Tresiba Flexpen100IU/ml

Tresiba Flexpen 100IU/ml is indicated for once-daily treatment of adults with diabetes mellitus to improve glycemic control. Tresiba Flexpen 100IU/ml is not recommended for the treatment of diabetic ketoacidosis.

Long Acting Insulin

The primary activity of insulin, including Tresiba Flexpen 100IU/ml, 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. Tresiba Flexpen 100IU/ml forms multihexamers when injected into the subcutaneous tissue resulting in a subcutaneous Tresiba Flexpen 100IU/ml depot. The protracted time action profile of Tresiba Flexpen 100IU/ml is predominantly due to delayed absorption of Tresiba Flexpen 100IU/ml from the subcutaneous tissue to the systemic circulation and to a lesser extent due to binding of Tresiba Flexpen 100IU/ml to circulating albumin.

Tresiba Flexpen 100IU/ml 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: Tresiba Flexpen 100IU/ml is to be used once-daily with meal-time insulin and requires subsequent individual dosage adjustments.In patients with type 2 diabetes mellitus, Tresiba Flexpen 100IU/ml 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, Tresiba Flexpen 100IU/ml 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, Tresiba Flexpen 100IU/ml 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 Flexpen 100IU/ml 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: Tresiba Flexpen 100IU/ml is to be used once-daily with meal-time insulin and requires subsequent individual dosage adjustments.In patients with type 2 diabetes mellitus, Tresiba Flexpen 100IU/ml 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, Tresiba Flexpen 100IU/ml 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, Tresiba Flexpen 100IU/ml 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.

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.

Hypersensitivity to the active substance or to any of the excipients. Hypoglycaemia, Hyperglycaemia, Eye disorder.

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

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 Tresiba Flexpen 100IU/ml 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 Tresiba Flexpen 100IU/ml is excreted in human milk. In rats, Tresiba Flexpen 100IU/ml was secreted in milk; the concentration in milk was lower than in plasma.

Tresiba Flexpen 100IU/mls 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 Tresiba Flexpen 100IU/ml in children and adolescents under 18 years of age.

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): Tresiba Flexpen 100IU/ml is not indicated for use in the pediatric population

Long Acting Insulin

The primary activity of insulin, including Tresiba Flexpen 100IU/ml, 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. Tresiba Flexpen 100IU/ml forms multihexamers when injected into the subcutaneous tissue resulting in a subcutaneous Tresiba Flexpen 100IU/ml depot. The protracted time action profile of Tresiba Flexpen 100IU/ml is predominantly due to delayed absorption of Tresiba Flexpen 100IU/ml from the subcutaneous tissue to the systemic circulation and to a lesser extent due to binding of Tresiba Flexpen 100IU/ml to circulating albumin.

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 Tresiba Flexpen 100IU/ml 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 Tresiba Flexpen 100IU/ml is excreted in human milk. In rats, Tresiba Flexpen 100IU/ml was secreted in milk; the concentration in milk was lower than in plasma.

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): Tresiba Flexpen 100IU/ml is not indicated for use in the pediatric population