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Insulin degludec + Insulin aspart 70/30 premixed is a combination of two medicines, a long-acting and a rapid-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. Insulin degludec + Insulin aspart 70/30 premixed can be prescribed by itself or along with 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 part of a 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 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 gain weight while taking insulin. You may also notice a rash, edema (swelling), or itching while taking this medicine. 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 + Insulin aspart 70/30 premixed is a combination of two insulin preparations: Insulin degludec and insulin aspart. Insulin degludec has a prolonged duration of action while insulin aspart has a fast onset of action. Together, they ensure rapid and consistent sugar control by facilitating reuptake of sugar in muscle and fat cells, and suppressing the production of sugar in the liver.

• Diabetes mellitus (Type 1 & Type 2)

Insulin degludec and insulin aspart binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin. The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.

Adult Dose: Subcutaneous Prefilled pen Insulin degludec 70 units/insulin aspart 30 units per mL (ie, 100 units/mL for combination) Starting dose in insulin naïve patients Type 1 diabetes mellitus: One third to one half of the total daily insulin dose; as a general rule; the remainder of the total daily insulin dose should be administered as a short- or rapid-acting insulin divided between each daily meal; 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 Type 2 diabetes mellitus: 10 units SC once daily Starting dose in patients with types 1 or 2 diabetes on a once or twice daily premix or self-mix insulin alone or as part of a regimen of multiple daily injections Start insulin degludec/insulin aspart 70/30 at the same unit dose and injection schedule as the premix or self-mix insulin In patients also using short- or rapid-acting insulin at mealtimes, continue the short- or rapid-acting insulin at the same dose for meals NOT covered by degludec/insulin aspart 70/30 Starting dose in patients with types 1 or 2 diabetes on a once or twice daily basal insulin alone or as part of a regimen of multiple daily injections Patients with T2DM switching from regimen that includes only a once- or twice-daily basal insulin, start insulin degludec/insulin aspart 70/30 at the same unit dose and injection schedule For patients switching from once-daily basal insulin to once-daily insulin degludec/insulin aspart 70/30, monitor blood glucose after starting therapy due to the rapid-acting insulin component In patients switching from a multiple daily injections regimen that includes a basal and short- or rapid-acting insulin at mealtimes, start insulin degludec/insulin aspart 70/30 once daily with the main meal at the same unit dose as the basal insulin; continue the short- or rapid-acting insulin at the same dose for meals NOT covered by insulin degludec/insulin aspart 70/30 Dose Adjustment Individualize and titrate the dose based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal Adjust dose according to blood glucose measurements before breakfast (fasting) 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 If a dose of insulin degludec/insulin aspart 70/30 is missed, the next dose should be taken with the next main meal of that day and thereafter resume the usual dosing schedule; patients should not take an extra dose to make up for a missed dose Child Dose: Safety and efficacy not established Renal Dose: Renal impairment: Dose adjustments may be needed.

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

Common: • Rash • Weight gain • Injection site allergic reaction • Lipodystrophy (skin thickening or pits at the injection site) • Edema (swelling) • Itching • Hypoglycemia (low blood glucose level)

[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. Take it 15 minutes before a meal or within 20 minutes after starting a meal. Injection below the skin of the abdomen results in faster absorption as compared to other injection sites such as skin of the upper arms, thighs, or buttocks. After injection, the site of injection should not be massaged. Injection sites must be rotated to prevent hard lumps from developing at one site. Change to another type or brand of insulin should be done under strict medical supervision as it may require a change in dosage. Hypoglycemia (low blood sugar level) may occur when taken along with other antidiabetic medicines, alcohol or on delaying/skipping a meal. Carry a sugar source with you for immediate relief. Do not share your insulin device with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. Opened vials / cartridge are 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 substances or to any of the excipients.

[UNSAFE] It is unsafe to consume alcohol with Insulin degludec + Insulin aspart 70/30 premixed.

[CONSULT YOUR DOCTOR] Insulin degludec + Insulin aspart 70/30 premixed 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 + Insulin aspart 70/30 premixed 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 + Insulin aspart 70/30 premixed should be used with caution in patients with kidney disease. Dose adjustment of Insulin degludec + Insulin aspart 70/30 premixed may be needed. Please consult your doctor. Regular monitoring of blood glucose levels is recommended for dose adjustment. [CAUTION] Insulin degludec + Insulin aspart 70/30 premixed should be used with caution in patients with liver disease. Dose adjustment of Insulin degludec + Insulin aspart 70/30 premixed may be needed. Please consult your doctor. Frequent and regular monitoring of blood glucose levels is advised.

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