Insulin Degludec

Insulin Degludec is an ultra long-acting type of insulin used to treat types 1 and 2 diabetes mellitus in both adults and children. It provides a steady level of insulin in the body for an entire day and helps control blood sugar levels. This helps to prevent complications of diabetes. Insulin Degludec can be prescribed by itself or along with a fast-acting type of insulin or other diabetes medicines. Your doctor or nurse will teach you the correct way of injecting it under the skin. You should use this medicine regularly as per the dose advised to get the most benefit. It is usually taken once daily at the same time every day. However, on occasions when administration at the same time of the day is not possible, it may be taken at a different time of the day. Always ensure that there is a minimum gap of 8 hours between doses. If you stop taking it your blood sugar levels may rise very high and put you at risk of serious complications. It is only a part of the treatment program that should also include a healthy diet, regular exercise, and weight reduction as advised by your doctor. The most common side effect of this medicine is low blood sugar levels (hypoglycemia). To prevent this, it is important to always inject only the correct dose of medicine only, have regular meals and monitor your blood sugar levels regularly. Drinking excessive alcohol can also lead to a fall in your blood sugar levels. Other side effects include allergy at the injection site like redness, swelling, or hard lumps (lipohypertrophy). Some people may also gain weight while taking insulin. Do not use this medicine when you have low blood sugar levels (hypoglycemia). Tell your doctor if you have ever had kidney, liver or heart problems before starting treatment. Pregnant or breastfeeding women should also consult their doctor before using it. Insulin Degludec is a long-acting insulin that provides consistent, all-day sugar control. It works like your body's natural insulin. Insulin facilitates reuptake of sugar in muscle and fat cells and also suppresses the production of sugar in the liver.

• Diabetes mellitus (Type 1 & Type 2)

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

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

Your doctor or nurse will guide you how to use this medicine.

If you miss a dose of Insulin Degludec take it as soon as you remember. Do not take two doses of Insulin Degludec within 8 hours of each other.

Common: • Hypoglycemia (low blood glucose level) • Injection site allergic reaction • Lipodystrophy (skin thickening or pits at the injection site)

[CAUTION] Your ability to drive may be affected if your blood sugar is too low or too high. Do not drive if these symptoms occur. This medicine is injected under the skin. It needs to be injected once daily, at the same time every day. Injection below the skin of the abdomen results in faster absorption than other injection sites. Injection sites must be rotated to prevent hard lumps from developing at one site. Do not use if the preparation is no longer clear and colorless or if it contains particles. Hypoglycemia (low blood sugar level) is a common side effect. Always carry some sugary food or fruit juice with you so that you can take it when you experience hypoglycemia symptoms such as cold sweats, cool pale skin, tremor and anxiety. Opened vials/cartridge stay good at room temperature for up to 4 weeks, while unopened vials must be placed in the refrigerator (2°C–8°C).

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

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.

[UNSAFE] It is unsafe to consume alcohol with Insulin Degludec.

[CONSULT YOUR DOCTOR] Insulin Degludec may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[SAFE IF PRESCRIBED] Insulin Degludec is safe to use during breastfeeding. Human studies suggest that the drug does not pass into the breastmilk in a significant amount and is not harmful to the baby.

[CAUTION] Insulin Degludec should be used with caution in patients with kidney disease. Dose adjustment of Insulin Degludec may be needed. Please consult your doctor. Frequent and regular monitoring of blood glucose levels is advised. [CAUTION] Insulin Degludec should be used with caution in patients with liver disease. Dose adjustment of Insulin Degludec may be needed. Please consult your doctor. Frequent and regular monitoring of blood glucose levels is advised.

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