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To improve glycemic control in patients w/ type 1 diabetes mellitus and in adults w/ type 2 diabetes mellitus.
Initial: Approx 1/3 of total daily insulin requirementsTitrate: 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
Not Currently Treated w/ Insulin: Initial: 0.2 U/kg or up to 10 U qdTitrate: Based on individual's metabolic needs, blood glucose monitoring results, and glycemic control goal
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
≥6 Years: Initial: Approx 1/3 of total daily insulin requirementsTitrate: Based on individual's metabolic needs, blood glucose monitoring results, and glycemic control goal
Concomitant MedicationsFor patients w/ type 2 diabetes, may need to adjust dosage of concomitant oral antidiabetic products
Renal ImpairmentFrequent glucose monitoring and dose adjustments may be necessary
Hepatic ImpairmentFrequent glucose monitoring and dose adjustments may be necessary
Other Important ConsiderationsDosage 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
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 PenFor single patient use only.
Inj: 100 U/mL [3mL SoloStar, 10mL vial]
During episodes of hypoglycemia.
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.
Hypoglycemia, URTI, peripheral edema, HTN, influenza, sinusitis, cataract, bronchitis, arthralgia, infection, pain in extremities, back pain, cough, UTI, diarrhea.
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: 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.
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.
Metabolism: M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin) (active metabolites).
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.
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.
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.
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.