insulin glargine (Rx)

Brand and Other Names:Lantus, Lantus SoloStar, more...Toujeo, Basaglar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 100 units/mL (Lantus; 10mL vial)
  • 100 units/mL (Lantus SoloSTAR; Basaglar KwikPen; 3 mL disposable prefilled pens)
  • 300 units/mL (Toujeo; 1.5 mL SoloStar disposable prefilled pen)
  • 300 units/mL (Toujeo Max; 3 mL SoloStar disposable prefilled pen)
  • Note: Recent studies have suggested that glargine-300 extends blood glucose control well beyond 24 hr
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Type 1 Diabetes Mellitus

Long-acting basal insulin indicated to improve glycemic control in adults with type 1 diabetes mellitus

Initial dose

  • For insulin-naïve patients
    • Start ~1/3 of total daily insulin dose; use remaining 2/3 of daily insulin dose on short-acting, premeal insulin
    • Usual initial dose range: 0.2-0.4 units/kg; optimal glucose lowering effect may take 5 days to fully manifest and the first insulin glargine dose may be insufficient to cover metabolic needs in the first 24 hr of use
    • Titrate insulin glargine per instructions, and adjust coadministered glucose-lowering therapies per standard of care
    • See Dosing Considerations and Administration

Type 2 Diabetes Mellitus

Long-acting basal insulin indicated to improve glycemic control in adults with type 2 diabetes mellitus

Initial dose

  • For insulin-naïve patients
    • Start 0.2 units/kg qDay; if necessary, adjust dosage of other antidiabetic drugs when starting insulin glargine to minimize the risk of hypoglycemia
    • See Dosing Considerations and Administration

Dosage Modifications

Hepatic and renal impairment

  • Not studied

Dosing Considerations

Dose must be individualized based on clinical response; blood glucose monitoring is essential in all patients receiving insulin therapy

Patients adjusting the amount or timing of dosage should do so only under medical supervision with appropriate glucose monitoring

Titrate Toujeo dose no more frequently than every 3-4 days

Use with caution in patients with visual impairment who may rely on audible clicks to dial their dose

Converting from other insulins

  • If changing from a treatment regimen with an intermediate- or long-acting insulin to a regimen with insulin glargine, the amount and timing of shorter-acting insulins and doses of any oral antidiabetic drugs may need to be adjusted
  • For patients controlled on Lantus expect that a higher daily dose of Toujeo will be needed to maintain the same level of glycemic control
  • From once-daily NPH insulin to once-daily insulin glargine: Initial dose is the same as the dose of NPH that is being discontinued
  • From twice-daily NPH insulin to once-daily insulin glargine: Initial dose is 80% of the total daily NPH dose that is being discontinued; this dose reduction will lower the likelihood of hypoglycemia
  • Switching from intermediate-to-long acting insulins to Toujeo
    • To minimize the risk of hypoglycemia when changing patients from a once daily long-acting or intermediate-acting insulin product to Toujeo, the starting dose of Toujeo can be the same as the once daily long-acting dose
    • For patients controlled on Lantus (insulin glargine, 100 units/mL) expect that a higher daily dose of Toujeo will be needed to maintain the same level of glycemic control
  • Switching from intermediate-to-long-acting insulins to Lantus
    • If changing from a treatment regimen with an intermediate- or long-acting insulin to Lantus or Basaglar, a change in the dose of the basal insulin may be required and the amount and timing of the shorter-acting insulins and doses of any oral antidiabetic drugs may be needed to be adjusted
    • If changing patients from once daily Toujeo (300 units/mL) to once daily Lantus or Basaglar (100 units/mL), the recommended initial Lantus or Basaglar dose is 80% of the Toujeo dose that is being discontinued; this dose reduction will lower the likelihood of hypoglycemia

Limitation of use

  • Not recommended for treating diabetic ketoacidosis

Dosage Forms & Strengths

injectable solution

  • 100 units/mL (Lantus; 10mL vial)
  • 100 units/mL (Lantus SoloSTAR; Basalglar KwikPen; 3 mL disposable prefilled pens)
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Type 1 Diabetes Mellitus

Long-acting human insulin analog indicated to improve glycemic control in children with type 1 diabetes mellitus; Toujeo is not approved for use in children

<6 years: Safety and efficacy not established

≥6 years: Start ~1/3 of total daily insulin dose; use remaining 2/3 of daily insulin dose on short-acting, premeal insulin; usual daily maintenance range in adolescents is ≤1.2 units/kg/day during growth spurts

Dosing Considerations

Dosage of human insulin, which is always expressed in USP units, must be based on the results of blood and urine glucose tests and must be carefully individualized to optimal effect

If changing from a treatment regimen with an intermediate- or a long-acting insulin to a regimen with insulin glargine, the amount and timing of shorter-acting insulins and doses of any oral antidiabetic drugs may need to be adjusted

If changing from once-daily NPH insulin to once-daily insulin glargine: Initial dose is the same as the dose of NPH that is being discontinued

If changing from twice-daily NPH insulin to once-daily insulin glargine: Initial dose is 80% of the total daily NPH dose that is being discontinued; this dose reduction will lower the likelihood of hypoglycemia

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Interactions

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            Adverse Effects

            Frequency Not Defined

            Headache

            Influenza-like symptoms

            Dyspepsia

            Diarrhea

            Back pain

            Pharyngitis

            Lipodystrophy

            Lipohypertrophy

            Pallor

            Palpitation

            Tachycardia

            Local allergic reaction

            Hypokalemia

            Peripheral edema

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            Warnings

            Contraindications

            Documented hypersensitivity

            During episodes of hypoglycemia

            Cautions

            Toujeo and Lantus are not interchangeable

            Not recommended for treating diabetic ketoacidosis; use IV short-acting insulin instead

            Never share insulin pens between patients, even if the needle is changed; pen sharing poses a risk for transmission of blood-borne pathogens

            To avoid dosing errors and potential overdose, never use a syringe to remove drug from TOUJEO SoloStar or TOUJEO Max SoloStar prefilled pen into a syringe

            Decreased insulin requirements: Diarrhea, nausea/vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment

            Increased insulin requirements include fever, hyperthyroidism, trauma, infection, surgery

            Hyper-or hypoglycemia may occur with changes in insulin regimen; carry out under close medical supervision

            Increase frequency of glucose monitoring with changes to insulin dosage, coadministered glucose lowering medications, meal pattern, or physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness

            Accidental mix-ups between insulin products can occur; instruct patients to check insulin labels before injection

            Rapid changes in serum glucose may induce symptoms of hypoglycemia

            Hypoglycemia is the most common cause of adverse reactions (eg, headache, tachycardia)

            May cause a shift in potassium from extracellular to intracellular space, possibly leading to hypokalemia; caution when coadministered with potassium-lowering drugs or conditions that may decrease potassium

            Frequent glucose monitoring and insulin dose reduction may be required with renal or hepatic impairment; not recommended during periods of rapidly declining renal or hepatic function because of risk for prolonged hypoglycemia

            Use caution during pregnancy

            Cancer risk data inconclusive

            • The FDA reviewed 4 published observational studies, 3 of which suggested an increased risk of cancer associated with insulin glargine
            • It was determined that the evidence presented in these studies is inconclusive due to methodologic limitations
            • The duration of patient follow-up in all 4 studies was shorter than that which is generally considered necessary to evaluate cancer risk from drug exposure
            • Also, the 4 studies provided limited information on patients' use of insulin products; some studies did not take into account whether the patients used any antidiabetic drugs before the study time period or whether there were any changes in how patients used these drugs during the study period
            • Furthermore, risk factors for cancer (eg, smoking, family history of cancer, obesity) may not have been adequately controlled for in these studies

            Drug interactions overview

            • Thiazolidinediones are peroxisome proliferator-activated receptor (PPAR)-gamma agonists and can cause dose-related fluid retention, particularly when used in combination with insulin; fluid retention may lead to or exacerbate heart failure; monitor for signs and symptoms of heart failure, treat accordingly, and consider discontinuing thiazolidinediones
            • Coadministration with these drugs (eg, antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs [eg, octreotide], sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors) may increase the risk of hypoglycemia
            • Coadministration with these drugs (eg, atypical antipsychotics [eg, olanzapine and clozapine], corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens [eg, oral contraceptives], protease inhibitors, somatropin, sympathomimetic agents [eg, albuterol, epinephrine, terbutaline], and thyroid hormones) may decrease the risk of hypoglycemia
            • Concomitant use of alcohol, beta-blockers, clonidine, and lithium salts with insulin glargine may increase or decrease blood glucose lowering effect of insulin glargine
            • Pentamidine may cause hypoglycemia, which may sometimes be followed with hyperglycemia
            • Coadministration with beta-blockers, clonidine, guanethidine, or reserpine may blunt signs and symptoms of hypoglycemia
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            Pregnancy & Lactation

            Pregnancy

            Pregnancy Published data do not report a clear association with insulin glargine products and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine products used during pregnancy; however, these studies cannot definitely establish absence of any risk because of methodological limitations including small sample size and some with no comparative group; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy; poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications

            Animal data

            • In animal reproduction studies, another insulin glargine product was administered to rats before, during and throughout pregnancy at doses up to 7 times clinical dose of 10 units/day and to rabbits during organogenesis at doses approximately 2 times the clinical dose of 10 units/day; effects of this other insulin glargine product did not generally differ from those observed with regular human insulin in rats or rabbits

            Lactation

            There are no data on presence of insulin glargine in human milk, effects on breastfed infant, or on milk production

            Use of insulin glargine is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses; health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Regulates glucose metabolism

            Insulin and its analogues lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production; insulin inhibits lipolysis and proteolysis and enhances protein synthesis; targets include skeletal muscle, liver, and adipose tissue

            Absorption

            Bioavailability: Delayed absorption from SC site

            Onset of action: 3-4 hr

            Duration: 24 hr (range: 10.8 hr to >24 hr)

            Peak plasma time: Forms microprecipitate in fatty tissue from which a small amount of insulin is gradually released; no pronounced peaks; released at constant rate over >24 h

            Metabolism

            Adipose tissue/muscle

            Partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form 2 active metabolites with in vitro activity similar to that of insulin

            Metabolites (active): M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30BThr-insulin)

            Elimination

            Excretion: Urine

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            Administration

            SC Administration

            Administer at any time during the day; should be administered SC once daily at the same time every day

            Inject SC once daily into the abdominal area, thigh, or deltoid at the same time each day

            Rotate injection sites within the same region from 1 injection to the next to reduce the risk of lipodystrophy

            Always check insulin labels before administration

            Visually inspect solution for particulate matter and discoloration prior to administration and only use if the solution is clear and colorless with no visible particles

            Do not administer IV, IM, or via insulin pump

            Do not dilute or mix with any other insulin products or solutions

            Switching between Toujeo SoloStar and Toujeo Max SoloStar

            • When changing between Toujeo SoloStar and Max SoloStar, if previous dose was an odd number, increase or decrease dose by 1 unit
            • Toujeo SoloStar or Max SoloStar disposable prefilled pen requires no conversion Never transfer cartridges of the Toujeo SoloStar or Max SoloStar prefilled pen into a syringe for administration
            • Toujeo SoloStar delivers doses in 1 unit increments (up to 80 units in a single injection)
            • Toujeo Max SoloStar delivers doses in 2 unit increments (up to 160 units in a single injection); recommended for patients requiring ≥20 units/day

            Storage

            Unopened vial or pen (not in-use)

            • Refrigerated (36-46°F [2-8°C]): Until expiration date
            • Unrefrigerated and kept from direct heat and light (ie, temperature does not exceed 86°F [30°C]): Up to 28 days
            • Do not freeze

            Opened vial or pen (in-use)

            • Vial: 28 days at room temperature or refrigerated
            • Pen: 28 days; store only at room temperature (do not refrigerate)
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.