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  • Lantus
    (insulin glargine (rDNA origin))

    THERAPEUTIC CLASS

    Insulin

    DEA CLASS

    RX

    INDICATIONS

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

    ADULT DOSAGE

    Type 1 Diabetes Mellitus

    Initial: 1/3 of total daily insulin requirements
    Titrate: Adjust dose based on blood glucose measurements

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

    Type 2 Diabetes Mellitus

    Not Currently Treated w/ Insulin:
    Initial: 10 U (or 0.2 U/kg) qd
    Titrate: Adjust dose based on blood glucose measurements

    Conversions

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

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

    PEDIATRIC DOSAGE

    Type 1 Diabetes Mellitus

    ≥6 Years:
    Initial: 1/3 of total daily insulin requirements
    Titrate: Adjust dose based on blood glucose measurements

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

    Conversions

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

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

    DOSE MODIFICATION

    Renal Impairment
    Dose adjustments may be necessary

    Hepatic Impairment
    Dose adjustments may be necessary

    Elderly
    Dose conservatively

    ADMINISTRATION

    SQ route

    Inject qd at same time every day
    Must be used in regimens w/ short-acting insulin in patients w/ type 1 diabetes mellitus
    Do not administer IV or via an insulin pump
    Rotate inj sites w/in the same region (abdomen, thigh, or deltoid) from 1 inj to the next
    Do not dilute or mix w/ any other insulin or sol

    HOW SUPPLIED

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

    WARNINGS/PRECAUTIONS

    Not recommended for the treatment of diabetic ketoacidosis. Insulin pens must never be shared between patients, even if needle is changed; may carry a risk for transmission of blood-borne pathogens. Glucose monitoring is essential for all patients receiving insulin therapy. Changes to an insulin regimen should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in need for a change in insulin dose or adjustment in concomitant oral antidiabetic treatment. Hypoglycemia may occur; caution in patients w/ hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (eg, pediatric population, patients who fast or have erratic food intake). Hypoglycemia may impair ability to concentrate and react. Severe, life-threatening, generalized allergy, including anaphylaxis, may occur. Careful glucose monitoring and dose adjustments may be necessary w/ renal/hepatic impairment. Not recommended during periods of rapidly declining renal/hepatic function. Caution in elderly.

    ADVERSE REACTIONS

    Hypoglycemia, allergic reactions, URTI, peripheral edema, HTN, influenza, sinusitis, cataract, bronchitis, arthralgia, infection, pain in extremities, back pain, cough, URI.

    DRUG INTERACTIONS

    May require dose adjustment and close monitoring w/ drugs that may increase the blood-glucose-lowering effect and susceptibility to hypoglycemia (eg, ACE inhibitors, MAOIs, salicylates, somatostatin analogues, sulfonamide antibiotics), drugs that may decrease the blood-glucose-lowering effect (eg, corticosteroids, niacin, phenothiazine derivatives, thyroid hormones, progestogens [eg, in oral contraceptives]), or drugs that may either potentiate or weaken the blood-glucose-lowering effect (β-blockers, clonidine, lithium salts, alcohol). Pentamidine may cause hypoglycemia, sometimes followed by hyperglycemia. Signs of hypoglycemia may be reduced or absent w/ sympatholytics (eg, β-blockers, clonidine, guanethidine, reserpine). Observe for signs/symptoms of heart failure (HF) if treated concomitantly w/ a peroxisome proliferator-activated receptor (PPAR)-gamma agonist (eg, thiazolidinedione); consider discontinuation or a dose reduction of the PPAR-gamma agonist if HF develops.

    PREGNANCY AND LACTATION

    Category C, caution in nursing.

    MECHANISM OF ACTION

    Insulin glargine (rDNA origin); 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, 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.

    PATIENT COUNSELING

    Advise never to share insulin pen w/ another person, even if needle is changed. Inform about potential side effects (eg, lipodystrophy, weight gain, allergic reactions, hypoglycemia). Inform that hypoglycemia may impair ability to concentrate and react; advise to use caution when driving or operating machinery. Instruct to always check the label before each inj to avoid medication errors. Advise to use only if sol is clear and colorless w/ no particles visible. Do not dilute or mix w/ any other insulin or sol. Instruct on self-management procedures, including glucose monitoring, proper inj technique, and management of hypoglycemia and hyperglycemia, and on handling of special situations, such as intercurrent conditions (eg, illness, stress, or emotional disturbances), inadequate or skipped dose, inadvertent administration of increased insulin dose, inadequate food intake, and 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. 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. Do not refrigerate opened (in-use) SoloStar.