Lantus 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.
Lantus 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 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.
Patients must be instructed in the skills necessary for the self-management of diabetes, such as blood sugar monitoring, proper injection technique, measures for recognising and managing reduced or increased blood sugar levels (hypo-or hyperglycaemia) as described as follows. In addition, they must learn how to handle special situations such as skipped, inadequate or increase insulin doses, inadequate food intake or missed meals. Moreover, patients and their relatives must learn how to recognize the signs and symptoms of hypo-or hyperglycaemia, what corrective actions need to be taken and when they must speak with their doctor.
Pens to be used with Lantus 100 units/ml in cartridges: Lantus 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used. The Lantus cartridges should only be used with the following pens: OptiPen, ClickSTAR, Autopen 24, and Allstar, and should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens.
Handling of the SoloStar pre-filled pen: Lantus SoloStar 100 units/ml in pre-filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used (see Dosage & Administration). Before using SoloStar, the instructions for use must be read carefully. SoloStar has to be used as recommended in these instructions for use (see Special precautions for disposal and other handling under Cautions for Usage).
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, less nocturnal but more early morning hypoglycaemia can be expected.
Hypoglycaemia is more likely to occur at the start of insulin treatment, following transfer to a different insulin preparation, where metabolic control is unstable, or in severe kidney or liver diseases.
Symptoms that may indicate the onset of hypoglycaemia may be, e.g., sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heart beat, chest pain (angina pectoris). In many patients, these signs and symptoms often develop before those of a low sugar level in the brain. The latter include headache, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesiae) numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after oneself, convulsions, and loss of consciousness.
The initial symptoms pointing to the onset of hypoglycaemia ("warning symptoms") may change be milder, or be entirely absent, e.g., in the following circumstances: markedly improved blood sugar control, slow-developing hypoglycaemia, advanced age, a certain type of nervous disease (autonomic neuropathy), long-standing diabetes, a psychiatric illness, or concurrent use of other medicines (see Interactions). In such circumstances severe hypoglycaemia (and even loss of consciousness) may develop without the patients noticing it. Affected patients should try to keep familiar at all times with their individual warning symptoms. More frequent blood sugar testing can help to identify mild hypoglycaemic episodes which otherwise might be overlooked. Patients not confident of recognizing their warning symptoms should avoid situations (e.g. driving a car) that might result in danger to themselves or others.
As with all insulins, particular caution should be exercised, and intensified blood glucose monitoring is advisable, in patients in whom hypoglycaemic episodes might be of particular clinical relevance. For example these could be 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 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 products.
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia.
If normal or decreased 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 hypoglycaemia. Presence of 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 e.g., removal of stress factors), unaccustomed, increased or prolonged physical activity, intercurrent illness (e.g. vomiting, diarrhoea), 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.
A hypoglycaemic attack can be corrected by immediately taking sugar, e.g., in the form of glucose, sugar cubes or sugar-sweetened beverages. In this regard, note that food or beverages containing artificial sweeteners (e.g. diet foods and drinks) are not suitable. Subsequently, some food having a long-acting blood-sugar-raising effect (e.g. bread) should be taken. The long action of Lantus may delay recovery from hypoglycaemia. If hypoglycaemia recurs, another 10 to 20 g of sugar should be taken. If a hypoglycaemia attack cannot be corrected or if it recurs, speak to a doctor immediately.
Carry at least 20 grams of sugar with the patient at all times, together with some information identifying the patient as a diabetic. Inability to swallow or unconsciousness will make necessary injections of glucose solution or glucagons (a medicine increasing blood sugar), even where the presence of hypoglycaemia is uncertain. Following intake of glucose, hypoglycaemia should be conformed by means of blood sugar testing.
Inform the doctor in the event of intercurrent illness, since this situation necessitates intensified metabolic monitoring and, possibly, further special measures (e.g., dose adjustment, urine tests for ketones).
Hyperglycaemia may occur under certain circumstances. These include: omission or reduction of injections or decrease in insulin effectiveness (e.g. due to incorrect storage); pen malfunction; decreased physical activity, stress situations (emotional distress, excitement), injuries, operations, feverish illnesses or certain other diseases; concurrent use of other medicines (see Interactions).
Thirst, increased need to pass water, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat and high concentrations of sugar and ketone bodies in the urine may be signs of hyperglycaemia. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious metabolic condition (ketoacidosis) resulting from lack of insulin. Blood sugar testing or tests for ketones in urine must be carried out as soon as any such symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
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 hypoglycaemia (see Pharmacology: Pharmacodynamics under Actions).
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.
Excipients: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The patients' ability to concentrate and react may be impaired as a result of, for example hypoglycaemia or hyperglycaemia 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 hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is advisable to drive or operate machinery in these circumstances.