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General: Patients must be instructed on the skills necessary for the self-management of diabetes, such as blood sugar monitoring, proper injection technique, measures for recognizing 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 increased 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 physician.
In the event of insufficient blood sugar control or a tendency to hypo- or hyperglycaemic episodes, possible underlying factors (such as patient compliance, choice of injection site and proper technique, handling of the pen) must be excluded prior to considering prescription of a dose adjustment.
Due to limited experience the efficacy and safety of Lantus could not be assessed in children below 2 years of age, in patients with impaired liver function or in patients with moderate to severe renal impairment.
Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and localized 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 (see Adverse Reactions).
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. The likelihood of hypoglycaemia in conjunction with Lantus is, given its more constant and prolonged effect, less during the night but greater in the early morning.
As with all insulins, particular caution should be exercised and intensified blood sugar monitoring is advisable in such patients. Patients in whom hypoglycaemic episodes might be of particular clinical relevance include those with significant narrowing of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia), or those with a certain eye disease related to diabetes (proliferative retinopathy), particularly when not treated with photocoagulation (risk of transient blindness).
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: 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 may change, be milder, or be absent in certain risk groups. These include patients: in whom blood sugar control is markedly improved, in whom hypoglycaemia develops gradually, who are elderly, in whom a certain type of nervous disease (autonomic neuropathy) is present, with a long history diabetes, suffering from a psychiatric illness or receiving concurrent treatment with certain other medicines (see Interactions). In such circumstances, severe hypoglycaemia (and even loss of consciousness) may develop without the patient 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.
The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycemia.
Compliance of the patient with the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential in reducing the risk of hypoglycaemia.
All factors increasing such risk require particularly close monitoring and may necessitate dose adjustment. These include: Change in the injection area (e.g. from the thigh to the upper arm); Improved insulin sensitivity by, e.g., removal of stress factors; Unaccustomed or increased physical activity; Concomitant illness (e.g. vomiting, diarrhoea); Inadequate food intake such as: missed or delayed meals, smaller than usual meals or such with less carbohydrate content than normal (sweet and starchy food), changes in diet; Consumption of alcohol; Certain uncompensated endocrine disorders such as, e.g., reduced thyroid function or anterior pituitary or adrenocortical insufficiency; Concurrent use of other medicines (see Interactions).
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism. In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
In patients with severe liver impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
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, please note that food or beverages containing artificial sweeteners (e.g. diet foods and drinks) are not suitable. Then, some food having a long-acting blood-sugar-raising effect (e.g. bread) should be taken. If hypoglycaemia comes back again, another 10 to 20 g of sugar should be taken. If a hypoglycaemic attack cannot be corrected or if it recurs, speak to a physician immediately.
The patient should always carry at least 20 grams of sugar 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 glucagon (a medicine increasing blood sugar), even where the presence of hypoglycaemia is uncertain.
It is advisable to test blood sugar immediately after taking glucose to check if the patient really has hypoglycaemia.
The prolonged action of Lantus may delay recovery from hypoglycaemia.
Hyperglycaemia: 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 physician, normally in a hospital.
Concomitant illness: Please inform the physician if the patient is ill, since this situation may necessitate intensified metabolic monitoring and, possibly, further special measures (e.g., dose adjustment, urine tests for ketones).
Operating a vehicle or performing other hazardous tasks: As a result, e.g., of hypoglycaemia, hyperglycaemia or visual impairment (see Adverse Reactions), the ability to concentrate and react may be affected, possibly constituting a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).
Pens to be used with Lantus cartridges: The Lantus cartridges should only be used with the following pens: ClickStar, OptiPen, TactiPen, 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.
