Insulin Aspart Biphasic

Insulin Aspart Biphasic is a biphasic suspension of 30% soluble insulin aspart (rapid-acting human insulin analogue) and 70% protamine-crystallised insulin aspart (intermediate-acting human insulin analogue). Soluble insulin aspart has a rapid onset of action, allowing it to be given closer to a meal (within 0-10 minutes) compared to soluble human insulin. The crystalline phase consists of protamine-crystallised insulin aspart with an activity profile similar to human NPH insulin.

• Type 1 diabetes mellitus (adults and children)
• Type 2 diabetes mellitus (adults)

Adult Dose (Subcutaneous):

• Insulin naive patients (Type 2): Recommended starting dose: 6 Units at breakfast and 6 Units at dinner; OR 12 units at dinner once daily
• Intensification: Once daily to twice daily (when reaching 30 units); Twice daily to thrice daily (split morning dose if recurrent daytime hypoglycemia)
• Dose adjustment: Based on lowest pre-meal blood glucose from previous 3 days; adjust once weekly; do not increase if hypoglycemia occurred within 3 days

Child Dose: Safety and efficacy not established

>10%:

• Hypoglycemia (47-69%)
• Headache (12-35%)
• Influenza-like symptoms (12-13%)

1-10%:

• Dyspepsia (9%)
• Diarrhea (7-8%)
• Back pain (7%)
• Pharyngitis (6-7%)

Frequency Not Defined: Insulin resistance, Lipodystrophy, Lipohypertrophy, Local allergic reaction, Hypokalemia, Weight gain, Peripheral edema

Precautions:

• Rapid changes in serum glucose may induce symptoms of hypoglycemia
• Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions (long duration of diabetes, diabetic nerve disease, beta-blockers, intensified diabetes control)
• Caution in conditions with decreased insulin requirements (diarrhea, nausea/vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment)
• Caution in conditions with increased insulin requirements (fever, hyperthyroidism, trauma, infection, surgery)
• Hypokalemia may occur; caution with potassium-lowering drugs
• Frequent glucose monitoring and insulin dose reduction may be required with renal or hepatic impairment

Contraindications:

• Hypoglycemia
• Hypersensitivity to any of the components

Drug Interactions:

• Oral hypoglycemics, octreotide, MAOIs, nonselective β-adrenergic blockers, ACE inhibitors, salicylates, alcohol, anabolic steroids, sulfonamides reduce insulin requirements
• OCs, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, danazol increase insulin requirements
• β-blocking agents may mask symptoms of hypoglycemia
• Alcohol may intensify and prolong glucose-lowering effect of insulin

Use in Pregnancy: Category B; insulin requirements fall during 1st trimester, increase during 2nd and 3rd; regular monitoring of glucose control essential; advise patients to tell physician if they intend to become or become pregnant.

Use in Lactation: It is unknown whether Insulin Aspart is excreted in human milk; lactating women may require dosage adjustment.

Renal Impairment: Dose adjustments may be needed (dose reduction may be required).

Hepatic Impairment: Dose adjustments may be needed (dose reduction may be required).

Overdose: May result in hypoglycemia; mild episodes treated with oral carbohydrates; severe hypoglycemia treated with parenteral glucose or glucagon injections; adjustments in drug dosage, meal patterns, or exercise may be needed.