Tresiba Flextouch Injection
Insulin Degludec
200 Units/ml
Novo Nordisk A/S
| Pack size | 3ml Pre-filled Pen x 3 |
|---|---|
| Dispensing mode | POM |
| Source | DENMARK |
| Agent | CITY MEDICAL STORE |
| Retail Price | 717.00 AED |
Available as:
Indications
Tresiba Flextouch Injection is used for:
Diabetes Mellitus
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
Renal Dose
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
Contra Indications
Hypersensitivity to the active substance or to any of the excipients.Hypoglycaemia, Hyperglycaemia, Eye disorder.
Precautions
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
Pregnancy-Lactation
Pregnancy
There are no available data with insulin degludec in pregnant women to inform a drug-associated risk for major birth defects and miscarriage
There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy
Animal studies
The effect of insulin degludec was consistent with those observed with human insulin as both caused preimplantation and postimplantation losses and visceral/skeletal abnormalities in rats at an insulin degludec dose of 21 U/kg/day (~5 times the human exposure [AUC] at a human SC dose of 0.75 U/kg/day) and in rabbits at a dose of 3.3 U/kg/day (~10 times the AUC at a human SC dose of 0.75 U/kg/day)
The effects are probably secondary to maternal hypoglycemia
Lactation
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
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
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.
Adverse Effects
Side effects of Insulin Degludec :
>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
Mechanism of Action
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
Note
Tresiba Flextouch 200 Units/ml Injection manufactured by Novo Nordisk A/S. Its generic name is Insulin Degludec. Tresiba Flextouch is availble in United Arab Emirates.
Farmaco UAE drug index information on Tresiba Flextouch Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.