ABASAGLAR 100 Units / mL Injectable box of 5 cartridges of 3 ml

Generic drug of the therapeutic class: Metabolism and nutrition
Active ingredients: Insulin glargine
laboratory: Lilly France Sas

Indication

Treatment of diabetes mellitus in adults, adolescents and children from 2 years.

Dosage ABASAGLAR 100 Units / mL Injectable box of 5 cartridges of 3 ml

Treatment of diabetes mellitus in adults, adolescents and children from 2 years.

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Adverse effects Abasaglar

Summary of the security profile

Hypoglycaemia, usually the most common side effect of any insulin therapy, can occur if the insulin dose is higher than needed.

Table listing the side effects

Adverse reactions reported in clinical studies are listed below, according to the MedDRA classification, by organ system classes and in descending order of occurrence frequencies (very common: ≥ 1/10, frequent: ≥ 1 / 100, <1/10, uncommon: ≥ 1/1000, <1/100, rare: ≥ 1/10 000, <1/1000, very rare: <1/10 000).

Within each frequency group, adverse effects are presented in descending order of severity.

Description of the above-mentioned adverse effects

Metabolism and nutrition disorders

Episodes of severe hypoglycemia, especially if repeated, can lead to neurological damage. Episodes of prolonged or severe hypoglycaemia may be life-threatening. In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of a compensatory adrenergic reaction. In general, the faster and faster the fall in blood glucose, the more marked the adrenoreactive reaction and its symptoms.

Immune system disorders

Immediate hypersensitivity reactions to insulin are rare. Such insulin reactions (including insulin glargine) or its excipients may be accompanied by, for example, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock and may be life threatening.

Insulin administration may cause the formation of insulin antibodies. In clinical studies, the frequency of cross-reactive antibodies to human insulin and insulin glargine was similar in the NPH insulin and insulin glargine groups.

In rare cases, the presence of these insulin antibodies may make it necessary to adjust the insulin dose to correct a tendency to hyper- or hypoglycemia.

Eye disorders

A marked change in glycemic equilibrium may result in transient impairment of vision due to temporary alteration of the turgor and refractive index of the lens.

Improved long-term glycemic control decreases the risk of progression of diabetic retinopathy. However, an intensification of insulin therapy inducing a sudden improvement in glycemic equilibrium may cause a transient aggravation of diabetic retinopathy. Severe hypoglycaemia may cause transient amaurosis in patients with proliferative retinopathy, particularly if it has not been treated with photocoagulation.

Skin and subcutaneous tissue disorders

As with any insulin therapy, lipodystrophy may occur at the injection site, which may delay local resorption of insulin. Continuous rotation of the injection sites in a given area may help to decrease or avoid these reactions.

General disorders and administration site conditions

Such reactions include redness, pain, pruritus, urticaria, swelling or inflammation. Most minor insulin reactions at the injection site usually disappear within a few days to a few weeks.

In rare cases, insulin may cause sodium retention and edema, especially if the previously poor metabolic balance is improved by intensive insulin therapy.

Pediatric population

In general, the safety profile is identical in children and adolescents (≤ 18 years) and in adults. Adverse reaction reports received during post marketing surveillance showed a relatively higher frequency of injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (≤ 18 years) than in adults. In children less than 2 years old, there are no safety data from clinical studies.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.