlled trials.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Toujeo, monitor and treat if indicated.
Comparable rates of anytime hypoglycemia over the full 24-week study, as well as the Maintenance Phase, were seen with Toujeo vs Tresiba.
During the Titration Phase, Toujeo demonstrated lower odds and event rates of anytime hypoglycemia. Given these data, consider Toujeo as an option for your appropriate adult patients starting basal insulin
DR. PETTUS:
“Hi, everyone, I’m Dr. Jeremy Pettus, endocrinologist at the University of California, San Diego.”
“In the last 10 years, I’ve seen how the number of treatment options have increased, and also how the decisions made by payers, managed care, and insurance companies affect the treatment options I have for my patients.”
“I’ve had to build my experience and adapt my approach to treatment choices—always with the goal of prescribing options that have proven safety and efficacy, and are covered by a variety of insurance plans.”
“I’m typically an early adopter of medications, which means I’ve had experience with treatments that include additional insurance requirements, such as prior authorizations.”
“I’ve also been able to see how a range of insurance providers, both commercial and Medicare Part D, process these prescriptions.”
“While each patient has a unique treatment history, there are concerns that most patients share.”
“Starting a different treatment can make some patients feel uncomfortable for various reasons.”
“So I talk to them about the different treatment we’re adding and how they can manage the treatment change.”
“Then Adriana, our staff Certified Diabetes Educator, helps them with adding the treatment to their routine.”
“Right, I spend a lot of time with patients as they’re starting something different like basal insulin.”
“One of the main things I help them with: is training on how to administer their insulin correctly.”
“I also help them think through how to take this treatment with their current medications.”
DR PETTUS:
“When I think about what basal insulin to prescribe, a lot of factors come to mind.”
“Clinical attributes are always most important, but then there are other things to consider, such as: Has our office’s experience processing this treatment with most insurance carriers been easy?”
“Are there co-pay offerings available for eligible patients?”
“I’ve found that some products take additional processing steps, like prior authorization.”
“While I work to get all the necessary paperwork filled out so patients can start their medication, knowing that some options require additional effort from my staff or me can discourage me from prescribing them as a first choice.”
DR PETTUS:
“Medicare Part D formulary coverage can be an issue for my patients.”
“I’ve had positive experience with coverage for my Medicare Part D patients with Toujeo® (insulin glargine injection) 300 Units/mL.”
DR PETTUS:
“In my practice, more of my patients are covered for Toujeo® than some other basal insulin options that I may consider prescribing.”
DR PETTUS:
“All my patients with commercial insurance are eligible for co-pay savings with Toujeo®.”
“They pay no more than $10 per prescription for the first year, no matter what their formulary status is.”
DR PETTUS:
“I encourage commercially-insured patients to enroll in the program as soon as I write their prescription.”
ADRIANA:
“They can enroll at Toujeo.com, or call 866-390-5622.”
DR PETTUS:
“Toujeo® has been accessible for most of my patients—with a range of insurance providers.”
DR PETTUS:
“To find out what your local coverage is like, go to ToujeoPro.com.”
“You select the state you practice in, and then can see both commercial and Medicare Part D insurance providers and their coverage details.”
DR PETTUS:
“I mentioned before that processing steps like prior authorizations are sometimes needed.”
ADRIANA:
“That’s right - sometimes authorization requires someone from our office staff to present the case, but often times they require a physician to be on the phone call.”
“The process is not always easy or consistent.”
DR PETTUS:
“Since Toujeo® is a Sanofi product, my patients can access support through Sanofi Patient Connection.”
“The program leads them through the steps required to receive their prescription, and helps them fill out insurance paperwork correctly.”
ADRIANA:
“When I’m talking to patients with a Toujeo® prescription I show them the website and help them get signed up right there in the office.”
DR PETTUS:
“I never want to make treatment decisions based on a product’s accessibility alone, but primarily based on the product’s clinical attributes.”
DR PETTUS:
“So I hope sharing our office’s experience prescribing Toujeo, including the co-pay savings program, and Medicare insurance coverage information, has been helpful to you.”
ADRIANA:
“Our office staff has had a positive experience with the resources Sanofi offers.”
DR PETTUS:
“Thanks for spending time watching this video. If you want to learn more about what Toujeo offers your patients, or see what coverage looks like in your local area, visit www.ToujeoPro.com.”
ADRIANA:
“Thanks!”
Toujeo® (insulin glargine injection 300 units per milliliter) is a long-acting, once-daily basal insulin with:
Toujeo® provides a long duration of action due to the substitution of glycine for asparagine on the A chain, and addition of two arginine amino acids to the end of the B chain.
These structural changes render the insulin glargine molecule completely soluble in the low pH of the Toujeo® prefilled pen. But on subcutaneous injection, the insulin glargine molecules form a compact precipitate of insulin glargine hexamers in the neutral pH of the body.
Toujeo® is formulated to contain 3 times as many units of insulin per milliliter as Lantus®, or insulin glargine injection 100 Units per milliliter, which results in a smaller precipitate with less surface area. The change in formulation of insulin glargine in Toujeo® impacts the size of the precipitate and its pharmacologic properties.
Slow dissociation of the precipitate follows, with insulin glargine released at a more gradual rate than Lantus®. It is hypothesized that the size, and hence the surface area, of the subcutaneous precipitate determines the redissolution rate.
Its dissolution from hexamers into dimers, and finally into physiologically active insulin monomers, allows a gradual release of insulin glargine molecules into the bloodstream.
Toujeo® U300 delivers insulin glargine from a smaller precipitate at a more gradual rate than Lantus® U100. As shown in the graph, Toujeo® has a longer activity profile. In this PK/PD study, Toujeo® demonstrated a glucose-lowering effect that lasted up to 36 hours,
and maintained consistent blood glucose levels throughout the day. In this PK/PD study, blood glucose levels were maintained within the ADA-recommended range.
This prolonged release of Toujeo® helps lower blood glucose for up to 36 hours.
Toujeo®: A long-acting, once-daily basal insulin with a reduced injection volume, a small precipitate, and a gradual insulin release.
Toujeo® is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use: Toujeo® is not recommended for treating diabetic ketoacidosis.
Contraindications
Toujeo® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any of its excipients.
Warnings and Precautions
Toujeo® contains the same active ingredient, insulin glargine, as Lantus®. The concentration of insulin glargine in Toujeo® is 300 units per mL.
Insulin pens and needles must never be shared between patients. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Modify insulin regimens cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Changes in insulin regimen may result in hyperglycemia or hypoglycemia.
Unit for unit, patients started on, or changed to, Toujeo® required a higher dose than patients controlled with Lantus®. When changing from another basal insulin to Toujeo®, patients experienced higher average fasting plasma glucose levels in the first few weeks of therapy until titrated to their individualized fasting plasma glucose targets. Higher doses were required in titrate-to-target studies to achieve glucose control similar to Lantus®.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Toujeo®, and may be life-threatening.
Medication errors, such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection.
Do not dilute or mix Toujeo® with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Toujeo® via an insulin pump or intravenously because severe hypoglycemia can occur.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Toujeo®, monitor and treat if indicated.
A reduction in the Toujeo® dose may be required in patients with renal or hepatic impairment.
As with all insulins, Toujeo® use can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) with 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.
Drug Interactions
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).
Adverse Reactions
Adverse reactions commonly associated with Toujeo® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.
Toujeo® SoloStar® and Toujeo® Max SoloStar® are disposable prefilled insulin pens. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose levels. It is especially important to perform a safety test when a patient is using a new pen for the first time.
Do not withdraw Toujeo® from the SoloStar® and Max SoloStar® disposable prefilled pens with a syringe.
ANNOUNCER: These instructions do not replace the guidance of your doctor or the instructions for use that accompanies the Toujeo (insulin glargine injection) 300 Units/mL SoloStar® or Toujeo Max SoloStar® pens. People who have vision problems should not use the Toujeo SoloStar or Toujeo Max SoloStar pen without help from a person trained to use the respective pens.
MAX AMY: In this diabetes journey we’re on, have you ever wished you could go back in time and tell yourself the things that you know now, but you didn’t know then?
MAX AMY: Thanks to the wonders of modern technology, we can.
MAX AMY: Hey look at that, our first SoloStar pen! I remember that.
MAX AMY: It was a really big deal when I came home with my first pen – it feels like it was only yesterday.
PAST AMY: Oh hey, is that one the same as this one?
MAX AMY: Well your pen is the SoloStar. This one is the Max SoloStar. They’re very similar but there’re some really important differences – but I’ll get to those in a second.
MAX AMY: Did your doctor show you how to use it?
PAST AMY: Yeah, she showed me, but now that I’m home I still have some questions.
MAX AMY: Let me help you get the hang of this.
MAX AMY: There are six steps you need to know: Check the pen, attach the needle, test for safety, select the dosage, inject the insulin, and then remove the needle.
PAST AMY [repeating as if memorizing]: OK. Check the pen, attach the needle, test for safety, select the dosage, inject the insulin, and remove the needle.
MAX AMY: That’s it! You’re ahead of the game already! I knew there was a reason why I liked you.
MAX AMY: So before we do anything, we’re going to make sure the pen is at room temperature, that we have the correct pen, and that it’s working properly.
MAX AMY: Did you take the pen out of the refrigerator about an hour ago? ‘Cause cold insulin can be painful…
PAST AMY: Really? Who knew?
MAX AMY: You.
PAST AMY: Good point. This one’s been out of the fridge about an hour.
MAX AMY: Now look at your pen. I mean, really look at it.
MAX AMY: Is that your pen?
PAST AMY: Yeah.
MAX AMY: Great. Take off the pen cap and check the insulin. It’s clear, not cloudy?
PAST AMY: Clear.
MAX AMY: Perfect! If the insulin’s cloudy, don’t use it, just take it back to your pharmacy.
MAX AMY: Is it past the use-by date?
PAST AMY: Nope.
MAX AMY: Great! Now it’s time to attach the needle.
MAX AMY: Remember, you’re going to need a fresh needle every time you use the pen.
MAX AMY: Don’t reuse and never share needles.
PAST AMY: Even with you?
MAX AMY: Yes, even with me.
PAST AMY: What kind of needles can I use?
MAX AMY: These kind.
MAX AMY: Before you attach the needle, sterilize the tip of the pen with an alcohol wipe.
MAX AMY: Then with the needle you’re going to peel off the protective seal and screw the needle onto the pen until it feels fixed.
MAX AMY: Then you’re going to remove the outer cap and put that somewhere safe. Then remove the inner needle cap and throw it in the trash.
PAST AMY: Keep the outer cap, toss the inner, got it.
MAX AMY: That’s step two done! With me so far?
PAST AMY: I’m with you.
MAX AMY: Yes, you are. So, before we do anything else, we need to make sure the pen’s working properly.
PAST AMY: What could go wrong?
MAX AMY: Well, sometimes the insulin won’t come out, so we usually check for that.
PAST AMY: OK.
MAX AMY: Testing the pen also resets the dosage knob, which is also important.
PAST AMY: Great, so how do I do that?
MAX AMY: Turn the dosage dial to 3, then you’re going to hold it straight up and you’re going to press the injection button all the way in.
MAX AMY: If you see insulin coming out of the needle, then the pen is working and you’re good to go.
MAX AMY: However, if you don’t see insulin coming out, repeat that last step again.
MAX AMY: If you have a new pen, you may need to do this up to six times. Just to get that working. If it still doesn’t work, you need to replace the needle.
PAST AMY: Like in step two?
MAX AMY: Precisely. Oh and by the way, if you see bubbles in your insulin, don’t sweat it.
PAST AMY: Aren’t bubbles in injections bad?
MAX AMY: Nope, not here. You’ve been watching too much TV.
MAX AMY: Ready to inject some insulin?
PAST AMY: OK.
MAX AMY: First, we need to select the correct dosage. So we’re going to turn the dosage selector to your dose.
MAX AMY: Whatever you and your doctor discussed is what you turn the dial to.
PAST AMY: OK, I need 38 units, so I turn the dial to 38, correct?
MAX AMY: Correct.
MAX AMY: Now this is important: If you have the SoloStar pen, the increments on the dial are one click for one unit, but on the Max SoloStar pen, it’s one click for two units.
MAX AMY: So don’t dial your dose by counting the clicks, or you may dial the wrong dose.
MAX AMY: Either way, just turn the dial so your prescribed dose appears in this window. If there’s not enough insulin in the pen for your prescribed dose, you’ll only be able to dial to the amount that’s left in the pen, and then you’ll need to supplement with a new pen.
PAST AMY: How do I know whether I need the SoloStar or the Max SoloStar?
MAX AMY: As your diabetes changes, your dose may change too, so your doctor may recommend you use a Max SoloStar. Like me.
PAST AMY: That makes total sense.
MAX AMY: OK, we’re in the home stretch.
MAX AMY: Are you ready for your injection?
PAST AMY: Where can I inject?
MAX AMY: You can inject your dose here, here, or here.
MAX AMY: Push the needle into your skin, but don’t touch the injection button yet.
MAX AMY: Put your thumb on the button, press all the way in and hold.
MAX AMY: Hold the button in. When you see “0” in the window, then count to five to make sure you get your full dose.
MAX AMY: After counting to five, release the button and remove the needle from your skin.
PAST AMY: OK, that was pretty easy.
PAST AMY: Well, I barely noticed it at all. How do they do that?
MAX AMY: Thin needles.
MAX AMY: We’re almost done. Now we just need to remove the needle and throw it away safely.
PAST AMY: This really is pretty straightforward.
MAX AMY: I know, right?
MAX AMY: To remove the needle, get the outer needle cap we set aside earlier and carefully place it back on the pen. You put that somewhere safe, right?
PAST AMY: Yep.
MAX AMY: OK.
MAX AMY: These things are sharp. Avoid puncturing the cap, ‘cause it will go through.
MAX AMY: Grip and squeeze the widest part of the outer needle cap, then turn your pen several times with your other hand to remove the needle.
PAST AMY: But what if it doesn’t come off right away?
MAX AMY: Just keep trying, it’ll come off eventually.
MAX AMY: Once the needle’s been removed, then we dispose of it in a puncture-resistant container.
PAST AMY: Can I just leave the needle on and use it again later?
MAX AMY: No, that’s not a great idea for several reasons: It can leak or get clogged if you leave it on, air could get into the insulin, and there’s the possibility of a bacterial infection.
PAST AMY: So, do I need to put the pen back in the refrigerator when I’m done?
MAX AMY: Nope, that’s the great thing about these pens – you’re good for up to six weeks after your first use without refrigeration.
PAST AMY: Well that’s handy.
MAX AMY: It sure is.
MAX AMY: So, there you go. That’s all six steps of how to use the Toujeo SoloStar and Max SoloStar insulin pens.
MAX AMY: Just to recap, we learned how to check the pen, attach the needle, test for safety, select your dosage, inject the insulin, and then remove the needle.
PAST AMY: Hey, that was really straightforward. I know the doctor explained it to me, but it really helped to have you explain it again.
MAX AMY: No sweat.
PAST AMY: You know, now that I know, it’s pretty simple. If I wasn’t so nervous, I guess I could have taught myself to do it.
MAX AMY: Well, you know, you kinda did.
ANNOUNCER: An unopened Toujeo SoloStar or Toujeo Max SoloStar pen should be stored in the refrigerator with the pen cap on, at a temperature between 36 degrees Fahrenheit and 46 degrees Fahrenheit (2 degrees Celsius and 8 degrees Celsius) in the box it came in.
Do not freeze new pens.
Refrigerate pens until expiration date.
Discard pens after the expiration date.
An opened Toujeo SoloStar or Toujeo Max SoloStar pen should be stored at room
temperature below 86 degrees Fahrenheit (30 degrees Celsius).
Do not refrigerate an opened pen.
Keep out of direct heat and light.
Do not store your pen with the needle attached.
Store your pen with the pen cap on.
Keep pens and needles out of the reach of children.
Discard 42 days after first use, even if the pen still contains insulin.
Do not take Toujeo® if you have low blood sugar or if you are allergic to insulin or any of the ingredients in Toujeo®.
Do NOT share your pen(s) with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Before starting Toujeo®, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant, or if you are breastfeeding or planning to breastfeed.
Heart failure can occur if you are taking insulin together with pills called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Toujeo®. Your treatment with TZDs and Toujeo® may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms, including:
Tell your doctor about all the medications you take, including OTC medicines, vitamins, supplements, and herbal supplements.
Toujeo® should be taken at the same time once a day. Test your blood sugar levels daily while using any insulin. Do not change your dose or type of insulin without talking to your doctor. Verify that you have the correct insulin before each injection. Do NOT use a syringe to remove Toujeo® from your pen. Your dose for Toujeo® may be different from other insulins you have taken. Any change of insulin should be made cautiously and only under medical supervision.
Do NOT dilute or mix Toujeo® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Use Toujeo® only if the solution is clear and colorless with no particles visible.
While using Toujeo®, do not drive or operate heavy machinery until you know how Toujeo® affects you. Don’t drink alcohol or use other medicines that contain alcohol.
The most common side effect of any insulin, including Toujeo®, is low blood sugar (hypoglycemia), which may be serious and life-threatening. Severe hypoglycemia may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.
Toujeo® may cause severe allergic reactions that can lead to death. Get medical help right away if you have:
Toujeo® may have additional side effects including swelling, weight gain, low potassium, and injection site reactions, which may include change in fat tissue, skin thickening, redness, swelling, and itching.
Toujeo® SoloStar® and Toujeo® Max SoloStar® are disposable prefilled insulin pens. It is important to perform a safety test when using a new pen for the first time. Talk to your doctor about proper injection technique and follow instructions in the Instruction Leaflet that comes with the pen.
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