Toujeo Special Precautions

General: Insulin therapy generally requires appropriate diabetes self-management skills, including glucose monitoring, proper injection technique, and hypo- and hyperglycemia management. Patients should be instructed on such self-management procedures. Additionally, patients must be instructed in how to handle special situations such as an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake or skipped meals. The extent of patient participation in his/her diabetes management is variable and is generally determined by the physician.
Insulin treatment requires constant alertness to the possibility of hyper- and hypoglycemia. Patients and their relatives must know what steps to take if hyperglycemia or hypoglycemia occurs or is suspected and they must know when to inform a physician.
In case of insufficient glucose control or a tendency to hyper- or hypoglycemic episodes, patient's compliance with the prescribed insulin regimen, injection sites and proper injection techniques, the handling of injection devices and all other relevant factors must be reviewed before dose adjustment is considered.
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).
Hypoglycemia: The time of occurrence of hypoglycemia depends on the action profiles of the insulin products used and may, therefore, change when the treatment regimen is changed.
As with all insulin products, particular caution should be exercised, and intensified blood glucose monitoring is advisable, in patients in whom sequelae of hypoglycemic 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 hypoglycemia) as well as patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycemia).
However, under certain conditions, as with all insulin products, the warning symptoms of hypoglycemia may be changed, be less pronounced or absent, for example: If glycemic control is markedly improved; if hypoglycemia is developing gradually; in elderly patients; after transfer from animal insulin to human insulin; where an autonomic neuropathy is present; in patients with a long history of diabetes; in patients suffering from a psychiatric illness; in patients receiving concurrent treatment with certain other drugs (see Interactions).
Such situations may result in severe hypoglycemia (and possibly, loss of consciousness) prior to patient's awareness of hypoglycemia.
The prolonged effect of subcutaneous Toujeo may delay recovery from hypoglycemia.
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycemia must be considered.
Compliance of the patient with the dosage and dietary regimen, correct insulin administration and awareness of hypoglycemia symptoms are essential to reduce the risk of hypoglycemia.
Presence of factors which increase the susceptibility to hypoglycemia requires particularly close monitoring and may necessitate dose adjustment. These factors include: change in the injection area; increase of insulin sensitivity (e.g. by removal of stress factors); unaccustomed, increased or prolonged physical exercise; intercurrent illness (e.g. vomiting, diarrhoea); inadequate food intake; alcohol consumption; certain uncompensated endocrine disorders; concomitant treatment with certain medications (see Interactions).
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism (see Special Population under Dosage & Administration and Pharmacology: Pharmacodynamics: Clinical efficacy and safety and Pharmacokinetics under Actions).
In the elderly, progressive deterioration of renal function may lead to steady decrease in insulin requirements (see Special Population under Dosage & Administration and Pharmacology: Pharmacodynamics: Clinical efficacy and safety and Pharmacokinetics under Actions).
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism (see Special Population under Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Hypoglycemia can generally be corrected by immediate carbohydrate intake. So that initial corrective action can be taken immediately, patients must carry a minimum of 20 grams of carbohydrates with them at all times.
Switch between insulin glargine 100 units/mL and Toujeo: Since insulin glargine 100 units/mL and Toujeo are not bioequivalent and are not interchangeable switching may result in the need for a change in dose and should only be done under strict medical supervision (see Dosage & Administration).
Switch between other insulins and Toujeo: Switching a patient between another type or brand of insulin and Toujeo 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 (see Dosage & Administration).
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. In patients with type 1 diabetes, carbohydrate supplies must be maintained even if patients are able to eat only little or no food, or are vomiting etc.; in patients with type 1 diabetes insulin must never be omitted 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.
Combination of Toujeo 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 Toujeo is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Medication errors prevention: Insulin label must always be checked before each injection to avoid medication errors between Toujeo and other insulins. Medication errors have been reported in which other insulins, particularly short-acting insulins, have been accidentally administered instead of long-acting insulins.
To avoid dosing errors and potential overdose, the patients must also be instructed to never use a syringe to remove Toujeo from the SoloStar pre-filled pen into a syringe (see Dosage & Administration and Overdosage).
Patients must also be instructed to not re-use needles. A new sterile needle must be attached before each injection. Re-use of needles increases the risk of blocked needles which may cause underdosing or overdosing. In the event of blocked needles, the patients must follow the instructions described in Step 3 of the Toujeo SoloStar Instructions for Use (see Administration under Dosage & Administration).
Like for all insulin pens, patients must visually verify the number of selected units on the dose counter of the pen. Patients who are blind or have poor vision must be instructed to get help/assistance from another person who has good vision and is trained in using the insulin device.
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 Machine: The patient's ability to concentrate and react may be impaired as a result of, for example, 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 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. The advisability of driving should be considered in these circumstances.