Biphasic Insulin Aspart (rDNA) injection is used to improve blood glucose control in adults and children with type 1 diabetes mellitus, and in adults with type 2 diabetes mellitus.

Each ml of suspension contains Insulin Aspart (rDNA) 100 units (equivalent to 3.5 mg), consisting of 30% soluble Insulin Aspart and 70% Insulin Aspart Protamine suspension.

This formulation contains 30% soluble Insulin Aspart and 70% Insulin Aspart Protamine (rDNA), a human insulin analog suspension. It provides rapid blood glucose reduction due to the soluble component, along with a longer, intermediate duration of action from the protamine-bound fraction. Insulin Aspart is structurally similar to human insulin, except for a single substitution where proline is replaced by aspartic acid at position B28. It is produced using recombinant DNA technology with Saccharomyces cerevisiae (baker’s yeast).

The main role of insulin, including Insulin Aspart, is to regulate glucose metabolism. It lowers blood glucose levels by increasing glucose uptake in peripheral tissues such as muscle and fat, and by reducing glucose production in the liver. Additionally, insulin suppresses fat breakdown (lipolysis) and protein breakdown (proteolysis), while promoting protein synthesis.

The dosage of insulin aspart must be individualized.

Subcutaneous injection: insulin aspart should generally be given immediately (within 5-10 minutes) prior to the start of a meal.

Use in pumps: Change the insulin aspart in the reservoir at least every 6 days, change the infusion set, and the infusion set insertion site at least every 3 days. insulin aspart should not be mixed with other insulins or with a diluent when it is used in the pump.

Intravenous use: insulin aspart should be used at concentrations from 0.05 U/mL to 1.0 U/mL insulin aspart in infusion systems using polypropylene infusion bags. insulin aspart has been shown to be stable in infusion fluids such as 0.9% sodiumchloride.

Administration

Before going for administration of Biphasic Insulin Aspart (rDNA) please follow the below mentioned check list:

• Insulin syringe of the right size (100 units/ml)
• Prescribed type of insulin injection
• Check the expiry date on Biphasic Insulin Aspart (rDNA) vial
• Ensure that the flip off cap on the Biphasic Insulin Aspart (rDNA) vial is intact

After that follow the below mentioned instructions:

• Wash your hands carefully. Shake or roll the vial 10 times to completely Mix the insulin.
• Inspect the vial. Vial should appear white and cloudy after mixing.
• When using a new vial, flip off the plastic protective cap, but do not remove the stopper. The tip of the vial should be wiped with an alcohol swab.
• Draw air into the syringe equal to your insulin dose.
• Insert needle into vial through rubber top & push plunger to empty the air into the vial.
• Turn the bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Make sure that the tip of the needle is in the liquid; withdraw the correct dose of insulin into the syringe.
• Before removing the needle from the vial, check the insulin syringe for air bubbles, which reduces the amount of insulin in it, if bubbles are present, hold the insulin straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose again.
• Lightly pinch up the skin, holding the syringe like a pencil.
• Insert the needle into the skin & push the plunger slowly. Make sure that the needle is all the way in.
• Wait for 5 seconds & pull out the syringe. Do not rub the area.

Various substances can influence glucose metabolism and may require dose adjustment along with close monitoring.

Some drugs may enhance the blood glucose–lowering effect and increase the risk of hypoglycemia, such as: oral antidiabetic agents, pramlintide, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), propoxyphene, salicylates, and sulfonamide antibiotics.

On the other hand, certain substances may reduce the glucose-lowering effect, including: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents, isoniazid, phenothiazine derivatives, somatropin, estrogens, progestogens, atypical antipsychotics, beta-blockers, clonidine, lithium salts, and alcohol. Alcohol may either increase or decrease the glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which can sometimes be followed by hyperglycemia.

Biphasic Insulin Aspart (rDNA) should not be used in the following conditions:

• During episodes of hypoglycemia
• In patients who are hypersensitive to Insulin Aspart or any of its components

Common side effects of Insulin Aspart include hypoglycemia, lipodystrophy, weight gain, and peripheral edema.

Pregnancy: Classified as category B. Careful monitoring of blood glucose is essential during pregnancy, as insulin requirements may change at different stages. Women should consult their physician if they plan to become pregnant or become pregnant while using insulin aspart.

Lactation: It is not known whether Insulin Aspart is excreted in human breast milk. There are no adequate and well-controlled studies in breastfeeding women. Dose adjustments may be necessary for lactating mothers.

Dose adjustment and monitoring: Blood glucose levels should be regularly monitored in all patients receiving insulin. Any changes in insulin regimen must be made cautiously and under proper medical supervision.

Renal or hepatic impairment: Patients with kidney or liver impairment may require a reduced dose of Insulin Aspart.

Pediatric: The safety and effectiveness have not been established in children with type 2 diabetes, and it has not been studied in children with type 1 diabetes below 2 years of age.

An overdose of Insulin Aspart may lead to hypoglycemia. Mild cases can usually be managed with oral carbohydrate intake. Severe cases may require treatment with intravenous glucose or glucagon injection. Adjustments in dosage, diet, or physical activity may also be necessary.

Combination Insulin

Store at 2°C to 8°C in a refrigerator. Do not freeze. If refrigeration is not available for insulin in current use, it should be kept in a cool place, protected from heat and light. Insulin currently in use may be stored at room temperature for up to one month.