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  • Lantus
    (insulin glargine)

    THERAPEUTIC CLASS

    Insulin (long-acting)

    DEA CLASS

    RX

    INDICATIONS

    To improve glycemic control in patients w/ type 1 diabetes mellitus and in adults w/ type 2 diabetes mellitus.

    ADULT DOSAGE

    Type 1 Diabetes Mellitus

    Initial: Approx 1/3 of total daily insulin requirements
    Titrate: Based on individual's metabolic needs, blood glucose monitoring results, and glycemic control goal

    Use short-acting, premeal insulin to satisfy remainder of the daily insulin requirements

    Type 2 Diabetes Mellitus

    Not Currently Treated w/ Insulin:
    Initial: 0.2 U/kg or up to 10 U qd
    Titrate: Based on individual's metabolic needs, blood glucose monitoring results, and glycemic control goal

    Conversions

    From QD Toujeo 300 U/mL:
    Initial Lantus dose is 80% of Toujeo that is being discontinued

    From Intermediate- or Long-Acting Insulin:
    Change in basal insulin dose may be required and amount and timing of the shorter-acting insulins and doses of any oral antidiabetic drugs may need to be adjusted

    From QD NPH Insulin:
    Initial Lantus dose is the same as the dose of NPH that is being discontinued

    From BID NPH Insulin:
    Initial Lantus dose is 80% of total NPH dose that is being discontinued

    PEDIATRIC DOSAGE

    Type 1 Diabetes Mellitus

    ≥6 Years:
    Initial: Approx 1/3 of total daily insulin requirements
    Titrate: Based on individual's metabolic needs, blood glucose monitoring results, and glycemic control goal

    Use short-acting, premeal insulin to satisfy remainder of the daily insulin requirements

    Conversions

    From QD Toujeo 300 U/mL:
    Initial Lantus dose is 80% of Toujeo that is being discontinued

    From Intermediate- or Long-Acting Insulin:
    Change in basal insulin dose may be required and amount and timing of the shorter-acting insulins and doses of any oral antidiabetic drugs may need to be adjusted

    From QD NPH Insulin:
    Initial Lantus dose is the same as the dose of NPH that is being discontinued

    From BID NPH Insulin:
    Initial Lantus dose is 80% of total NPH dose that is being discontinued

    DOSING CONSIDERATIONS

    Concomitant Medications
    For patients w/ type 2 diabetes, may need to adjust dosage of concomitant oral antidiabetic products

    Renal Impairment
    Frequent glucose monitoring and dose adjustments may be necessary

    Hepatic Impairment
    Frequent glucose monitoring and dose adjustments may be necessary

    Elderly
    Dose conservatively

    Other Important Considerations
    Dosage adjustments may be needed w/ changes in physical activity, changes in meal patterns (eg, macronutrient content, timing of food intake), changes in hepatic/renal function, or during acute illness

    ADMINISTRATION

    SQ route

    Inject into the abdominal area, thigh, or deltoid, and rotate inj sites w/in the same region from 1 inj to the next.
    Inject qd at the same time every day.
    Must be used w/ short-acting insulin in patients w/ type 1 diabetes mellitus.
    Do not administer IV or via an insulin pump.
    Do not dilute or mix w/ any other insulin or sol.
    Refrigerate unused (unopened) vials and SoloStar prefilled pens.

    SoloStar Prefilled Pen
    For single patient use only.

    HOW SUPPLIED

    Inj: 100 U/mL [3mL SoloStar, 10mL vial]

    CONTRAINDICATIONS

    During episodes of hypoglycemia.

    WARNINGS/PRECAUTIONS

    Not recommended for the treatment of diabetic ketoacidosis. Insulin pens, syringes, or needles must never be shared between patients, even if the needle is changed; may carry a risk for transmission of blood-borne pathogens. Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypo/hyperglycemia. Hypoglycemia may occur and may impair concentration ability and reaction time. Symptomatic awareness of hypoglycemia may be less pronounced in patients w/ longstanding diabetes, diabetic nerve disease, w/ medications that block the sympathetic nervous system (eg, β-blockers), or in patients who experience recurrent hypoglycemia. The long-acting effect of insulin glargine may delay recovery from hypoglycemia. Accidental mix-ups among insulin products reported. Severe, life-threatening, generalized allergy, including anaphylaxis, may occur. If hypersensitivity reactions occur, d/c therapy; treat per standard of care and monitor until signs/symptoms resolve. May cause hypokalemia; monitor K+ levels in patients at risk for hypokalemia (eg, patients using K+-lowering medications or medications sensitive to serum K+ concentrations) if indicated.

    ADVERSE REACTIONS

    Hypoglycemia, URTI, peripheral edema, HTN, influenza, sinusitis, cataract, bronchitis, arthralgia, infection, pain in extremities, back pain, cough, UTI, diarrhea.

    DRUG INTERACTIONS

    See Dosing Considerations. Dose adjustments and increased frequency of glucose monitoring may be required w/ drugs that may increase the risk of hypoglycemia (eg, ACE inhibitors, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogues [eg, octreotide], sulfonamide antibiotics), drugs that may decrease blood glucose-lowering effect (eg, atypical antipsychotics [eg, olanzapine, clozapine], corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens [eg, in oral contraceptives], protease inhibitors, somatropin, sympathomimetic agents [eg, albuterol, epinephrine, terbutaline], thyroid hormones), or drugs that may increase/decrease blood glucose-lowering effect (eg, alcohol, β-blockers, clonidine, lithium salts, pentamidine). Signs/symptoms of hypoglycemia may be blunted w/ β-blockers, clonidine, guanethidine, or reserpine. Observe for signs/symptoms of heart failure (HF) if treated concomitantly w/ a peroxisome proliferator-activated receptor (PPAR)-gamma agonist (eg, thiazolidinediones); consider discontinuation or dose reduction of the PPAR-gamma agonist if HF develops.

    PREGNANCY AND LACTATION

    Pregnancy: There are no well-controlled clinical studies in pregnant women; use during pregnancy only if potential benefit justifies potential risk to the fetus.
    Lactation: It is not known if insulin glargine is excreted in human milk; caution in nursing. Use is compatible w/ breastfeeding, but women may require adjustments of insulin doses.

    MECHANISM OF ACTION

    Insulin glargine; regulates glucose metabolism. Lowers blood glucose by stimulating peripheral glucose uptake and by inhibiting hepatic glucose production. Inhibits lipolysis and proteolysis, and enhances protein synthesis.

    PHARMACOKINETICS

    Metabolism: M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin) (active metabolites).

    ASSESSMENT

    Assess for diabetic ketoacidosis, predisposition to hypoglycemia,  risk factors for hypokalemia, hypersensitivity, renal/hepatic impairment, pregnancy/nursing status, and possible drug interactions. Obtain baseline blood glucose and HbA1c levels.

    MONITORING

    Monitor for signs/symptoms of hypoglycemia, allergic reactions, and other adverse reactions. Monitor blood glucose and HbA1c levels, and renal/hepatic function. Monitor K+ levels in patients at risk for hypokalemia if indicated.

    PATIENT COUNSELING

    Advise to never share SoloStar pen w/ another person, even if needle is changed. Instruct not to reuse or share needles or syringes. Inform of hypoglycemia symptoms, including impairment of the ability to concentrate and react; advise to use caution when driving/operating machinery. Advise that changes in insulin regimen can predispose to hypo/hyperglycemia and that changes should be made under close medical supervision. Instruct to always check the label before each inj to avoid medication errors and to not dilute or mix w/ any other insulin or sol. Instruct on self-management procedures, including glucose monitoring, proper inj technique, management of hypo/hyperglycemia, and on handling of special situations (eg, intercurrent conditions, inadequate or skipped dose, inadvertent administration of increased insulin dose, inadequate food intake, skipped meals). Advise to inform physician if pregnant or contemplating pregnancy.

    STORAGE

    Do not freeze; discard if drug has been frozen. Unopened: 2-8°C (36-46°F) until expiration date or <30°C (86°F) for 28 days. Open (In-Use): 2-8°C (36-46°F) or <30°C (86°F) for vials and <30°C (86°F) for SoloStar. Discard after 28 days. Protect from direct heat and light.