Classes
DEA Class; Rx
Common Brand Names; NovoLog Mix 70/30, NovoLog Mix 70/30 FlexPen
- Antidiabetics, Insulins
Description
Insulin is essential for the metabolism and homeostasis of carbohydrate, fat, and protein; this combination is a premixed combination of insulin aspart and insulin aspart protamine
Used to treat Type 1 and Type 2 diabetes mellitus
Provides the fast onset of action of insulin aspart (15 min) and the intermediate duration of action of insulin aspart protamine
Indications
Indicated for the treatment of type 1 diabetes mellitus.
Contraindications
Hypersensitivity
Hypoglycemia
Adverse Effects
- Hypoglycemia (47-69%)
- Headache (12-35%)
- Influenza-like symptoms (12-13%)
- Headache (9%)
- Dyspepsia (9%)
- Diarrhea (7-8%)
- Back pain (7%)
- Pharyngitis (6-7%)
- Insulin resistance
- Lipodystrophy
- Lipohypertrophy
- Local allergic reaction
- Hypokalemia
- Weight gain
- Peripheral edema
- Localized cutaneous amyloidosis
- Hypersensitivity reactions
Warnings
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
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products; if hypersensitivity reactions occur, discontinue therapy; treat per standard of care and monitor until symptoms and signs resolve; this drug is contraindicated in patients who have had hypersensitivity reactions to insulin aspart or one of theexcipients
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; untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death; monitor potassium levels in patients at risk for hypokalemia if indicated (eg, patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentration)
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, patients treated with insulin, and a PPAR-gamma antagonist should be observed for signs and symptoms of heart failure; if heart failure develops, manage according to current standards of care; consider discontinuation or dose reduction of the PPAR-gamma agonist
Accidental mix-ups between this drug and other insulin products reported; to avoid medication errors between this drug and other insulins, instruct patients to always check insulin label before each injection; 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
Available information from published randomized controlled trials during second trimester of pregnancy have not reported association with insulin aspart and major birth defects or adverse maternal or fetal outcomes
There are no data on presence of insulin in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
Specific maximum dosage information is not available. Individualize dosage based on careful monitoring of blood glucose and other clinical parameters in all patient populations.
How supplied
insulin aspart protamine rDNA origin/insulin aspart rDNA origin
insulin aspart protamine/insulin aspart
subcutaneous injection
- (70units/30units)/mL