Generic Name and Formulations:
Insulin glargine (recombinant) 300 Units/mL; soln for SC inj.
Indications for TOUJEO:
Limitations Of use:
Not for treating diabetic ketoacidosis.
Give by SC inj once daily at same time each day into abdominal area, thigh, or deltoid. Rotate inj sites. Onset 6hrs, duration 24hrs–5 days. Individualize; monitor and adjust as needed. Usual range: 1–80 Units per inj. Titrate every 3–4 days. Insulin-naïve with type 1 diabetes: Initially ⅓–½ of total daily insulin dose. Give remainder of the total dose as short-acting insulin divided between each daily meal. Insulin-naïve with type 2 diabetes: Initially 0.2 Units/kg once daily. May need to adjust dose of other co-administered antidiabetic drugs. Switching from once-daily long-acting or intermediate acting insulin: initial dose should be the same on a unit-for-unit basis. Switching from Lantus: higher daily dose will be needed. Switching from twice-daily NPH: reduce initial insulin glargine dose by 20% from previous total daily NPH dose.
During episodes of hypoglycemia.
Increased risk of hypoglycemia if changes in physical activity, meal patterns, renal or hepatic function, insulin regimen and if acute illness occurs: monitor glucose more frequently and may need to adjust dose. Discontinue if hypersensitivity reactions occur. Visual impairment. Renal or hepatic impairment; monitor more frequently and adjust dose if needed. 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 agonists, DPP-4 inhibitors, SGLT-2 inhibitors; monitor more frequently and adjust dose as needed. Reduced efficacy with concomitant atypical antipsychotics (eg, olanzapine, clozapine), steroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, protease inhibitors, somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), thyroid hormones; monitor more frequently and adjust dose if needed. Variable effects with alcohol, β-blockers, clonidine, lithium salts, pentamidine; monitor more frequently and adjust dose if needed. Concomitant β-blockers, clonidine, guanethidine, or reserpine may reduce or mask signs/symptoms of hypoglycemia; monitor.
Hypoglycemia, allergic reactions, inj. site reactions, lipodystrophy, pruritus, rash, edema, weight gain; hypokalemia (monitor).
SoloStar prefilled pen (1.5mL)—3; Max SoloStar prefilled pen (3mL)—2