Apidra Special Precautions

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Any change of insulin should be made cautiously and only under medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc.), species (animal) and/or method of manufacturing may result in a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted.
Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened gylcaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.
The use of inadequate dosages or discontinuation of treatment, especially in insulin-dependent diabetic, may lead to hyperglycemia and diabetic ketoacidosis; conditions which are potentially lethal.
Switching a patient to another type or brand of insulin should be done under strict medical supervision and may require change in dose.
Pens to be used with Apidra 100 units/ml solution for injection in a cartridges: Apidra 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used.
The Apidra cartridges should only be used with the following pens: OptiPen, ClickStar, Autopen, and Allstar, and should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens.
Hypoglycemia: The time of occurrence of hypoglycemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed. Conditions which may make the early warning symptoms of hypoglycemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease, medicinal products such as beta blockers or after transfer from animal-source insulin to human insulin.
Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan. Exercise taken immediately after a meal may increase the risk of hypoglycemia.
When compared with soluble human insulin, if hypoglycemia occurs after an injection with rapid acting analogues, it may occur earlier. Uncorrected hypoglycemic or hyperglycemic reactions can cause loss of consciousness, coma, or death.
Insulin requirements may be altered during illness or emotional disturbances.
Effects on Ability to Drive and Use Machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycemia or hyperglycemia or, for example, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery). Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycemia or have frequent episodes of hypoglycemia. The advisability of driving should be considered in the circumstances.