Insulin Aspart Protamine-Insulin Aspart

Insulin Aspart Protamine-Insulin Aspart is a combination medication of rapid-onset (faster than regular insulin) and intermediate-acting insulins in a fixed dose, used to improve glycemic control in patients with diabetes mellitus.

• Insulin Aspart Protamine-Insulin Aspart is available under the following different brand names: NovoLog Mix 70/30, NovoLog Mix 70/30 FlexPen

Common side effects of Insulin Aspart Protamine-Insulin Aspart include:

• redness
• swelling or itching at the injection site
• low blood sugar

Serious side effects of Insulin Aspart Protamine-Insulin Aspart include:

• weight gain
• peripheral edema

Rare side effects of Insulin Aspart Protamine-Insulin Aspart include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Subcutaneous injection

• (70 units/30 units)/mL

Diabetes Mellitus

Adult dosage

• Dose regimen varies among patients depending on their metabolic needs; typical daily insulin requirements range between 0.5-1 unit/kg
• Administer SC every 12 hours (ie, before breakfast and evening meal); each dose intended to cover 2 meals or a meal and snack
• Inject SC into the abdominal wall, thigh, or upper arm

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Insulin Aspart Protamine-Insulin Aspart has severe interactions with no other drugs
• Insulin Aspart Protamine-Insulin Aspart has serious interactions with the following drugs:
  • ethanol
  • macimorelin
• Insulin Aspart Protamine-Insulin Aspart has moderate interactions with at least 61 other drugs
• Insulin Aspart Protamine-Insulin Aspart has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Hypoglycemia

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Insulin Aspart Protamine-Insulin Aspart?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Insulin Aspart Protamine-Insulin Aspart?”

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
• Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products; if hypersensitivity reactions occur, discontinue therapy; treat as 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 the excipients
• 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; use 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 the 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, in 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 the insulin label before each injection; do not mix with other insulins
• Do not administer via insulin infusion pump
• Never share a pen between patients even if the needle is changed
• Hypoglycemia
  • Hypoglycemia is the most common adverse effect of all insulin therapies; severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life-threatening, or cause death
  • Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (eg, driving or operating other machinery)
  • Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual
  • Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (eg, beta-blockers), or in patients who experience recurring hypoglycemia
  • Risk for hypoglycemia after injection is related to the duration of action of insulin and, in general, is highest when the glucose-lowering effect of insulin is maximal; as with all insulin preparations, the glucose-lowering effect time course of this drug may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature
  • Other factors that may increase the risk for hypoglycemia include changes in meal pattern (eg, macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication; patients with renal or hepatic impairment may be at higher risk of hypoglycemia
  • Patients and caregivers must be educated to recognize and manage hypoglycemia; self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia, and it is recommended to increase the frequency of blood glucose monitoring
  • In patients at a higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, it is recommended to increase the frequency of blood glucose monitoring
• Hyperglycemia or hypoglycemia with changes in insulin regimen
  • Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia
  • Changes should be made cautiously and only under close medical supervision and the frequency of blood glucose monitoring should be increased
  • Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis are reported to result in hyperglycemia; a sudden change in the injection site (to the unaffected area) has been reported to result in hypoglycemia
  • Make any changes to a patient’s insulin regimen under close medical supervision with an increased frequency of blood glucose monitoring
  • Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia
  • For patients with type 2 diabetes, dosage adjustments in concomitant oral antidiabetic treatment may be needed

Pregnancy and Lactation

• Available information from published randomized controlled trials during the second trimester of pregnancy has not reported an association between insulin aspart and major birth defects or adverse maternal or fetal outcomes
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
• Lactation
  • There are no data on the presence of insulin in human milk, its effects on breastfed infants, or on milk production; one small published study reported that exogenous insulin, including insulin aspart, was present in human milk; however, there is insufficient information to determine the effects of insulin aspart on the breastfed infant; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from the drug or from any underlying maternal condition