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Context, anatomy, and key evidence

← Peptide library

long-acting insulin

Insulin Glargine

Published evidence · coverage incomplete
Anatomical contextAnatomy connections are not mapped yet.

No body region is highlighted until this profile has a supported anatomical connection. This does not mean the peptide has no biological effects.

Read published mechanism findings ↓

At a glance

What is it—and why does it matter?

The mechanism described is increased peripheral glucose uptake (notably skeletal muscle and fat) and inhibition of hepatic glucose output, producing a blood-glucose–lowering effect. In COMBINE 4, HbA1c fell by an average of 2·44 percentage points by week 40 in the glargine U100 group (starting from 9·50%). Among adverse reactions to insulin therapy, hypoglycemia is reported as the most common for insulin glargine as well as other insulins. Dose conversion guidance: for a switch from twice-daily NPH insulin to once-daily Insulin Glargine-yfgn, initiate Insulin Glargine-yfgn at 80% of the discontinued total NPH dose.

Sources for this introduction: [1] [2] [3] [4]

This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.

What is it?

A molecule, not a product name.

This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.

How does it work?

Target, response, and disposition.

Mechanism

Insulin glargine’s pH-dependent precipitation in subcutaneous tissue creates microprecipitates that enable slow release and a relatively peakless 24-hour concentration/time profile.

Sources[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 12.2 Pharmacodynamics

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

Mechanism

The mechanism described is increased peripheral glucose uptake (notably skeletal muscle and fat) and inhibition of hepatic glucose output, producing a blood-glucose–lowering effect.

Sources[2]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine).Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
Source records
2
Regulatory records
2

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine). · 12.1 Mechanism of Action

    dailymed:72cfe377-52f6-0348-fc71-5d4ac1992ffb:849001cbe5cb:849001cbe5cb
  2. supports · Source-backed record
    “Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 12.1 Mechanism of Action

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

Pharmacokinetics

Human metabolism data indicate insulin glargine undergoes partial biotransformation in the subcutaneous depot at the B-chain carboxyl terminus, generating two active metabolites (M1 and M2) with in vitro insulin-like activity.

Sources[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of insulin, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of insulin, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 12.3 Pharmacokinetics

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

What has been studied?

What the evidence says.

Comparative evidence

In COMBINE 4, IcoSema lowered HbA1c more than glargine U100 by 0·88 percentage points on average (95% CI 0·63 to 1·12; p<0·001).

Sources[6]pubmedOnce-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial.For HbA1c, from baseline (9·57% for IcoSema and 9·50% for glargine U100), mean change to week 40 was greater with IcoSema versus glargine U100 (-3·32 vs -2·44 percentage points; estimated treatment difference [ETD] -0·88 percentage points [95% CI -1·12 to -0·63]), confirming superiority of IcoSema (p<0·001).
Reported result
ETD -0·88 percentage points (95% CI -1·12 to -0·63); p<0·001
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “For HbA1c, from baseline (9·57% for IcoSema and 9·50% for glargine U100), mean change to week 40 was greater with IcoSema versus glargine U100 (-3·32 vs -2·44 percentage points; estimated treatment difference [ETD] -0·88 percentage points [95% CI -1·12 to -0·63]), confirming superiority of IcoSema (p<0·001).”

    Once-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial. · FINDINGS

    pubmed:42594928:7452bf113486:7452bf113486

Comparative evidence

This trial included a basal-insulin comparator arm using insulin glargine U100 for efficacy and safety comparisons against once-weekly IcoSema in adults with type 2 diabetes on oral agents.

Sources[6]pubmedOnce-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial.COMBINE 4 evaluated the efficacy and safety of IcoSema, a once-weekly combination therapy of basal insulin icodec and semaglutide (a GLP-1-receptor agonist) versus insulin glargine U100 (glargine U100) in people with type 2 diabetes on oral glucose-lowering medications.
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “COMBINE 4 evaluated the efficacy and safety of IcoSema, a once-weekly combination therapy of basal insulin icodec and semaglutide (a GLP-1-receptor agonist) versus insulin glargine U100 (glargine U100) in people with type 2 diabetes on oral glucose-lowering medications.”

    Once-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial. · BACKGROUND

    pubmed:42594928:7452bf113486:7452bf113486

Comparative evidence

In COMBINE 4, hypoglycaemia rates were lower with IcoSema than with glargine U100 (rate ratio 0·56; p=0·04).

Sources[6]pubmedOnce-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial.Rate of combined clinically significant (blood glucose <3·0 mmol/L [<54 mg/dL], confirmed with a blood glucose meter) or severe hypoglycaemia (severe cognitive impairment requiring external assistance for recovery) was statistically significantly lower with IcoSema versus glargine U100 (0·29 vs 0·59 episodes per person-year of exposure; estimated rate ratio 0·56 [95% CI 0·32 to 0·97]; p=0·04).
Reported result
Estimated rate ratio 0·56 (95% CI 0·32 to 0·97); p=0·04
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Rate of combined clinically significant (blood glucose <3·0 mmol/L [<54 mg/dL], confirmed with a blood glucose meter) or severe hypoglycaemia (severe cognitive impairment requiring external assistance for recovery) was statistically significantly lower with IcoSema versus glargine U100 (0·29 vs 0·59 episodes per person-year of exposure; estimated rate ratio 0·56 [95% CI 0·32 to 0·97]; p=0·04).”

    Once-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial. · FINDINGS

    pubmed:42594928:7452bf113486:7452bf113486

Study findings

Using in vitro incubation in human serum, the analytical approach detected insulin glargine-derived metabolites and distinguished in-source fragmentation artifacts; it also localized the peptide’s metabolic soft spots without ambiguity.

Sources[7]pubmedRapid and comprehensive identification of the metabolic soft spots of peptide drugs with highly cross-linked disulfide bonds by integrating established proteomic workflow with a product ion filtering strategy.analysis of insulin glargine in human serum under in vitro incubation conditions identified 20 metabolites and 3 in-source fragmentation artifacts, with metabolic soft spots unambiguously assigned.
Reported result
20 metabolites and 3 in-source fragmentation artifacts
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “analysis of insulin glargine in human serum under in vitro incubation conditions identified 20 metabolites and 3 in-source fragmentation artifacts, with metabolic soft spots unambiguously assigned.”

    Rapid and comprehensive identification of the metabolic soft spots of peptide drugs with highly cross-linked disulfide bonds by integrating established proteomic workflow with a product ion filtering strategy. · Abstract

    pubmed:42612545:9fe585b8b73a:9fe585b8b73a

Study findings

Insulin glargine U-300 is indicated for improving glycemic control in diabetes mellitus in adults and pediatric patients aged 6 years and older.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).Insulin Glargine, U-300 is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Insulin Glargine, U-300 is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 1 INDICATIONS AND USAGE

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Study findings

In COMBINE 4, HbA1c fell by an average of 2·44 percentage points by week 40 in the glargine U100 group (starting from 9·50%).

Sources[6]pubmedOnce-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial.For HbA1c, from baseline (9·57% for IcoSema and 9·50% for glargine U100), mean change to week 40 was greater with IcoSema versus glargine U100 (-3·32 vs -2·44 percentage points; estimated treatment difference [ETD] -0·88 percentage points [95% CI -1·12 to -0·63]), confirming superiority of IcoSema (p<0·001).
Reported result
-2·44 percentage points (baseline 9·50%)
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “For HbA1c, from baseline (9·57% for IcoSema and 9·50% for glargine U100), mean change to week 40 was greater with IcoSema versus glargine U100 (-3·32 vs -2·44 percentage points; estimated treatment difference [ETD] -0·88 percentage points [95% CI -1·12 to -0·63]), confirming superiority of IcoSema (p<0·001).”

    Once-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial. · FINDINGS

    pubmed:42594928:7452bf113486:7452bf113486

Study findings

Insulin glargine is indicated for improving glycemic control in both adult and pediatric patients with diabetes mellitus.

Sources[5]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000 · 1 INDICATIONS AND USAGE

    dailymed:d5e07a0c-7e14-4756-9152-9fea485d654a:b64d292aad43:b64d292aad43

Risks and interactions

Risks, organized for scanning.

Contraindications

Contraindications for insulin glargine U-300 include use during hypoglycemia and use in patients with hypersensitivity to insulin glargine or excipients.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).Insulin Glargine, U-300 is contraindicated:During episodes of hypoglycemia[seeWarnings and Precautions (5.3)].In patients with hypersensitivity to insulin glargine or any excipients in Insulin Glargine, U-300[seeWarnings and Precautions (5.5)].
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Insulin Glargine, U-300 is contraindicated:During episodes of hypoglycemia[seeWarnings and Precautions (5.3)].In patients with hypersensitivity to insulin glargine or any excipients in Insulin Glargine, U-300[seeWarnings and Precautions (5.5)].”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 4 CONTRAINDICATIONS

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Contraindications

Insulin glargine (LANTUS) is not recommended for diabetic ketoacidosis treatment.

Sources[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000LANTUS is not recommended for the treatment of diabetic ketoacidosis.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “LANTUS is not recommended for the treatment of diabetic ketoacidosis.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 1 INDICATIONS AND USAGE

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

Contraindications

Insulin glargine (LANTUS) is contraindicated in individuals with hypersensitivity to insulin glargine product or excipients.

Sources[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000LANTUS is contraindicated in patients with hypersensitivity to LANTUS or one of its excipients.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “LANTUS is contraindicated in patients with hypersensitivity to LANTUS or one of its excipients.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 4 CONTRAINDICATIONS

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

Contraindications

A history of hypersensitivity to insulin glargine products or formulation excipients is a labeled contraindication.

Sources[2]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine).In patients with hypersensitivity to insulin glargine products or any of the excipients in Insulin Glargine-yfgn
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “In patients with hypersensitivity to insulin glargine products or any of the excipients in Insulin Glargine-yfgn”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine). · 4 CONTRAINDICATIONS

    dailymed:72cfe377-52f6-0348-fc71-5d4ac1992ffb:849001cbe5cb:849001cbe5cb

Contraindications

Insulin glargine U-300 should not be administered intravenously and should not be used in insulin pumps.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).Do not administer Insulin Glargine, U-300 intravenously or in an insulin pump.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Do not administer Insulin Glargine, U-300 intravenously or in an insulin pump.”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 2.1 Important Administration Instructions

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Contraindications

Insulin glargine is contraindicated when a patient is experiencing hypoglycemia.

Sources[5]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000LANTUS is contraindicated:During episodes of hypoglycemia
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “LANTUS is contraindicated:During episodes of hypoglycemia”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000 · 4 CONTRAINDICATIONS

    dailymed:d5e07a0c-7e14-4756-9152-9fea485d654a:b64d292aad43:b64d292aad43

Contraindications

Insulin glargine (LANTUS) is not to be administered by intravenous route or by continuous subcutaneous insulin infusion (pump).

Sources[5]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000Do not administer intravenously or via an insulin pump.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Do not administer intravenously or via an insulin pump.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000 · 2.1 Important Administration Instructions

    dailymed:d5e07a0c-7e14-4756-9152-9fea485d654a:b64d292aad43:b64d292aad43

Interactions

Insulin glargine should be used as supplied without dilution or admixture with other insulin preparations or solutions.

Sources[5]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000Do not dilute or mix LANTUS with any other insulin or solution.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Do not dilute or mix LANTUS with any other insulin or solution.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000 · 2.1 Important Administration Instructions

    dailymed:d5e07a0c-7e14-4756-9152-9fea485d654a:b64d292aad43:b64d292aad43

Interactions

Insulin glargine U-300 should not be diluted or mixed with other insulin products or solutions, which can alter its intended properties.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).Do not dilute or mix Insulin Glargine, U-300 with any other insulin products or solutions.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Do not dilute or mix Insulin Glargine, U-300 with any other insulin products or solutions.”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 2.1 Important Administration Instructions

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Safety findings

With insulin glargine U-300, hypoglycemia is the most common adverse reaction; severe episodes can progress to seizures and may be life-threatening or fatal.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).Hypoglycemia is the most common adverse reaction associated with insulin, including Insulin Glargine, U-300. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Hypoglycemia is the most common adverse reaction associated with insulin, including Insulin Glargine, U-300. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 5.3 Hypoglycemia

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Safety findings

Among adverse reactions to insulin therapy, hypoglycemia is the most frequently occurring event, including for insulin glargine products.

Sources[1]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine).Hypoglycemia is the most common adverse reaction associated with insulins, including insulin glargine products.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Hypoglycemia is the most common adverse reaction associated with insulins, including insulin glargine products.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine). · 5.3 Hypoglycemia

    dailymed:3ac85ebb-5594-59c8-77fd-df254329d151:53f0bcd0e281:53f0bcd0e281

Safety findings

Pen sharing of insulin glargine U-300 devices is prohibited because it carries a risk of transmitting blood-borne pathogens despite needle changes.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).Insulin Glargine, U-300 SoloStar or Insulin Glargine, U-300 Max SoloStar single-patient-use prefilled pens must never be shared between patients, even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Insulin Glargine, U-300 SoloStar or Insulin Glargine, U-300 Max SoloStar single-patient-use prefilled pens must never be shared between patients, even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 5.1 Never Share an Insulin Glargine, U-300 SoloStar or Insulin Glargine, U-300 Max SoloStar Pen Between Patients

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Safety findings

Among insulin adverse reactions, hypoglycemia is the most frequent, including with insulin glargine (LANTUS).

Sources[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000Hypoglycemia is the most common adverse reaction of insulin, including LANTUS.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Hypoglycemia is the most common adverse reaction of insulin, including LANTUS.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 5.3 Hypoglycemia

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

Safety findings

Insulin glargine (LANTUS), like other insulin products, can cause severe generalized hypersensitivity reactions including anaphylaxis.

Sources[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including LANTUS.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including LANTUS.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 5.4 Hypersensitivity and allergic reactions

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

Safety findings

Among adverse reactions to insulin therapy, hypoglycemia is reported as the most common for insulin glargine as well as other insulins.

Sources[5]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000Hypoglycemia is the most common adverse reaction associated with insulins, including LANTUS.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Hypoglycemia is the most common adverse reaction associated with insulins, including LANTUS.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000 · 5.3 Hypoglycemia

    dailymed:d5e07a0c-7e14-4756-9152-9fea485d654a:b64d292aad43:b64d292aad43

Products and regulatory status

Same ingredient. Different records.

Regulatory status

The product’s labeled indication is improvement of glycemic control in both adult and pediatric patients with diabetes mellitus.

Sources[1]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine).Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.[2]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine).Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
Source records
2
Regulatory records
2

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine). · 1 INDICATIONS AND USAGE

    dailymed:3ac85ebb-5594-59c8-77fd-df254329d151:53f0bcd0e281:53f0bcd0e281
  2. supports · Source-backed record
    “Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine). · 1 INDICATIONS AND USAGE

    dailymed:72cfe377-52f6-0348-fc71-5d4ac1992ffb:849001cbe5cb:849001cbe5cb

Regulatory status

For diabetic ketoacidosis, Insulin Glargine-yfgn is not recommended as a treatment option.

Sources[1]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine).Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine). · 1 INDICATIONS AND USAGE

    dailymed:3ac85ebb-5594-59c8-77fd-df254329d151:53f0bcd0e281:53f0bcd0e281

Regulatory status

Insulin glargine (LANTUS) is indicated for improving glycemic control in type 1 diabetes (adults and children) and type 2 diabetes (adults).

Sources[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000LANTUS is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “LANTUS is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 1 INDICATIONS AND USAGE

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

Administration context

The practical clinical context.

Administration

Insulin glargine (LANTUS) is intended for once-daily subcutaneous dosing with consistent daily timing.

Sources[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000LANTUS should be administered subcutaneously once a day at the same time every day.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “LANTUS should be administered subcutaneously once a day at the same time every day.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 2.1 Dosing

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

Administration

The dosing schedule is once-daily subcutaneous administration with consistent daily timing.

Sources[2]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine).Administer Insulin Glargine-yfgn subcutaneously once daily at any time of day but at the same time every day.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Administer Insulin Glargine-yfgn subcutaneously once daily at any time of day but at the same time every day.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine). · 2.2 General Dosing Instructions

    dailymed:72cfe377-52f6-0348-fc71-5d4ac1992ffb:849001cbe5cb:849001cbe5cb

Administration

Insulin glargine is administered subcutaneously (abdomen, thigh, or deltoid) with site rotation to reduce injection-site complications.

Sources[5]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000Administer LANTUS subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Administer LANTUS subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000 · 2.1 Important Administration Instructions

    dailymed:d5e07a0c-7e14-4756-9152-9fea485d654a:b64d292aad43:b64d292aad43

Administration

Insulin glargine U-300 dosing is once-daily subcutaneous administration, timed consistently each day.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).Inject Insulin Glargine, U-300 subcutaneously once a day at the same time of day.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Inject Insulin Glargine, U-300 subcutaneously once a day at the same time of day.”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 2.2 General Dosing Instructions

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Administration

Insulin Glargine-yfgn dosing is subcutaneous once daily, with consistent timing each day.

Sources[1]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine).Administer Insulin Glargine-yfgn subcutaneously once daily at any time of day but at the same time every day.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Administer Insulin Glargine-yfgn subcutaneously once daily at any time of day but at the same time every day.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine). · 2.2 General Dosing Instructions

    dailymed:3ac85ebb-5594-59c8-77fd-df254329d151:53f0bcd0e281:53f0bcd0e281

Administration

For type 1 diabetes management, insulin glargine serves as basal insulin and must be combined with short-acting insulin for prandial coverage.

Sources[5]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000In patients with type 1 diabetes, LANTUS must be used concomitantly with short-acting insulin.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “In patients with type 1 diabetes, LANTUS must be used concomitantly with short-acting insulin.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000 · 2.2 General Dosing Instructions

    dailymed:d5e07a0c-7e14-4756-9152-9fea485d654a:b64d292aad43:b64d292aad43

Administration

Insulin glargine U-300 is administered by subcutaneous injection, with recommended sites including the abdominal area, thigh, or deltoid.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).Inject Insulin Glargine, U-300 subcutaneously into the abdominal area, thigh, or deltoid.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Inject Insulin Glargine, U-300 subcutaneously into the abdominal area, thigh, or deltoid.”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 2.1 Important Administration Instructions

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Administration

Type 1 diabetes management with Insulin Glargine-yfgn requires concomitant short-acting insulin.

Sources[1]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine).In patients with type 1 diabetes, Insulin Glargine-yfgn must be used concomitantly with short-acting insulin.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “In patients with type 1 diabetes, Insulin Glargine-yfgn must be used concomitantly with short-acting insulin.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine). · 2.2 General Dosing Instructions

    dailymed:3ac85ebb-5594-59c8-77fd-df254329d151:53f0bcd0e281:53f0bcd0e281

Administration

The label prohibits intravenous administration and use via insulin pump for Insulin Glargine-yfgn.

Sources[1]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine).Administer Insulin Glargine-yfgn subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.[2]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine).Do not administer intravenously or via an insulin pump.[2]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine).Do not dilute or mix Insulin Glargine-yfgn with any other insulin or solution.
Source records
3
Regulatory records
2

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Administer Insulin Glargine-yfgn subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine). · 2.1 Important Administration Instructions

    dailymed:3ac85ebb-5594-59c8-77fd-df254329d151:53f0bcd0e281:53f0bcd0e281
  2. supports · Source-backed record
    “Do not administer intravenously or via an insulin pump.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine). · 2.1 Important Administration Instructions

    dailymed:72cfe377-52f6-0348-fc71-5d4ac1992ffb:849001cbe5cb:849001cbe5cb
  3. supports · Source-backed record
    “Do not dilute or mix Insulin Glargine-yfgn with any other insulin or solution.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine). · 2.1 Important Administration Instructions

    dailymed:72cfe377-52f6-0348-fc71-5d4ac1992ffb:849001cbe5cb:849001cbe5cb

Dose records

Dose titration for insulin glargine U-300 should not occur more frequently than every 3 to 4 days to allow stabilization of response.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).Titrate the dose of Insulin Glargine, U-300 no more frequently than every 3 to 4 days.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Titrate the dose of Insulin Glargine, U-300 no more frequently than every 3 to 4 days.”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 2.2 General Dosing Instructions

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Dose records

For insulin-naïve type 2 diabetes, the recommended initial insulin glargine (LANTUS) dose is 10 units or 0.2 Units/kg once daily, then titrated to patient needs.

Sources[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000The recommended starting dose of LANTUS in patients with type 2 diabetes who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted to the patient's needs.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The recommended starting dose of LANTUS in patients with type 2 diabetes who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted to the patient's needs.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 2.2 Initiation of LANTUS therapy

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

Dose records

Insulin glargine (LANTUS) dosing is once daily by subcutaneous administration, with consistent daily timing.

Sources[5]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000Administer LANTUS subcutaneously once daily at any time of day but at the same time every day.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Administer LANTUS subcutaneously once daily at any time of day but at the same time every day.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000 · 2.2 General Dosing Instructions

    dailymed:d5e07a0c-7e14-4756-9152-9fea485d654a:b64d292aad43:b64d292aad43

Dose records

For conversion from insulin glargine 300 units/mL (TOUJEO) to insulin glargine 100 units/mL (LANTUS) on a once-daily regimen, initiate LANTUS at 80% of the prior TOUJEO dose.

Sources[5]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000When switching from:Once-daily TOUJEO (insulin glargine 300 units/mL) to once-daily LANTUS (100 units/mL), the recommended starting LANTUS dosage is 80% of the TOUJEO dosage that is being discontinued.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “When switching from:Once-daily TOUJEO (insulin glargine 300 units/mL) to once-daily LANTUS (100 units/mL), the recommended starting LANTUS dosage is 80% of the TOUJEO dosage that is being discontinued.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000 · 2.4 Switching to LANTUS from Other Insulin Therapies

    dailymed:d5e07a0c-7e14-4756-9152-9fea485d654a:b64d292aad43:b64d292aad43

Dose records

The label recommends a 20% dose reduction when converting from once-daily insulin glargine 300 units/mL to once-daily Insulin Glargine-yfgn 100 units/mL to lower hypoglycemia risk.

Sources[2]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine).Once-daily insulin glargine 300 units/mL to once-daily Insulin Glargine-yfgn (100 units/mL), the recommended starting Insulin Glargine-yfgn dosage is 80% of the insulin glargine, 300 units/mL dosage that is being discontinued.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Once-daily insulin glargine 300 units/mL to once-daily Insulin Glargine-yfgn (100 units/mL), the recommended starting Insulin Glargine-yfgn dosage is 80% of the insulin glargine, 300 units/mL dosage that is being discontinued.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine). · 2.4 Switching to Insulin Glargine-yfgn from Other Insulin Therapies

    dailymed:72cfe377-52f6-0348-fc71-5d4ac1992ffb:849001cbe5cb:849001cbe5cb

Dose records

Dose conversion guidance: from twice-daily NPH to once-daily insulin glargine (LANTUS), initiate LANTUS at 80% of the discontinued total NPH daily dose.

Sources[4]dailymedThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000If transferring patients from twice-daily NPH insulin to once-daily LANTUS, the recommended initial LANTUS dose is 80% of the total NPH dose that is being discontinued.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “If transferring patients from twice-daily NPH insulin to once-daily LANTUS, the recommended initial LANTUS dose is 80% of the total NPH dose that is being discontinued.”

    These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 · 2.3 Converting to LANTUS from other insulin therapies

    dailymed:b861fdd9-e134-436e-8c0c-a60dd0006dd3:86e1283c3403:86e1283c3403

Dose records

The insulin glargine U-300 SoloStar pen contains 450 units and supports 1-unit dose titration with a maximum of 80 units per injection.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).The Insulin Glargine, U-300 SoloStar prefilled pen contains 450 units of insulin glargine. It delivers doses in 1-unit increments and can deliver up to 80 units in a single injection.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The Insulin Glargine, U-300 SoloStar prefilled pen contains 450 units of insulin glargine. It delivers doses in 1-unit increments and can deliver up to 80 units in a single injection.”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 2.2 General Dosing Instructions

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Dose records

Dose conversion guidance: for a switch from twice-daily NPH insulin to once-daily Insulin Glargine-yfgn, initiate Insulin Glargine-yfgn at 80% of the discontinued total NPH dose.

Sources[1]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine).•Twice-daily NPH insulin to once-daily Insulin Glargine-yfgn, the recommended starting Insulin Glargine-yfgn dosage is 80% of the total NPH dosage that is being discontinued.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “•Twice-daily NPH insulin to once-daily Insulin Glargine-yfgn, the recommended starting Insulin Glargine-yfgn dosage is 80% of the total NPH dosage that is being discontinued.”

    These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine). · 2.4 Switching to Insulin Glargine-yfgn from Other Insulin Therapies

    dailymed:3ac85ebb-5594-59c8-77fd-df254329d151:53f0bcd0e281:53f0bcd0e281

Dose records

The insulin glargine U-300 Max SoloStar pen contains 900 units and provides 2-unit dose increments with a maximum of 160 units per injection; it is recommended for patients needing at least 20 units/day.

Sources[3]dailymedThese highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine).The Insulin Glargine, U-300 Max SoloStar prefilled pen contains 900 units of insulin glargine. It delivers doses in 2-unit increments and can deliver up to 160 units in a single injection. It is recommended for patients requiring at least 20 units per day.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The Insulin Glargine, U-300 Max SoloStar prefilled pen contains 900 units of insulin glargine. It delivers doses in 2-unit increments and can deliver up to 160 units in a single injection. It is recommended for patients requiring at least 20 units per day.”

    These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). · 2.2 General Dosing Instructions

    dailymed:99ea856d-9562-443a-9422-1006a3cff2f4:94c1f2cb405a:94c1f2cb405a

Research status + gaps

What still needs better answers?

  • No publishable claim yet for: identity
  • 71 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (42), assurance_score_below_0.72 (21), current_regulatory_source_required (17), extraction_ambiguity (34), high_risk_requires_regulatory_or_two_independent_sources (27), no_direct_support (63)

These are the limits of this profile, not an exhaustive list of scientific uncertainties.

References + discovery

Open the records yourself.

  1. These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine). ↗

    dailymed · published 2026-01-23 · retrieved 2026-09-04T19:34:10Z

  2. These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN.INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine). ↗

    dailymed · published 2025-07-24 · retrieved 2026-09-04T19:34:11Z

  3. These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300.INSULIN GLARGINE, U-300, injection, for subcutaneous useInitial U.S. Approval: 2015This product is TOUJEO®(insulin glargine). ↗

    dailymed · published 2025-05-30 · retrieved 2026-09-04T19:34:05Z

  4. These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 ↗

    dailymed · published 2010-01-05 · retrieved 2026-09-04T19:34:05Z

  5. These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS.LANTUS®(insulin glargine) injection, for subcutaneous useInitial U.S. Approval: 2000 ↗

    dailymed · published 2025-06-02 · retrieved 2026-09-04T19:34:04Z

  6. Once-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial. ↗

    pubmed · published 2026-08-13 · retrieved 2026-08-18T08:28:36Z

  7. Rapid and comprehensive identification of the metabolic soft spots of peptide drugs with highly cross-linked disulfide bonds by integrating established proteomic workflow with a product ion filtering strategy. ↗

    pubmed · published 2026-07-17 · retrieved 2026-08-27T11:48:55Z

Publication history and provenance

Version 7 · Automated assessment · 2026-09-04T19:34:11Z

55a06c5ebf13522d8632a3dac84a65d365cfba6b7639d927801dd714f67e9d25