Biphasic Insulin Aspart

• Approved Indications:
• Treatment of type 1 diabetes mellitus requiring insulin for glycemic control.
• Treatment of type 2 diabetes mellitus when diet, exercise, and oral antidiabetic agents do not provide adequate glycemic control and insulin therapy is required.
• Off-label / Clinically Accepted Uses:
• Use in diabetic ketoacidosis stabilization after initial management (under specialist supervision).
• May be used in combination with other antidiabetic therapies.

• Route: Subcutaneous injection.
• Adults:
• Initial dose individualized based on previous insulin requirements, blood glucose monitoring, and patient condition.
• Typical starting dose for type 2 diabetes is 0.2–0.4 units/kg/day, divided into two doses, typically before breakfast and dinner.
• Dose adjustment guided by blood glucose levels.
• Pediatrics:
• Dosing individualized based on weight, glycemic control, and clinical response.
• Generally used in children and adolescents with type 1 diabetes.
• Elderly:
• Start with lower doses and titrate carefully to minimize hypoglycemia risk.
• Special Populations:
• Renal or hepatic impairment may increase risk of hypoglycemia; dosage adjustment and close monitoring advised.
• Administration Instructions:
• Inject subcutaneously into the thigh, abdomen, or upper arm.
• Rotate injection sites to reduce lipodystrophy risk.
• Do not administer intravenously or intramuscularly.
• Usually administered twice daily before meals (breakfast and dinner).

Biphasic Insulin Aspart is a premixed insulin formulation containing rapid-acting insulin aspart and intermediate-acting insulin aspart protamine suspension. Insulin aspart acts by binding to insulin receptors on cell surfaces, promoting glucose uptake primarily in muscle and adipose tissue and inhibiting hepatic glucose production. The rapid-acting component controls postprandial glucose excursions, while the intermediate component provides basal insulin coverage. Together, they improve glycemic control by mimicking physiological insulin secretion patterns.

• Absorption:
• Rapid-acting component (insulin aspart) onset within 10-20 minutes after subcutaneous injection.
• Intermediate component onset approximately 1-4 hours post-injection.
• Peak:
• Rapid-acting peak at 1-3 hours.
• Intermediate-acting peak at 4-12 hours.
• Duration:
• Total duration approximately 24 hours due to the biphasic profile.
• Distribution:
• Insulin distributes mainly in the extracellular fluid.
• Metabolism:
• Metabolized by insulinases in the liver and kidneys.
• Excretion:
• Metabolites are excreted primarily via the kidneys.

• Pregnancy: Category B — No adequate human studies but animal studies show no harm; insulin is the preferred agent to manage diabetes during pregnancy.
• Lactation: Insulin passes minimally into breast milk; considered safe during breastfeeding with appropriate glucose monitoring.

• Primary Class: Antidiabetic agent
• Subclass: Rapid/intermediate-acting insulin combination (biphasic insulin analog)

• Known hypersensitivity to insulin aspart or any formulation excipients.
• Hypoglycemia or conditions predisposing to hypoglycemia (unless managed carefully).

• Risk of hypoglycemia, especially with dose adjustments, missed meals, or exercise.
• Monitor blood glucose regularly.
• Adjust dose carefully during illness, changes in diet or activity, or concomitant medications.
• Use cautiously in patients with renal or hepatic impairment.
• Potential for allergic reactions or local injection site reactions.
• Rotate injection sites to prevent lipodystrophy.

• Common:
• Hypoglycemia (most frequent and potentially serious)
• Injection site reactions (pain, redness, swelling, lipodystrophy)
• Weight gain
• Rare:
• Allergic reactions (rash, pruritus, anaphylaxis)
• Edema

• Drugs that may potentiate hypoglycemia: sulfonylureas, meglitinides, ACE inhibitors, fibrates, fluoxetine, monoamine oxidase inhibitors, beta-blockers, alcohol.
• Drugs that may reduce hypoglycemic effect: corticosteroids, diuretics, thyroid hormones, oral contraceptives, sympathomimetics.
• Beta-blockers may mask hypoglycemia symptoms.
• Dose adjustments may be necessary when starting or stopping interacting drugs.

• Guidelines recommend individualized insulin regimens for optimal glycemic control.
• Biphasic insulin analogs are favored for convenience and better postprandial glucose control compared to human insulin mixtures.
• Continuous glucose monitoring integration encouraged for dose optimization.
• Newer basal-bolus regimens and insulin pumps gaining preference in type 1 diabetes but biphasic insulin remains widely used.

• Store unopened vials/pens at 2°C to 8°C (refrigerated).
• Do not freeze.
• Protect from light.
• Once opened, may be kept at room temperature (below 25°C) for up to 28 days.
• Discard if discoloration, clumping, or precipitation occurs.
• Keep out of reach of children.