Generic Name

Glargine

Brand Names
Glargine U-300, Toujeo, Lantus Solostar, Lantus, Glargine Solostar, Rezvoglar, Semglee, Basaglar
FDA approval date: September 23, 2009
Classification: Insulin Analog
Form: Injection

What is Glargine U-300 (Glargine)?

BASAGLAR ® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. BASAGLAR ® is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Limitations of Use : Not recommended for treating diabetic ketoacidosis. Limitations of Use BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.

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Brand Information

    Insulin glargine U-300 (insulin glargine)
    1INDICATIONS AND USAGE
    Insulin Glargine, U-300 is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.
    2DOSAGE FORMS AND STRENGTHS
    Injection: 300 units/mL (U-300) of insulin glargine in a clear, colorless, solution available as:
    • 1.5 mL SoloStar single-patient-use prefilled pen (450 units per 1.5 mL pen)
    • 3 mL Max SoloStar single-patient-use prefilled pen (900 units per 3 mL pen)
    3CONTRAINDICATIONS
    Insulin Glargine, U-300 is contraindicated:
    • During episodes of hypoglycemia
    • In patients with hypersensitivity to insulin glargine or any excipients in Insulin Glargine, U-300
    4ADVERSE REACTIONS
    The following adverse reactions are discussed elsewhere:
    • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
    • Hypoglycemia
    • Hypoglycemia Due to Medication Errors
    • Hypersensitivity Reactions
    • Hypokalemia
    4.1Clinical Trials Experience
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates actually observed in clinical practice.
    The data in Table 1 reflect the exposure of 304 patients with type 1 diabetes to Insulin Glargine, U-300 with mean exposure duration of 23 weeks. The type 1 diabetes population had the following characteristics: Mean age was 46 years and mean duration of diabetes was 21 years. Fifty-five percent were male, 86% were White, 5% were Black or African American, and 5% were Hispanic or Latino. At baseline, the mean eGFR was 82 mL/min/1.73 m
    The data in Table 2 reflect the exposure of 1242 patients with type 2 diabetes to Insulin Glargine, U-300 with mean exposure duration of 25 weeks. The type 2 diabetes population had the following characteristics: Mean age was 59 years and mean duration of diabetes was 13 years. Fifty-three percent were male, 88% were White, 7% were Black or African American, and 17% were Hispanic or Latino. At baseline, mean eGFR was 79 mL/min/1.73 m
    Insulin Glargine, U-300 was studied in 233 pediatric patients (6–17 years of age) with type 1 diabetes for a mean duration of 26 weeks
    Common adverse reactions (occurring ≥5%) in Insulin Glargine, U-300-treated subjects during clinical trials in adult patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in Table 1 and Table 2, respectively. Common adverse reactions for Insulin Glargine, U-300-treated pediatric subjects with type 1 diabetes mellitus were similar to the adverse reactions listed in Table 1. Hypoglycemia is discussed in a dedicated subsection below.
    4.2Immunogenicity
    As with all therapeutic proteins, there is potential for immunogenicity.
    In a 6-month study of type 1 diabetes patients, 79% of patients who received Insulin Glargine, U-300 once daily were positive for anti-insulin antibodies (AIA) at least once during the study, including 62% that were positive at baseline and 44% of patients who developed antidrug antibody (i.e., anti-insulin glargine antibody [ADA]) during the study. Eighty percent of the AIA-positive patients on Insulin Glargine, U-300 with antibody test at baseline remained AIA positive at month 6.
    In two 6-month studies in type 2 diabetes patients, 25% of patients who received Insulin Glargine, U-300 once daily were positive for AIA at least once during the study, including 42% who were positive at baseline and 20% of patients who developed ADA during the study. Ninety percent of the AIA-positive patients on Insulin Glargine, U-300 with antibody test at baseline, remained AIA positive at month 6.
    The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to Insulin Glargine, U-300 with the incidence of antibodies in other studies or to other products may be misleading.
    4.3Postmarketing Experience
    The following additional adverse reactions have been identified during postapproval use of Insulin Glargine, U-300. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
    Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
    5DRUG INTERACTIONS
    Table 3 includes clinically significant drug interactions with Insulin Glargine, U-300.
    6OVERDOSAGE
    Excess insulin administration may cause hypoglycemia and hypokalemia
    7DESCRIPTION
    Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of
    Insulin Glargine, U-300 injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of Insulin Glargine, U-300 contains 300 units of insulin glargine dissolved in a clear aqueous fluid.
    The 1.5 mL Insulin Glargine, U-300 SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP.
    The 3 mL Insulin Glargine, U-300 Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP.
    The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. Insulin Glargine, U-300 has a pH of approximately 4.
    8PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). There are separate Instructions for Use for Insulin Glargine, U-300 SoloStar and Insulin Glargine, U-300 Max SoloStar.
    9PRINCIPAL DISPLAY PANEL - 1.5 mL Pen Carton
    NDC 0955-3900-03
    Insulin Glargine U-300
    For Single Patient Use Only
    300 units/mL (U-300)
    For subcutaneous use only
    Use within 56 days after opening
    sanofi
    PRINCIPAL DISPLAY PANEL - 1.5 mL Pen Carton
    10PRINCIPAL DISPLAY PANEL - 3 mL Pen Carton
    NDC 0955-2900-02
    Insulin Glargine U-300
    For Single Patient Use Only
    300 units/mL (U-300)
    Adjusts by 2 units
    For subcutaneous use only
    Use within 56 days after opening
    sanofi
    PRINCIPAL DISPLAY PANEL - 3 mL Pen Carton
    Glargine U-300 has been selected.