Inadequate dosage or discontinuation of treatment may, especially in type 1 diabetes may lead to hyperglycaemia and diabetic ketoacidosis. Usually the first symptoms of hyperglycaemia come on gradually over a period of hours and days. They include nausea, vomiting, drowsiness, flushed dry skin, dry mouth, increased urination, thirst and loss of appetite as well as acetone odour of the breath. Untreated hyperglycaemic events are potentially lethal.
Patients whose blood glucose control is greatly improved eg, by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.
A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human insulin. NovoRapid should be administered in immediate relation to a meal. The rapid onset of action should therefore be considered in patients with concomitant diseases or medication where a delayed absorption of food might be expected.
Concomitant illness, especially infections, usually increases the patient's insulin requirements.
When patients are transferred between different types of insulin products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with previous insulin.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision. Changes in strength, brand, type, species (animal, human, human insulin analogue) and/or method of manufacture may result in a change in dosage. Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet. Exercise immediately after a meal may increase the risk of hypoglycaemia. Patients taking NovoRapid may require an increased number of daily injections or a change in dosage from that used with their usual insulins. If an adjustment is needed, it may occur with the 1st dose or during the 1st several weeks or months.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
NovoRapid contains metacresol, which in rare cases may cause allergic reactions.
Effects on the Ability to Drive or Operate Machinery: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machinery).
Patients should be advised to take precautions in order to avoid hypoglycaemia while driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.
Use in pregnancy & lactation: There is limited clinical experience with NovoRapid in pregnancy. An open-label, randomised study compared the safety and efficacy of Novorapid versus human insulin in the treatment of pregnant women with type 1 diabetes [322 exposed pregnancies (NovoRapid: 157, human insulin: 165)]. Two-thirds of the enrolled patients were already pregnant when they entered the study. Since only 1/3 of the patients enrolled before conception, the study was not large enough to evaluate the risk of congenital malformations. Mean HBA1c of ~6% was observed in both groups during pregnancy and there was no significant difference in the incidence of maternal hypoglycaemia.
Intensified blood glucose control and monitoring of pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes) is recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the 1st trimester and increase subsequently during the 2nd and 3rd trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy levels.
There are no restrictions on the treatment with NovoRapid during lactation. Insulin treatment of the nursing mother presents no risk to the baby. However, the NovoRapid dosage may need to be adjusted.