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Tresiba Generic Name & Formulations
Legal Class
Rx
General Description
Insulin degludec 100 Units/mL, 200 Units/mL; SC inj; contains zinc, m-cresol.
How Supplied
FlexTouch pen (3mL)—5 (U-100), 3 (U-200); Multi-dose vial (10mL)—1 (U-100)
Manufacturer
Generic Availability
NO
Tresiba Indications
Indications
To improve glycemic control in patients with diabetes mellitus.
Limitations of Use
Not for treating diabetic ketoacidosis.
Tresiba Dosage and Administration
Adult
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.
Children
<1yrs: not established. Use vial for doses <5 Units. ≥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.
Tresiba Contraindications
Contraindications
During episodes of hypoglycemia.
Tresiba Boxed Warnings
Not Applicable
Tresiba Warnings/Precautions
Warnings/Precautions
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, even if the needle is changed. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis. Increased risk of hyperglycemia or hypoglycemia with intensity of glycemic control; changes in physical activity, meal patterns, insulin regimen, or administration site; renal or hepatic impairment; and if acute illness occurs; monitor. Monitor potassium levels in patients at risk for hypokalemia (eg, concomitant K+-lowering or K+-sensitive drugs). Discontinue if hypersensitivity reactions occur. Visual impairment. Elderly. Pregnancy. Nursing mothers.
Tresiba Pharmacokinetics
See Literature
Tresiba Interactions
Interactions
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.
Tresiba Adverse Reactions
Adverse Reactions
Hypoglycemia, allergic reactions, inj site reactions, lipodystrophy, pruritus, rash, edema, weight gain, hypokalemia.
Tresiba Clinical Trials
See Literature
Tresiba Note
Not Applicable
Tresiba Patient Counseling
See Literature
