Indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Not recommended for the treatment of diabetic ketoacidosis.

Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen. Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis.

DO NOT administer TRESIBA intravenously or in an insulin infusion pump.

TRESIBA is contraindicated during episodes of hypoglycemia.

Hypoglycemia is the most common adverse reaction of insulin, including TRESIBA.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including TRESIBA.

All insulin products, including TRESIBA, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists can cause dose related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate congestive heart failure. Patients treated with insulin, including TRESIBA and a PPAR-gamma agonist should be observed for signs and symptoms of congestive heart failure.

Weight gain can occur with insulin therapy, including TRESIBA, and has been attributed to the anabolic effects of insulin.

Insulin, including TRESIBA, may cause sodium retention and edema.

As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form.

Dose reductions and increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs as they may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors.

Dose increases and increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs as they may decrease the blood glucose lowering effect of TRESIBA:  atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.

Dose adjustment and increased frequency of glucose monitoring may be required when TRESIBA is co administered with these drugs as they may increase or decrease the blood glucose lowering effect of TRESIBA: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs as they may blunt signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine.

There are no available data with TRESIBA or insulin degludec in pregnant women to inform a drug associated risk for major birth defects and miscarriage. Animal studies: pre- and post-implantation losses
and visceral/skeletal abnormalities. 

There are no data on the presence of insulin degludec in human milk, the effects on the breastfed infant, or the effects on milk production. Insulin degludec is present in rat milk.

GoToSource

• Use in patients under 1 year of age. GoToSource

Hypoglycemia (low blood sugar), allergic reactions, injection site reactions, lipodystrophy (pitting at injection site), itching, rash, swelling and weight gain. GoToSource

Increased risk of cardiovascular events (acute coronary syndrome). GoToSource

No major injury lawsuits reported.