Novolog Mix 70/30

What is Novolog Mix 70/30?

• Novolog Mix 70/30 (insulin aspart protamine and insulin aspart) is a mixture of insulin aspart protamine, an intermediate-acting human insulin analog, and insulin aspart, a rapid-acting human insulin analog, used to improve glycemic control in adult patients with diabetes mellitus.

What are the uses of this medicine?

• NovoLog Mix 70/30 is a man-made insulin that is used to control high blood sugar in people with diabetes mellitus.
• NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine and insulin aspart.

Limitations of Use:

• Not recommended for the treatment of diabetic ketoacidosis.
• The proportions of rapid-acting and long-acting insulins are fixed and do not allow for basal versus prandial dose adjustments

How does this medicine work?

• The primary activity of insulin, including NOVOLOG MIX 70/30 is the regulation of glucose metabolism.
• Insulin and its analog 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to NovoLog Mix 70/30 or any of the ingredients in NovoLog Mix 70/30.

What drug interactions can this medicine cause?

• Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLOG MIX 70/30 is co-administered with Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics.
• Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLOG MIX 70/30 is co-administered with Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
• Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLOG MIX 70/30 is co-administered with Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
• Increased frequency of glucose monitoring may be required when NOVOLOG MIX 70/30 is co-administered with Beta-blockers, clonidine, guanethidine, and reserpine.

Is this medicine FDA approved?

• Initial U.S. Approval: 2001

How should this medicine be used?

Recommended dosage:

• NOVOLOG MIX 70/30 is typically dosed twice-daily (with each dose intended to cover 2 meals or a meal and a snack).
• Individualize dosage based on metabolic needs, blood glucose monitoring results, glycemic control goal.
• Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness.
• Dosage adjustment may be needed when switching from another insulin to NOVOLOG MIX 70/30.

Administration:

• NovoLog Mix 70/30 starts acting fast. If you have Type 1 diabetes, inject it up to 15 minutes before you eat a meal. Do not inject NovoLog Mix 70/30 if you are not planning to eat within 15 minutes. If you have Type 2 diabetes, you may inject NovoLog Mix 70/30 up to 15 minutes before or after starting your meal.
• Do not mix NovoLog Mix 70/30 with other insulin products or use in an insulin pump.
• Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
• Do not reuse or share your needles or syringes with other people. You may give other people a serious infection or get a serious infection from them.
• NovoLog Mix 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs, or upper arms.
• Change (rotate) your injection sites within the same area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
• Do not use the exact same spot for each injection.
• Do not inject where skin has pits, is thickened, or has lumps.
• Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injectable suspension: 100 units/mL (U-100) of NOVOLOG MIX 70/30, 70% insulin aspart protamine and 30% insulin aspart available as:
• 10 mL multiple-dose vial
• 3 mL single-patient-use NOVOLOG MIX 70/30 FlexPen

This medicine is available in fallowing brand namesː

• NovoLog Mix 70/30

What side effects can this medication cause?

The most common side effects of this medicine include:

• low potassium in your blood (hypokalemia), reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.

NovoLog Mix 70/30 may cause serious side effects that can lead to death, including:

• hypoglycemia

What special precautions should I follow?

While taking NovoLog Mix 70/30 do not:

• Drive or operate heavy machinery, until you know how NovoLog Mix 70/30 affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

• Never share a NOVOLOG MIX 70/30 FlexPen between patients, even if the needle is changed.
• Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring.
• Hypoglycemia is the most common adverse effect of all insulins, including NOVOLOG MIX 70/30. Increase frequency of glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairments and hypoglycemia unawareness.
• Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.
• Severe, life-threatening, generalized allergy, including anaphylaxis, may occur. Discontinue NOVOLOG MIX 70/30, treat, and monitor, if indicated.
• All insulins, including NOVOLOG MIX 70/30, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
• Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypoglycemia
• hypokalemia

Management of overdosage:

• Mild episodes of hypoglycemia usually can be treated with oral glucose.
• Adjustments in drug dosage, meal patterns, or exercise, may be needed.
• More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
• Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery.
• Hypokalemia must be corrected appropriately.

Can this medicine be used in pregnancy?

• There are no available data with NOVOLOG MIX 70/30 in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.
• Available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes.
• There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Can this medicine be used in children?

• Safety and effectiveness of NOVOLOG MIX 70/30 have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: 70% insulin aspart protamine and 30% insulin aspart.
• Inactive Ingredients: disodium hydrogen phosphate dihydrate, glycerol, metacresol, phenol, protamine sulfate, sodium chloride, zinc, and Water for Injection, USP. Hydrochloric acid or sodium hydroxide may be added to adjust pH.

Who manufactures and distributes this medicine?

Manufactured by:

• Novo Nordisk Inc.
• 800 Scudders Mill Road
• Plainsboro, New Jersey

What should I know about storage and disposal of this medication?

• Do not freeze NovoLog Mix 70/30.
• Do not use NovoLog Mix 70/30 if it has been frozen.
• Keep NovoLog Mix 70/30 away from heat or light.

All unopened vials:

• Store unopened NovoLog Mix 70/30 vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Unopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator.
• Unopened vials should be thrown away after 28 days, if they are stored at room temperature.

After vials have been opened:

• Opened NovoLog Mix 70/30 vials can be stored in the refrigerator 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C) for up to 28 days.
• Throw away all opened NovoLog Mix 70/30 vials after 28 days, even if they still have insulin left in them.

• Dailymed label info on Novolog Mix 70/30
• FDA Novolog Mix 70/30

Novolog Mix 70/30 Resources
Latest articles Most recent articles Ongoing trials	Wikipedia