Tresiba 100 IU/ml | INDICATIONS AND USES

Insulin Degludec is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Insulin Degludec is not recommended for the treatment of diabetic ketoacidosis.

Tresiba 100 IU/ml | PHARMACOLOGY

The primary activity of insulin, including Insulin Degludec, is regulation of glucose metabolism. Insulin and its analogues lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis. Insulin Degludec forms multihexamers when injected into the subcutaneous tissue resulting in a subcutaneous insulin degludec depot. The protracted time action profile of Insulin Degludec is predominantly due to delayed absorption of insulin degludec from the subcutaneous tissue to the systemic circulation and to a lesser extent due to binding of insulin degludec to circulating albumin.

Tresiba 100 IU/ml | DOSAGE & ADMINISTRATION

Insulin Degludec is ultra long-acting basal insulin for once-daily at any time of the day, preferably at the same time every day.Patients with type 2 diabetes mellitus: The recommended daily starting dose is 10 units followed by individual dosage adjustments.Patients with type 1 diabetes mellitus: Insulin Degludec is to be used once-daily with meal-time insulin and requires subsequent individual dosage adjustments.In patients with type 2 diabetes mellitus, Insulin Degludec can be administered alone or in any combination with oral anti-diabetic medicinal products, GLP-1 receptor agonists and bolus insulin. In type 1 diabetes mellitus, Insulin Degludec must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements. On occasions when administration at the same time of the day is not possible, Insulin Degludec allows for flexibility in the timing of insulin administration. A minimum of 8 hours between injections should always be ensured. Patients who forget a dose, are advised to take it upon discovery and then resume their usual once-daily dosing schedule.

Tresiba 100 IU/ml | DRUG INTERACTIONS

Decreased hypoglycaemic effect with corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents, thyroid hormones, oestrogens, progestins (e.g. in oral contraceptives), protease inhibitors and atypical antipsychotic (e.g. olanzapine and clozapine). Increased hypoglycaemic effect with oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Decreased insulin resistance with octreotide and lanreotide. Increased risk of wt gain and peripheral oedema with pioglitazone, rosiglitazone. Decreased effect of sermorelin.

Tresiba 100 IU/ml | SIDE EFFECTS

Nasopharyngitis, Severe hypoglycemic episode, Upper respiratory tract infection, Headache, Diarrhea, Sinusitis, Gastroenteritis, Injection site reactions, Peripheral edema

Tresiba 100 IU/ml | USE DURING PREGNANCY AND LACTATION

Pregnant Women: There is no clinical experience from well-controlled studies with Insulin degludec in pregnant women. Animal reproduction studies have not revealed any differences between insulin degludec and human insulin regarding embryotoxicity and teratogenicity. Animal reproduction studies are not always predictive of human response; therefore, Insulin degludec should not be used during pregnancy unless the potential benefits to the mother justify the potential risks to the fetusNursing Women: There is no clinical experience from well controlled studies with Insulin degludec during breast-feeding. It is unknown whether insulin degludec is excreted in human milk. In rats, insulin degludec was secreted in milk; the concentration in milk was lower than in plasma.

Tresiba 100 IU/ml | PRECAUTIONS & WARNINGS

Insulin Degludecs must not be injected into a vein (intravenously) or a muscle (intramuscularly) and must not be used in infusion pumps.There is no experience with Insulin Degludec in children and adolescents under 18 years of age.

Tresiba 100 IU/ml | USE IN SPECIAL POPULATIONS

Geriatrics (≥ 65 years of age): No overall clinical differences in safety or effectiveness have been observed between elderly and adult patients.Pediatrics (< 18 years of age): Insulin Degludec is not indicated for use in the pediatric population