NOVORAPID ® - Insulin aspart

NOVORAPID ® a drug based on insulin aspart.

THERAPEUTIC GROUP: Insulin aspart for injectable use - insulins and analogues

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications NOVORAPID ® - Insulin aspart

NOVORAPID ® is a medicine used to control glucose metabolism in patients with diabetes mellitus.

Mechanism of action NOVORAPID ® - Insulin aspart

NOVORAPID ® is an hypoglycemic drug based on insulin aspart, so defined as it presents an amino acid substitution (Proline with Aspartate) compared to the normal sequence of this hormone.

This single amino acid variation significantly influences the pharmacokinetic properties of the hormone, which by reducing the normal tendency to form hexamers, is rapidly absorbed following subcutaneous administration, determining the start of the hypoglycemic effect after about 10 -20 minutes, the optimum between the first and third hours and a persistence of the effect for about 4 hours.

From the pharmacodynamic point of view, on the other hand, the mechanism of action remains unchanged, allowing insulin to interact with its specific receptor expressed by insulin-sensitive tissue cells and increase glucose uptake and utilization, reducing blood concentrations.

The important anabolic effect of this hormone on the one hand (inducer of glycogen synthesis, protein synthesis and lipid synthesis) and the ability to act by inhibiting metabolic pathways useful for producing glucose, allows insulin to be the hypoglycemic hormone par excellence .

Studies carried out and clinical efficacy

1. INSULIN ASPART AND GESTATIONAL DIABETES

Important study that shows how the treatment of gestational diabetes with insulin aspart can guarantee good post-prandial glycemic control, reducing the frequency of hypoglycemic events and reducing the number of premature abortions.

2. INSULIN AND ANALOGUES OF INSULIN

Insulin analogues are known to differ from human insulin due to the different kinetics of action. This all-Italian study also demonstrates how these differences may also affect molecular dynamics with intracellular mechanisms activated differently depending on the type of insulin used. These studies could partly clarify some important variations on the different efficacy of insulin analogues.

3. ASPART INSULIN AND ANTI-INFLAMMATORY ACTION

Although insulin aspart has a more rapid mode of action and guarantees a significant lowering of post-prandial glycaemia than regular insulin, the effects on modulation of inflammatory markers and endothelial health of second-type diabetic patients are almost identical.

Method of use and dosage

NOVORAPID ® 100 IU / ml of insulin: 5 cartridges of 3 ml or pre-filled pen of 3 ml: the dosage of insulin aspart to be used in the treatment of diabetic disease, depends strictly on the physical condition of the patient and his clinical picture.

In principle, the useful dosage should be in the range of 0.5 - 1 IU / kg of body weight and NOVORAPID ® should be administered immediately before a meal, given the particularly fast action times.

It must be remembered that the dosage formulation and any other adjustments should be established by your doctor.

Warnings NOVORAPID ® - Insulin aspart

To ensure good glycemic control, it is necessary that the diabetic patient undergoes a periodic evaluation of serum glucose concentrations before and during the treatment period, and possibly the adaptation of the relative insulin therapy.

It is also necessary for the doctor to inform the patient about the correct preparation, administration and storage of the drug and about the potential risks, so as to be able to recognize the signs of hypoglycemia promptly and intervene before the hypoglycemic crisis occurs.

Insulin aspart, given the faster mode of action, may require more frequent administration than the soluble human insulin.

Any adjustment of the dosage, variations in the drug used or suspension of therapy should be supervised by medical personnel.

In the case of reduced kidney function it may be necessary to reduce the dose of the drug used, as opposed to infections that may require an increase in the concentrations normally used.

The possible onset of hypoglycaemia could reduce the patient's perceptive capacities, making it dangerous to use machinery and drive vehicles.

PREGNANCY AND BREASTFEEDING

Studies of the use of insulin aspart in pregnant women have not reported any side effects on the fetus or pregnant woman.

Consequently NOVORAPID ® could be effectively used in the treatment of gestational diabetes, adapting the dose used to the patient's physiopathological conditions and to the gestation period.

Interactions

Like classical insulin, insulin aspart is also able to interact with numerous active ingredients.

More precisely the interaction with oral hypoglycemic agents, octreotide, anti-MAO, beta-blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids could potentiate the hypoglycemic effects of the drug reducing the need for insulin itself, while the simultaneous intake of oral contraceptives, Thiazides, glucorticoids, thyroid hormones and sympathomimetics could reduce the therapeutic effect of NOVORAPID ®

Contraindications NOVORAPID ® - Insulin aspart

NOVORAPID ® contraindicated in case of hypoglycemia and hypersensitivity to human insulin or its excipients.

Undesirable effects - Side effects

NOVORAPID ® therapy could, like other hypoglycemic therapies, be associated with hypoglycemia conditions recognizable by classic signs such as cold sweat, skin pallor, nervousness, tremors, anxiety, fatigue, weakness, confusion, difficulty concentrating, headache, nausea, palpitations, visual disturbances and in severe cases loss of consciousness and death.

In addition, at the injection site, manifestations such as redness, itching and pain may occur, while the application of the injection at the same point for prolonged periods may be responsible for localized lipoatrophy.

Rarely, hypersensitivity reactions have been described such as rash, dyspnoea and difficulty breathing, edema and sudden drop in blood pressure.