NovoRapid® [Insulin aspart]

Clinical experience with NovoRapid FlexPen during pregnancy is very limited. In experimental animal studies, no differences were found between embryotoxicity and teratogenicity of insulin aspart and human insulin. During the period of possible pregnancy and throughout its life, it is necessary to carefully monitor the condition of patients suffering from diabetes, and to control the level of glucose in the blood. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. During childbirth and immediately after them, the need for insulin can dramatically decrease. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy.
During lactation (breastfeeding) NovoRapid FlexPen can be used without restrictions (the administration of insulin to a nursing mother does not pose a threat to the child). However, it may be necessary to adjust the dose of the drug.

An inadequate dose or discontinuation of treatment, especially for type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis. As a rule, symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia include nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine, thirst and loss of appetite, as well as the smell of acetone in exhaled air. Without appropriate treatment, hyperglycemia can lead to death. After compensation of carbohydrate metabolism, for example, in case of intensified insulin therapy, the typical symptoms of hypoglycemia, which are typical for them, may change in patients, about which patients should be informed.
In patients with diabetes mellitus with optimal metabolic control, late complications of diabetes develop later and progress more slowly. In this regard, it is recommended to carry out activities aimed at optimizing metabolic control, including monitoring of blood glucose levels.
The consequence of the pharmacodynamic features of the short-acting insulin analogues is that the development of hypoglycemia in their use begins earlier than with the use of soluble human insulin.
NovoRapid FlexPen should be used in direct connection with food intake. It is necessary to take into account the high rate of onset of the effect of the drug in the treatment of patients with concomitant diseases or taking drugs that slow down the absorption of food. In the presence of concomitant diseases, especially of an infectious nature, the need for insulin, as a rule, increases. Impaired renal or hepatic function may reduce insulin requirements.
When a patient is transferred to other types of insulin, the early symptoms of precursors of hypoglycemia may change or become less pronounced compared to those of the previous type of insulin.
Transferring a patient to a new type of insulin or another manufacturer’s insulin should be carried out under strict medical supervision. If you change the concentration, type, manufacturer and type (human insulin, animal insulin, human insulin analogue) of insulin preparations and / or method of manufacture, you may need to change the dose. Patients who switch to treatment with NovoRapid FlexPen may need to increase the frequency of injections or change the dose compared to doses of previously used insulin preparations. If necessary, dose adjustment, it can be made already at the first injection of the drug or during the first weeks or months of treatment.
In addition, changing the dose of the drug may be required when changing the diet and with increased physical exertion. Exercise immediately after a meal can increase the risk of hypoglycemia. Skipping meals or unplanned exercise can lead to hypoglycemia.
A significant improvement in the state of carbohydrate metabolism compensation can lead to a state of acute pain neuropathy, which is usually reversible.
Long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. However, the intensification of insulin therapy with a dramatic improvement in glycemic control may be accompanied by a temporary deterioration of diabetic retinopathy.
NovoRapid FlexPen contains metacresol, which in rare cases can cause allergic reactions.
Use in Pediatrics
NovoRapid FlexPen should be used instead of soluble human insulin in children only when a rapid onset of the drug is necessary, for example, when it is difficult for the child to observe the necessary time interval between injection and food intake.
Influence on ability to drive motor transport and control mechanisms
The ability of patients to concentrate and the reaction rate may be impaired during hypoglycemia and hyperglycemia, which may be dangerous in situations where these abilities are especially needed (for example, when driving or working with machines and mechanisms). Patients should be advised to take measures to prevent the development of hypoglycemia and hyperglycemia while driving a car and working with mechanisms. This is especially important for patients with the absence or decrease in the severity of symptoms, precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia.In these cases, the feasibility of performing such work should be considered.

Symptoms: hypoglycemia.
Treatment: The patient can eliminate light hypoglycemia on his own by ingesting glucose, sugar, or carbohydrate-rich foods (patients are encouraged to constantly carry sugar, sweets, cookies, or sweet fruit juice). In severe cases, when the patient loses consciousness, a 40% dextrose (glucose) solution is injected / in; i / m or s / c - glucagon (0.5-1 mg). After regaining consciousness, the patient is recommended to take carbohydrate-rich food to prevent the recurrence of hypoglycemia.