NovoMix^® (Suspension) Instructions for Use

ATC Code

A10AD05 (Insulin aspart)

Active Substance

Insulin aspart – biphasic (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Combination of intermediate-acting or long-acting and short-acting human insulin analogues

Pharmacotherapeutic Group

Hypoglycemic agent – combination of short- and intermediate-acting insulin analogs

Pharmacological Action

It is a biphasic suspension consisting of a mixture of insulin analogues: soluble insulin aspart (30% short-acting insulin analogue) and insulin aspart protamine crystals (70% intermediate-acting insulin analogue).

Blood glucose reduction occurs due to increased intracellular transport after binding of biphasic insulin aspart to insulin receptors in muscle and adipose tissues and simultaneous inhibition of glucose production by the liver.

Indications

Diabetes mellitus requiring insulin therapy.

ICD codes

Dosage Regimen

Determine the dosage individually based on blood glucose measurements.

Administer subcutaneously immediately before a meal or, if necessary, soon after a meal.

Rotate injection sites within the same anatomical region to reduce the risk of lipodystrophy.

Do not administer intravenously or intramuscularly.

Do not mix with other insulin preparations.

For adults and children over 10 years of age, the total daily insulin requirement is typically between 0.5 and 1.0 IU/kg/day.

In a basal-bolus regimen, premixed insulin like NovoMix^® 30 often covers two main meals, with 50-70% of the total daily dose split between these two injections.

Adjust the dose based on metabolic needs, blood glucose levels, and glycemic control targets.

Dose adjustments may be necessary during intercurrent illness, changes in physical activity, or meal patterns.

In patients with renal or hepatic impairment, carefully titrate the dose and monitor blood glucose closely due to altered insulin requirements.

When transferring from other insulin preparations, dose adjustment may be required; perform the transition under strict medical supervision.

Inspect the suspension visually before use; it should be uniformly white and cloudy. Do not use if clear or if solid particles are visible.

Resuspend the insulin before use by rolling the pen between your palms 10 times and tipping it end-to-end 10 times until it appears uniformly cloudy.

Always use a new needle for each injection to ensure sterility and accurate dosing.

Check the injection site for signs of lipodystrophy or localized cutaneous amyloidosis; do not inject into such areas.

Adverse Reactions

Immune system disorders uncommon – urticaria, skin rash, skin eruptions; very rare – anaphylactic reactions.

Metabolism and nutrition disorders very common – hypoglycemia.

Nervous system disorders rare – peripheral neuropathy (acute painful neuropathy).

Eye disorders uncommon – refraction disorders, diabetic retinopathy.

Skin and subcutaneous tissue disorders uncommon – lipodystrophy.

General disorders uncommon – edema.

Contraindications

Hypersensitivity to insulin aspart.

Not recommended for use in children under 6 years of age.

Use in Pregnancy and Lactation

Clinical experience with use during pregnancy is limited.

During the period of possible conception and throughout pregnancy, careful monitoring of the condition of patients with diabetes mellitus and monitoring of blood glucose concentration is necessary. The need for insulin usually decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. Soon after delivery, the insulin requirement quickly returns to the level that was before pregnancy.

Can be used without restrictions during breastfeeding. Insulin administration to a nursing mother does not pose a threat to the child. However, dose adjustment may be necessary.

Pediatric Use

Not recommended for use in children under 6 years of age, because clinical studies have not been conducted in them.

Can be used for the treatment of children and adolescents over 10 years of age in cases where the use of premixed insulin is preferable. There are limited clinical data for children aged 6-9 years.

Geriatric Use

Can be used in elderly patients, however, experience with its use in combination with oral hypoglycemic drugs in patients over 75 years of age is limited.

Special Precautions

Before a long trip associated with a change in time zones, the patient should consult with their attending physician, since a change in time zone means that the patient must eat and administer insulin at a different time.

Insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis. As a rule, the first symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia are thirst, increased amount of urine, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, as well as the appearance of acetone odor in the exhaled air. Without appropriate treatment, hyperglycemia in patients with type 1 diabetes mellitus can lead to diabetic ketoacidosis – a condition that is potentially fatal.

Missing a meal or unplanned intense physical activity can lead to hypoglycemia. Hypoglycemia can also develop if a dose of insulin that is too high relative to the patient’s needs is administered.

After compensation of carbohydrate metabolism, for example, during intensive insulin therapy, the typical warning symptoms of hypoglycemia for patients may change, and patients should be informed about this. Common warning symptoms may disappear with long-term diabetes.

Concomitant diseases, especially infectious ones and those accompanied by fever, usually increase the body’s need for insulin. Dose adjustment may also be required if the patient has concomitant diseases of the kidneys, liver, impaired function of the adrenal glands, pituitary gland or thyroid gland.

When switching a patient to other types of insulin, the early warning symptoms of hypoglycemia may change or become less pronounced compared to those when using the previous type of insulin.

Switching a patient to a new type of insulin or an insulin preparation from another manufacturer must be carried out under strict medical supervision. When changing the concentration, type, manufacturer and type (human insulin, human insulin analogue) of insulin preparations and/or method of production, a dose change may be required.

Cases of chronic heart failure have been reported during treatment of patients with thiazolidinediones in combination with insulin preparations, especially in the presence of risk factors for the development of chronic heart failure in such patients. This fact should be taken into account when prescribing combined therapy with thiazolidinediones and insulin preparations to patients. When prescribing such combination therapy, medical examinations of patients should be carried out to identify signs and symptoms of chronic heart failure, weight gain and the presence of edema. If symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.

Effect on ability to drive vehicles and mechanisms

Patients’ ability to concentrate and reaction speed may be impaired during hypoglycemia, which may be dangerous in situations where these abilities are especially necessary (for example, when driving vehicles or working with machines and mechanisms).

Patients should be advised to take measures to prevent the development of hypoglycemia while driving. This is especially important for patients with absent or reduced severity of warning symptoms of developing hypoglycemia or those suffering from frequent episodes of hypoglycemia. In these cases, the advisability of driving vehicles and performing similar work should be considered.

Drug Interactions

There are a number of drugs that affect the need for insulin. The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, salicylates.

The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Beta-blockers may mask the symptoms of hypoglycemia.

Octreotide/lanreotide can either increase or decrease the body’s need for insulin.

Alcohol can enhance or reduce the hypoglycemic effect of insulin.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.