Indications for SEMGLEE:
Type 1 diabetes (in adults and children) and type 2 diabetes (in adults).
Limitations of Use:
Not for treating diabetic ketoacidosis.
Adults and Children:
Give by SC inj once daily at same time each day into abdominal area, thigh, buttocks or deltoids; rotate inj sites. No pronounced peak, duration over 24hrs. <6yrs: not established. ≥6yrs: individualize; monitor and adjust as needed. Type 1 diabetes: initially ⅓ of total daily insulin dose. Give remainder of the total dose as short-acting, premeal insulin. Insulin-naïve with type 2 diabetes: initially 0.2 Units/kg or up to 10 Units once daily. May need to adjust amount, timing of short- or rapid-acting insulins and doses of any oral antidiabetics. Switching from once-daily insulin glargine 300 Units/mL: initially 80% of the previous insulin glargine 300 Units/mL dose. Switching from an intermediate- or long-acting insulin regimen: may need to change basal insulin dose; and adjust the amount, timing of the short-acting insulins and doses of other antidiabetics. Switching from once-daily NPH: initial Semglee dose should be the same as previous NPH dose. Switching from twice-daily NPH: initially 80% of the previous total NPH dose.
During episodes of hypoglycemia.
Instruct patients on proper administration of insulin, type of insulin, and management of hypoglycemia. Do not reuse or share pens, needles, or syringes between patients, even if the needle is changed. Visual impairment: will need assistance with prefilled pens. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis. Increased risk of hyper- or hypoglycemia if changes in physical activity, meal patterns, renal or hepatic function, insulin regimen, administration site, and if acute illness occurs: monitor glucose more frequently and may need to adjust dose. Discontinue if hypersensitivity reactions occur. Monitor potassium levels in patients at risk for hypokalemia (eg, concomitant K+-lowering or K+-sensitive drugs). Renal or hepatic impairment: monitor more frequently and adjust dose if needed. Elderly. Pregnancy. Nursing mothers.
Do not mix or dilute with other insulins. Concomitant thiazolidinediones (TZDs) may cause fluid retention and heart failure; consider dose reduction or discontinue TZDs. Potentiated by antidiabetic agents, ACEIs, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, salicylates, somatostatin analogs (eg, octreotide), sulfonamide antibiotics. Antagonized by atypical antipsychotics (eg, olanzapine, clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, phenothiazines, progestogens (eg, in oral contraceptives), protease inhibitors, somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), thyroid hormones. Variable effects with alcohol, β-blockers, clonidine, lithium salts, pentamidine. Concomitant β-blockers, clonidine, guanethidine, or reserpine may blunt signs of hypoglycemia.
Hypoglycemia, allergic reactions, inj site reactions, lipodystrophy, pruritus, rash, edema, weight gain; hypokalemia.
Generic Drug Availability:
Vials (10mL)—1; prefilled pens (3mL)—5