NOVOMIX ® Soluble insulin aspart + protamine-crystallized insulin aspart

NOVOMIX ® a drug based on soluble insulin aspart + protamine-crystallized insulin aspart

THERAPEUTIC GROUP: Biphasic insulin for injectable use - insulins and analogues


Indications NOVOMIX ® Soluble insulin aspart + protamine-crystallized insulin aspart

NOVOMIX ® indicated in the treatment of diabetic pathology that requires insulin therapy.


Mechanism of action NOVOMIX ® Soluble insulin aspart + protamine-crystallized insulin aspart

NOVOMIX ® is a hypoglycemic drug consisting of soluble insulin aspart and protamine-crystallized insulin aspart in the ratio 30/70.
These are respectively fast-acting and intermediate-acting insulin analogues that allow the drug to carry out the hypoglycemic effect about 10 - 20 minutes after subcutaneous administration, reaching maximum therapeutic activity within the first 4 hours and guaranteeing coverage of about 24 hours.
The most rapid action kinetics is guaranteed by the replacement of proline in position B28 with aspartic acid, which reduces the tendency of insulin to form hexamers, thus facilitating the passage of the hormone from the subcutaneous tissue to the bloodstream.
Through the bloodstream, the hormone reaches insulin sensitive tissues such as muscle and adipose tissue, activating specific receptors involved in the regulation of cellular activity and useful for improving the uptake and utilization of blood glucose.
At the same time, insulin acts metabolically on the liver, inhibiting enzymatic pathways necessary to produce glucose and pour it into the circulation.
In this way, the hypoglycemic effect of insulin is therefore guaranteed.

Studies carried out and clinical efficacy

1. BIPHASIC ASPART INSULIN AND DIABETIC PATHOLOGY

Diabetes Metab Syndr Obes. 2009 Jun 3; 2: 61-71.

Biphasic insulin aspart 30/70 (BIAsp 30) in the treatment of type 1 and type 2 diabetes.

Valensi P.


Numerous studies in the literature demonstrate the particular efficacy of biphasic insulin aspart in the management of diabetic pathology both in patients with type 1 and type 2 diabetes. The excellent results obtained in terms of reduction of glycated hemoglobin and glycemic control make NOVOMIX a ideal drug for the modern management of diabetic pathology.


2. EFFECTIVENESS AND SAFETY OF THERAPY WITH BIPHASIC ASPART INSULIN

Prim Care Diabetes. 2011 Mar 25.

Initiation of biphasic insulin aspart 30/70 in subjects with type 2 diabetes mellitus in a largely primary care-based setting in Sweden.

Berntorp K, Haglund M, Larsen S, Petruckevitch A, Landin-Olsson M; on behalf of the Swedish BIAsp Study Group.


Study conducted on 1154 patients with type II diabetes and treated with biphasic insulin aspart. The prolonged treatment for six months was completed by 89% of the enrolled patients, an index of excellent compliance, guaranteeing the reduction of glycated hemoglobin by more than 1% with only two episodes of hypoglycemia.


3. BIPHASIC ASPART INSULIN AND TYPE SECOND DIABETES

Diabetes Obes Metab. 2009 Jan; 11: 27-32. Epub 2007 Oct 17.

Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: The ACTION Study (Achieving Control Through Insulin plus Oral ageNts).

Raskin P, Matfin G, Schwartz SL, Chaykin L, Chu PL, Braceras R, Wynne A.


The therapy of type II diabetes, in most cases entrusted to the use of oral hypoglycemic agents, often proves ineffective in restoring correct glycemic control. The addition of biphasic insulin aspart to therapy with metformin or pioglitazone has been useful to the " optimization of glycemic control.

Method of use and dosage

NOVOMIX ® 100 IU / ml of insulin consisting of soluble insulin aspart and protamine-crystallized insulin aspart in the ratio 30/70:
the correct dosage and the relative timing of intake should be established by the doctor after a careful evaluation of the patient's health and metabolic balance.
Like the other biphasic insulins, NOVOMIX ® must necessarily be administered subcutaneously but unlike the others, its intake can be carried out shortly before a meal.

Warnings NOVOMIX ® Soluble insulin aspart + protamine-crystallized insulin aspart

The dosage of NOVOMIX ® should be established by the doctor after a careful evaluation of the patient's physio-pathological state, of his eating and athletic habits and clearly of his glycemic balance.
Variations of the formulated dose should be considered in case of liver and kidney diseases, infectious diseases, surgery, changes in dietary and lifestyle habits and various needs, in order to maintain good homeostasis.
The active participation of the patient in the daily therapeutic routine is of fundamental importance for the success of the therapy, while the correct awareness of the disease and of the potential side effects could minimize the onset of clinically dangerous adverse reactions.
Hypoglycemia, which is certainly the most serious problem associated with insulin therapy, could reduce the patient's normal perceptive and reactive abilities, making the use of machinery and driving cars dangerous.


PREGNANCY AND BREASTFEEDING

Although the experimentation on the use of insulin aspart in pregnant women is still not very significant, insulin remains today the only safe and effective pharmacological remedy for the treatment of gestational diabetes.
However, in order for the therapy to carry out the expected therapeutic effect, it is important that the dosage used also takes into account the week of pregnancy, given the varying requirements in this period.
It is clear that insulin treatment, especially in this case, must be carried out under strict medical supervision.

Interactions

Insulin aspart, like human insulin, lends itself in a similar way to the same drug interactions.
In fact, the concomitant intake of oral hypoglycemic agents, octreotide, anti-MAO, beta blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids could potentiate the hypoglycemic effect of NOVOMIX ® thus increasing the risk of hypoglycemia.
On the contrary, the simultaneous administration of oral contraceptives, thiazides, glucorticoids, thyroid hormones and sympathomimetics could reduce the therapeutic effect of this hormone, altering the normal glycemic control required.
In both cases it would be necessary to make an appropriate adjustment of the dosage.
It is known from the literature that sympatholytics can mask some important signs of hypoglycemia, increasing the risk of serious reactions.

Contraindications NOVOMIX ® Soluble insulin aspart + protamine-crystallized insulin aspart

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

Undesirable Effects - Side Effects

Therapeutic treatment with insulin aspart also exposes the diabetic patient to the same side effects observed in human insulin therapy.
Among the most common local side effects it is possible to describe irritation, redness and itching at the injection site, which in particular cases, such as failure to rotate the injection site, could also be associated with lipoatrophy.
Gastrointestinal and visual disturbances, or related to hypersensitivity reactions to the hormone, were less frequent, while hypoglycemia certainly remains the adverse reaction of greatest concern from a clinical point of view.
In fact, this initially characterized by mild but highly indicative symptoms such as cold sweat, drowsiness, asthenia, loss of attention could subsequently be responsible for loss of consciousness and coma.

Note

NOVOMIX ® sold only under medical prescription.
NOVOMIX ® falls within the doping class: Hormones and related substances (prohibited in and out of competition)


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