Insulin glargine, insulin glargine-aglr, and insulin glargine-yfgn are biosynthetic (rDNA origin), long-acting human insulin analogs.1, 2, 3, 30, 31, 56, 57
Insulin glargine (Lantus® ) and insulin glargine (Basaglar® ) are structurally and pharmacologically similar drugs that contain a related drug substance.1, 30 Basaglar® was licensed by FDA through an abbreviated approval pathway [505(b)(2)] that relied in part on FDA's finding of safety and effectiveness for Lantus®.41, 42, 44 Comparative studies found no substantial differences between the pharmacokinetics, immunogenicity, or toxicity of Lantus® and Basaglar®.42, 45, 48 Although Basaglar® is highly similar to Lantus® in terms of composition, strength, presentation, structure, and physicochemical and biological properties, it was not approved as a biosimilar or an interchangeable biologic product.42, 44 At the time of the approval, insulin was classified by FDA as a chemical, not a biologic product, and there was no biologic reference product for insulin glargine; thus, biosimilarity to insulin glargine could not be established.42, 44 Instead, Basaglar® was referred to as a “follow-on” insulin glargine preparation; FDA determined that there was no need to use a different nonproprietary name (insulin glargine) for Basaglar® at that time.42, 44 Subsequently, the classification of insulin was changed to a biologic product, and Basaglar® was included as a "rollover" drug product under this definition; however, Basaglar® is still not considered a biosimilar or interchangeable with Lantus®.61, 62
Insulin glargine-aglr (Rezvoglar®) and insulin glargine-yfgn (Semglee®) are biosimilar to insulin glargine (Lantus®).61 FDA defines a biosimilar as a biological product that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency.59, 60 The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies).60 Therefore, biosimilarity may be established even when there are formulation or minor structural differences as long as these differences are not clinically meaningful.60 Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological.60 In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alteration or switch.58 Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.58 Both insulin glargine-aglr (Rezvoglar®) and insulin glargine-yfgn (Semglee®) are designated as interchangeable with insulin glargine (Lantus®).61
In this monograph, unless otherwise stated, the term "insulin glargine products" refers to insulin glargine (the reference drug) and its biosimilars (insulin glargine-aglr and insulin glargine-yfgn).
Insulin glargine is commercially available as Lantus® (100 units/mL), Basaglar® (100 units/mL), and a concentrated preparation (Toujeo®; 300 units/mL).1, 30, 31
Two insulin glargine biosimilars are currently available.61 Biosimilarity of these products has been demonstrated for the indications described in Table 1.56, 57, 61, 63, 67 Biosimilarity to originator insulin glargine is additionally supported by comparative clinical studies in patients with type 1 and type 2 diabetes mellitus.64, 65, 66, 68, 69
FDA Labeled Indication | Type 1 Diabetes Mellitus | Type 2 Diabetes Mellitus |
|---|---|---|
Insulin glargine-aglr | X | X |
Insulin glargine-yfgn | X | X |
Insulin glargine 100-unit/mL (Lantus®) and its biosimilars (insulin glargine-aglr [Rezvoglar®] and insulin glargine-yfgn [Semglee®]) are used for the treatment of type 1 or type 2 diabetes mellitus in adults and pediatric patients who require long-acting insulin for control of hyperglycemia.1, 56, 57 Insulin glargine 100-unit/mL (Basaglar®) is used for the treatment of type 1 diabetes mellitus in adults and pediatric patients or type 2 diabetes mellitus in adults who require long-acting insulin for control of hyperglycemia.30 The 300-unit/mL preparation of insulin glargine (Toujeo®) is used for the treatment of type 1 or type 2 diabetes mellitus in adults and pediatric patients 6 years of age and older who require long-acting insulin for control of hyperglycemia.31, 70
Insulin glargine in fixed combination with lixisenatide (Soliqua® 100/33) is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.49, 50, 52
Insulin glargine products, alone or in combination with lixisenatide, are not indicated for the treatment of diabetic ketoacidosis.1, 30, 31, 49, 56, 57
Efficacy of insulin glargine administered once daily at bedtime (as Lantus®) in patients with type 1 diabetes mellitus has been demonstrated in comparisons with isophane (NPH) insulin human administered once or twice daily in 3 open-label, randomized studies of up to 28 weeks' duration in adults and one study in pediatric patients 6-15 years of a patients also received regular insulin or insulin lispro before meals during these studies.1, 3, 7, 56, 57 Glycemic control (as determined by glycosylated hemoglobin [hemoglobin A1c, HbA1c]) was similar in patients receiving insulin glargine or isophane insulin human.1, 2, 3, 56, 57
Efficacy of insulin glargine administered once daily at bedtime (as Lantus®) in adults with type 2 diabetes mellitus has been established in 2 open-label, randomized clinical studies comparing insulin glargine with isophane (NPH) insulin human administered once or twice daily; patients continued to receive regular insulin or oral antidiabetic agents during these studies.1, 8, 9 Insulin glargine achieved a level of glycemic control similar to that of isophane insulin human as measured by HbA1c.1, 2, 8, 9
Glycemic control with insulin glargine appears to be similar regardless of which meal it is administered before during the day.1, 12 In a 24-week, open-label, randomized clinical study in adults with type 1 diabetes mellitus, insulin glargine (as Lantus®) was administered prior to breakfast, dinner, or bedtime; patients received supplemental insulin lispro at mealtimes.1, 12 Glycemic control (as determined by HbA1c values at the end of the study, the primary end point) was not significantly different among the 3 treatment groups; only minor reductions in HbA1c occurred.1, 12 Symptomatic and documented nocturnal hypoglycemia occurred in fewer patients receiving insulin glargine before breakfast than in the other 2 groups.12 However, 5% of patients in the before-breakfast group discontinued treatment because of lack of efficacy.1
In another open-label, randomized, 24-week clinical study in patients with type 2 diabetes mellitus poorly controlled on oral antidiabetic agents, insulin glargine (as Lantus®) given prior to breakfast was more effective in reducing HbA1c than insulin glargine or isophane (NPH) insulin human given at bedtime.1, 11 All patients were switched to or continued to receive glimepiride (3 mg daily in the morning) for 4 weeks prior to the addition of insulin therapy, and glimepiride therapy was continued throughout the remainder of the study.1, 11 The incidence of hypoglycemia (primary safety end point) was similar across all treatment groups.11
Safety and efficacy of the “follow-on” 100-unit/mL preparation of insulin glargine (Basaglar®) have been established by studies demonstrating its similarity to Lantus®45 and by the clinical trials that established the safety and efficacy of Lantus®, as well as by 2 clinical trials conducted using Basaglar® in patients with type 1 or type 2 diabetes mellitus.30, 46, 47 In these studies, Basaglar® was deemed sufficiently similar to Lantus® in terms of pharmacokinetics, toxicity, and immunogenicity and provided comparable glycemic control.42, 45, 46, 47
Safety and efficacy of the 300-unit/mL preparation of insulin glargine (Toujeo®) administered once daily in adults with type 1 or type 2 diabetes mellitus have been established in 4 open-label, controlled trials comparing a 100-unit/mL insulin glargine preparation (Lantus®) to Toujeo®.31, 35, 36, 37, 38 In these trials, the 300-unit/mL preparation of insulin glargine provided similar glycemic control as the 100-unit/mL preparation (as assessed by reductions in HbA1c).31, 35, 36, 37, 38 Patients treated with insulin glargine 300-unit/mL required approximately 11-17.5% higher insulin dosages after 6 months of therapy compared with those receiving the 100-unit/mL preparation.31 Additionally, there were no clinically important differences in weight gain between the 2 insulin groups.31
Efficacy of the 300-unit/mL preparation of insulin glargine (Toujeo®) in pediatric patients with type 1 diabetes mellitus was evaluated in a randomized, open-label, multicenter trial comparing a 100-unit/mL insulin glargine preparation (Lantus®) to Toujeo®31, 70 Patients were randomized to basal-bolus treatment with either the 100-unit/mL or 300-unit/mL preparation of insulin glargine administered once daily in either the morning or the evening along with a mealtime insulin analogue before each meal.31, 70 The mean age of enrolled patients was 13 years; 31% were <12 years of age and 69% were ≥12 years of age.31 At week 26, glycemic control (as assessed by reduction in HbA1c from baseline) was similar between the two groups.31, 70
Insulin Glargine in Fixed Combination with Lixisenatide
Current data indicate that treatment with the fixed combination of insulin glargine and lixisenatide (insulin glargine/lixisenatide) is more effective than monotherapy with either drug in improving glycemic control (as determined by reductions in HbA1c) in patients with type 2 diabetes mellitus.49, 51, 52 Additionally, therapy with insulin glargine/lixisenatide was associated with weight loss, while weight gain was observed with insulin glargine monotherapy.51, 52
Safety and efficacy of insulin glargine/lixisenatide have been established in an open-label trial in approximately 740 patients with type 2 diabetes mellitus inadequately controlled on basal insulin (e.g., insulin glargine, NPH insulin, insulin detemir) alone or in conjunction with 1 or 2 oral antidiabetic agents (e.g., metformin, a sulfonylurea, a meglitinide, a sodium-glucose cotransporter 2 [SGLT2] inhibitor, a dipeptidyl peptidase-4 [DPP-4] inhibitor).49, 50 Patients underwent a 6-week run-in period in which all oral antidiabetic drugs (except metformin) were discontinued and therapy with insulin glargine was initiated and titrated prior to randomization.49, 50 Patients then received treatment with insulin glargine/lixisenatide or continued insulin glargine monotherapy.49, 50 The dosages of insulin glargine or insulin glargine/lixisenatide were titrated once weekly based upon fasting plasma glucose concentrations (mean final doses of insulin glargine/lixisenatide or insulin glargine were equivalent at week 30 [46.7 units]).49, 50 At week 30, there was a substantially greater reduction in HbA1c with insulin glargine/lixisenatide than with insulin glargine alone (reduction of 1.1 versus 0.6%, respectively).49, 50 Patients receiving insulin glargine/lixisenatide had an average weight loss of 0.7 kg while those receiving insulin glargine monotherapy gained an average of 0.7 kg.50
In another open-label trial of 30 weeks' duration, approximately 1170 patients with type 2 diabetes mellitus inadequately controlled on metformin with or without another antidiabetic agent (e.g., a sulfonylurea, a meglitinide, an SGLT2 inhibitor, a DPP-4 inhibitor) received therapy with insulin glargine/lixisenatide, insulin glargine, or lixisenatide, all in conjunction with metformin.51, 52 Greater reductions in HbA1c were observed with insulin glargine/lixisenatide than with either component alone (reduction of 1.6, 1.3, or 0.9% with insulin glargine/lixisenatide, insulin glargine, or lixisenatide therapy, respectively).51, 52 Mean body weight was reduced by 0.3 or 2.3 kg in patients receiving insulin glargine/lixisenatide or lixisenatide, respectively.51, 52 Mean body weight was increased by 1.1 kg in patients receiving insulin glargine monotherapy.51, 52
The manufacturer states that insulin glargine/lixisenatide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.49 The safety and efficacy of insulin glargine/lixisenatide in conjunction with short-acting (e.g., prandial) insulin have not been established, and such concomitant use is not recommended.49 Insulin glargine/lixisenatide is not recommended for use with any other drug preparations containing lixisenatide or another glucagon-like peptide-1 (GLP-1) receptor agonist.49
Progression of Retinopathy and Cardiovascular Outcomes
In an open-label study of 5 years' duration comparing therapy with once-daily insulin glargine (as Lantus®) to twice-daily NPH insulin in patients with type 2 diabetes mellitus, the progression of diabetic retinopathy was similar between the 2 treatment groups.1, 32
In a study evaluating the cardiovascular safety of insulin glargine (Outcome Reduction with Initial Glargine Intervention [ORIGIN]), the early use of insulin glargine to achieve normal plasma glucose concentrations in patients with dysglycemia neither reduced nor increased adverse cardiovascular outcomes as compared with guideline-suggested glycemic control.33 In this study, approximately 12,500 adults with cardiovascular risk factors in addition to impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes mellitus received treatment with insulin glargine (as Lantus®, median dosage: 0.45 units/kg daily) or standard care (antidiabetic drugs other than insulin glargine in patients with a diagnosis of type 2 diabetes mellitus) for a median duration of 6 years.1, 33 Patients who received standard care were not able to receive insulin therapy until maximal dosages of 2 different oral antidiabetic drugs had been used.33 There were 2 coprimary composite end points in this study: the composite of death from cardiovascular causes, nonfatal myocardial infarction (MI), and nonfatal stroke, and a composite of any of the previously mentioned cardiovascular adverse events, a revascularization procedure, or hospitalization due to heart failure.1, 33 At a median follow-up of 6.2 years, there was no substantial difference between the 2 treatment groups in terms of major adverse cardiovascular outcomes or all-cause mortality.1, 33 Additionally, the incidence of cancer or death from cancer was similar between treatment groups.1, 33 Therapy with insulin glargine reduced the incidence of diabetes mellitus; however, the long-term clinical benefits of this reduction is unknown.33
The American Diabetes Association (ADA) publishes an annual guideline, which provides clinical practice recommendations for glucose-lowering therapies in patients with diabetes mellitus.71 The current 2025 ADA guideline states that in adults with type 2 diabetes mellitus, pharmacologic strategies that provide sufficient effectiveness to achieve and maintain the intended treatment goals should be used and guided by a person-centered shared decision-making approach.71 In general, higher-efficacy approaches have a greater likelihood of achieving glycemic control.71 Weight management should be included as a distinct treatment goal, and other healthy lifestyle behaviors should also be considered.71 When selecting an appropriate treatment regimen, clinicians should be guided by factors such as cardiovascular and renal comorbidities, drug efficacy and adverse effects, hypoglycemic risk, presence of overweight or obesity, cost, access, and patient preferences.71 For the treatment of type 2 diabetes mellitus, insulin should be considered in patients with symptoms of hyperglycemia or when the HbA1c or blood glucose is very high (i.e., HbA1c>10% or blood glucose ≥300 mg/dL).71 Insulin therapy, typically starting with basal insulin, may also be considered in patients on other antidiabetic agents who require additional glycemic control.71 When insulin is used for the treatment of type 2 diabetes mellitus, combination therapy with a glucagon-like peptide-1 (GLP-1) receptor agonist should be considered for greater glycemic control and for the beneficial effect on weight and hypoglycemia risk.71 For the treatment of type 1 diabetes mellitus, treatment with insulin is essential and should be tailored to the individual patient to meet glycemic goals, prevent diabetic ketoacidosis, and minimize the risk of hypoglycemia.71 Typical insulin treatment plans for patients with type 1 diabetes mellitus include a combination of basal, mealtime, and correction insulin.71 In all patients with diabetes mellitus treated with insulin, routine assessment of administration technique is essential to ensure optimized safety and efficacy.71
The American Association of Clinical Endocrinology (AACE) also publishes guidelines for the management of diabetes mellitus.72, 73 The principles of diabetes management outlined in the guidelines are similar to those recommended by the ADA.72, 73 For patients with type 2 diabetes mellitus, insulin may be used to achieve glycemic control after failure of other antidiabetic agents or in those patients with catabolic symptoms (e.g., weight loss) or high HbA1c or blood glucose values (i.e., HbA1c>10% or blood glucose ≥300 mg/dL).72 Insulin therapy (starting with basal insulin alone or in combination with a GLP-1 receptor agonist) may also be considered in patients on other antidiabetic agents (including a GLP-1 receptor agonist) who require additional glycemic control.72 Insulin is recommended for the treatment of all patients with type 1 diabetes mellitus.73
Dispensing and Administration Precautions
Insulin glargine products are administered by subcutaneous injection once daily into the abdomen, thigh, or upper arm at the same time each day using a conventional insulin syringe or the appropriate injection pen (e.g., SoloStar®, KwikPen®).1, 10, 30, 31, 56, 57
The fixed combination preparation of insulin glargine and lixisenatide (insulin glargine/lixisenatide) is administered by subcutaneous injection once daily using a prefilled injection pen.49 Insulin glargine/lixisenatide should be administered within 1 hour before the first meal of the day.49 If a dose of insulin glargine/lixisenatide is missed, the patient should resume the once-daily regimen with the next scheduled dose.49
Insulin glargine products or insulin glargine/lixisenatide should not be administered IV, IM, or via an infusion pump.1, 30, 31, 49, 56, 57 A planned rotation of sites within an area should be followed to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.1, 30, 31, 56, 57, 71 Clinical studies have not indicated important differences in absorption of insulin glargine products from the various injection areas (e.g., abdomen, thigh, upper arm).1, 56, 57 It is not necessary to shake the vials of insulin glargine products prior to measuring the dosage.1, 56 Insulin glargine products or insulin glargine/lixisenatide should not be mixed with other insulins, other drugs, or diluted with other solutions.1, 30, 31, 49, 56, 57
Insulin glargine products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.1, 30, 31, 56, 57 The drug should be administered only if the solution is clear, colorless, and without particulates.1, 30, 31, 49, 56, 57
Unopened injection pens and vials containing insulin glargine products 100 units/mL should be stored at 2-8°C and protected from direct heat and light until the expiration date; the drug should not be frozen.1, 30, 56, 57 Alternatively, unopened injection pens and vials containing insulin glargine products 100 units/mL may be stored at room temperature (below 30°C) and away from direct heat and light for up to 28 days.1, 30, 56, 57 Opened (in-use) vials containing insulin glargine products 100 units/mL should be stored at 2-8°C for up to 28 days.1, 56 Alternatively, such in-use vials may be stored at room temperature away from direct heat and light for up to 28 days.1, 56 In-use injection pens of insulin glargine products 100 units/mL (e.g., Kwikpen®, SoloStar®) should be stored at room temperature away from heat and direct light for up to 28 days; in-use injection pens should not be refrigerated.1, 30, 56, 57
Unopened injection pens of insulin glargine 300 units/mL (Toujeo®) should be stored at 2-8°C and protected from direct heat and light until the expiration date; the drug should not be frozen.31 In-use injection pens of insulin glargine 300 units/mL should be stored at room temperature away from heat and direct light for up to 56 days; such in-use injection pens should not be refrigerated.31
Injection pens containing insulin glargine/lixisenatide should be stored at 2-8°C in the original carton and protected from light before first use; after first use, the injection pens should be stored at room temperature below 25°C.49 The injection pens should not be frozen; they should not be used if freezing has occurred.49 Injection pens of insulin glargine/lixisenatide should be discarded 28 days after first use, even if some drug remains in the pen.49
The accompanying labeling should be consulted for additional details about the administration of insulin glargine products or insulin glargine/lixisenatide.1, 30, 31, 49, 56, 57
The dosage of insulin glargine products is expressed in units.1, 30, 31, 56, 57 Each unit of insulin glargine is approximately equal to 0.036 mg of the drug.1
The dosage of the fixed combination of insulin glargine and lixisenatide (insulin glargine/lixisenatide) has been expressed in terms of the insulin glargine component; however, each mL of insulin glargine/lixisenatide contains 100 units of insulin glargine and 33 mcg of lixisenatide.49
Individualize dosage based on the patient's metabolic needs, blood glucose determinations, and glycemic control goals to obtain optimum therapeutic effect.1, 30, 31, 56, 57
The dosage and timing of concurrent short- or rapid-acting insulins or other concomitant antidiabetic agents may need to be adjusted in patients receiving insulin glargine products.1, 30, 31, 56, 57 Insulin requirements may be altered with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), or during illness, emotional disturbances, or other stresses.1, 30, 31, 56, 57
Insulin Glargine (100 units/mL; Basaglar®)
Type 1 diabetes mellitus in pediatric patients ≥6 years of age and adults: The recommended initial dosage of insulin glargine (Basaglar®) is approximately one-third of the total daily insulin dosage administered once daily; remainder of total daily dosage should be given as a short- or rapid-acting insulin and divided between each daily meal. 30
Type 2 diabetes mellitus in adults: The recommended initial dosage of insulin glargine (Basaglar®) 0.2 units/kg or up to 10 units once daily.30
Insulin Glargine Products (100 units/mL; Lantus® , Semglee®, or Rezvoglar® )
Type 1 diabetes mellitus in pediatric patients ≥6 years of age and adults: The recommended initial dosage of Lantus®, Semglee®, and Rezvoglar® is approximately one-third of the total daily insulin dosage administered once daily; the remainder of total daily dosage should be given as a short- or rapid-acting insulin and divided between each daily meal.1, 56, 57
Type 2 diabetes mellitus in pediatric patients ≥6 years of age and adults who are not currently treated with insulin: 0.2 units/kg or up to 10 units once daily.1, 56, 57
Insulin Glargine (300 units/mL; Toujeo®)
Type 1 diabetes mellitus in insulin-naïve pediatric patients ≥6 years of age and adults: The recommended initial dosage of Toujeo® is approximately one-third to one-half of the total daily insulin dosage administered once daily; the remainder of total daily dosage should be given as a short- or rapid-acting insulin and divided between each daily meal.31 In general, 0.2—0.4 units/kg as an initial total daily dosage may be used.31
Type 2 diabetes mellitus in insulin-naïve pediatric patients ≥6 years of age and adults: The recommended initial dosage is 0.2 units/kg once daily.31
Increase dosage no more frequently than every 3-4 days to minimize the risk of hypoglycemia.31
Maximum glucose-lowering effect of a dose of insulin glargine 300 units/mL may take 5 days to fully manifest; first dose may not be able to fulfill the metabolic needs of the patient in first 24 hours of use.31 Monitor blood glucose concentrations and adjust coadministered antidiabetic drug therapy per standard of care.31
Transferring from Therapy with Other Insulins
When insulin glargine products are substituted for another intermediate- or long-acting insulin in patients with diabetes mellitus, a change in the dosage of the basal insulin may be required.1, 30, 56, 57
In patients transferring from another 100-unit/mL preparation of insulin glargine (e.g., Lantus®) to Basaglar®, the dosage of Basaglar® should be the same as the other preparation, and the administration time should be determined by the clinician.30
In patients currently receiving once-daily isophane (NPH) insulin, the 100-unit/mL preparation of insulin glargine products administered once daily may be substituted on a unit-for-unit basis for NPH insulin.1, 56, 57 In patients currently receiving twice-daily NPH insulin, the recommended initial dosage of the 100-unit/mL preparation of insulin glargine products once daily is 80% of the total daily NPH insulin dosage that is being discontinued.1, 30, 56, 57
For patients transferring from the 300-unit/mL preparation of insulin glargine to the 100-unit/mL preparation of insulin glargine products, the recommended initial dosage of the 100-unit/mL insulin glargine preparation is 80% of the insulin glargine 300-unit/mL preparation dosage.1, 30, 56, 57
On a unit-for-unit basis, the 300-unit/mL preparation of insulin glargine has less of a glucose-lowering effect than the 100-unit/mL preparation.31 In patients currently receiving once-daily insulin glargine (100 units/mL) or an intermediate-acting insulin preparation, the recommended initial dosage of the 300-unit/mL preparation of insulin glargine is the same as the current long-acting insulin dosage.31 For patients controlled on the 100-unit/mL preparation of insulin glargine, a higher daily dose of the 300-unit/mL preparation of insulin glargine will be needed to maintain the current level of glycemic control.31 Patients transferring from other basal insulins to the 300-unit/mL preparation of insulin glargine may experience higher average fasting plasma glucose concentrations during the first weeks of therapy.31 In patients currently receiving twice-daily NPH insulin, the recommended initial dosage of the 300-unit/mL preparation of insulin glargine once daily is 80% of the total daily NPH insulin dosage that is being discontinued.31 Close monitoring of blood glucose concentrations is recommended during the transition to insulin glargine and in the initial weeks thereafter.31
For patients with type 1 diabetes mellitus transitioning from IV insulin to the 300-unit/mL preparation of insulin glargine, the longer onset of action of the 300-unit/mL preparation of insulin glargine (onset of action develops over 6 hours) should be considered before stopping IV insulin.31 The full glucose-lowering effect of the 300-unit/mL preparation of insulin glargine may not be apparent for at least 5 days.31
Insulin Glargine/Lixisenatide Fixed-combination Therapy
Therapy with a glucagon-like peptide-1 (GLP-1) receptor agonist or basal insulin should be discontinued prior to initiating therapy with insulin glargine/lixisenatide.49
The recommended initial dosage of insulin glargine/lixisenatide for adults with type 2 diabetes mellitus naïve to basal insulin or a GLP-1 receptor agonist, currently on a GLP-1 receptor agonist, or inadequately controlled on less than 30 units of basal insulin is 15 units (15 units insulin glargine/5 mcg lixisenatide) subcutaneously once daily.49 For adults inadequately controlled on 30-60 units of basal insulin with or without a GLP-1 receptor agonist, the recommended initial dosage of insulin glargine/lixisenatide is 30 units (30 units insulin glargine/10 mcg lixisenatide) subcutaneously once daily.49 The dosage should be titrated by 2-4 units every week based on the patient's metabolic needs, blood glucose concentrations, and glycemic control goal.49 The recommended daily dosage of insulin glargine/lixisenatide is 15-60 units (15-60 units insulin glargine/5-20 mcg lixisenatide) once daily.49 Alternative antidiabetic therapy should be used if the patient requires a daily dosage of insulin glargine/lixisenatide of less than 15 units (15 units insulin glargine/5 mcg lixisenatide) or exceeding 60 units (60 units insulin glargine/20 mcg lixisenatide) daily.49
Data regarding the effects of hepatic impairment on the pharmacokinetics of insulin glargine products in patients with diabetes mellitus are lacking.1, 30, 31, 49, 56, 57 Careful monitoring of blood glucose and adjustment of insulin glargine or insulin glargine/lixisenatide dosage may be necessary in such patients.1, 30, 31, 49, 56, 57
Data regarding the effects of renal impairment on the pharmacokinetics of insulin glargine products in patients with diabetes mellitus are lacking.1, 30, 31 However, increased circulating concentrations of insulin have been observed in patients with renal impairment who were receiving insulin human; therefore, insulin glargine requirements may be reduced in these patients.1, 30, 31 Careful monitoring of blood glucose and adjustment of insulin glargine or insulin glargine/lixisenatide dosage may be necessary in such patients.1, 30, 31, 49
Safety and efficacy of insulin glargine/lixisenatide have not been established in patients with end-stage renal disease (estimated glomerular filtration rate [eGFR] less than 15 mL/minute per 1.73 m2); the fixed combination is not recommended for use in such patients.49
In geriatric patients, the initial dosage, dose increments, and maintenance dosage of insulin glargine or insulin glargine/lixisenatide should be conservative in order to avoid hypoglycemia.1, 30, 31, 49
Sharing of Injection Pens, Syringes, or Needles
Injection pens containing insulin glargine products or insulin glargine/lixisenatide must never be shared among patients, even if the needle has been changed.1, 30, 31, 49, 56, 57 Syringes or needles used with insulin glargine product vials should never be reused or shared with another person.1, 56 Sharing poses a risk for transmission of blood-borne pathogens.1, 30, 31, 49, 56, 57
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia.1, 30, 31, 49, 56, 57
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia.1, 30, 31, 49, 56, 57 Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and monitor for hypoglycemia.1, 30, 31, 49, 56, 57
Changes to a patient's insulin regimen should be performed under close medical supervision with increased frequency of blood glucose monitoring.1, 30, 31, 49, 56, 57 Dosage adjustments of concomitant oral antidiabetic agents may be needed in patients with type 2 diabetes mellitus.1, 30, 31, 49, 56, 57
On a unit-for-unit basis, the 300-unit/mL preparation of insulin glargine has less of a glucose lowering effect than the 100-unit/mL preparation.31 To minimize the risk of hyperglycemia when initiating insulin glargine 300 unit/mL, blood glucose concentrations should be monitored daily, the dosage of the 300-unit/mL insulin glargine preparation should be titrated appropriately, and dosage of coadministered antidiabetic drugs should be adjusted per the standard of care.31
Hypoglycemia is the most common adverse effect of insulins, including insulin glargine products, and monitoring of blood glucose concentrations is recommended for all patients with diabetes mellitus.1, 2, 5, 30, 31, 71, 72, 73 Hypoglycemia can impair the ability to concentrate and reaction time, which may place the patient and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).1, 30, 31, 49, 56, 57 Severe hypoglycemia may cause seizures, may be life-threatening or cause death.1, 30, 31, 49, 56, 57 The prolonged effect of subcutaneous insulin glargine products may delay recovery from hypoglycemia.1, 30 As with all insulin preparations, the time course of the glucose-lowering effect of insulin glargine or insulin glargine/lixisenatide may vary among different individuals or at different times in the same individual and depends on many factors (e.g., area of injection, injection site blood supply, temperature).1, 31, 49 Symptomatic awareness may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, in patients taking concurrent drugs that block the sympathetic nervous system (e.g., beta-adrenergic blocking agents), or in patients who experience recurrent hypoglycemia.1, 30, 31, 49, 56, 57
The risk of hypoglycemia generally increases with the intensity of glycemic control.30 Other factors that may increase a patient's risk of hypoglycemia include changes in meal patterns (e.g., macronutrient content, timing of meals), level of physical activity, and concomitant drug therapy.1, 30, 31 Patients with renal or hepatic impairment may be at a higher risk of hypoglycemia.1, 30, 31 In comparative studies, the overall rate of hypoglycemic reactions with insulin glargine was similar to that with isophane insulin human.1, 2, 3
Educate patients and caregivers to recognize and manage hypoglycemia.1, 30, 31, 49, 56, 57 Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia.1, 30, 31, 49, 56, 57 In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness, increased frequency of blood glucose monitoring is recommended.1, 30, 31, 49, 56, 57
Hypoglycemia Due to Medication Errors
Confusion between basal insulin preparations and other insulins, particularly rapid-acting insulins, has caused medication errors.1, 30, 31, 56, 57 To avoid such errors, patients should be advised to check the label on all insulin preparations to confirm the correct preparation and strength prior to administration.1, 30, 31, 56, 57
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including insulin glargine products.1, 30, 31, 56, 57 If hypersensitivity reactions occur, discontinue the drug; treat per standard of care and monitor until signs and symptoms resolve.1, 30, 31, 56, 57 Insulin glargine products are contraindicated in patients who have had hypersensitivity to insulin glargine or excipients.1, 30, 31, 56, 57
All insulin preparations, including insulin glargine products, cause a shift in potassium from the extracellular to the intracellular space, possibly leading to hypokalemia.1, 30, 31, 49, 56, 57 Untreated hypokalemia can lead to respiratory paralysis, ventricular arrhythmias, and death.1, 30, 31, 49, 56, 57 Serum potassium concentrations should be monitored in patients at risk for hypokalemia (e.g., patients receiving potassium-lowering drugs, patients taking drugs with effects sensitive to serum potassium concentrations).1, 30, 31, 49, 56, 57
Fluid Retention and Heart Failure
Peroxisome proliferator-activated receptor (PPAR)-γ agonists (e.g., thiazolidinediones) can cause dose-related fluid retention, particularly when used in conjunction with insulin.1, 30, 31, 49, 56, 57 Fluid retention may lead to or exacerbate heart failure.1, 30, 31, 49, 56, 57 Patients treated with insulin, including insulin glargine products, and a PPAR-γ agonist should be observed for manifestations of heart failure (e.g., excessive/rapid weight gain, shortness of breath, edema).1, 30, 31, 49, 56, 57 If heart failure develops, it should be managed according to current standards of care, and discontinuance or reduction of the dosage of the PPAR-γ agonist must be considered.1, 30, 31, 49, 56, 57
As with all therapeutic proteins, there is a potential for immunogenicity with insulin glargine products or insulin glargine/lixisenatide.1, 30, 31, 49, 56, 57 Insulin antibodies may increase or decrease the efficacy of insulin, and insulin dosage adjustments may be required.1, 56, 57 During phase 3 clinical trials of insulin glargine (as Lantus®), the incidence of insulin antibody development with insulin glargine therapy was similar to the incidence observed with isophane (NPH) insulin.1 Insulin antibodies have also been detected in patients receiving other insulin glargine preparations (Basaglar® or Toujeo®).30, 31
FDA has notified healthcare professionals and patients about the results of several observational studies suggesting an increased risk of cancer in patients with diabetes receiving insulin glargine;14, 15, 16, 17, 18, 20, 21 however, upon further analysis, FDA states that the results of these studies are inconclusive due to limitations in how the studies were designed and carried out and in the data available for analysis.24 At this time, FDA states that it has not concluded that insulin glargine increases the risk of cancer.24
In a health insurance database cohort of over 127,000 diabetic patients in Germany, a positive, dose-related association was found between diagnosis of a malignant neoplasm and use of insulin human or an insulin analog (insulin glargine, insulin aspart, insulin lispro) over a mean follow-up period of 1.63 years.15, 20 After adjusting for insulin dosage, patients who had received insulin glargine dosages of 10, 30, or 50 units daily had a 9, 19, or 31% increase, respectively, in cancer risk compared with that for insulin human; no such increased risk was found for insulin aspart or insulin lispro.15, 20 The results of this study prompted similar reviews of patient databases in Sweden and Scotland, both of which also suggested a positive association between cancer (e.g., of the breast) and use of insulin glargine.16, 17, 20 Review of a third database of patients in the United Kingdom18 and post hoc analysis of data from a controlled trial in patients with type 2 diabetes mellitus receiving insulin glargine or isophane (NPH) insulin human for a mean cumulative period exceeding 4 years did not reveal such an association.19 Potentially confounding factors (e.g., patient age, blood pressure, weight, concomitant antidiabetic therapy) and other limitations of retrospective analyses prevent firm conclusions based on these data.15, 22 However, in vitro studies indicating that insulin promotes the growth of cancer cells and that insulin glargine is more mitogenic than insulin human support the concerns raised by these observations15, 20, 21, 23 and additional epidemiologic analyses worldwide have been called for to further examine any association between insulin analogs such as insulin glargine and cancer.20, 22, 23 In a study evaluating the cardiovascular safety of insulin glargine (Outcomes Reduction with Initial Glargine Intervention [ORIGIN]), the overall incidence of cancer or death from cancer was similar among patients who received insulin glargine and those who received other antidiabetic drugs (e.g., oral antidiabetic agents, insulin other than insulin glargine).1, 33
Based on currently available data, FDA recommends that patients not stop taking their insulin therapy without consulting a clinician, since uncontrolled hyperglycemia can have both immediate and long-term serious adverse effects.14, 24 Some clinicians suggest that use of a long-acting human insulin (e.g., isophane [NPH] insulin human) or a combination of a long- and short-acting insulin twice daily may be considered as an alternative to insulin glargine therapy.22, 23 FDA is continuing to evaluate the long-term risk, if any, for cancer associated with the use of insulin glargine.24 FDA encourages both healthcare professionals and patients to report adverse effects with the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program14, 24 ([Web]).
When insulin glargine is used in fixed combination with lixisenatide or other drugs, the cautions, precautions, contraindications, and interactions associated with the concomitant agent(s) should be considered in addition to those associated with insulin glargine.1, 49
Published studies with use of insulin glargine products during pregnancy have not reported a clear association with adverse developmental outcomes including major birth defects, miscarriage, or adverse maternal or fetal outcomes.1, 30, 31, 56, 57 However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups.1, 31, 30, 56, 57 In animal reproduction studies, rats and rabbits were exposed to insulin glargine during organogenesis at 50 and 10 times the human subcutaneous dosage of 0.2 units/kg per day, respectively.1, 31, 56, 57 Overall, the effects of insulin glargine products did not generally differ from those observed with regular human insulin.1, 31, 56, 57 However, dilation of the cerebral ventricles was observed in some rabbit fetuses.1, 30, 31, 56, 57
There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy, including increased maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications, and increased fetal risk of major birth defects, stillbirth, and macrosomia-related morbidity.1, 30, 31, 56, 57
There may be risks to the fetus from exposure to lixisenatide during pregnancy based on animal reproduction studies.49 Insulin glargine/lixisenatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.49
There are either no or limited data on the presence of insulin glargine products in human milk, the effects on the breast-fed infant, or the effects on milk production.1, 30, 31, 49, 56, 57 Endogenous insulin is present in human milk.1, 30, 31, 49, 56, 57 The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin glargine products, and any potential adverse effects on the breast-fed child from insulin glargine products or from the underlying maternal condition.1, 30, 31, 49, 56, 57
Safety and efficacy of the 100-unit/mL preparations of insulin glargine products (Lantus®, Semglee®, Rezvoglar® ) have been established in pediatric patients.1, 56, 57 Use for this indication is supported by evidence from an adequate and well-controlled study in 174 pediatric patients 6—15 years of age with type 1 diabetes mellitus, and from adequate and well-controlled studies in adults with diabetes mellitus.1, 56, 57 In the pediatric clinical study, pediatric patients with type 1 diabetes mellitus had a higher incidence of severe symptomatic hypoglycemia compared to adults in studies with type 1 diabetes mellitus.1, 56, 57
Safety and efficacy of the 100-unit/mL preparation of insulin glargine (Basaglar®) have been established in pediatric patients 6—15 years of age with type 1 diabetes mellitus based on an adequate and well-controlled trial of another insulin glargine product in pediatric patients 6—15 years of age with type 1 diabetes mellitus and additional data in adult patients with type 1 diabetes mellitus.30 In the pediatric clinical trials, pediatric patients (aged 6—15 years) with type 1 diabetes mellitus had a higher incidence of severe symptomatic hypoglycemia compared to adults in trials with type 1 diabetes mellitus.30 Safety and efficacy have not been established in children younger than 6 years of age with type 1 diabetes mellitus or in pediatric patients with type 2 diabetes mellitus.30
Safety and efficacy of the 300-unit/mL preparation of insulin glargine (Toujeo®) have been established in pediatric patients 6 years of age and older with diabetes mellitus.31, 70 Use for this indication is supported by evidence from an adequate and well-controlled study in 463 pediatric patients 6—17 years of age with type 1 diabetes mellitus and from studies in adults with diabetes mellitus.31 Safety and efficacy of the 300-unit/mL preparation of insulin glargine (Toujeo®) have not been established in children younger than 6 years of age.31
Safety and efficacy of insulin glargine/lixisenatide have not been established in pediatric patients.49
Of the total number of subjects enrolled in clinical studies of patients with type 1 and type 2 diabetes mellitus who were treated with the 100-unit/mL preparation of insulin glargine (Lantus®), 316 patients (15%) were ≥65 years of age and 42 patients (2%) were ≥75 years of age.1, 56, 57 Of the total number of subjects enrolled in clinical studies of patients with type 2 diabetes who were treated with the 100-unit/mL preparation of insulin glargine (Basaglar®) or another insulin glargine product, each in combination with oral agents in a controlled clinical trial environment, 28.3% of patients were ≥65 years of age and 4.5% were ≥75 years of age.30 In controlled clinical studies with the 300-unit/mL preparation of insulin glargine (Toujeo®), 30 patients (9.8%) with type 1 diabetes mellitus and 327 patients (26.3%) with type 2 diabetes mellitus were ≥65 years of a among them, 2% with type 1 diabetes mellitus and 3% with type 2 diabetes mellitus were ≥75 years of age.31 In controlled clinical studies with insulin glargine/lixisenatide, 210 patients (25.2%) were ≥65 years of age and 33 patients (4%) were ≥75 years of age.49 No overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger adult patients;1, 30, 31, 49, 56, 57 greater sensitivity of some older individuals cannot be ruled out.30
Initial dosage, dose increments, and maintenance dosage of insulin glargine or insulin glargine/lixisenatide should be conservative to avoid hypoglycemia.1, 30, 31, 49, 56, 57
The effect of hepatic impairment on the pharmacokinetics of insulin glargine products has not been studied.1, 30, 31, 49, 56, 57 Frequent glucose monitoring and dosage adjustment may be necessary in patients with hepatic impairment.1, 30, 31, 49, 56, 57
The effect of renal impairment on the pharmacokinetics of insulin glargine products has not been studied.1, 30, 31, 56, 57 Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure.1, 30, 31, 56, 57 Frequent glucose monitoring and dosage adjustment may be necessary for insulin glargine in patients with renal impairment.1, 30, 31, 56, 57
Frequent glucose monitoring and dosage adjustment may be necessary for insulin glargine/lixisenatide in patients with renal impairment.49 In patients with mild and moderate renal impairment, no dosage adjustment of insulin glargine/lixisenatide is required but close monitoring for lixisenatide related adverse effects and for changes in renal function is recommended because of a higher incidence of hypoglycemia, nausea, and vomiting that were observed in these patients.49 Increased GI adverse effects may lead to dehydration and acute renal failure and worsening of chronic renal failure in these patients.49 Clinical experience with insulin glargine/lixisenatide in patients with severe renal impairment is limited; lixisenatide exposure is higher in these patients.49 Patients with severe renal impairment should be closely monitored for occurrence of GI adverse effects and for changes in renal function.49 There is no therapeutic experience with insulin glargine/lixisenatide in patients with end-stage renal disease (estimated glomerular filtration rate <15 mL/minute per 1.73 m2); use is not recommended in this population.49
Common adverse effects associated with insulin glargine products during clinical trials include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.1, 30, 31, 56, 57
Adverse effects occurring in at least 5% patients receiving insulin glargine/lixisenatide in clinical trials include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.49
Drugs Affecting Glycemic Control
Drugs That May Potentiate Hypoglycemic Effects
Drug interactions are possible with drugs that may potentiate hypoglycemic effects of insulin glargine products (e.g., angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, antidiabetic agents, disopyramide, fibrate derivatives, fluoxetine, monoamine oxidase [MAO] inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin derivatives [e.g., octreotide], sulfonamide anti-infectives).1, 30, 31, 56, 57 Dosage reductions and increased frequency of glucose monitoring may be required if insulin glargine is used concomitantly with these drugs.1, 30, 31, 56, 57
Drugs That May Antagonize Hypoglycemic Effects
Drug interactions are possible with drugs that may antagonize hypoglycemic effects such as atypical antipsychotics (e.g., olanzapine, clozapine), corticosteroids, danazol, diuretics, estrogens and progestins (e.g., oral contraceptives), glucagon, isoniazid, niacin, phenothiazines, protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.1, 30, 31, 56, 57 Dosage increases and increased frequency of glucose monitoring may be required if an insulin glargine product is used concomitantly with these drugs.1, 30, 31, 56, 57
Drugs That May Have a Variable Effect on Glycemic Control
Drug interactions are possible with drugs that may have a variable effect on glycemic control (e.g., alcohol, β-adrenergic blocking agents, clonidine, lithium salts, pentamidine).1, 30, 31, 56, 57 Dosage adjustments and increased frequency of glucose monitoring may be required if an insulin glargine product is used concomitantly with these drugs.1, 30, 31, 56, 57
Sympatholytic agents (e.g., β-adrenergic blocking agents, clonidine, guanethidine, reserpine) may decrease or eliminate the signs of hypoglycemia.1, 30, 31, 56, 57 Increased frequency of glucose monitoring may be required when an insulin glargine product is used concomitantly with these drugs.1, 30, 31, 56, 57
Insulin glargine is a biosynthetic (rDNA origin), long-acting human insulin analog that is prepared using recombinant DNA technology and a special laboratory strain of nonpathogenic Escherichia coli (K12).1, 2, 3, 30, 31, 56, 57 Insulin glargine differs structurally from insulin human by the replacement of asparagine at position A21 with glycine and the addition of 2 arginines to the C-terminus of the B-chain.1, 2, 3, 30, 31, 56, 57 Insulin glargine has pharmacologic effects comparable to those of insulin human.1, 2, 56, 57 In clinical studies, the glucose-lowering effect of the 100-unit/mL preparation of insulin glargine was approximately the same as insulin human on a molar basis.1, 56, 57
Insulin glargine products are commercially available as an acidic solution with a pH of approximately 4.1, 2, 30, 31, 56, 57 Neutralization of the acidic insulin glargine solution following injection into subcutaneous tissue results in the formation of microprecipitates of the drug from which small amounts of insulin glargine are slowly released.1, 2, 3, 31 This results in a relatively constant concentration-time profile over 24-36 hours (dependent upon insulin concentration) with no pronounced peak.1, 2, 3, 30, 31, 40, 55, 56, 57 Compared with the 100-unit/mL preparation of insulin glargine, the pharmacokinetic and pharmacodynamic profiles of the 300-unit/mL preparation of insulin glargine demonstrate a less variable response and a longer duration of action (36 versus 24 hours).1, 40 The absorption of the 300-unit/mL preparation of insulin glargine is more prolonged than that of the 100-unit/mL preparation.40 Following subcutaneous injection of the 100- or 300-unit/mL preparation of insulin glargine, duration of hypoglycemic action is approximately 24 or 36 hours, respectively.1, 30, 40 Duration of action is similar following subcutaneous injection at abdominal, deltoid, or thigh sites.1, 30, 56, 57 Substantial interindividual and intraindividual variation in duration may occur based on tissue blood supply, temperature, exercise, and/or interindividual and intraindividual differences in response.1, 5, 56, 57
In the subcutaneous tissue depot, insulin glargine products are partially metabolized to form 2 metabolites with activity similar to that of insulin.1, 30, 31, 56, 57 There are no differences in metabolism of insulin glargine products when administered as the 100- or 300-unit/mL preparation.40 Effect of age, race, body mass index (BMI), and gender on the pharmacokinetics of insulin glargine products has not been evaluated;1, 30, 31, 56, 57 however, in controlled clinical studies in adult and pediatric patients, subgroup analyses based on age, race, and BMI did not show differences in safety and efficacy between insulin glargine products and isophane (NPH) insulin.1, 56, 57
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use only | 100 units/mL (U-100) | Basaglar® (in prefilled KwikPen® and Tempo® pens) | Eli Lilly and Company |
Lantus® (in vials and prefilled SoloStar® pens) | ||||
300 units/mL (U-300) | Toujeo® (in prefilled SoloStar® and Max SoloStar® pens) | Sanofi-Aventis |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use only | 100 units/mL (U-100) | Semglee® (in vials and prefilled pens) | Biocon Biologics |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use only | 100 units/mL (U-100) | Rezvoglar® (in prefilled KwikPen® pens) | Eli Lilly and Company |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use | 100 units/mL with Lixisenatide 33 mcg/mL | Soliqua® 100/33 (available as prefilled injection pens) | Sanofi-Aventis |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions October 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
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