Generic Name and Formulations:
Insulin degludec 100 Units/mL, 200 Units/mL; SC inj; contains zinc, m-cresol.
Indications for TRESIBA:
To improve glycemic control in patients with diabetes mellitus.
Limitations Of use:
Not for treating diabetic ketoacidosis. Not for use in pediatric patients requiring <5 Units.
Give by SC inj once daily at any time of day into thigh, upper arm, or abdomen. Rotate inj sites. Individualize. Titrate every 3–4 days. Insulin-naïve with type 1 diabetes: initially ⅓–½ of total daily insulin dose (usually 0.2–0.4 Units/kg). Give remainder of the total dose as short-acting insulin divided between each daily meal. Insulin-naïve with type 2 diabetes: initially 10 Units once daily. May need to adjust dose of concomitant oral antidiabetic drugs. Already on insulin therapy (Types 1 and 2): start at same unit dose as total daily long- or intermediate-acting insulin unit dose.
<1yrs: not established. ≥1yrs: Give by SC inj once daily at same time every day into thigh, upper arm, or abdomen. Rotate inj sites. Individualize. Titrate every 3–4 days. Insulin-naïve with type 1 diabetes: initially ⅓–½ of total daily insulin dose (usually 0.2–0.4 Units/kg). Give remainder of the total dose as short-acting insulin divided between each daily meal. Insulin-naïve with type 2 diabetes: initially 10 Units once daily. May need to adjust dose of concomitant oral antidiabetic drugs. Already on insulin therapy (Types 1 and 2): start at 80% of the total daily long- or intermediate-acting insulin unit dose.
During episodes of hypoglycemia.
Instruct patients on diet, exercise, changes in insulin, manufacturer, type, or method of administration, and management of hypoglycemia. Do not reuse or share pens, needles, or syringes between patients. Increased risk of hypoglycemia with intensity of glycemic control; changes in physical activity, meal patterns, or insulin regimen; renal or hepatic impairment; and if acute illness occurs; monitor. Discontinue if hypersensitivity reactions occur. Visual impairment. Elderly. Pregnancy. Nursing mothers.
Do not mix or dilute with other insulins or solutions. Caution with K+-depleting drugs or those sensitive to serum K+ concentrations; may cause hypokalemia. Concomitant thiazolidinediones (TZDs) may cause fluid retention and heart failure; consider dose reduction or discontinue TZDs. Increased risk of hypoglycemia with concomitant antidiabetics, ACEIs, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (eg, octreotide), sulfonamides, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors; monitor more frequently and reduce dose as needed. Reduced efficacy with concomitant atypical antipsychotics (eg, olanzapine), steroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, protease inhibitors, somatropin, sympathomimetics, thyroid hormones; monitor more frequently and increase dose as needed. Variable effects with alcohol, β-blockers, clonidine, lithium salts, pentamidine; may need to adjust dose. Concomitant β-blockers, clonidine, guanethidine, reserpine may mask hypoglycemia.
Hypoglycemia, allergic reactions, inj site reactions, lipodystrophy, pruritus, rash, edema, weight gain, hypokalemia (monitor).
FlexTouch pen (3mL)—5 (U-100), 3 (U-200)
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