insulin aspart protamine/insulin aspart (NovoLog Mix 50/50, NovoLog Mix 70/30, NovoLog Mix 70/30 FlexPen)

Dosing and uses of NovoLog Mix 50/50, NovoLog Mix 70/30 (insulin aspart protamine/insulin aspart)

• Adult
• Pediatric

 

Adult dosage forms and strengths

insulin aspart protamine/insulin aspart

subcutaneous injection

• (70units/30units)/mL

 

Diabetes Mellitus

Combination rapid-onset (faster than regular insulin) and intermediate-acting insulins in fixed dose

Dose regimen varies among patients depending on metabolic needs; typical daily insulin requirements range between 0.5-1 unit/kg

Administer SC q12hr (ie, before breakfast and evening meal); each dose intended to cover 2 meals or a meal and snack

Inject SC into abdominal wall, thigh, or upper arm

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

NovoLog Mix 50/50, NovoLog Mix 70/30 (insulin aspart protamine/insulin aspart) adverse (side) effects

>10%

Hypoglycemia (47-69%)

Headache (12-35%)

Influenza-like symptoms (12-13%)

 

1-10%

Headache (9%)

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

 

Warnings

Contraindications

Hypersensitivity

Hypoglycemia

 

Cautions

Suspension for SC use, do not administer IV

Administer within 15 minutes of meals (rapid onset and peak ~1 hr)

Rapid changes in serum glucose may induce symptoms of hypoglycemia

Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions (eg, long duration of diabetes, diabetic nerve disease, use of beta-blockers or intensified diabetes control)

Caution in conditions with decreased insulin requirements (eg, diarrhea, nausea, vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment)

Caution in conditions with increased insulin requirements (eg, fever, hyperthyroidism, trauma, infection, surgery)

May cause a shift in potassium from extracellular to intracellular space, possibly leading to hypokalemia; caution when coadministered with potassium-lowering drugs or conditions that may decrease potassium

Frequent glucose monitoring and insulin dose reduction may be required with renal or hepatic impairment; not recommended during periods of rapidly declining renal or hepatic function because of risk for prolonged hypoglycemia

Thiazolidinediones are peroxisome proliferator-activated receptor (PPAR)-gamma agonists and can cause dose-related fluid retention, particularly when used in combination with insulin; fluid retention may lead to or exacerbate heart failure, monitor for signs and symptoms of heart failure and treat accordingly and consider discontinuing thiazolidinediones

Do not mix with other insulins

Do not administer via insulin infusion pump

Never share pen between patients even if needle is changed

 

Pregnancy and lactation

Pregnancy category: B

Lactation: Unknown whether distributed in breast milk; compatible with breast feeding, but lactating women may require dosage adjustment; caution advised

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of NovoLog Mix 50/50, NovoLog Mix 70/30 (insulin aspart protamine/insulin aspart)

Mechanism of action

Regulates glucose metabolism

Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production; insulin inhibits lipolysis and proteolysis, and enhances protein synthesis

 

Pharmacokinetics

Bioavailability: SC, well absorbed (2-3 times faster than regular insulin)

Half-Life: 8-9 hr Onset: <15 min

Peak Plasma Time: 1-1.5 hr  

Peak Pharmacodynamic Activity: 1-4 hr after dose administration

Peak Plasma Concentration: 23.4 mU/L (after 0.2 unit/kg dose)

Protein Bound: 0-9%; similar to regular human insulin

Metabolism: Liver >50%, kidney 30%, adipose tissue/muscle 20%

Clearance:  1.2 L/hr/kg

Vd: 0.15 L/kg