Basaglar KwikPen Special Precautions

Insulin Glargine (Basaglar) is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered intravenously is recommended in such cases.
In case of insufficient glucose control or a tendency to hyperglycemic or hypoglycemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
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. Due to more sustained basal insulin supply with insulin glargine, less nocturnal but more early morning hypoglycemia can be expected.
Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycemia).
Patients should be aware of circumstances where warning symptoms of hypoglycemia are diminished. The warning symptoms of hypoglycemia may be changed, be less pronounced or be absent in certain risk groups. These include patients: in whom glycemic control is markedly improved, in whom hypoglycemia develops gradually, who are elderly, after transfer from animal insulin to human insulin, in whom an autonomic neuropathy is present, with a long history of diabetes, suffering from a psychiatric illness, receiving concurrent treatment with certain other medicinal products (see Interactions).
Such situations may result in severe hypoglycemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycemia.
The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycemia.
If normal or decreased values for glycated hemoglobin are noted, the possibility of recurrent, unrecognized (especially nocturnal) episodes of hypoglycemia must be considered.
Adherence of the patient to the dose and dietary regimen, correct insulin administration and awareness of hypoglycemia symptoms are essential to reduce the risk of hypoglycemia. Factors increasing the susceptibility to hypoglycemia require particularly close monitoring and may necessitate dose adjustment. These include: change in the injection area, improved insulin sensitivity (e.g., by removal of stress factors), unaccustomed, increased or prolonged physical activity, intercurrent illness (e.g. vomiting, diarrhea), inadequate food intake, missed meals, alcohol consumption, certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency), concomitant treatment with certain other medicinal products.
Injection technique: 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 glycemic 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 hypoglycemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.
Intercurrent illness: Intercurrent illness requires intensified metabolic monitoring. In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Insulin antibodies: Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycemia (see Adverse Reactions).
Medication errors: Medication errors have been reported in which other insulins, particularly short-acting insulins, have been accidentally administered instead of insulin glargine. Insulin label must always be checked before each injection to avoid medication errors between Insulin Glargine (Basaglar) and other insulins.
Combination of Insulin Glargine (Basaglar) with pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Insulin Glargine (Basaglar) is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and edema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Sodium Content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially "sodium-free".
Effect 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 using machines).
Patients should be advised to take precautions to avoid hypoglycemia 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. It should be considered whether it is advisable to drive or operate machines in these circumstances.