Toujeo Adverse Reactions

The following adverse reactions were observed during clinical studies conducted with Toujeo (see Pharmacology: Pharmacodynamics: Clinical efficacy and safety under Actions) and during clinical experience with insulin glargine 100 U/mL.
The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%, Not known (cannot be estimated from available data).
Hypoglycemia: Hypoglycemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
As with all insulins, severe hypoglycemic attacks, especially if recurrent, may lead to neurological damage. Prolonged or severe hypoglycemic episodes may be life-threatening.
In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counterregulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
For hypoglycaemia incidences from clinical trials, see table in Pharmacology: Pharmacodynamics: Clinical efficacy and safety under Actions.
Eyes: A marked change in glycemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Long-term improved glycemic control decreases the risk of progression of diabetic retinopathy. However, as for all insulin regimens, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycemic episodes may result in transient amaurosis.
See Pharmacology: Pharmacodynamics: Clinical efficacy and safety under Actions for additional information regarding retinopathy study results.
Skin and subcutaneous tissue disorders: Lipodystrophy, as with any insulin therapy, may occur at the injection site and delay insulin absorption. In clinical studies, in regimens, which included insulin glargine, lipohypertrophy was observed in 1 to 2% of patients, whereas lipoatrophy was uncommon.
Localized cutaneous amyloidosis at the injection site has occurred with insulins. Hyperglycemia has been reported with repeated insulin injections into areas of cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions (see Precautions).
Allergic reactions: Local Allergy at the injection site: As with any insulin therapy, such reactions include redness, pain, itching, hives, swelling, or inflammation. In Toujeo clinical studies in adult patients, the incidence of overall injection site reactions was similar in Toujeo-treated patients (2.5%) and Lantus-treated patients (2.8%). Most minor reactions to insulins usually resolve in a few days to a few weeks.
Systemic Allergy: Immediate-type allergic reactions are rare. Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio-oedema, bronchospasm, and hypotension and anaphylactic shock, and may be life threatening. In Toujeo clinical studies in adult patients, the incidence of allergic reactions was similar in Toujeo-treated patients (5.3%) and insulin glargine 100 units/mL-treated patients (4.5%).
Other reactions: Insulin administration may cause anti-insulin antibodies to form. In clinical studies comparing Toujeo and Lantus, anti-insulin antibodies were observed with similar frequencies in both treatment groups. As with all insulins, in rare cases, the presence of such anti-insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyperglycemia or hypoglycemia (see Pharmacology: Pharmacodynamics: Clinical efficacy and safety under Actions).
Insulin may cause, in rare cases, sodium retention and oedema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Paediatric population: Safety and efficacy of Toujeo have been demonstrated in a trial in paediatric patients aged 6 to less than 18 years. The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences from the experience in the general diabetes population.
Other special populations: Based on the results from clinical studies, the safety profile of Toujeo in elderly patients and in patients with renal impairment was similar to that of the overall population (see Pharmacology: Pharmacodynamics under Actions).