Lantus Solostar Special Precautions

Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered IV is recommended in such cases.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic 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.
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 hypoglycaemia.
Hypoglycaemia: The time of occurrence of hypoglycaemia 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 Lantus Solostar, less nocturnal but early morning hypoglycaemia can be expected.
Particular caution should be exercised and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance eg, in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Patients should be aware of the circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. These include patients: In whom glycaemic control is markedly improved; in whom hypoglycaemia 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 product (see Interactions).
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
The prolonged effect of SC insulin glargine may delay recovery from hypoglycaemia.
If normal or deceased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognized (especially nocturnal) episodes of hypoglycaemia must be considered.
Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These include change in the injection area; improved insulin sensitivity (by eg, removal of stress factors); unaccustomed, increased or prolonged physical activity; intercurrent illness (eg, vomiting, diarrhea); inadequate food intake; missed meals; alcohol consumption; certain uncompensated endocrine disorders (eg, in hypothyroidism and in anterior pituitary or adrenocortical insufficiency) and concomitant treatment with certain other medicinal products.
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.
Handling of the Pen: Before using Solostar, the Instructions for Use included in the package insert must be read carefully. Solostar has to be used as recommended in these Instructions for Use.
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 and other insulins.
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 or hyperglycaemia or ie, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machines).
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 hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is advisable to drive or operate machines in these circumstances.
Impairment of Fertility: Animal studies do not indicate direct harmful effects with respect to fertility.
Use in pregnancy: For insulin glargine, no clinical data on exposed pregnancies from controlled clinical trials are available.
A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.
Animal data do not indicate reproductive toxicity.
The use of Lantus may be considered during pregnancy, if necessary.
It is essential for patients with preexisting or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the 1st trimester and generally increase during the 2nd and 3rd trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.
Use in lactation: It is unknown whether insulin glargine is excreted in human milk. No metabolic effects of ingested insulin glargine on the breastfed newborn/infant are anticipated since insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract.
Breastfeeding women may require adjustments in insulin dose and diet.