Brand names: Basaglar, Lantus, Soliqua 100/33 (combination), Toujeo
Drug class: Long-acting Insulins
ATC class: A10AB01
VA class: HS501
Chemical name: 21A-Glycine-30Ba-l-arginine-30Bb-l-arginine insulin (human)
Molecular formula: C₂₆₇H₄₀₄N₇₂O₇₈S₆
CAS number: 160337-95-1

Medically reviewed by Drugs.com on Jul 22, 2024. Written by ASHP.

Introduction

Long-acting, biosynthetic (rDNA origin) human insulin analog.

Uses for Insulin Glargine

Diabetes Mellitus

Insulin glargine (100 units/mL; Basaglar or Lantus): Treatment of type 1 diabetes mellitus in adults and children ≥6 years of age or type 2 diabetes mellitus in adults who require long-acting insulin for control of hyperglycemia.

Insulin glargine (300 units/mL; Toujeo): Treatment of type 1 or type 2 diabetes mellitus in adults who require long-acting insulin for control of hyperglycemia.

Insulin glargine not the insulin of choice for treatment of diabetic ketoacidosis; short-acting IV insulins are preferred.

Used in fixed combination with lixisenatide (Soliqua 100/33) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on <60 units daily of basal insulin or on lixisenatide.

Insulin Glargine Dosage and Administration

Administration

Administer insulin glargine or the fixed combination of insulin glargine and lixisenatide (insulin glargine/lixisenatide) by sub-Q injection into abdomen, thigh, or upper arm. Should not be given IV, IM, or via an infusion pump.

Sub-Q Administration

For solution and drug compatibility information, see Compatibility under Stability.

Insulin glargine: Administer once daily at the same time each day using a conventional insulin syringe or appropriate injection pen (e.g., SoloStar, KwikPen). Rotate sites within an injection area so that no site is injected more than once every 1–2 weeks.

Insulin glargine/lixisenatide: Administer within 1 hour before the first meal of the day. If a dose is missed, resume the once-daily regimen with the next scheduled dose.

Administer insulin glargine or insulin glargine/lixisenatide only if solution is clear and colorless with no particles visible.

Dosage

Dosage of insulin glargine is expressed in units.

Dosage of 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.

Individualize dosage based on the patient's metabolic needs, blood glucose determinations, and glycemic control goals to obtain optimum therapeutic effect. Glucose monitoring is recommended for all patients with diabetes mellitus.

Pediatric Patients

Diabetes Mellitus

Insulin Glargine (100 units/mL; Basaglar or Lantus)

Sub-Q

Individualize dosage.

Children ≥6 years of age, type 1 (insulin-naive): Initially, one-third of the total daily insulin dosage; remainder of total daily dosage should be given as a short- or rapid-acting insulin and divided between each daily meal. Recommendations for changing from another insulin to insulin glargine (100 units/mL) are the same as for adults. (See Transferring from Other Insulins to Insulin Glargine under Dosage and Administration.)

Adults

Diabetes Mellitus

Insulin Glargine (100 units/mL; Basaglar or Lantus)

Sub-Q

Individualize dosage.

Type 1 (insulin-naive): Initially, one-third of the total daily insulin dosage; remainder of total daily dosage should be given as a short- or rapid-acting insulin and divided between each daily meal.

Type 2 (insulin-naive): Initial dosage 0.2 units/kg up to 10 units once daily.

Insulin Glargine (300 units/mL; Toujeo)

Sub-Q

Individualize dosage.

Type 1 (insulin naive): One-third to one-half the total daily insulin dosage; remainder of total daily dosage should be given as a short- or rapid-acting insulin and divided between each daily meal.

Type 2 (insulin naive): Initial dosage 0.2 units/kg once daily.

Increase dosage no more frequently than every 3–4 days to minimize the risk of hypoglycemia.

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. Monitor blood glucose concentrations and adjust coadministered antidiabetic drug therapy per standard of care.

Transferring from Other Insulins to Insulin Glargine

Sub-Q

Transferring from one 100-unit/mL preparation of insulin glargine to another (i.e., Lantus to Basaglar). Dosage of Basaglar should be the same as that of the other preparation; administration time determined by clinician.

Transferring from 100-unit/mL preparation to 300-unit/mL preparation of insulin glargine: Higher daily dosage of the 300-unit/mL preparation required to maintain same level of glycemic control.

Transferring from 300-unit/mL preparation to 100-unit/mL preparation of insulin glargine: Recommended initial dosage of the 100-unit/mL preparation is 80% of the 300-unit/mL preparation.

Transferring from once-daily NPH insulin: Recommended initial insulin glargine (100- or 300-unit/mL) dosage is the same as the dosage of NPH insulin being discontinued.

Transferring from twice-daily NPH insulin: Recommended initial insulin glargine (100- or 300-unit/mL) dosage is 80% of total NPH insulin dosage being discontinued.

Transferring from another intermediate- or long-acting insulin: Dosage adjustment of the 100-unit/mL preparation of insulin glargine may be required. Recommended initial dosage of the 300-unit/mL preparation of insulin glargine is the same as that of the dosage of insulin being discontinued.

Patients with type 1 diabetes mellitus transitioning from IV insulin to the 300-unit/mL preparation of insulin glargine: Consider longer onset of action of insulin glargine 300 units/mL (onset of action develops over 6 hours) before stopping IV insulin. Full glucose-lowering effect of the 300-unit/mL preparation of insulin glargine may not be apparent for ≥5 days.

Dosage and timing of concurrent short- or rapid-acting insulins or other concomitant antidiabetic agents may also need to be adjusted.

Insulin Glargine/Lixisenatide Fixed-combination Therapy

Sub-Q

Type 2 diabetes mellitus, inadequately controlled on <30 units of basal insulin or on lixisenatide: Initial dosage is 15 units (15 units insulin glargine/5 mcg lixisenatide) once daily.

Type 2 diabetes mellitus, inadequately controlled on 30–60 units of basal insulin: Initial dosage is 30 units (30 units insulin glargine/10 mcg lixisenatide) once daily.

Titrate dosage by 2–4 units every week as needed. Recommended daily dosage of insulin glargine/lixisenatide is 15–60 units (15–60 units insulin glargine/5–20 mcg lixisenatide) once daily. Use alternative antidiabetic agent if the patient requires a daily dosage of insulin glargine/lixisenatide <15 units (15 units insulin glargine/5 mcg lixisenatide) or >60 units (60 units insulin glargine/20 mcg lixisenatide) daily.

Special Populations

Hepatic Impairment

Insulin glargine requirements may be reduced. Careful monitoring of blood glucose and adjustment of dosage of insulin glargine or insulin glargine/lixisenatide may be necessary.

Renal Impairment

Insulin glargine requirements may be reduced. Careful monitoring of blood glucose and adjustment of dosage of insulin glargine or insulin glargine/lixisenatide may be necessary.

Safety and efficacy of insulin glargine/lixisenatide not established in patients with end-stage renal disease (ESRD; eGFR <15 mL/minute per 1.73 m²); fixed combination not recommended for use in such patients.

Geriatric Patients

Conservative initial dosage, dose increments, and maintenance dosage of insulin glargine or insulin glargine/lixisenatide recommended to avoid hypoglycemia.

Cautions for Insulin Glargine

Contraindications

• Known hypersensitivity to insulin glargine or any ingredient in the formulation. Contraindicated during episodes of hypoglycemia.

Warnings/Precautions

Use of Fixed Combinations

When insulin glargine is used in fixed combination with lixisenatide or other drugs, consider the cautions, precautions, contraindications, and interactions associated with the concomitant agent(s) in addition to those associated with insulin glargine.

Hypoglycemia

Most common adverse effect of insulins. Monitor blood glucose concentrations.

Time course of glucose-lowering effect of insulin glargine may vary among different individuals or at different times in the same individual and depends on many conditions, including area of injection and injection site blood supply and temperature. The risk of hypoglycemia generally increases with the intensity of glycemic control. Changes in meal patterns, changes in level of physical activity, or changes to coadministered medications may also increase risk of hypoglycemia. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia. (See Renal Impairment and also see Hepatic Impairment under Dosage and Administration.)

Hypoglycemia due to Medication Errors

Confusion between basal insulin preparations and other insulins, particularly rapid-acting insulins, has caused medication errors.

Check labels on all insulin preparations to confirm the correct preparation and strength prior to administration.

Formulation Considerations

Make any dosage change cautiously and only under medical supervision. Change in dosage may be required if insulin therapy is changed to insulin glargine. Adjustment of oral antidiabetic dosage may be necessary in patients receiving concomitant therapy with insulin glargine. Changes in insulin strength, type, manufacturer, and/or method of manufacture may predispose patients to hypoglycemia or hyperglycemia; increase frequency of blood glucose monitoring.

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. Monitor blood glucose concentrations daily, titrate insulin glargine 300 units/mL appropriately and adjust dosage of concomitant antidiabetic drugs per standard of care. (See Transferring from Therapy with Other Insulins under Dosage and Administration.)

Sharing of Injection Pens

Do not share injections pens of insulin glargine or insulin glargine/lixisenatide among patients, even if the needle has been changed; sharing poses risk for transmission of blood-borne pathogens.

Hypokalemia

All insulin preparations cause a shift in potassium from the extracellular to intracellular space; may cause hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor serum potassium concentrations in patients at risk for hypokalemia.

Metabolic Effects

Insulin therapy may cause sodium retention and edema. Therapy with insulin, including insulin glargine, also may cause weight gain attributable to the anabolic effects of insulin and the decrease in glucosuria.

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.

Observe patients receiving insulin glargine or insulin glargine/lixisenatide and a PPAR-γ agonist for manifestations of heart failure (e.g., excessive/rapid weight gain, shortness of breath, edema); discontinue or reduce dose of PPAR-γ agonist if heart failure develops. Concomitant use of rosiglitazone and insulin therapy not recommended.

Immunogenicity

Potential risk of immunogenicity. Insulin antibodies detected in patients receiving insulin glargine therapy during clinical trials.

Potential Carcinogenicity

Several observational studies suggest increased risk of cancer in patients with diabetes mellitus receiving insulin glargine; however, FDA states 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. At this time, FDA has not concluded that insulin glargine increases the risk of cancer.

Based on currently available data, FDA recommends that patients not stop taking their insulin therapy without consulting a clinician because of risks of uncontrolled hyperglycemia. Some clinicians suggest consideration of long-acting human insulin (e.g., isophane [NPH] insulin human) or a combination of a long- and short-acting insulin twice daily as alternative to insulin glargine therapy.

FDA continuing to evaluate the long-term risk, if any, for cancer associated with use of insulin glargine. FDA encourages both healthcare professionals and patients to report adverse effects with use of insulin glargine to FDA's MedWatch Adverse Event Reporting Program.

Sensitivity Reactions

Dermatologic and Sensitivity Reactions

Lipodystrophy may occur at sites of insulin injections and may affect insulin absorption.

Other local reactions (e.g., pain at injection site, redness, itching, hives, swelling, inflammation) also reported.

Hypersensitivity reactions (e.g., skin reactions, angioedema, bronchospasm, hypotension, shock) reported rarely; may be life-threatening.

Specific Populations

Pregnancy

Data lacking on the use of insulin glargine or insulin glargine/lixisenatide in pregnant women. Use during pregnancy only if potential benefit justifies potential risk to the fetus.

Lactation

Insulin human is distributed into milk. Not known whether insulin glargine is distributed into milk; caution is advised if used in nursing women.

Pediatric Use

Safety and efficacy of the 100-unit/mL preparation of insulin glargine not established in children with type 1 diabetes mellitus <6 years of age or pediatric patients with type 2 diabetes mellitus. Safety and efficacy of the 300-unit/mL insulin glargine preparation or of insulin glargine/lixisenatide not established in pediatric patients.

Common Adverse Effects

Insulin glargine: Hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, weight gain.

Insulin glargine/lixisenatide: Hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, headache.

Drug Interactions

Many drugs affect glucose metabolism; if such drugs are used concomitantly, insulin glargine dosage adjustment and careful monitoring may be required.

Specific Drugs1 30 31

Insulin Glargine Pharmacokinetics

Absorption

Bioavailability

Following injection into sub-Q tissue, neutralization of insulin glargine solution results in formation of microprecipitates from which the drug is slowly released.

Following sub-Q injection, absorption of insulin glargine is slower and more prolonged compared with that of isophane insulin human; serum concentration-time profile for the 100- or 300- unit/mL preparation of insulin glargine is relatively constant over 24 or 36 hours, respectively.

Absorption of the 300-unit/mL preparation of insulin glargine is more prolonged compared with the 100-unit/mL preparation of insulin glargine.

Onset

Following sub-Q injection of the 100-unit/mL preparation of insulin glargine, onset of hypoglycemic action is 1.1 hours. Following sub-Q injection of the 300-unit/mL preparation of insulin glargine, onset of hypoglycemic action develops over 6 hours. Substantial interindividual and intraindividual variation may occur based on tissue blood supply, temperature, exercise, and/or interindividual and intraindividual differences in response.

Duration

Following sub-Q injection of the 100- or 300-unit/mL preparation of insulin glargine, duration of hypoglycemic action is 24 or 36 hours, respectively. Duration of action is similar following sub-Q injection at abdominal, deltoid, or thigh sites. Substantial interindividual and intraindividual variation in duration may occur based on tissue blood supply, temperature, exercise, and/or interindividual and intraindividual differences in response.

Elimination

Metabolism

In the sub-Q tissue depot, insulin glargine is partially metabolized to form 2 metabolites with activity similar to that of insulin. No differences in metabolism between the 100- and 300-unit/mL preparation of insulin glargine.

Stability

Storage

Parenteral

Injection

100-unit/mL preparations of insulin glargine (Basaglar, Lantus): Unopened vials and injection pens, 2–8°C. Do not freeze; discard if frozen. Opened (in-use) vials, may keep unrefrigerated away from direct heat and light at temperature ≤30°C for up to 28 days if refrigeration is not possible; whether refrigerated or not, use vials within 28 days or discard. Opened (in-use) injection pens, room temperature for up to 28 days; do not refrigerate.

300-unit/mL preparation of insulin glargine (Toujeo): Unopened injection pens, 2–8°C and protected from light until expiration date. Do not freeze; discard if frozen. Opened (in-use) injection pens, room temperature away from direct heat and light for up to 42 days; do not refrigerate.

Insulin glargine/lixisenatide: Unopened injections pens, 2–8°C in original carton. Opened (in-use), ≤25ºC. Do not freeze; protect from light. Discard pen 28 days after first use.

Compatibility

Parenteral

Must not mix with other insulins or dilute with other solutions; dilution or mixing may result in a cloudy solution and alter pharmacokinetic or pharmacodynamic profile of insulin glargine or mixed insulin in unpredictable manner.

Actions

• Pharmacologic effects comparable to those of insulin human; stimulates peripheral glucose uptake by tissues (e.g., skeletal muscle, fat), inhibits hepatic glucose production, inhibits lipolysis, inhibits proteolysis, and enhances protein synthesis. On molar basis, the 100-unit/mL preparation of insulin glargine has approximately the same glucose-lowering effect as insulin human.

• Compared with the 100-unit/mL preparation of insulin glargine, the pharmacokinetic and pharmacodynamic profiles of the 300-unit/mL preparation of insulin glargine exhibit a less variable response and a longer duration of action (36 versus 24 hours).

Advice to Patients

• Provide copy of manufacturer’s patient information.

• Importance of not mixing or diluting insulin glargine or insulin glargine/lixisenatide with any other insulins or solutions. Importance of using insulin glargine or insulin glargine/lixisenatide only if solution is clear and colorless with no particles visible.

• Importance of proper glucose monitoring, injection technique, and management of hyperglycemia or hypoglycemia. Risk of inadequate or variably timed food intake. Advise regarding insulin requirements in special situations such as intercurrent conditions (illness, stress, emotional disturbances), missed doses, or inadvertent administration of incorrect doses.

• Advise patients to refer to patient information for additional information about the potential adverse effects of insulin therapy, including lipodystrophy (and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and hypoglycemia.

• Provide instructions to patient regarding use of the sub-Q insulin glargine devices. Caution patients against reuse of needles. Advise patients to never use a syringe to remove insulin glargine from the SoloStar injection pen.

• Importance of informing patients that they should never share injection pens containing insulin glargine or insulin glargine/lixisenatide with another person, even if the needle is changed; sharing of the pen may pose a risk of transmission of infection.

• Importance of informing patients that changes to insulin regimens should be made cautiously and only under medical supervision. Importance of advising patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia.

• Importance of informing patients that their ability to concentrate and react may be impaired as a result of hypoglycemia, which may pose a risk in situations where these abilities are especially important (e.g., driving, operating machinery). Importance of advising patients who experience frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.

• Importance of advising patients to always check the insulin label prior to each injection; medication errors involving confusion between insulins, particularly long- and short-acting insulins, have occurred.

• Importance of informing patients that the 300-unit/mL preparation of insulin glargine (Toujeo) contains 3 times as much insulin as in 1 mL of standard insulin (100 units/mL).

• Importance of informing patients that the dose counter of the SoloStar injection pen displays the number of units to be injected; no recalculation of the dose is required to convert between different concentrations of insulin glargine.

• Importance of informing patients that if they are transitioned to the 300-unit/mL preparation of insulin glargine (Toujeo) from other basal insulins, they may experience higher average fasting plasma glucose concentrations during the first weeks of therapy. Importance of advising patients to monitor glucose concentrations daily when initiating insulin glargine.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

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.

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Frequently asked questions

• How and where should I inject insulin?
• When is the best time to take Toujeo?
• How long can Toujeo stay out of the refrigerator?
• What are the different types of insulin?
• Soliqua vs Lantus: What’s the difference between them?
• Can Toujeo be given twice a day?
• How many pens are in a box of Toujeo?
• Is Toujeo a fast or long-acting insulin?
• What is the difference between Soliqua and Xultophy?

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