RapiMix

Insulin Aspart + Insulin Aspart Protamine is indicated for glycemic control in diabetes mellitus:

Approved Indications:

• Type 1 Diabetes Mellitus (T1DM):
  Provides both rapid-acting prandial coverage (Aspart) and intermediate-acting basal coverage (Aspart Protamine), suitable for patients requiring multiple daily insulin doses.
• Type 2 Diabetes Mellitus (T2DM):
  For patients inadequately controlled on oral antidiabetic agents or requiring insulin therapy, particularly when both postprandial and basal control is needed.

Clinically Accepted Off-Label Uses:

• Selected cases of gestational diabetes under close medical supervision.
• Inpatient hyperglycemia management when combined basal-prandial insulin therapy is preferred.

Administration Route: Subcutaneous injection in the thigh, upper arm, or abdomen. Rotate injection sites to reduce lipodystrophy. Do not mix with other insulin formulations in the same syringe.

Adults:

• Dose individualized based on previous insulin therapy, glucose levels, and body weight.
• Commonly administered twice daily, before major meals.
• Dose titration: Adjust based on pre-meal and postprandial glucose monitoring, typically in 2–4 unit increments every 3–4 days.

Pediatrics (≥1 year):

• Initial dose based on body weight, prior insulin exposure, and glycemic targets.
• Frequent glucose monitoring is required during initiation and titration.

Elderly:

• Initiate at lower doses due to increased hypoglycemia risk.
• Close monitoring of renal and hepatic function is recommended.

Special Populations:

• Renal Impairment: Reduced clearance may require dose adjustments; frequent monitoring is recommended.
• Hepatic Impairment: Initiate cautiously and titrate according to glucose response.
• Transitioning from Other Insulins: Total daily dose calculated and divided according to rapid-acting/basal ratio.

Insulin Aspart is a rapid-acting insulin analog that mimics the body’s natural postprandial insulin secretion, facilitating rapid glucose uptake by muscle and adipose tissue and suppressing hepatic glucose output. Insulin Aspart Protamine is an intermediate-acting insulin formed by complexing Aspart with protamine, which slows absorption and provides basal insulin coverage. Together, the premixed formulation offers both prandial glucose control and basal glycemic stability, reducing fluctuations in blood glucose throughout the day.

• Absorption:
• Aspart: Rapid, peak effect 1–3 hours post-injection.
• Aspart Protamine: Slower absorption with peak effect 4–12 hours.
• Distribution: Distributed in extracellular fluid; plasma protein binding minimal.
• Metabolism: Proteolytic degradation in liver and kidneys; no active metabolites.
• Elimination: Primarily renal; half-life: Aspart ~1 hour, Aspart Protamine ~4–6 hours.
• Onset of Action: Aspart 10–20 minutes, Aspart Protamine 1–2 hours.
• Duration: Aspart 3–5 hours, Aspart Protamine 12–16 hours.

• Pregnancy: Insulin is the preferred agent for glycemic control. Aspart and Aspart Protamine have limited pregnancy-specific data but are generally considered safe under clinical supervision.
• Lactation: Compatible with breastfeeding; minimal transfer to milk. Monitor infant for hypoglycemia.
• Caution: Dose adjustments may be required based on frequent blood glucose monitoring during pregnancy and lactation.

• Primary Class: Antidiabetic Agent
• Subclass: Insulin analog, premixed rapid-acting/intermediate-acting

• Known hypersensitivity to Insulin Aspart, Insulin Aspart Protamine, or any excipients.
• Severe hypoglycemia.
• Diabetic ketoacidosis unless used as part of treatment regimen.

• Hypoglycemia: Risk higher in elderly, renal/hepatic impairment, or when combined with other hypoglycemic agents.
• Allergic Reactions: Rare anaphylaxis possible; discontinue if severe.
• Fluid Retention/Heart Failure: Monitor patients on thiazolidinediones.
• Injection Site Reactions: Lipodystrophy may occur; rotate injection sites.
• Monitoring: Frequent glucose monitoring and HbA1c assessments recommended.

Common:

• Hypoglycemia (most frequent)
• Injection site reactions: redness, swelling, itching
• Weight gain

Less Common:

• Edema
• Allergic reactions
• Lipodystrophy

Rare/Severe:

• Severe hypoglycemia with neuroglycopenic symptoms
• Anaphylactic reactions

• Sulfonylureas, meglitinides: Increased risk of hypoglycemia.
• Beta-blockers: May mask hypoglycemia symptoms.
• Alcohol: Can potentiate or reduce hypoglycemic effect.
• Corticosteroids, thiazide diuretics: Can reduce insulin effectiveness.
• CYP450: Minimal involvement; insulin is metabolized via proteolytic pathways.

• Premixed Aspart/Aspart Protamine formulations recommended for patients needing both rapid and intermediate insulin coverage.
• Guidelines highlight individualized dosing and frequent glucose monitoring to reduce hypoglycemia risk.
• Flexible timing for twice-daily injections is supported to improve adherence.

• Temperature: Store 2°C–8°C (refrigerated); do not freeze.
• Room Temperature Use: Can be kept at ≤30°C for up to 4 weeks (specific to pen/vial).
• Light Protection: Keep in original pen/vial; protect from direct sunlight.
• Handling: Roll gently before use; do not shake vigorously.
• Reconstitution: Not required; solution is clear and ready-to-use.