Uses of Tresiba Flexpen: - Diabetes mellitus (Type 1 & Type 2) Diabetes Mellitus Hypersensitivity to the active substance or to any of the excipients.Hypoglycaemia, Hyperglycaemia, Eye disorder.

Long Acting Insulin

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.

How to use Insulin Degludec: Your doctor or nurse will guide you how to use this medicine. Administration: Inject SC once daily at any time of day Inject SC 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 Do not administer IV, IM, or in an insulin infusion pump Adult Dose: Adult: S/C: Insulin Degludec is ultra long-acting basal insulin for once-daily at any time of the day, preferably at the same time every day. Initiation: 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: One third to one half of the total daily insulin dose; as a general rule, 0.2-0.4 units/kg can be used to calculate the initial total daily insulin dose in insulin-naïve patients with type 1 diabetes Insulin Degludec is to be used once-daily with meal-time insulin and requires subsequent individual dosage adjustments. Starting dose in patients already on insulin therapy Type 1 and type 2 diabetes mellitus: Start insulin degludec at the same unit dose as the total daily long- or intermediate-acting insulin unit dose 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. Dose Adjustments Individualize and titrate the dose based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal The recommended days between dose increases is 3-4 days Dose adjustments may be needed with changes in physical activity, changes in meal patterns (ie, macronutrient content or timing of food intake), changes in renal or hepatic function, or during acute illness to minimize the risk of hypoglycemia or hyperglycemia Child Dose: Safety and efficacy not established

Possible absence of hypoglycaemic warning symptoms with ?-blockers. 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.

Common - Hypoglycemia (low blood glucose level) - Injection site allergic reaction - Lipodystrophy (skin thickening or pits at the injection site) >10% Nasopharyngitis (12.9-23.9%),Severe hypoglycemic episode (0.3-12.3%),Upper respiratory tract infection (8.4-11.9%),Headache (8.8-11.8%) 1-10% Diarrhea (6.3%),Sinusitis (5.1%),Gastroenteritis (5.1%),Injection site reactions (3.8%),Peripheral edema (0.9-3%) <1% Lipodystrophy

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.

Precaution: 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. Lactation: Unknown if distributed in human breast milk

Long Acting Insulin

Once-daily basal insulin analogue 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 inhibits lipolysis and proteolysis and enhances protein synthesis; targets include skeletal muscle, liver, and adipose tissue

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.